Phase II Study of Cediranib (AZD2171) in Patients With Alveolar Soft Part Sarcoma

• ClinicalTrials.gov Identifier: NCT00942877
• Recruitment Status: Active, not recruiting
• First Posted: July 21, 2009
• Results First Posted: April 27, 2021
• Last Update Posted: March 12, 2024
• Sponsor: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Alice Chen, M.D., National Cancer Institute (NCI)

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Sarcoma, Alveolar Soft Part
• Intervention: Drug: AZD2171
• Enrollment: 53

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Adult Participants w/Alveolar Soft Part Sarcoma	Pediatric Participants w/Alveolar Soft Part Sarcoma
Arm/Group Description	Adult participants will be treated with 30 mg by mouth once a day for 28 days (28-day cycles). AZD2171: Cediranib (AZD2171), a vascular endothelial growth factor (VEGF)/KIT tyrosine kinase inhibitor, has demonstrated antitumor activity in early phase clinical trials in adult and pediatric patients with Alveolar Soft Part Sarcoma (ASPS).	Pediatric participants (<16 years old) will be treated with 12 mg/m^2/day once a day for 28 days (28-day cycles). AZD2171: Cediranib (AZD2171), a vascular endothelial growth factor (VEGF)/KIT tyrosine kinase inhibitor, has demonstrated antitumor activity in early phase clinical trials in adult and pediatric patients with Alveolar Soft Part Sarcoma (ASPS).
Period Title: Overall Study
Started	46	7
Completed	1	3
Not Completed	45	4
Reason Not Completed
Refused further treatment	1	1
Patient was not treated	1	0
Adverse Event	1	0
Progressive disease	42	3

Baseline Characteristics

Arm/Group Title		Adult Participants w/Alveolar Soft Part Sarcoma	Pediatric Participants w/Alveolar Soft Part Sarcoma	Total
Arm/Group Description		Adult participants will be treated with 30 mg by mouth once a day for 28 days (28-day cycles). AZD2171: Cediranib (AZD2171), a vascular endothelial growth factor (VEGF)/KIT tyrosine kinase inhibitor, has demonstrated antitumor activity in early phase clinical trials in adult and pediatric patients with Alveolar Soft Part Sarcoma (ASPS).	Pediatric participants will be treated with 12 mg/m^2/day once a day for 28 days (28-day cycles). AZD2171: Cediranib (AZD2171), a vascular endothelial growth factor (VEGF)/KIT tyrosine kinase inhibitor, has demonstrated antitumor activity in early phase clinical trials in adult and pediatric patients with Alveolar Soft Part Sarcoma (ASPS).	Total of all reporting groups
Overall Number of Baseline Participants		46	7	53
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	46 participants	7 participants	53 participants
	<=18 years	0 0.0%	7 100.0%	7 13.2%
	Between 18 and 65 years	46 100.0%	0 0.0%	46 86.8%
	>=65 years	0 0.0%	0 0.0%	0 0.0%
Age, Continuous; Mean (Full Range); Unit of measure: Years
	Number Analyzed	46 participants	7 participants	53 participants
		30; (19 to 59)	13; (9 to 15)	21.5; (9 to 59)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	46 participants	7 participants	53 participants
	Female	23 50.0%	4 57.1%	27 50.9%
	Male	23 50.0%	3 42.9%	26 49.1%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	46 participants	7 participants	53 participants
	Hispanic or Latino	8 17.4%	0 0.0%	8 15.1%
	Not Hispanic or Latino	38 82.6%	7 100.0%	45 84.9%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	46 participants	7 participants	53 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	5 10.9%	0 0.0%	5 9.4%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	11 23.9%	3 42.9%	14 26.4%
	White	25 54.3%	3 42.9%	28 52.8%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	5 10.9%	1 14.3%	6 11.3%
Region of Enrollment; Measure Type: Count of Participants; Unit of measure: Participants
United States	Number Analyzed	46 participants	7 participants	53 participants
		46 100.0%	7 100.0%	53 100.0%
Eastern Cooperative Oncology Group (ECOG) Status [1] [2]; Measure Type: Count of Participants; Unit of measure: Participants
0	Number Analyzed	46 participants	0 participants	46 participants
		4 8.7%		4 8.7%
1	Number Analyzed	46 participants	0 participants	46 participants
		38 82.6%		38 82.6%
2	Number Analyzed	46 participants	0 participants	46 participants
		4 8.7%		4 8.7%
		[1] Measure Description: ECOG status for adults indicates level of participant activity. 0 = fully active; = ambulatory and can perform light work; = capable of all self-care but unable to perform work activities; [2] Measure Analysis Population Description: ECOG applies to the adult participants only.
Lansky/Karnofsky Performance Status [1] [2]; Measure Type: Count of Participants; Unit of measure: Participants
100%	Number Analyzed	0 participants	7 participants	7 participants
			1 14.3%	1 14.3%
90%	Number Analyzed	0 participants	7 participants	7 participants
			4 57.1%	4 57.1%
80%	Number Analyzed	0 participants	7 participants	7 participants
			2 28.6%	2 28.6%
		[1] Measure Description: Lansky/Karnofsky for pediatric participants indicates level of activity. 100% = normal activity with no signs/symptoms of disease 90% = normal activity with a few signs/symptoms of disease 80% =normal activity with some difficulty; [2] Measure Analysis Population Description: Lansky/Karnofsky applies to the pediatric participants only.
Prior Resection; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	46 participants	7 participants	53 participants
		35 76.1%	3 42.9%	38 71.7%
Prior Radiation; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	46 participants	7 participants	53 participants
		27 58.7%	2 28.6%	29 54.7%
Prior Systemic Therapy [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	0 participants	7 participants	7 participants
			4 57.1%	4 57.1%
		[1] Measure Analysis Population Description: Applies to the pediatric participants only.
Prior Systemic Therapies; Measure Type: Count of Participants; Unit of measure: Participants
0	Number Analyzed	46 participants	7 participants	53 participants
		18 39.1%	4 57.1%	22 41.5%
1	Number Analyzed	46 participants	7 participants	53 participants
		18 39.1%	1 14.3%	19 35.8%
2	Number Analyzed	46 participants	7 participants	53 participants
		5 10.9%	0 0.0%	5 9.4%
≥3	Number Analyzed	46 participants	7 participants	53 participants
		5 10.9%	3 42.9%	8 15.1%

