Study of Adding AMG 479 to First Line Chemotherapy in Patients With Optimally Debulked Epithelial Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT00718523

Recruitment Status : Terminated (The steering committee of the TRIO014 study has taken the decision to stop the TRIO014 trial.)

First Posted : July 18, 2008

Results First Posted : January 12, 2016

Last Update Posted : January 12, 2016

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Sponsor:

Information provided by (Responsible Party):

Translational Research in Oncology

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition	Ovarian Neoplasms
Interventions	Drug: AMG 479 Drug: AMG 479 Placebo
Enrollment	170

Participant Flow

Recruitment Details	The study was conducted over a total of 55 sites in 8 countries.
Pre-assignment Details


Arm/Group Title	A Control	B Experimental
Arm/Group Description	Placebo plus paclitaxel/carboplatin...	AMG 479 plus paclitaxel/carboplatin...
Arm/Group Description	Placebo plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of placebo administered on Day 1 of each 21-day cycle. AMG 479 Placebo: Matching placebo administered Day 1 of each 21 day cycle.	AMG 479 plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of AMG 479 single agent administered on Day 1 of each 21-day cycle. AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle
Period Title: Overall Study
Started	84	86
Completed	66	62
Not Completed	18	24
Reason Not Completed
Withdrawal by Subject	5	7
Death	13	17

Baseline Characteristics

Arm/Group Title		A Control	B Experimental	Total
Arm/Group Description		Placebo plus paclitaxel/carboplatin...	AMG 479 plus paclitaxel/carboplatin...	Total of all reporting groups
Arm/Group Description		Placebo plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of placebo administered on Day 1 of each 21-day cycle. AMG 479 Placebo: Matching placebo administered Day 1 of each 21 day cycle.	AMG 479 plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of AMG 479 single agent administered on Day 1 of each 21-day cycle. AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle	Total of all reporting groups
Overall Number of Baseline Participants		84	86	170
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	84 participants	86 participants	170 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	59 70.2%	61 70.9%	120 70.6%
	>=65 years	25 29.8%	25 29.1%	50 29.4%
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	84 participants	86 participants	170 participants
		58.1 (10.0)	57.2 (12.3)	57.6 (11.2)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	84 participants	86 participants	170 participants
	Female	84 100.0%	86 100.0%	170 100.0%
	Male	0 0.0%	0 0.0%	0 0.0%
Region of Enrollment Measure Type: Number Unit of measure: Participants	Number Analyzed	84 participants	86 participants	170 participants
United States		25	34	59
United Kingdom		1	2	3
Canada		4	6	10
France		7	3	10
Israel		2	2	4
Spain		1	1	2
Germany		44	38	82
Eastern Cooperative Oncology Group Performance Status (ECOG PS) ^[1] Measure Type: Number Unit of measure: Participants	Number Analyzed	84 participants	86 participants	170 participants
PS 0 (fully active)		36	32	68
PS 1 (restricted in physically strenuous activity)		43	46	89
PS2(ambulatory and capable of all selfcare)		5	6	11
Missing		0	2	2
		[1] Measure Description: 6-point (0 to 5) ordinal scale to assess how the disease affects the daily living abilities of the patients and determine appropriate treatment and prognosis
Time from Surgery to first treatment dose Mean (Standard Deviation) Unit of measure: Weeks
	Number Analyzed	84 participants	86 participants	170 participants
		5.1 (1.2)	5.1 (1.4)	5.1 (1.3)
Time from diagnosis to randomization Mean (Standard Deviation) Unit of measure: Weeks
	Number Analyzed	84 participants	86 participants	170 participants
		5.2 (2.3)	5.4 (3.4)	5.3 (2.9)
Origin of tumor Measure Type: Number Unit of measure: Participants	Number Analyzed	84 participants	86 participants	170 participants
Primary peritoneal		8	4	12
Fallopian tube		4	4	8
Ovarian		69	77	146
Ovarian + Primary peritoneal		0	1	1
Ovarian + Fallopian tube		2	0	2
Missing		1	0	1
Stage at first diagnosis (International Federation of Gynecology and Obstetrics (FIGO)) ^[1] Measure Type: Number Unit of measure: Participants	Number Analyzed	84 participants	86 participants	170 participants
IIIA		3	2	5
IIIB		10	6	16
IIIC		65	72	137
IV		6	6	12
		[1] Measure Description: 5-point ordinal scale to assess the extent of the disease (0->IV). Roman numeral staging from the less to the most advanced cancer. Individual stage (I to III) is broken down in substage: IA, IB, IC,...
Histopathologic type Measure Type: Number Unit of measure: Participants	Number Analyzed	84 participants	86 participants	170 participants
papillary serous		69	72	141
mucinous		0	1	1
endometroid		4	5	9
clear cell		2	2	4
mixed		5	3	8
other		4	3	7
Histologic Grade ^[1] Measure Type: Number Unit of measure: Participants	Number Analyzed	84 participants	86 participants	170 participants
G1 (well differentiated)		1	5	6
G2 (moderately differentiated)		15	18	33
G3 (poorly differentiated)		65	57	122
Not done		3	6	9
		[1] Measure Description: Cancer cells compared with normal cells
Number of prior therapies ^[1] Measure Type: Number Unit of measure: Participants	Number Analyzed	84 participants	86 participants	170 participants
1 therapy		80	78	158
2 therapies		4	8	12
		[1] Measure Description: Prior anti-tumor treatment characteristics
CA 125 status Measure Type: Number Unit of measure: Participants	Number Analyzed	84 participants	86 participants	170 participants
with elevated CA 125		67	70	137
with CA 125 in the normal range		17	15	32
missing		0	1	1

