Study of Zalypsis® (PM00104) in Patients With Unresectable Locally Advanced and/or Metastatic Ewing Family of Tumors (EFT) Progressing After at Least One Prior Line of Chemotherapy

• ClinicalTrials.gov Identifier: NCT01222767
• Recruitment Status: Completed
• First Posted: October 18, 2010
• Results First Posted: October 29, 2021
• Last Update Posted: October 29, 2021
• Sponsor: PharmaMar
• Information provided by (Responsible Party): PharmaMar

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Conditions: Ewing's Sarcoma; Primitive Neuroectodermal Tumor (PNET); Askin's Tumor of the Chest Wall; Extraosseous Ewing's Sarcoma (EOE)
• Intervention: Drug: Zalypsis
• Enrollment: 17

Participant Flow

Recruitment Details	A total of 17 patients were included and 16 of them were treated with PM00104 at five investigational sites from the USA (n=3), France and Italy. The patients participated in this study between 22 December 2010 (first consent) and 21 May 2012 (last follow-up). First and last doses were administered on 4 January 2011 and 24 January 2012, respectively
Pre-assignment Details

Arm/Group Title	PM00104
Arm/Group Description	PM00104 was administered at a dose of 2 mg/m2 as a 1-hour i.v. infusion d1, d8 and d15 q4wk to patients with advanced and/or metastatic Ewing's sarcoma previously treated with at least one line of chemotherapy. A treatment cycle consisted of PM00104 administration on Days 1, 8 and 15, plus one week of follow-up. Study evaluations had to be completed during each cycle prior to subsequent PM00104 infusion. Treatment cycles were repeated every four weeks
Period Title: Overall Study
Started	17
Received Treatment	16
Completed	0
Not Completed	17
Reason Not Completed
Progressive disease	13
Adverse Event	2
Surgical resection	1
Never treated	1

Baseline Characteristics

Arm/Group Title		PM00104
Arm/Group Description		PM00104 was administered at a dose of 2 mg/m2 as a 1-hour i.v. infusion d1, d8 and d15 q4wk to patients with advanced and/or metastatic Ewing's sarcoma previously treated with at least one line of chemotherapy. A treatment cycle consisted of PM00104 administration on Days 1, 8 and 15, plus one week of follow-up. Study evaluations had to be completed during each cycle prior to subsequent PM00104 infusion. Treatment cycles were repeated every four weeks
Overall Number of Baseline Participants		17
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	17 participants
	<=18 years	4 23.5%
	Between 18 and 65 years	13 76.5%
	>=65 years	0 0.0%
Age, Continuous; Median (Full Range); Unit of measure: Years
	Number Analyzed	17 participants
		23; (15 to 53)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	17 participants
	Female	5 29.4%
	Male	12 70.6%
Race and Ethnicity Not Collected [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	0 participants
		[1] Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment; Measure Type: Count of Participants; Unit of measure: Participants
United States	Number Analyzed	17 participants
		12 70.6%
Italy	Number Analyzed	17 participants
		3 17.6%
France	Number Analyzed	17 participants
		2 11.8%
ECOG PS [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	17 participants
	0	9 52.9%
	1	7 41.2%
	2	1 5.9%
		[1] Measure Description: Eastern Cooperative Oncology Group Performance Status, ECOG PS 0 Fully active, able to carry on all pre-disease performance without restriction; Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours; Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours; Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair; Dead
Tumor diagnosis; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	17 participants
	Ewing's bone sarcoma	13 76.5%
	Extraosseous sarcoma	4 23.5%
Primary location at diagnosis; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	17 participants
	Lower extremity	7 41.2%
	Trunk/abdominal wall	7 41.2%
	Upper extremity	1 5.9%
	Unknown	2 11.8%
Metastatic disease; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	17 participants
		17 100.0%
Time from diagnosis to first infusion; Median (Full Range); Unit of measure: Months
	Number Analyzed	17 participants
		43.3; (13.8 to 81.3)
Time from last disease progression to first infusion; Median (Full Range); Unit of measure: Months
	Number Analyzed	17 participants
		0.3; (0.1 to 1.8)
Sites of disease at diagnosis; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	17 participants
	1	7 41.2%
	2	6 35.3%
	3	3 17.6%
	>3	1 5.9%
Prior radiotherapy; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	17 participants
		14 82.4%
Prior Antitumor surgery (palliative or curative); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	17 participants
		14 82.4%
Prior Systemic anticancer therapy; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	17 participants
		17 100.0%