Outcome Measures

1. Primary Outcome

Title	Minimal Response Rate in Pediatric Participants With Alveolar Soft Part Sarcoma (ASPS)
Description	Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST)v1.0. A minimal response is defined as a 5% overall response rate (Partial Response (PR) + Complete Response (CR)
Time Frame	Date treatment initiated to date off study, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pediatric Participants w/Alveolar Soft Part Sarcoma
Arm/Group Description:	Pediatric participants (<16 years old) will be treated with 12 mg/m^2/day once a day for 28 days (28-day cycles). AZD2171: Cediranib (AZD2171), a vascular endothelial growth factor (VEGF)/KIT tyrosine kinase inhibitor, has demonstrated antitumor activity in early phase clinical trials in adult and pediatric patients with Alveolar Soft Part Sarcoma (ASPS).
Overall Number of Participants Analyzed	7
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%

2. Primary Outcome

Title	Number of Participants With a Response (Partial Response (PR) + Complete Response (CR)) of AZD2171 in Adult Participants With Alveolar Soft Part Sarcoma (ASPS)
Description	Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is disappearance of all no-target lesions and normalization of tumor marker level. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Time Frame	2 cycles (e.g., one cycle = 28 days)

Outcome Measure Data

Analysis Population Description

45/46 participants were analyzed because one participant was not treated.

Arm/Group Title	Adult Participants w/Alveolar Soft Part Sarcoma
Arm/Group Description:	Adult participants will be treated with 30 mg by mouth once a day for 28 days (28-day cycles). AZD2171: Cediranib (AZD2171), a vascular endothelial growth factor (VEGF)/KIT tyrosine kinase inhibitor, has demonstrated antitumor activity in early phase clinical trials in adult and pediatric patients with Alveolar Soft Part Sarcoma (ASPS).
Overall Number of Participants Analyzed	45
Measure Type: Count of Participants; Unit of Measure: Participants
Complete Response	0 0.0%
Partial Response	13 28.9%