Outcome Measures

1.Primary Outcome


Title	Progression Free Survival (PFS): Time From Randomization Until Date of Progression or Death.
Description	A patient may have been declared to have progressive disease on the ba...
Description	A patient may have been declared to have progressive disease on the basis of radiological measuremt of tumor lesions assessmt or CA125 evaluation (tumor measuremts taking precedence).Radiological progression was defined as per the RECIST guidelines (Therasse et al, JNCI2000) as at least 20% increase in the sum of the longest diameters of target lesions(ref the smallest sum of the longest diam recorded since the treatmt started or since the appearance of at least 1 new lesion).Serum CA125 progression was defined, according to the 2005 GCIG def: pts with: Elevated CA125 pretreatmt and normalization of CA125 has to show evidence of CA125≥ 2 times the upper normal limit on 2 occasions at least 1 wk apart OR Elevated CA125 pretreatmt which never normalized must show evidence of CA125≥ 2 times the nadir value on 2 occasions at least 1 wk apart OR CA125 in the normal range pretreatmt had to show evidence of CA125 ≥ 2 times the upper normal limit on 2 occasions at least 1 wk apart
Time Frame	Radiological tumor assessment: every 12(+/- 1) weeks for 3 years after randomization + CA 125: day 1 of each cycle

Outcome Measure Data

Analysis Population Description

Unstratified Intent To Treat


Arm/Group Title	A Control	B Experimental
Arm/Group Description:	Placebo plus paclitaxel/carboplatin...	AMG 479 plus paclitaxel/carboplatin...
Arm/Group Description:	Placebo plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of placebo administered on Day 1 of each 21-day cycle. AMG 479 Placebo: Matching placebo administered Day 1 of each 21 day cycle.	AMG 479 plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of AMG 479 single agent administered on Day 1 of each 21-day cycle. AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle
Overall Number of Participants Analyzed	84	86
Median (95% Confidence Interval) Unit of Measure: months
	16.690 (14.686 to 28.123)	15.737 (12.090 to 21.388)

2.Secondary Outcome


Title	Time To Progression (TTP): Interval From the Date of Randomization to the Date of Disease Progression
Description	A patient may have been declared to have progressive disease on the ba...
Description	A patient may have been declared to have progressive disease on the basis of radiological measuremt of tumor lesions assessmt or CA125 evaluation (tumor measuremts taking precedence).Radiological progression was defined as per the RECIST guidelines (Therasse et al, JNCI2000) as at least 20% increase in the sum of the longest diameters of target lesions(ref the smallest sum of the longest diam recorded since the treatmt started or since the appearance of at least 1 new lesion).Serum CA125 progression was defined, according to the 2005 GCIG def: pts with: Elevated CA125 pretreatmt and normalization of CA125 has to show evidence of CA125≥ 2 times the upper normal limit on 2 occasions at least 1 wk apart OR Elevated CA125 pretreatmt which never normalized must show evidence of CA125≥ 2 times the nadir value on 2 occasions at least 1 wk apart OR CA125 in the normal range pretreatmt had to show evidence of CA125 ≥ 2 times the upper normal limit on 2 occasions at least 1 wk apart
Time Frame	Radiological tumor assessment: every 12 (+/- 1) weeks for 3 years after randomization + CA125: day 1 of each cycle