Outcome Measures

1. Primary Outcome

Title	Overall Response Rate (ORR)
Description	Overall response rate (ORR), defined as the percentage of patients with confirmed objective response (OR), either CR or PR according to the RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; RECIST, Response Evaluation Criteria in Solid Tumors
Time Frame	At baseline and every other cycle (± 1 week) until evidence of PD, up to 2 years

Outcome Measure Data

Analysis Population Description

One patient never treated

Arm/Group Title	PM00104
Arm/Group Description:	PM00104 was administered at a dose of 2 mg/m2 as a 1-hour i.v. infusion d1, d8 and d15 q4wk to patients with advanced and/or metastatic Ewing's sarcoma previously treated with at least one line of chemotherapy. A treatment cycle consisted of PM00104 administration on Days 1, 8 and 15, plus one week of follow-up. Study evaluations had to be completed during each cycle prior to subsequent PM00104 infusion. Treatment cycles were repeated every four weeks
Overall Number of Participants Analyzed	16
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%

2. Secondary Outcome

Title	Best Tumor Response
Description	Best tumor response was defined as the best response achieved during the study according to RECIST v1.1 CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; RECIST, Response Evaluation Criteria in Solid Tumors
Time Frame	At baseline and every other cycle (± 1 week) until evidence of PD, up to 2 years

Outcome Measure Data

Analysis Population Description

One patient never treated Two patients were non-evaluable for efficacy because they were withdrawn due to toxicity without any tumor assessment after the start of study treatment and were considered as "treatment failures"

Arm/Group Title	PM00104
Arm/Group Description:	PM00104 was administered at a dose of 2 mg/m2 as a 1-hour i.v. infusion d1, d8 and d15 q4wk to patients with advanced and/or metastatic Ewing's sarcoma previously treated with at least one line of chemotherapy. A treatment cycle consisted of PM00104 administration on Days 1, 8 and 15, plus one week of follow-up. Study evaluations had to be completed during each cycle prior to subsequent PM00104 infusion. Treatment cycles were repeated every four weeks
Overall Number of Participants Analyzed	14
Measure Type: Count of Participants; Unit of Measure: Participants
SD	4 28.6%
PD	10 71.4%

3. Secondary Outcome

Title	Progression-free Survival
Description	Progression-free survival (PFS), defined as the time from the first day of study treatment to the day of negative assessment (progression or death), start of subsequent antitumor therapy, or last tumor evaluation. PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density
Time Frame	From the first day of study treatment to the day of negative assessment (progression or death), start of subsequent antitumor therapy, or last tumor evaluation, up to 2 years

Outcome Measure Data

Analysis Population Description

One patient never treated

Arm/Group Title	PM00104
Arm/Group Description:	PM00104 was administered at a dose of 2 mg/m2 as a 1-hour i.v. infusion d1, d8 and d15 q4wk to patients with advanced and/or metastatic Ewing's sarcoma previously treated with at least one line of chemotherapy. A treatment cycle consisted of PM00104 administration on Days 1, 8 and 15, plus one week of follow-up. Study evaluations had to be completed during each cycle prior to subsequent PM00104 infusion. Treatment cycles were repeated every four weeks
Overall Number of Participants Analyzed	16
Median (95% Confidence Interval); Unit of Measure: months
	1.8; (0.9 to 3.5)

4. Secondary Outcome

Title	Progression-free Survival at 3 Months
Description	Progression-free survival (PFS), defined as the time from the first day of study treatment to the day of negative assessment (progression or death), start of subsequent antitumor therapy, or last tumor evaluation. PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density
Time Frame	At 3 months

Outcome Measure Data

Analysis Population Description

One patient never treated

Arm/Group Title	PM00104
Arm/Group Description:	PM00104 was administered at a dose of 2 mg/m2 as a 1-hour i.v. infusion d1, d8 and d15 q4wk to patients with advanced and/or metastatic Ewing's sarcoma previously treated with at least one line of chemotherapy. A treatment cycle consisted of PM00104 administration on Days 1, 8 and 15, plus one week of follow-up. Study evaluations had to be completed during each cycle prior to subsequent PM00104 infusion. Treatment cycles were repeated every four weeks
Overall Number of Participants Analyzed	16
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	28.6; (4.9 to 52.2)

5. Secondary Outcome

Title	Overall Survival
Description	Overall survival (OS), defined as the time from the first day of treatment to the date of death (or the last day when the patient was known to be alive). Survival was to be followed for up to six months after the last treatment visit of the last patient, or 12 months after the last patient was included, whichever occurred first.
Time Frame	from the first day of treatment to the date of death, up to 2 years