3. Primary Outcome

Title	Number of Participants With a Best Observed Response
Description	Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Complete Response is disappearance of all target lesions and normalization of tumor marker level. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Progressive disease is at least a 20% increase in the sum of the LD of target lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.
Time Frame	Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pediatric Participants w/Alveolar Soft Part Sarcoma
Arm/Group Description:	Pediatric participants (<16 years old) will be treated with 12 mg/m^2/day once a day for 28 days (28-day cycles). AZD2171: Cediranib (AZD2171), a vascular endothelial growth factor (VEGF)/KIT tyrosine kinase inhibitor, has demonstrated antitumor activity in early phase clinical trials in adult and pediatric patients with Alveolar Soft Part Sarcoma (ASPS).
Overall Number of Participants Analyzed	7
Measure Type: Count of Participants; Unit of Measure: Participants
Complete Response	0 0.0%
Partial Response	0 0.0%
Stable Disease	5 71.4%
Progressive Disease	2 28.6%

4. Primary Outcome

Title	Number of Participants With a Best Response
Description	Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Complete Response is disappearance of all target lesions and normalization of tumor marker level. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Progressive disease is at least a 20% increase in the sum of the LD of target lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.
Time Frame	Date treatment initiated to date off study, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)

Outcome Measure Data

Analysis Population Description

45/46 participants were analyzed because one participant did not receive any treatment on the trial.

Arm/Group Title	Adult Participants w/Alveolar Soft Part Sarcoma
Arm/Group Description:	Adult participants will be treated with 30 mg by mouth once a day for 28 days (28-day cycles). AZD2171: Cediranib (AZD2171), a vascular endothelial growth factor (VEGF)/KIT tyrosine kinase inhibitor, has demonstrated antitumor activity in early phase clinical trials in adult and pediatric patients with Alveolar Soft Part Sarcoma (ASPS).
Overall Number of Participants Analyzed	45
Measure Type: Count of Participants; Unit of Measure: Participants
Complete Response	0 0.0%
Partial Response	13 28.9%
Stable Disease	30 66.7%
Progressive Disease	2 4.4%

5. Secondary Outcome

Title	Number of Participants With Serious and Non-serious Adverse Events
Description	Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Time Frame	Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Adult Participants w/Alveolar Soft Part Sarcoma	Pediatric Participants w/Alveolar Soft Part Sarcoma
Arm/Group Description:	Adult participants will be treated with 30 mg by mouth once a day for 28 days (28-day cycles). AZD2171: Cediranib (AZD2171), a vascular endothelial growth factor (VEGF)/KIT tyrosine kinase inhibitor, has demonstrated antitumor activity in early phase clinical trials in adult and pediatric patients with Alveolar Soft Part Sarcoma (ASPS).	Pediatric participants (<16 years old) will be treated with 12 mg/m^2/day once a day for 28 days (28-day cycles). AZD2171: Cediranib (AZD2171), a vascular endothelial growth factor (VEGF)/KIT tyrosine kinase inhibitor, has demonstrated antitumor activity in early phase clinical trials in adult and pediatric patients with Alveolar Soft Part Sarcoma (ASPS).
Overall Number of Participants Analyzed	46	7
Measure Type: Count of Participants; Unit of Measure: Participants
	45 97.8%	7 100.0%

