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Trial record 27 of 49 for:    rucaparib

A Study of Rucaparib as Switch Maintenance Following Platinum-Based Chemotherapy in Patients With Platinum-Sensitive, High-Grade Serous or Endometrioid Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer (ARIEL3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01968213
Recruitment Status : Active, not recruiting
First Posted : October 23, 2013
Results First Posted : August 3, 2018
Last Update Posted : August 1, 2019
Sponsor:
Collaborators:
Foundation Medicine
Myriad Genetics, Inc.
Information provided by (Responsible Party):
Clovis Oncology, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Cancer
Interventions Drug: Rucaparib
Drug: Placebo
Enrollment 564
Recruitment Details 564 subjects were recruited from 87 sites across 11 countries and randomized (2:1) to treatment with rucaparib or placebo
Pre-assignment Details  
Arm/Group Title Rucaparib 600 mg Tablets Placebo Tablets
Hide Arm/Group Description Taken orally twice daily (continuous 28 day treatment cycles) Taken orally twice daily (continuous 28 day treatment cycles)
Period Title: Overall Study
Started 375 189
Completed 285 180
Not Completed 90 9
Reason Not Completed
Ongoing             90             9
Arm/Group Title Rucaparib 600 mg Tablets Placebo Tablets Total
Hide Arm/Group Description Taken orally twice daily (continuous 28 day treatment cycles) Taken orally twice daily (continuous 28 day treatment cycles) Total of all reporting groups
Overall Number of Baseline Participants 375 189 564
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 375 participants 189 participants 564 participants
61
(39 to 84)
62
(36 to 85)
61
(36 to 85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 375 participants 189 participants 564 participants
Female
375
 100.0%
189
 100.0%
564
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 375 participants 189 participants 564 participants
American Indian or Alaska Native
3
   0.8%
1
   0.5%
4
   0.7%
Asian
14
   3.7%
7
   3.7%
21
   3.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
   1.6%
2
   1.1%
8
   1.4%
White
302
  80.5%
149
  78.8%
451
  80.0%
More than one race
3
   0.8%
3
   1.6%
6
   1.1%
Unknown or Not Reported
47
  12.5%
27
  14.3%
74
  13.1%
Best Response from Previous Platinum Therapy   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 375 participants 189 participants 564 participants
RECIST CR
126
  33.6%
64
  33.9%
190
  33.7%
RECIST / CA-125 PR
249
  66.4%
125
  66.1%
374
  66.3%
[1]
Measure Description: Complete and partial responses at baseline must have been reported according to RECIST v1.1, as assessed by CT/MRI, and GCIG CA-125 response criteria, and defined as: Complete Response (CR) i.e. absence of any detectable disease and CA-125<ULN; Partial Response (PR), ≥30% decrease in the sum of the longest diameter of measurable lesions or if non-measurable disease at baseline, a GCIG CA-125 response (least a 50% reduction in CA-125 levels from a pretreatment sample (which must have initially been 2xULN) and confirmed after ≥21 days). CA-125 must have been <ULN for all PRs.
Penultimate Progression-free (PF) Interval   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 375 participants 189 participants 564 participants
6-12 Months
151
  40.3%
76
  40.2%
227
  40.2%
>12 Months
224
  59.7%
113
  59.8%
337
  59.8%
[1]
Measure Description: Progressive disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).
Bulky Lesions (lesion >20 mm) at Baseline  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 375 participants 189 participants 564 participants
Yes
71
  18.9%
29
  15.3%
100
  17.7%
No
304
  81.1%
160
  84.7%
464
  82.3%
1.Primary Outcome
Title Disease Progression According to RECIST Version 1.1, as Assessed by the Investigator, or Death From Any Cause (Investigator Progression Free Survival as Per invPFS)
Hide Description Progression-free survival by Investigator (invPFS) is defined as the time from randomization to disease progression, according to RECIST v1.1 criteria as assessed by the investigator, or death due to any cause, whichever occurs first. Progressive disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).
Time Frame Every 12 calendar weeks (within 7 days prior is permitted) after start of treatment until treatment discontinuation due to disease progression. Study data collection expected to last for ~3 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat: All patients randomized
Arm/Group Title Rucaparib 600 mg Tablets Placebo Tablets
Hide Arm/Group Description:
Taken orally twice daily (continuous 28 day treatment cycles)
Taken orally twice daily (continuous 28 day treatment cycles)
Overall Number of Participants Analyzed 375 189
Median (95% Confidence Interval)
Unit of Measure: Months
10.8
(8.3 to 11.4)
5.4
(5.3 to 5.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rucaparib 600 mg Tablets, Placebo Tablets
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.365
Confidence Interval (2-Sided) 95%
0.295 to 0.451
Estimation Comments [Not Specified]
Other Statistical Analysis Analysis is performed by randomization strata of HRD classification by CTA, best response, and penultimate platinum progression-free interval.