Outcome Measure Data

Analysis Population Description

Unstratified Intent To Treat


Arm/Group Title	A Control	B Experimental
Arm/Group Description:	Placebo plus paclitaxel/carboplatin...	AMG 479 plus paclitaxel/carboplatin...
Arm/Group Description:	Placebo plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of placebo administered on Day 1 of each 21-day cycle. AMG 479 Placebo: Matching placebo administered Day 1 of each 21 day cycle.	AMG 479 plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of AMG 479 single agent administered on Day 1 of each 21-day cycle. AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle
Overall Number of Participants Analyzed	84	86
Median (95% Confidence Interval) Unit of Measure: months
	17.840 (14.784 to 34.037)	16.066 (12.090 to 22.341)

3.Secondary Outcome


Title	Overall Survival (OS)
Description	Interval between the date from randomization to death from any cause w...
Description	Interval between the date from randomization to death from any cause whichever came first.
Time Frame	Day 1 of each cycle up to 4 years after randomization

Outcome Measure Data

Analysis Population Description

Unstratified Intent To Treat


Arm/Group Title	A Control	B Experimental
Arm/Group Description:	Placebo plus paclitaxel/carboplatin...	AMG 479 plus paclitaxel/carboplatin...
Arm/Group Description:	Placebo plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of placebo administered on Day 1 of each 21-day cycle. AMG 479 Placebo: Matching placebo administered Day 1 of each 21 day cycle.	AMG 479 plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of AMG 479 single agent administered on Day 1 of each 21-day cycle. AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle
Overall Number of Participants Analyzed	84	86
Median (95% Confidence Interval) Unit of Measure: months
	NA ^[1] (NA to NA)	45.207 ^[1] (45.207 to NA)

[1]

The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.

Adverse Events

Time Frame	The monitoring period for AEs started from signature of the ICF and continued up to 30 days after last dose.
Adverse Event Reporting Description	For participant flow module it is based on Intent To Treat so the patients are counted according to their "randomization group".For "participants at risk" the patients are grouped by the "actual treatment" 4 patients were allocated with incorrect treatment and received AMG479 instead of Placebo.The total number of patients treated remains the same.