Outcome Measure Data

Analysis Population Description

One patient never treated

Arm/Group Title	PM00104
Arm/Group Description:	PM00104 was administered at a dose of 2 mg/m2 as a 1-hour i.v. infusion d1, d8 and d15 q4wk to patients with advanced and/or metastatic Ewing's sarcoma previously treated with at least one line of chemotherapy. A treatment cycle consisted of PM00104 administration on Days 1, 8 and 15, plus one week of follow-up. Study evaluations had to be completed during each cycle prior to subsequent PM00104 infusion. Treatment cycles were repeated every four weeks
Overall Number of Participants Analyzed	16
Median (95% Confidence Interval); Unit of Measure: months
	NA [1]; (NA to NA)

[1]

Median survival could not be calculated because more than half of patients were still living

6. Secondary Outcome

Title	Overall Survival Rate at 6 Months
Description	Overall survival (OS), defined as the time from the first day of treatment to the date of death (or the last day when the patient was known to be alive). Survival was to be followed for up to six months after the last treatment visit of the last patient, or 12 months after the last patient was included, whichever occurred first.
Time Frame	At 6 months

Outcome Measure Data

Analysis Population Description

One patient never treated

Arm/Group Title	PM00104
Arm/Group Description:	PM00104 was administered at a dose of 2 mg/m2 as a 1-hour i.v. infusion d1, d8 and d15 q4wk to patients with advanced and/or metastatic Ewing's sarcoma previously treated with at least one line of chemotherapy. A treatment cycle consisted of PM00104 administration on Days 1, 8 and 15, plus one week of follow-up. Study evaluations had to be completed during each cycle prior to subsequent PM00104 infusion. Treatment cycles were repeated every four weeks
Overall Number of Participants Analyzed	16
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	62.5; (38.8 to 86.2)

7. Secondary Outcome

Title	Overall Survival Rate at 12 Months
Description	Overall survival (OS), defined as the time from the first day of treatment to the date of death (or the last day when the patient was known to be alive). Survival was to be followed for up to six months after the last treatment visit of the last patient, or 12 months after the last patient was included, whichever occurred first.
Time Frame	At 12 months

Outcome Measure Data

Analysis Population Description

One patient never treated

Arm/Group Title	PM00104
Arm/Group Description:	PM00104 was administered at a dose of 2 mg/m2 as a 1-hour i.v. infusion d1, d8 and d15 q4wk to patients with advanced and/or metastatic Ewing's sarcoma previously treated with at least one line of chemotherapy. A treatment cycle consisted of PM00104 administration on Days 1, 8 and 15, plus one week of follow-up. Study evaluations had to be completed during each cycle prior to subsequent PM00104 infusion. Treatment cycles were repeated every four weeks
Overall Number of Participants Analyzed	16
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	54.7; (29.5 to 79.9)

8. Secondary Outcome

Title	PM00104 Plasma PK Parameters (Cmax) at First Infusion
Description	Cmax Maximum plasma concentration, directly determined from the experimental data
Time Frame	0 (Pre-infusion) and 5 min, 30 min, 2 hours, 6 hours, 24 hours, 48 hours and 168 hours after the end of first infusion (Day 1)

Outcome Measure Data

Analysis Population Description

Fourteen of the 16 patients treated in this study had plasma profiles

Arm/Group Title	PM00104
Arm/Group Description:	PM00104 was administered at a dose of 2 mg/m2 as a 1-hour i.v. infusion d1, d8 and d15 q4wk to patients with advanced and/or metastatic Ewing's sarcoma previously treated with at least one line of chemotherapy. A treatment cycle consisted of PM00104 administration on Days 1, 8 and 15, plus one week of follow-up. Study evaluations had to be completed during each cycle prior to subsequent PM00104 infusion. Treatment cycles were repeated every four weeks
Overall Number of Participants Analyzed	14
Mean (Standard Deviation); Unit of Measure: μg/l
	21.23 (8.35)

9. Secondary Outcome

Title	PM00104 Plasma PK Parameters (AUC) at First Infusion
Description	AUC Area under the plasma concentration-time curve from time zero to infinity
Time Frame	0 (Pre-infusion) and 5 min, 30 min, 2 hours, 6 hours, 24 hours, 48 hours and 168 hours after the end of first infusion (Day 1)

Outcome Measure Data

Analysis Population Description

Fourteen of the 16 patients treated in this study had plasma profiles

Arm/Group Title	PM00104
Arm/Group Description:	PM00104 was administered at a dose of 2 mg/m2 as a 1-hour i.v. infusion d1, d8 and d15 q4wk to patients with advanced and/or metastatic Ewing's sarcoma previously treated with at least one line of chemotherapy. A treatment cycle consisted of PM00104 administration on Days 1, 8 and 15, plus one week of follow-up. Study evaluations had to be completed during each cycle prior to subsequent PM00104 infusion. Treatment cycles were repeated every four weeks
Overall Number of Participants Analyzed	14
Mean (Standard Deviation); Unit of Measure: h*μg/l
	87.06 (75.49)