Adverse Events

Time Frame	Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Adult Participants w/Alveolar Soft Part Sarcoma		Pediatric Participants w/Alveolar Soft Part Sarcoma
Arm/Group Description	Adult participants will be treated with 30 mg by mouth once a day for 28 days (28-day cycles). AZD2171: Cediranib (AZD2171), a vascular endothelial growth factor (VEGF)/KIT tyrosine kinase inhibitor, has demonstrated antitumor activity in early phase clinical trials in adult and pediatric patients with Alveolar Soft Part Sarcoma (ASPS).		Pediatric participants (<16 years old) will be treated with 12 mg/m^2/day once a day for 28 days (28-day cycles). AZD2171: Cediranib (AZD2171), a vascular endothelial growth factor (VEGF)/KIT tyrosine kinase inhibitor, has demonstrated antitumor activity in early phase clinical trials in adult and pediatric patients with Alveolar Soft Part Sarcoma (ASPS).
All-Cause Mortality
	Adult Participants w/Alveolar Soft Part Sarcoma		Pediatric Participants w/Alveolar Soft Part Sarcoma
	Affected / at Risk (%)		Affected / at Risk (%)
Total	2/46 (4.35%)		0/7 (0.00%)
Serious Adverse Events
	Adult Participants w/Alveolar Soft Part Sarcoma		Pediatric Participants w/Alveolar Soft Part Sarcoma
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	22/46 (47.83%)		6/7 (85.71%)
Cardiac disorders
Left ventricular systolic dysfunction † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Palpitations † 1	0/46 (0.00%)	0	1/7 (14.29%)	1
Sinus bradycardia † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Eye disorders
Papilledema † 1	0/46 (0.00%)	0	1/7 (14.29%)	1
Gastrointestinal disorders
Abdominal pain † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Diarrhea † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Dyspepsia † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Fever † 1	0/46 (0.00%)	0	1/7 (14.29%)	1
Gastroesophageal reflux disease † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Nausea † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
General disorders
Sudden death NOS † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Infections and infestations
Hepatitis viral † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Lung infection † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Paronychia † 1	0/46 (0.00%)	0	1/7 (14.29%)	1
Injury, poisoning and procedural complications
Fracture † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Investigations
Alanine aminotransferase increased † 1	3/46 (6.52%)	3	1/7 (14.29%)	1
Alkaline phosphatase increased † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Aspartate aminotransferase increased † 1	2/46 (4.35%)	2	0/7 (0.00%)	0
Blood bilirubin increased † 1	2/46 (4.35%)	2	0/7 (0.00%)	0
CPK increased † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Creatinine increased † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Lipase increased † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Neutrophil count decreased † 1	2/46 (4.35%)	2	1/7 (14.29%)	2
Serum amylase increased † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
White blood cell decreased † 1	1/46 (2.17%)	1	1/7 (14.29%)	1
Metabolism and nutrition disorders
Dehydration † 1	3/46 (6.52%)	3	0/7 (0.00%)	0
Hyponatremia † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Musculoskeletal and connective tissue disorder - Other, specify † 1 [1]	0/46 (0.00%)	0	1/7 (14.29%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify † 1 [2]	1/46 (2.17%)	1	0/7 (0.00%)	0
Tumor pain † 1	3/46 (6.52%)	3	0/7 (0.00%)	0
Nervous system disorders
Dizziness † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Headache † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Presyncope † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Syncope † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Psychiatric disorders
Confusion † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Suicidal ideation † 1	0/46 (0.00%)	0	1/7 (14.29%)	1
Renal and urinary disorders
Acute kidney injury † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Proteinuria † 1	5/46 (10.87%)	7	1/7 (14.29%)	1
Reproductive system and breast disorders
Pregnancy, puerperium and perinatal conditions - Other, Pregnancy † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Testicular disorder † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Atelectasis † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Bronchopulmonary hemorrhage † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Dyspnea † 1	2/46 (4.35%)	2	0/7 (0.00%)	0