2.Secondary Outcome
Title Disease Progression According to RECIST v1.1, as Assessed by Independent Radiology Review (IRR), or Death From Any Cause (irrPFS)
Hide Description To evaluate PFS by RECIST, as assessed by independent radiology review (IRR)
Time Frame Every 12 calendar weeks (within 7 days prior is permitted) after start of treatment until treatment discontinuation due to disease progression. Study data collection expected to last for ~3 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat: All patients randomized
Arm/Group Title Rucaparib 600 mg Tablets Placebo Tablets
Hide Arm/Group Description:
Taken orally twice daily (continuous 28 day treatment cycles)
Taken orally twice daily (continuous 28 day treatment cycles)
Overall Number of Participants Analyzed 375 189
Median (95% Confidence Interval)
Unit of Measure: months
13.7
(11.0 to 19.1)
5.4
(5.1 to 5.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rucaparib 600 mg Tablets, Placebo Tablets
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.354
Confidence Interval (2-Sided) 95%
0.278 to 0.450
Estimation Comments [Not Specified]
Other Statistical Analysis Analysis is performed by randomization strata of HRD classification by CTA, best response, and penultimate platinum progression-free interval.
3.Secondary Outcome
Title Time to a 4-point Decrease in the Disease-related Symptoms – Physical (DRS-P) Subscale of the FOSI-18
Hide Description The National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy (NCCN-FACT) FACT-Ovarian Symptom Index (FOSI-18) is a questionnaire, for completion by patients, designed to assess the impact of cancer therapy on ovarian cancer-related symptoms and is based on numerical point scoring of symptoms. The DRS-P subscale of the questionnaire is specifically designed to assess physical symptoms of ovarian cancer and evaluate changes in the subscale point score in individual assessments over time. This study looked at the time to a 4-point reduction in subscale score as an indicator of improvement in disease-related physical symptoms on cancer therapy.
Time Frame Screening, Day 1 of each treatment cycle, Treatment Discontinuation visit, and 28-day Follow-up visit. Study data collection expected to last for ~3 years.
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Time to an 8-point Decrease in the Total Score of the FOSI-18
Hide Description The National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy (NCCN-FACT) FACT-Ovarian Symptom Index (FOSI-18) is a questionnaire, for completion by patients, designed to assess the impact of cancer therapy on ovarian cancer-related physical, emotional and treatment-related symptoms, and is based on numerical point scoring of symptoms. The questionnaire is designed to evaluate changes in the total score in individual assessments over time. This study looked at the time to an 8-point reduction in the total score as an indicator of improvement in disease-related symptoms on cancer therapy
Time Frame Screening, Day 1 of each treatment cycle, Treatment Discontinuation visit, and 28-day Follow-up visit. Study data collection expected to last for ~3 years.
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Overall Survival (OS)
Hide Description The final OS analysis has not been performed yet and will be performed when 70% of the events have been collected.
Time Frame Continuously for ~5 years after patient enrolls into study.
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Individual Model Parameter Estimates of Rucaparib and Covariates Identification
Hide Description Concentration summary statistics
Time Frame Study data collection expected to last for ~7 months.
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who are treated with rucaparib with at least one pharmacokinetic (PK) measurement
Arm/Group Title Rucaparib 600 mg Tablets
Hide Arm/Group Description:
Taken orally twice daily (continuous 28 day treatment cycles)
Overall Number of Participants Analyzed 295
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
Cycle 2 Day 1
1128
(95.42%)
Cycle 4 Day 1
1136
(86.19%)
Cycle 7 Day 1
1165
(78.53%)
Time Frame Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug.
Adverse Event Reporting Description

Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug.