10. Secondary Outcome

Title	PM00104 Plasma PK Parameters (Cmax) at Second Infusion
Description	Cmax Maximum plasma concentration, directly determined from the experimental data
Time Frame	0 (Pre-infusion) and 5 min, 30 min, 2 hours, 6 hours, 24 hours, 48 hours and 168 hours after the end of second infusion (Day 8)

Outcome Measure Data

Analysis Population Description

Eleven of the 16 patients treated in this study had plasma profiles at second infusion

Arm/Group Title	PM00104
Arm/Group Description:	PM00104 was administered at a dose of 2 mg/m2 as a 1-hour i.v. infusion d1, d8 and d15 q4wk to patients with advanced and/or metastatic Ewing's sarcoma previously treated with at least one line of chemotherapy. A treatment cycle consisted of PM00104 administration on Days 1, 8 and 15, plus one week of follow-up. Study evaluations had to be completed during each cycle prior to subsequent PM00104 infusion. Treatment cycles were repeated every four weeks
Overall Number of Participants Analyzed	11
Mean (Standard Deviation); Unit of Measure: μg/l
	22.37 (8.77)

11. Secondary Outcome

Title	PM00104 Plasma PK Parameters (AUC) at Second Infusion
Description	AUC Area under the plasma concentration-time curve from time zero to infinity
Time Frame	0 (Pre-infusion) and 5 min, 30 min, 2 hours, 6 hours, 24 hours, 48 hours and 168 hours after the end of second infusion (Day 8)

Outcome Measure Data

Analysis Population Description

Eleven of the 16 patients treated in this study had plasma profiles at second infusion

Arm/Group Title	PM00104
Arm/Group Description:	PM00104 was administered at a dose of 2 mg/m2 as a 1-hour i.v. infusion d1, d8 and d15 q4wk to patients with advanced and/or metastatic Ewing's sarcoma previously treated with at least one line of chemotherapy. A treatment cycle consisted of PM00104 administration on Days 1, 8 and 15, plus one week of follow-up. Study evaluations had to be completed during each cycle prior to subsequent PM00104 infusion. Treatment cycles were repeated every four weeks
Overall Number of Participants Analyzed	11
Mean (Standard Deviation); Unit of Measure: h*μg/l
	69.76 (17.69)