Pneumothorax † 1	1/46 (2.17%)	2	0/7 (0.00%)	0
Respiratory, thoracic and mediastinal disorders - Other, Asthma † 1	0/46 (0.00%)	0	1/7 (14.29%)	1
Surgical and medical procedures
Surgical and medical procedures - Other, SCFE † 1	0/46 (0.00%)	0	1/7 (14.29%)	1
Vascular disorders
Hypertension † 1	1/46 (2.17%)	1	2/7 (28.57%)	2
Hypotension † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
1 Term from vocabulary, CTCAE (5.0); † Indicates events were collected by systematic assessment; [1] Slipped capital femoral epiphysis right side; [2] Death due to disease progression
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Adult Participants w/Alveolar Soft Part Sarcoma		Pediatric Participants w/Alveolar Soft Part Sarcoma
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	45/46 (97.83%)		7/7 (100.00%)
Blood and lymphatic system disorders
Anemia † 1	18/46 (39.13%)	59	5/7 (71.43%)	10
Cardiac disorders
Chest pain - cardiac † 1	0/46 (0.00%)	0	1/7 (14.29%)	1
Electrocardiogram QT corrected interval prolonged † 1	3/46 (6.52%)	4	0/7 (0.00%)	0
Palpitations † 1	4/46 (8.70%)	4	1/7 (14.29%)	1
Sinus bradycardia † 1	2/46 (4.35%)	3	1/7 (14.29%)	1
Sinus tachycardia † 1	5/46 (10.87%)	5	2/7 (28.57%)	2
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, ear fluid collection † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Ear pain † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Endocrine disorders - Other, TSH elevated † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Hearing impaired † 1	1/46 (2.17%)	2	0/7 (0.00%)	0
Otitis externa † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Otitis media † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Tinnitus † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Endocrine disorders
Adrenal insufficiency † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Hyperthyroidism † 1	4/46 (8.70%)	7	1/7 (14.29%)	3
Hypothyroidism † 1	33/46 (71.74%)	70	2/7 (28.57%)	6
Eye disorders
Blurred vision † 1	5/46 (10.87%)	8	1/7 (14.29%)	2
Dry eye † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Extraocular muscle paresis † 1	1/46 (2.17%)	2	0/7 (0.00%)	0
Eye disorders - Other, Retinal degeneration † 1	0/46 (0.00%)	0	1/7 (14.29%)	1
Eye pain † 1	2/46 (4.35%)	2	0/7 (0.00%)	0
Eyelid function disorder † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Scleral disorder † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Watering eyes † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Gastrointestinal disorders
Abdominal distension † 1	3/46 (6.52%)	5	0/7 (0.00%)	0
Abdominal pain † 1	30/46 (65.22%)	66	4/7 (57.14%)	7
Bloating † 1	0/46 (0.00%)	0	1/7 (14.29%)	1
Cheilitis † 1	2/46 (4.35%)	2	0/7 (0.00%)	0
Colitis † 1	0/46 (0.00%)	0	1/7 (14.29%)	1
Constipation † 1	13/46 (28.26%)	33	3/7 (42.86%)	4
Dental caries † 1	2/46 (4.35%)	2	1/7 (14.29%)	1
Diarrhea † 1	44/46 (95.65%)	181	6/7 (85.71%)	36
Dry mouth † 1	4/46 (8.70%)	4	1/7 (14.29%)	1
Dyspepsia † 1	6/46 (13.04%)	6	1/7 (14.29%)	1
Dysphagia † 1	2/46 (4.35%)	2	0/7 (0.00%)	0
Edema limbs † 1	5/46 (10.87%)	7	1/7 (14.29%)	1
Esophageal hemorrhage † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Flatulence † 1	4/46 (8.70%)	4	2/7 (28.57%)	2
Gastrointestinal disorders - Other, Gastroenteritis † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Gastrointestinal pain † 1	0/46 (0.00%)	0	1/7 (14.29%)	1
Hemorrhoidal hemorrhage † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Mucositis oral † 1	29/46 (63.04%)	51	1/7 (14.29%)	2
Nausea † 1	27/46 (58.70%)	56	5/7 (71.43%)	6
Oral hemorrhage † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Oral pain † 1	2/46 (4.35%)	2	0/7 (0.00%)	0
Periodontal disease † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Rectal hemorrhage † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Rectal pain † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Stomach pain † 1	2/46 (4.35%)	2	1/7 (14.29%)	2
Toothache † 1	2/46 (4.35%)	3	2/7 (28.57%)	2
Vomiting † 1	23/46 (50.00%)	67	4/7 (57.14%)	5
General disorders
Chills † 1	3/46 (6.52%)	7	0/7 (0.00%)	0
Fatigue † 1	33/46 (71.74%)	49	5/7 (71.43%)	16
Fever † 1	5/46 (10.87%)	6	5/7 (71.43%)	10
Flu like symptoms † 1	5/46 (10.87%)	8	2/7 (28.57%)	2
Gait disturbance † 1	0/46 (0.00%)	0	1/7 (14.29%)	3
Malaise † 1	1/46 (2.17%)	2	0/7 (0.00%)	0
Pain † 1	1/46 (2.17%)	1	2/7 (28.57%)	2
Immune system disorders
Allergic reaction † 1	2/46 (4.35%)	2	0/7 (0.00%)	0