Arm/Group Title	A Control		B Experimental
Arm/Group Description	Placebo plus paclitaxel/carboplatin...		AMG 479 plus paclitaxel/carboplatin...
Arm/Group Description	Placebo plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of placebo administered on Day 1 of each 21-day cycle. AMG 479 Placebo: Matching placebo administered Day 1 of each 21 day cycle.		AMG 479 plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of AMG 479 single agent administered on Day 1 of each 21-day cycle. AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle
All-Cause Mortality
	A Control		B Experimental
	Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events Serious Adverse Events
	A Control		B Experimental
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	31/77 (40.26%)		30/88 (34.09%)
Blood and lymphatic system disorders
Anaemia ^* 1	1/77 (1.30%)	1	6/88 (6.82%)	6
Leukopenia ^* 1	1/77 (1.30%)	1	1/88 (1.14%)	1
Thrombocytopenia ^* 1	1/77 (1.30%)	1	5/88 (5.68%)	7
Neutropenia ^* 1	0/77 (0.00%)	0	1/88 (1.14%)	1
Pancytopenia ^* 1	0/77 (0.00%)	0	1/88 (1.14%)	1
Febrile neutropenia ^* 1	0/77 (0.00%)	0	1/88 (1.14%)	1
Cardiac disorders
Cardiac failure ^* 1	1/77 (1.30%)	1	0/88 (0.00%)	0
Ear and labyrinth disorders
Deafness neurosensory ^* 1	1/77 (1.30%)	1	0/88 (0.00%)	0
Gastrointestinal disorders
Intestinal obstruction ^* 1	2/77 (2.60%)	2	3/88 (3.41%)	4
Diarrhoea ^* 1	1/77 (1.30%)	1	1/88 (1.14%)	1
Ileus ^* 1	2/77 (2.60%)	2	2/88 (2.27%)	3
Abdominal pain ^* 1	2/77 (2.60%)	2	1/88 (1.14%)	1
Ascites ^* 1	1/77 (1.30%)	1	0/88 (0.00%)	0
Constipation ^* 1	1/77 (1.30%)	1	1/88 (1.14%)	1
Abdominal Pain Upper ^* 1	0/77 (0.00%)	0	1/88 (1.14%)	1
Abdominal pain lower ^* 1	1/77 (1.30%)	1	0/88 (0.00%)	0
Vomiting ^* 1	1/77 (1.30%)	1	1/88 (1.14%)	1
Gastrointestinal Hypomotility ^* 1	1/77 (1.30%)	1	0/88 (0.00%)	0
Nausea ^* 1	0/77 (0.00%)	0	1/88 (1.14%)	1
Subileus ^* 1	1/77 (1.30%)	1	1/88 (1.14%)	1
Faecaloma ^* 1	1/77 (1.30%)	1	0/88 (0.00%)	0
Intestinal infarction ^* 1	0/77 (0.00%)	0	1/88 (1.14%)	1
General disorders
General Physical health deterioration ^* 1	1/77 (1.30%)	1	5/88 (5.68%)	5
non cardiac chest pain ^* 1	2/77 (2.60%)	2	0/88 (0.00%)	0
Asthenia ^* 1	0/77 (0.00%)	0	1/88 (1.14%)	1
Hepatobiliary disorders
Cholestasis ^* 1	1/77 (1.30%)	1	0/88 (0.00%)	0
Infections and infestations
Viral infection ^* 1	0/77 (0.00%)	0	1/88 (1.14%)	1
Gastroenteritis ^* 1	1/77 (1.30%)	1	1/88 (1.14%)	1
Device related infection ^* 1	0/77 (0.00%)	0	3/88 (3.41%)	3
Tracheobronchitis ^* 1	0/77 (0.00%)	0	1/88 (1.14%)	1
Hepatitis C ^* 1	0/77 (0.00%)	0	1/88 (1.14%)	1
Neutropenic infection ^* 1	0/77 (0.00%)	0	2/88 (2.27%)	2
Bacterial infection ^* 1	1/77 (1.30%)	1	0/88 (0.00%)	0
Streptococcal bacteraemia ^* 1	1/77 (1.30%)	1	0/88 (0.00%)	0
Infection ^* 1	1/77 (1.30%)	1	0/88 (0.00%)	0
Abdominal abscess ^* 1	1/77 (1.30%)	1	0/88 (0.00%)	0
Neutropenic sepsis ^* 1	0/77 (0.00%)	0	1/88 (1.14%)	1
Infected lymphocele ^* 1	1/77 (1.30%)	1	0/88 (0.00%)	0
Respiratory tract infection ^* 1	1/77 (1.30%)	1	0/88 (0.00%)	0
Urinary tract infection ^* 1	1/77 (1.30%)	1	0/88 (0.00%)	0