Adverse Events

Time Frame	From first infusion to study termination, up to 2 years
Adverse Event Reporting Description	Sixteen of 17 patients included in this study were treated with PM00104 and were therefore evaluable for safety
Arm/Group Title	PM00104
Arm/Group Description	PM00104 was administered at a dose of 2 mg/m2 as a 1-hour i.v. infusion d1, d8 and d15 q4wk to patients with advanced and/or metastatic Ewing's sarcoma previously treated with at least one line of chemotherapy. A treatment cycle consisted of PM00104 administration on Days 1, 8 and 15, plus one week of follow-up. Study evaluations had to be completed during each cycle prior to subsequent PM00104 infusion. Treatment cycles were repeated every four weeks
All-Cause Mortality
	PM00104
	Affected / at Risk (%)
Total	7/16 (43.75%)
Serious Adverse Events
	PM00104
	Affected / at Risk (%)	# Events
Total	2/16 (12.50%)
Infections and infestations
Acute sinusitis * 1	1/16 (6.25%)	1
Bronchitis * 1	1/16 (6.25%)	1
Pneumonia * 1	1/16 (6.25%)	1
Metabolism and nutrition disorders
Dehydration * 1	1/16 (6.25%)	1
Respiratory, thoracic and mediastinal disorders
Respiratory failure * 1	1/16 (6.25%)	1
1 Term from vocabulary, MedDRA (11.0); * Indicates events were collected by non-systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	PM00104
	Affected / at Risk (%)	# Events
Total	16/16 (100.00%)
Blood and lymphatic system disorders
Anaemia * 1	2/16 (12.50%)	4
Neutropenia * 1	7/16 (43.75%)	11
Thrombocytopenia * 1	2/16 (12.50%)	2
Cardiac disorders
Palpitations * 1	3/16 (18.75%)	3
Pericardial effusion * 1	1/16 (6.25%)	1
Tachycardia * 1	2/16 (12.50%)	2
Ear and labyrinth disorders
Ear congestion * 1	1/16 (6.25%)	1
Tinnitus * 1	1/16 (6.25%)	1
Eye disorders
Eye swelling * 1	1/16 (6.25%)	1
Myopia * 1	1/16 (6.25%)	1
Vision blurred * 1	1/16 (6.25%)	1
Gastrointestinal disorders
Abdominal distension * 1	2/16 (12.50%)	2
Abdominal pain * 1	2/16 (12.50%)	2
Constipation * 1	2/16 (12.50%)	3
Diarrhoea * 1	1/16 (6.25%)	1
Dry mouth * 1	1/16 (6.25%)	4
Gastrooesophageal reflux disease * 1	2/16 (12.50%)	2
Nausea * 1	4/16 (25.00%)	7
Stomach discomfort * 1	1/16 (6.25%)	1
Stomatitis * 1	1/16 (6.25%)	1
Vomiting * 1	2/16 (12.50%)	2
General disorders
Chest pain * 1	3/16 (18.75%)	3
Chills * 1	1/16 (6.25%)	1
Fatigue * 1	7/16 (43.75%)	10
Non-cardiac chest pain * 1	1/16 (6.25%)	1
Oedema peripheral * 1	1/16 (6.25%)	1
Pyrexia * 1	6/16 (37.50%)	6
Infections and infestations
Nasopharyngitis * 1	1/16 (6.25%)	1
Pneumonia * 1	1/16 (6.25%)	1
Investigations
Breath sounds abnormal * 1	1/16 (6.25%)	1
Metabolism and nutrition disorders
Anorexia * 1	2/16 (12.50%)	2
Dehydration * 1	1/16 (6.25%)	1
Hyperglycaemia * 1	1/16 (6.25%)	1
Hypocalcaemia * 1	1/16 (6.25%)	1
Hypokalaemia * 1	1/16 (6.25%)	1
Musculoskeletal and connective tissue disorders
Back pain * 1	1/16 (6.25%)	1
Bone pain * 1	2/16 (12.50%)	3
Musculoskeletal pain * 1	3/16 (18.75%)	5
Myalgia * 1	1/16 (6.25%)	2
Pain in extremity * 1	1/16 (6.25%)	2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain * 1	2/16 (12.50%)	2
Nervous system disorders
Depressed level of consciousness * 1	1/16 (6.25%)	1
Dizziness * 1	2/16 (12.50%)	2
Dysgeusia * 1	2/16 (12.50%)	3
Headache * 1	2/16 (12.50%)	2
Peripheral sensory neuropathy * 1	1/16 (6.25%)	1
Psychiatric disorders
Anxiety * 1	2/16 (12.50%)	2
Insomnia * 1	2/16 (12.50%)	2
Renal and urinary disorders
Urinary retention * 1	1/16 (6.25%)	1
Respiratory, thoracic and mediastinal disorders
Cough * 1	4/16 (25.00%)	10
Dry throat * 1	1/16 (6.25%)	1
Dyspnoea * 1	2/16 (12.50%)	4
Dyspnoea exertional * 1	1/16 (6.25%)	1
Haemoptysis * 1	1/16 (6.25%)	1
Hypoxia * 1	1/16 (6.25%)	2
Oropharyngeal blistering * 1	1/16 (6.25%)	1
Pleuritic pain * 1	1/16 (6.25%)	1
Pneumothorax * 1	1/16 (6.25%)	1
Throat irritation * 1	1/16 (6.25%)	3
Skin and subcutaneous tissue disorders
Alopecia * 1	2/16 (12.50%)	2
Hyperhidrosis * 1	1/16 (6.25%)	1
Night sweats * 1	1/16 (6.25%)	1
Pruritus * 1	2/16 (12.50%)	2
Rash * 1	1/16 (6.25%)	1
Vascular disorders
Pallor * 1	1/16 (6.25%)	1
Superior vena caval occlusion * 1	1/16 (6.25%)	2
Venous thrombosis * 1	1/16 (6.25%)	1
1 Term from vocabulary, MedDRA (11.0); * Indicates events were collected by non-systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

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

There IS 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.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review.

Results Point of Contact

• Name/Title: Clinical Developtment, Department of PharmaMar´s Oncology., Business Unit.
• Organization: Pharma Mar S.A.
• Phone: 0034 91846 60 00
• EMail: clinicaltrials@pharmamar.com

• Responsible Party: PharmaMar
• ClinicalTrials.gov Identifier: NCT01222767
• Other Study ID Numbers: PM104-B-003-10
• First Submitted: October 8, 2010
• First Posted: October 18, 2010
• Results First Submitted: July 13, 2021
• Results First Posted: October 29, 2021
• Last Update Posted: October 29, 2021