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Trial record 1 of 1 for:    TRIO 014
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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
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
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
Hide 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
Arm/Group Title A Control B Experimental Total
Hide 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
Hide 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
1.Primary Outcome
Title Progression Free Survival (PFS): Time From Randomization Until Date of Progression or Death.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Unstratified Intent To Treat
Arm/Group Title A Control B Experimental
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Unstratified Intent To Treat
Arm/Group Title A Control B Experimental
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Unstratified Intent To Treat
Arm/Group Title A Control B Experimental
Hide 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.
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
Hide 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   --/--      --/--    
Hide 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)
Hide 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)
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