Immune system disorders - Other, Total protein decreased † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Infections and infestations
Infections and infestations - Other, Cold sores † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Infections and infestations - Other, Infection in armpit † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Infections and infestations - Other, Mouth infection † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Infections and infestations - Other, Toe nail † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Lung infection † 1	2/46 (4.35%)	4	0/7 (0.00%)	0
Mucosal infection † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Nail infection † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Paronychia † 1	0/46 (0.00%)	0	1/7 (14.29%)	1
Pharyngitis † 1	1/46 (2.17%)	1	1/7 (14.29%)	1
Rhinitis infective † 1	0/46 (0.00%)	0	1/7 (14.29%)	1
Sinusitis † 1	3/46 (6.52%)	6	2/7 (28.57%)	3
Skin infection † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Upper respiratory infection † 1	10/46 (21.74%)	10	0/7 (0.00%)	0
Urinary tract infection † 1	11/46 (23.91%)	13	0/7 (0.00%)	0
Vaginal infection † 1	3/46 (6.52%)	3	0/7 (0.00%)	0
Injury, poisoning and procedural complications
Fall † 1	0/46 (0.00%)	0	1/7 (14.29%)	1
Fracture † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Wound complication † 1	0/46 (0.00%)	0	1/7 (14.29%)	1
Investigations
Activated partial thromboplastin time prolonged † 1	2/46 (4.35%)	2	1/7 (14.29%)	1
Alanine aminotransferase increased † 1	34/46 (73.91%)	130	2/7 (28.57%)	10
Alkaline phosphatase increased † 1	16/46 (34.78%)	43	3/7 (42.86%)	12
Aspartate aminotransferase increased † 1	34/46 (73.91%)	126	3/7 (42.86%)	6
Blood bilirubin increased † 1	13/46 (28.26%)	62	2/7 (28.57%)	31
CPK increased † 1	10/46 (21.74%)	18	2/7 (28.57%)	5
Creatinine increased † 1	7/46 (15.22%)	17	2/7 (28.57%)	2
Hemoglobin increased † 1	0/46 (0.00%)	0	1/7 (14.29%)	1
Investigations - Other, Bicarbonate, serum-low † 1	4/46 (8.70%)	10	0/7 (0.00%)	0
Lipase increased † 1	1/46 (2.17%)	4	0/7 (0.00%)	0
Lymphocyte count decreased † 1	21/46 (45.65%)	98	3/7 (42.86%)	18
Neutrophil count decreased † 1	11/46 (23.91%)	57	3/7 (42.86%)	48
Platelet count decreased † 1	16/46 (34.78%)	71	4/7 (57.14%)	14
Serum amylase increased † 1	1/46 (2.17%)	8	1/7 (14.29%)	3
Weight gain † 1	2/46 (4.35%)	3	0/7 (0.00%)	0
Weight loss † 1	25/46 (54.35%)	73	3/7 (42.86%)	9
White blood cell decreased † 1	22/46 (47.83%)	79	3/7 (42.86%)	37
Lymphocyte count increased † 1	3/46 (6.52%)	4	0/7 (0.00%)	0
Thyroid stimulating hormone increased † 1	0/46 (0.00%)	0	1/7 (14.29%)	1
Metabolism and nutrition disorders
Anorexia † 1	17/46 (36.96%)	22	5/7 (71.43%)	6
Dehydration † 1	6/46 (13.04%)	10	2/7 (28.57%)	3
Hypercalcemia † 1	22/46 (47.83%)	46	2/7 (28.57%)	2
Hyperglycemia † 1	5/46 (10.87%)	7	1/7 (14.29%)	1
Hyperkalemia † 1	11/46 (23.91%)	16	1/7 (14.29%)	3
Hypermagnesemia † 1	13/46 (28.26%)	15	0/7 (0.00%)	0
Hypernatremia † 1	3/46 (6.52%)	4	3/7 (42.86%)	3
Hyperuricemia † 1	7/46 (15.22%)	23	0/7 (0.00%)	0
Hypoalbuminemia † 1	27/46 (58.70%)	101	0/7 (0.00%)	0
Hypocalcemia † 1	10/46 (21.74%)	17	3/7 (42.86%)	4
Hypoglycemia † 1	4/46 (8.70%)	4	0/7 (0.00%)	0
Hypokalemia † 1	9/46 (19.57%)	11	1/7 (14.29%)	1
Hypomagnesemia † 1	27/46 (58.70%)	79	0/7 (0.00%)	0
Hyponatremia † 1	29/46 (63.04%)	71	1/7 (14.29%)	2
Hypophosphatemia † 1	8/46 (17.39%)	28	1/7 (14.29%)	1
Musculoskeletal and connective tissue disorders
Arthralgia † 1	5/46 (10.87%)	5	1/7 (14.29%)	1
Back pain † 1	14/46 (30.43%)	17	4/7 (57.14%)	5
Bone pain † 1	4/46 (8.70%)	5	0/7 (0.00%)	0
Chest wall pain † 1	4/46 (8.70%)	4	1/7 (14.29%)	4
Flank pain † 1	1/46 (2.17%)	1	1/7 (14.29%)	1
Joint range of motion decreased † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Myalgia † 1	4/46 (8.70%)	6	2/7 (28.57%)	3
Neck pain † 1	3/46 (6.52%)	5	0/7 (0.00%)	0
Non-cardiac chest pain † 1	6/46 (13.04%)	7	3/7 (42.86%)	8
Pain in extremity † 1	7/46 (15.22%)	12	5/7 (71.43%)	8
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain † 1	14/46 (30.43%)	22	2/7 (28.57%)	5
Nervous system disorders
Dizziness † 1	16/46 (34.78%)	26	1/7 (14.29%)	1
Dysgeusia † 1	3/46 (6.52%)	3	2/7 (28.57%)	2
Headache † 1	22/46 (47.83%)	80	6/7 (85.71%)	15
Hypersomnia † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Nervous system disorders - Other, Right side paresthesia † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Paresthesia † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Peripheral sensory neuropathy † 1	6/46 (13.04%)	6	0/7 (0.00%)	0