Reason for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)

 
Arm/Group Title Rucaparib 600 mg Tablets Placebo Tablets
Hide Arm/Group Description Taken orally twice daily (continuous 28 day treatment cycles) Taken orally twice daily (continuous 28 day treatment cycles)
All-Cause Mortality
Rucaparib 600 mg Tablets Placebo Tablets
Affected / at Risk (%) Affected / at Risk (%)
Total   7/372 (1.88%)   2/189 (1.06%) 
Show Serious Adverse Events Hide Serious Adverse Events
Rucaparib 600 mg Tablets Placebo Tablets
Affected / at Risk (%) Affected / at Risk (%)
Total   83/372 (22.31%)   20/189 (10.58%) 
Blood and lymphatic system disorders     
Combined Anemia and/or low hemoglobin  1  17/372 (4.57%)  1/189 (0.53%) 
Combined Netropenia and/or low ANC  1 [1]  2/372 (0.54%)  0/189 (0.00%) 
Combined Thrombocytopenia and/or low platelets  1  4/372 (1.08%)  0/189 (0.00%) 
Febrile neutropenia  1  5/372 (1.34%)  0/189 (0.00%) 
Histiocytosis haematophagic  1  1/372 (0.27%)  0/189 (0.00%) 
Pancytopenia  1  2/372 (0.54%)  0/189 (0.00%) 
Cardiac disorders     
Atrial fibrillation  1  1/372 (0.27%)  0/189 (0.00%) 
Pericardial effusion  1  1/372 (0.27%)  0/189 (0.00%) 
Sinus bradycardia  1  0/372 (0.00%)  1/189 (0.53%) 
Cardiac arrest  1  1/372 (0.27%)  0/189 (0.00%) 
Eye disorders     
Diplopia  1  1/372 (0.27%)  0/189 (0.00%) 
Gastrointestinal disorders     
Abdominal hernia  1  1/372 (0.27%)  0/189 (0.00%) 
Abdominal pain  1  5/372 (1.34%)  0/189 (0.00%) 
Constipation  1  5/372 (1.34%)  2/189 (1.06%) 
Diarrhoea  1  0/372 (0.00%)  1/189 (0.53%) 
Duodenal obstruction  1  1/372 (0.27%)  0/189 (0.00%) 
Faecaloma  1  1/372 (0.27%)  0/189 (0.00%) 
Gastrointestinal pain  1  1/372 (0.27%)  0/189 (0.00%) 
Intestinal obstruction  1  3/372 (0.81%)  2/189 (1.06%) 
Nausea  1  2/372 (0.54%)  1/189 (0.53%) 
Neutropenic colitis  1  1/372 (0.27%)  0/189 (0.00%) 
Small intestinal obstruction  1  4/372 (1.08%)  3/189 (1.59%) 
Vomiting  1  7/372 (1.88%)  2/189 (1.06%) 
General disorders     
Combined Asthenia/Fatigue  1  2/372 (0.54%)  0/189 (0.00%) 
General physical health deterioration  1  1/372 (0.27%)  0/189 (0.00%) 
Incarcerated hernia  1  1/372 (0.27%)  0/189 (0.00%) 
Pyrexia  1  6/372 (1.61%)  0/189 (0.00%) 
Hepatobiliary disorders     
Bile duct obstruction  1  1/372 (0.27%)  0/189 (0.00%) 
Cholecystitis  1  1/372 (0.27%)  0/189 (0.00%) 
Hepatic failure  1  1/372 (0.27%)  0/189 (0.00%) 
Infections and infestations     
Arthritis infective  1  1/372 (0.27%)  0/189 (0.00%) 
Cellulitis  1  1/372 (0.27%)  0/189 (0.00%) 
Gastroenteritis  1  1/372 (0.27%)  0/189 (0.00%) 
Lower respiratory tract infection  1  1/372 (0.27%)  0/189 (0.00%) 
Lung infection  1  0/372 (0.00%)  1/189 (0.53%) 
Pyelonephritis  1  1/372 (0.27%)  0/189 (0.00%) 
Sepsis  1  2/372 (0.54%)  0/189 (0.00%) 
Sinusitis  1  1/372 (0.27%)  0/189 (0.00%) 
Stoma site infection  1  0/372 (0.00%)  1/189 (0.53%) 
Upper respiratory tract infection  1  0/372 (0.00%)  1/189 (0.53%) 
Urinary tract infection  1  2/372 (0.54%)  1/189 (0.53%) 
Varicella  1  0/372 (0.00%)  1/189 (0.53%) 
Viral infection  1  1/372 (0.27%)  0/189 (0.00%) 
Injury, poisoning and procedural complications     
Femoral neck fracture  1  1/372 (0.27%)  1/189 (0.53%) 
Femur fracture  1  1/372 (0.27%)  0/189 (0.00%) 
Fibula fracture  1  1/372 (0.27%)  0/189 (0.00%) 
Forearm fracture  1  0/372 (0.00%)  1/189 (0.53%) 
Incisional hernia  1  0/372 (0.00%)  1/189 (0.53%) 
Tibia fracture  1  1/372 (0.27%)  0/189 (0.00%) 
Investigations     