Pneumonia ^* 1	1/77 (1.30%)	1	0/88 (0.00%)	0
Postoperative Wound Infection ^* 1	0/77 (0.00%)	0	1/88 (1.14%)	1
Injury, poisoning and procedural complications
Femoral neck fracture ^* 1	2/77 (2.60%)	2	0/88 (0.00%)	0
Anastomotic leak ^* 1	1/77 (1.30%)	1	0/88 (0.00%)	0
Seroma ^* 1	0/77 (0.00%)	0	1/88 (1.14%)	1
Metabolism and nutrition disorders
Hypocalcaemia ^* 1	0/77 (0.00%)	0	1/88 (1.14%)	1
Diabetes melitus ^* 1	0/77 (0.00%)	0	1/88 (1.14%)	1
Musculoskeletal and connective tissue disorders
Muscle spasms ^* 1	1/77 (1.30%)	1	0/88 (0.00%)	0
Arthralgia ^* 1	1/77 (1.30%)	1	1/88 (1.14%)	1
Bone pain ^* 1	1/77 (1.30%)	1	0/88 (0.00%)	0
Rheumatoid arthritis ^* 1	1/77 (1.30%)	1	0/88 (0.00%)	0
Nervous system disorders
Convulsion ^* 1	1/77 (1.30%)	1	0/88 (0.00%)	0
Haemorrhage intracranial ^* 1	0/77 (0.00%)	0	1/88 (1.14%)	1
Syncope ^* 1	1/77 (1.30%)	1	0/88 (0.00%)	0
Nervous system disorder ^* 1	0/77 (0.00%)	0	1/88 (1.14%)	1
Dizziness ^* 1	0/77 (0.00%)	0	1/88 (1.14%)	1
Psychiatric disorders
Mental status changes ^* 1	0/77 (0.00%)	0	1/88 (1.14%)	1
Reproductive system and breast disorders
Female genital tract fistula ^* 1	0/77 (0.00%)	0	1/88 (1.14%)	1
Vaginal haemorrhage ^* 1	0/77 (0.00%)	0	1/88 (1.14%)	1
Respiratory, thoracic and mediastinal disorders
Dyspnoea ^* 1	3/77 (3.90%)	3	0/88 (0.00%)	0
Pulmonary embolism ^* 1	1/77 (1.30%)	1	0/88 (0.00%)	0
Epistaxis ^* 1	0/77 (0.00%)	0	1/88 (1.14%)	1
Lung disorder ^* 1	1/77 (1.30%)	1	0/88 (0.00%)	0
Skin and subcutaneous tissue disorders
Rash maculo papular ^* 1	0/77 (0.00%)	0	1/88 (1.14%)	1
Petechiae ^* 1	0/77 (0.00%)	0	1/88 (1.14%)	1
Vascular disorders
Lymphocele ^* 1	2/77 (2.60%)	4	0/88 (0.00%)	0
Aortic aneurysm ^* 1	0/77 (0.00%)	0	1/88 (1.14%)	1
Subclavian vein thrombosis ^* 1	1/77 (1.30%)	1	0/88 (0.00%)	0
* Indicates events were collected by non-systematic assessment 1 Term from vocabulary, MedDRA (Unspecified)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	A Control		B Experimental
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	77/77 (100.00%)		86/88 (97.73%)
Ear and labyrinth disorders
Tinnitus ^* 1	4/77 (5.19%)	4	3/88 (3.41%)	3
Vertigo ^* 1	4/77 (5.19%)	4	8/88 (9.09%)	8
Eye disorders
Vision blurred ^* 1	4/77 (5.19%)	4	4/88 (4.55%)	4
Gastrointestinal disorders
Constipation ^* 1	28/77 (36.36%)	33	28/88 (31.82%)	32
Dry mouth ^* 1	6/77 (7.79%)	6	11/88 (12.50%)	13
Stomatitis ^* 1	17/77 (22.08%)	19	24/88 (27.27%)	25
Abdominal Pain ^* 1	16/77 (20.78%)	16	18/88 (20.45%)	22
Abdominal Pain Upper ^* 1	14/77 (18.18%)	16	6/88 (6.82%)	6
Diarrhoea ^* 1	24/77 (31.17%)	32	37/88 (42.05%)	45
Nausea ^* 1	51/77 (66.23%)	67	46/88 (52.27%)	53
Vomiting ^* 1	31/77 (40.26%)	38	29/88 (32.95%)	32
General disorders
Chills ^* 1	4/77 (5.19%)	4	10/88 (11.36%)	12
Fatigue ^* 1	46/77 (59.74%)	55	49/88 (55.68%)	55
Oedema peripheral ^* 1	8/77 (10.39%)	8	5/88 (5.68%)	5
Pain ^* 1	9/77 (11.69%)	10	11/88 (12.50%)	11
Pyrexia ^* 1	13/77 (16.88%)	15	9/88 (10.23%)	12
Asthenia ^* 1	9/77 (11.69%)	17	5/88 (5.68%)	6
Immune system disorders
Hypersensitivity ^* 1	10/77 (12.99%)	14	8/88 (9.09%)	10