Seizure † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Sinus pain † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Somnolence † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Tremor † 1	2/46 (4.35%)	2	0/7 (0.00%)	0
Psychiatric disorders
Anxiety † 1	6/46 (13.04%)	10	1/7 (14.29%)	1
Confusion † 1	2/46 (4.35%)	3	0/7 (0.00%)	0
Depression † 1	5/46 (10.87%)	9	2/7 (28.57%)	4
Insomnia † 1	11/46 (23.91%)	15	1/7 (14.29%)	1
Personality change † 1	0/46 (0.00%)	0	1/7 (14.29%)	1
Renal and urinary disorders
Acute kidney injury † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Hematuria † 1	3/46 (6.52%)	6	1/7 (14.29%)	1
Hemoglobinuria † 1	19/46 (41.30%)	53	1/7 (14.29%)	1
Proteinuria † 1	34/46 (73.91%)	152	5/7 (71.43%)	21
Renal and urinary disorders - Other, Dysuria † 1	1/46 (2.17%)	1	1/7 (14.29%)	1
Urinary frequency † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Urinary tract pain † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Urinary urgency † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Urine discoloration † 1	1/46 (2.17%)	2	0/7 (0.00%)	0
Reproductive system and breast disorders
Breast pain † 1	2/46 (4.35%)	2	0/7 (0.00%)	0
Erectile dysfunction † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Irregular menstruation † 1	4/46 (8.70%)	5	0/7 (0.00%)	0
Menorrhagia † 1	3/46 (6.52%)	4	0/7 (0.00%)	0
Pelvic pain † 1	1/46 (2.17%)	20	0/7 (0.00%)	0
Testicular disorder † 1	1/46 (2.17%)	2	0/7 (0.00%)	0
Testicular pain † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Uterine hemorrhage † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Vaginal hemorrhage † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Vaginal pain † 1	0/46 (0.00%)	0	1/7 (14.29%)	2
Gynecomastia † 1	0/46 (0.00%)	0	1/7 (14.29%)	1
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis † 1	7/46 (15.22%)	8	2/7 (28.57%)	2
Cough † 1	12/46 (26.09%)	14	3/7 (42.86%)	3
Dyspnea † 1	3/46 (6.52%)	4	2/7 (28.57%)	2
Epistaxis † 1	8/46 (17.39%)	12	3/7 (42.86%)	9
Hoarseness † 1	4/46 (8.70%)	4	0/7 (0.00%)	0
Hypoxia † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Laryngeal hemorrhage † 1	2/46 (4.35%)	2	0/7 (0.00%)	0
Nasal congestion † 1	9/46 (19.57%)	18	1/7 (14.29%)	1
Pericardial effusion † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Pharyngolaryngeal pain † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Postnasal drip † 1	3/46 (6.52%)	3	0/7 (0.00%)	0
Productive cough † 1	0/46 (0.00%)	0	1/7 (14.29%)	1
Respiratory, thoracic and mediastinal disorders - Other, Running nose † 1	0/46 (0.00%)	0	1/7 (14.29%)	1
Sneezing † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Sore throat † 1	4/46 (8.70%)	4	4/7 (57.14%)	6
Voice alteration † 1	11/46 (23.91%)	12	1/7 (14.29%)	1
Wheezing † 1	1/46 (2.17%)	2	0/7 (0.00%)	0
Rhinorrhea † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Skin and subcutaneous tissue disorders
Alopecia † 1	5/46 (10.87%)	9	0/7 (0.00%)	0
Dry skin † 1	4/46 (8.70%)	5	1/7 (14.29%)	1
Hyperhidrosis † 1	6/46 (13.04%)	7	0/7 (0.00%)	0
Nail loss † 1	4/46 (8.70%)	4	0/7 (0.00%)	0
Palmar-plantar erythrodysesthesia syndrome † 1	25/46 (54.35%)	35	1/7 (14.29%)	3
Photosensitivity † 1	0/46 (0.00%)	0	1/7 (14.29%)	1
Pruritus † 1	3/46 (6.52%)	3	1/7 (14.29%)	1
Rash acneiform † 1	11/46 (23.91%)	19	2/7 (28.57%)	5
Rash maculo-papular † 1	3/46 (6.52%)	3	3/7 (42.86%)	3
Skin and subcutaneous tissue disorders - Other, Acne † 1	0/46 (0.00%)	0	1/7 (14.29%)	1
Skin and subcutaneous tissue disorders - Other, Fight laceration † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Skin and subcutaneous tissue disorders - Other, Perianal irritation † 1	0/46 (0.00%)	0	1/7 (14.29%)	1
Skin and subcutaneous tissue disorders - Other, Skin and subcut. Tissue disorder † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Skin hyperpigmentation † 1	1/46 (2.17%)	1	1/7 (14.29%)	1
Skin hypopigmentation † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Vascular disorders
Hot flashes † 1	3/46 (6.52%)	4	0/7 (0.00%)	0
Hypertension † 1	35/46 (76.09%)	879	3/7 (42.86%)	13
Hypotension † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Thromboembolic event † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
Vascular disorders - Other, Hemoptysis † 1	1/46 (2.17%)	1	0/7 (0.00%)	0
1 Term from vocabulary, CTCAE (5.0); † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Dr. Alice Chen
• Organization: National Cancer Institute
• Phone: 240-781-3274
• EMail: chenali@nih.gov