Blood creatinine increased  1  3/372 (0.81%)  0/189 (0.00%) 
Gastrointestinal stoma output increased  1  1/372 (0.27%)  0/189 (0.00%) 
White blood cell count decreased  1  1/372 (0.27%)  0/189 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite  1  1/372 (0.27%)  0/189 (0.00%) 
Dehydration  1  3/372 (0.81%)  0/189 (0.00%) 
Hyponatraemia  1  0/372 (0.00%)  1/189 (0.53%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  1/372 (0.27%)  0/189 (0.00%) 
Groin pain  1  1/372 (0.27%)  0/189 (0.00%) 
Muscular weakness  1  2/372 (0.54%)  0/189 (0.00%) 
Osteoarthritis  1  1/372 (0.27%)  0/189 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acute myeloid leukaemia  1  1/372 (0.27%)  0/189 (0.00%) 
B-cell unclassifiable lymphoma high grade  1  1/372 (0.27%)  0/189 (0.00%) 
Malignant melanoma  1  2/372 (0.54%)  0/189 (0.00%) 
Malignant neoplasm progression  1  4/372 (1.08%)  0/189 (0.00%) 
Metastases to meninges  1  0/372 (0.00%)  1/189 (0.53%) 
Myelodysplastic syndrome  1  2/372 (0.54%)  0/189 (0.00%) 
Peripheral nerve sheath tumour malignant  1  1/372 (0.27%)  0/189 (0.00%) 
Squamous cell carcinoma of lung  1  1/372 (0.27%)  0/189 (0.00%) 
Nervous system disorders     
Amnesia  1  1/372 (0.27%)  0/189 (0.00%) 
Cognitive disorder  1  1/372 (0.27%)  0/189 (0.00%) 
Hypoaesthesia  1  1/372 (0.27%)  0/189 (0.00%) 
Sciatica  1  1/372 (0.27%)  0/189 (0.00%) 
Seizure  1  3/372 (0.81%)  0/189 (0.00%) 
Psychiatric disorders     
Abnormal behaviour  1  0/372 (0.00%)  1/189 (0.53%) 
Confusional state  1  1/372 (0.27%)  0/189 (0.00%) 
Mental status changes  1  1/372 (0.27%)  0/189 (0.00%) 
Renal and urinary disorders     
Acute kidney injury  1  4/372 (1.08%)  0/189 (0.00%) 
Renal failure  1  2/372 (0.54%)  0/189 (0.00%) 
Urinary tract obstruction  1  1/372 (0.27%)  0/189 (0.00%) 
Reproductive system and breast disorders     
Female genital tract fistula  1  1/372 (0.27%)  0/189 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute pulmonary oedema  1  1/372 (0.27%)  0/189 (0.00%) 
Acute respiratory distress syndrome  1  1/372 (0.27%)  0/189 (0.00%) 
Alveolitis allergic  1  1/372 (0.27%)  0/189 (0.00%) 
Cough  1  1/372 (0.27%)  0/189 (0.00%) 
Dyspnoea  1  1/372 (0.27%)  0/189 (0.00%) 
Pleural effusion  1  1/372 (0.27%)  0/189 (0.00%) 
Pulmonary embolism  1  2/372 (0.54%)  1/189 (0.53%) 
Vascular disorders     
Hypertension  1  0/372 (0.00%)  1/189 (0.53%) 
Hypotension  1  1/372 (0.27%)  0/189 (0.00%) 
1
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
[1]
ANC = Absolute Neutrophil Count
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Rucaparib 600 mg Tablets Placebo Tablets
Affected / at Risk (%) Affected / at Risk (%)
Total   372/372 (100.00%)   182/189 (96.30%) 
Blood and lymphatic system disorders     
Combined Anaemia and/or decreased hemoglobin  1  144/372 (38.71%)  10/189 (5.29%) 
Combined Neutropenia and/or decreased ANC  1 [1]  71/372 (19.09%)  9/189 (4.76%) 
Combined Thrombocytopenia and/or decreased platelets  1  107/372 (28.76%)  5/189 (2.65%) 
Gastrointestinal disorders     
Abdominal distension  1  41/372 (11.02%)  24/189 (12.70%) 
Abdominal pain  1  112/372 (30.11%)  49/189 (25.93%) 
Abdominal pain upper  1  53/372 (14.25%)  11/189 (5.82%) 
Constipation  1  139/372 (37.37%)  46/189 (24.34%) 
Diarrhoea  1  119/372 (31.99%)  41/189 (21.69%) 
Dry mouth  1  28/372 (7.53%)  9/189 (4.76%) 
Dyspepsia  1  54/372 (14.52%)  9/189 (4.76%) 
Nausea  1  282/372 (75.81%)  68/189 (35.98%) 
Stomatitis  1  35/372 (9.41%)  5/189 (2.65%) 
Vomiting  1  138/372 (37.10%)  29/189 (15.34%) 