Infections and infestations
Bronchitis ^* 1	5/77 (6.49%)	5	2/88 (2.27%)	2
Cystitis ^* 1	5/77 (6.49%)	9	2/88 (2.27%)	2
Nasopharyngitis ^* 1	12/77 (15.58%)	13	7/88 (7.95%)	10
Urinary Tract Infection ^* 1	11/77 (14.29%)	15	7/88 (7.95%)	8
Investigations
Weight increased ^* 1	2/77 (2.60%)	2	5/88 (5.68%)	6
Metabolism and nutrition disorders
Decreased appetite ^* 1	16/77 (20.78%)	17	12/88 (13.64%)	14
Hypomagnesaemia ^* 1	2/77 (2.60%)	2	5/88 (5.68%)	5
Musculoskeletal and connective tissue disorders
Back pain ^* 1	14/77 (18.18%)	16	8/88 (9.09%)	8
Musculoskeletal chest pain ^* 1	4/77 (5.19%)	4	0/88 (0.00%)	0
Musculoskeletal pain ^* 1	5/77 (6.49%)	6	3/88 (3.41%)	3
Myalgia ^* 1	20/77 (25.97%)	26	27/88 (30.68%)	33
Pain in extremity ^* 1	16/77 (20.78%)	17	11/88 (12.50%)	13
Arthralgia ^* 1	24/77 (31.17%)	39	30/88 (34.09%)	34
Bone Pain ^* 1	13/77 (16.88%)	15	18/88 (20.45%)	21
Muscle Spasms ^* 1	2/77 (2.60%)	2	6/88 (6.82%)	6
Nervous system disorders
Dysgueusia ^* 1	15/77 (19.48%)	17	15/88 (17.05%)	16
Headache ^* 1	17/77 (22.08%)	20	23/88 (26.14%)	30
Neuropathy peripheral ^* 1	15/77 (19.48%)	17	24/88 (27.27%)	25
Paraesthesia ^* 1	7/77 (9.09%)	9	3/88 (3.41%)	3
Peripheral sensory neuropathy ^* 1	32/77 (41.56%)	35	27/88 (30.68%)	31
Polyneuropathy ^* 1	11/77 (14.29%)	11	8/88 (9.09%)	8
Dizziness ^* 1	15/77 (19.48%)	16	9/88 (10.23%)	9
Syncope ^* 1	4/77 (5.19%)	4	1/88 (1.14%)	1
Psychiatric disorders
Anxiety ^* 1	4/77 (5.19%)	4	2/88 (2.27%)	2
Depression ^* 1	6/77 (7.79%)	6	2/88 (2.27%)	2
Insomnia ^* 1	6/77 (7.79%)	6	7/88 (7.95%)	7
Respiratory, thoracic and mediastinal disorders
Cough ^* 1	7/77 (9.09%)	7	9/88 (10.23%)	9
Oropharyngeal pain ^* 1	5/77 (6.49%)	5	4/88 (4.55%)	4
Rhinorrhoea ^* 1	4/77 (5.19%)	4	3/88 (3.41%)	3
Dyspnoea ^* 1	15/77 (19.48%)	15	12/88 (13.64%)	12
Epistaxis ^* 1	6/77 (7.79%)	6	12/88 (13.64%)	13
Skin and subcutaneous tissue disorders
Acne ^* 1	1/77 (1.30%)	1	5/88 (5.68%)	6
Alopecia ^* 1	68/77 (88.31%)	68	66/88 (75.00%)	66
Dry skin ^* 1	3/77 (3.90%)	3	5/88 (5.68%)	5
Nail disorder ^* 1	2/77 (2.60%)	2	8/88 (9.09%)	8
Pruritus ^* 1	11/77 (14.29%)	15	11/88 (12.50%)	12
Rash ^* 1	17/77 (22.08%)	22	24/88 (27.27%)	28
Vascular disorders
Hot flush ^* 1	13/77 (16.88%)	13	7/88 (7.95%)	8
Hypertension ^* 1	3/77 (3.90%)	3	6/88 (6.82%)	6
* Indicates events were collected by non-systematic assessment 1 Term from vocabulary, MedDRA (Unspecified)

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

Layout table for Results Point of Contact information

Name/Title:	Matthieu Rupin
Organization:	Translational Research In Oncology (formerly CIRG)
Phone:	+331 58 10 08 89
EMail:	matthieu.rupin@trioncology.org

Layout table for additonal information

Responsible Party:	Translational Research in Oncology
ClinicalTrials.gov Identifier:	NCT00718523
Other Study ID Numbers:	TRIO 014
First Submitted:	July 17, 2008
First Posted:	July 18, 2008
Results First Submitted:	October 22, 2015
Results First Posted:	January 12, 2016
Last Update Posted:	January 12, 2016

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