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Cohen JW, Widemann BC, Derdak J, Dombi E, Goodwin A, Dompierre J, Onukwubiri U, Steinberg SM, O'Sullivan Coyne G, Kummar S, Chen AP, Glod J. Cediranib phase-II study in children with metastatic alveolar soft-part sarcoma (ASPS). Pediatr Blood Cancer. 2019 Dec;66(12):e27987. doi: 10.1002/pbc.27987. Epub 2019 Sep 10.

Hall PE, Shepherd STC, Brown J, Larkin J, Jones R, Ralph C, Hawkins R, Chowdhury S, Boleti E, Bahl A, Fife K, Webb A, Crabb SJ, Geldart T, Hill R, Dunlop J, McLaren D, Ackerman C, Wimalasingham A, Beltran L, Nathan P, Powles T. Radiological Response Heterogeneity Is of Prognostic Significance in Metastatic Renal Cell Carcinoma Treated with Vascular Endothelial Growth Factor-targeted Therapy. Eur Urol Focus. 2020 Sep 15;6(5):999-1005. doi: 10.1016/j.euf.2019.01.010. Epub 2019 Feb 6.

Powles T, Brown J, Larkin J, Jones R, Ralph C, Hawkins R, Chowdhury S, Boleti E, Bhal A, Fife K, Webb A, Crabb S, Geldart T, Hill R, Dunlop J, Hall PE, McLaren D, Ackerman C, Beltran L, Nathan P. A randomized, double-blind phase II study evaluating cediranib versus cediranib and saracatinib in patients with relapsed metastatic clear-cell renal cancer (COSAK). Ann Oncol. 2016 May;27(5):880-6. doi: 10.1093/annonc/mdw014. Epub 2016 Jan 22.

Kummar S, Allen D, Monks A, Polley EC, Hose CD, Ivy SP, Turkbey IB, Lawrence S, Kinders RJ, Choyke P, Simon R, Steinberg SM, Doroshow JH, Helman L. Cediranib for metastatic alveolar soft part sarcoma. J Clin Oncol. 2013 Jun 20;31(18):2296-302. doi: 10.1200/JCO.2012.47.4288. Epub 2013 Apr 29.

• Responsible Party: Alice Chen, M.D., National Cancer Institute (NCI)
• ClinicalTrials.gov Identifier: NCT00942877
• Other Study ID Numbers: 090192; 09-C-0192
• First Submitted: July 18, 2009
• First Posted: July 21, 2009
• Results First Submitted: March 2, 2021
• Results First Posted: April 27, 2021
• Last Update Posted: March 12, 2024