General disorders     
Combined Asthenia/Fatigue  1  261/372 (70.16%)  84/189 (44.44%) 
Mucosal inflammation  1  33/372 (8.87%)  9/189 (4.76%) 
Oedema peripheral  1  40/372 (10.75%)  14/189 (7.41%) 
Pyrexia  1  44/372 (11.83%)  9/189 (4.76%) 
Infections and infestations     
Influenza  1  26/372 (6.99%)  4/189 (2.12%) 
Nasopharyngitis  1  32/372 (8.60%)  11/189 (5.82%) 
Sinusitis  1  19/372 (5.11%)  3/189 (1.59%) 
Upper respiratory tract infection  1  43/372 (11.56%)  6/189 (3.17%) 
Urinary tract infection  1  33/372 (8.87%)  9/189 (4.76%) 
Investigations     
Combined ALT/AST increased  1 [2]  128/372 (34.41%)  7/189 (3.70%) 
Blood alkaline phosphatase increased  1  19/372 (5.11%)  1/189 (0.53%) 
Blood creatinine increased  1  57/372 (15.32%)  3/189 (1.59%) 
Weight decreased  1  23/372 (6.18%)  2/189 (1.06%) 
White blood cell count decreased  1  22/372 (5.91%)  8/189 (4.23%) 
Metabolism and nutrition disorders     
Decreased appetite  1  87/372 (23.39%)  26/189 (13.76%) 
Hypercholesterolaemia  1  26/372 (6.99%)  4/189 (2.12%) 
Hypomagnesaemia  1  41/372 (11.02%)  11/189 (5.82%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  57/372 (15.32%)  24/189 (12.70%) 
Back pain  1  47/372 (12.63%)  28/189 (14.81%) 
Muscle spasms  1  12/372 (3.23%)  16/189 (8.47%) 
Myalgia  1  20/372 (5.38%)  7/189 (3.70%) 
Pain in extremity  1  18/372 (4.84%)  15/189 (7.94%) 
Nervous system disorders     
Dizziness  1  57/372 (15.32%)  15/189 (7.94%) 
Dysgeusia  1  147/372 (39.52%)  13/189 (6.88%) 
Headache  1  68/372 (18.28%)  30/189 (15.87%) 
Psychiatric disorders     
Anxiety  1  27/372 (7.26%)  14/189 (7.41%) 
Depression  1  32/372 (8.60%)  6/189 (3.17%) 
Insomnia  1  53/372 (14.25%)  15/189 (7.94%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  54/372 (14.52%)  25/189 (13.23%) 
Dyspnoea  1  53/372 (14.25%)  14/189 (7.41%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  31/372 (8.33%)  14/189 (7.41%) 
Dry skin  1  33/372 (8.87%)  17/189 (8.99%) 
Erythema  1  32/372 (8.60%)  5/189 (2.65%) 
Photosensitivity reaction  1  69/372 (18.55%)  1/189 (0.53%) 
Pruritus  1  49/372 (13.17%)  20/189 (10.58%) 
Rash  1  48/372 (12.90%)  18/189 (9.52%) 
Vascular disorders     
Hot flush  1  21/372 (5.65%)  8/189 (4.23%) 
Hypertension  1  35/372 (9.41%)  16/189 (8.47%) 
1
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
[1]
ANC = Absolute Neutrophil Count
[2]
ALT = Alanine aminotransferase, AST = Aspartate aminotransferase
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.
All parties agree to submit all manuscripts or abstracts to all other parties 30 days prior to submission. This will enable all parties to protect proprietary information and to provide comments based on information that may not yet be available to other parties. The sponsor may request a delay in publication if there are important intellectual property concerns relating to publication, but does not have the right to suppress publication of the study results indefinitely.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clovis Oncology Clinical Trial Navigation Service
Organization: Clovis Oncology
Phone: 1-855-262-3040
EMail: clovistrials@emergingmed.com
Layout table for additonal information
Responsible Party: Clovis Oncology, Inc.
ClinicalTrials.gov Identifier: NCT01968213     History of Changes
Other Study ID Numbers: CO-338-014
First Submitted: October 17, 2013
First Posted: October 23, 2013
Results First Submitted: May 8, 2018
Results First Posted: August 3, 2018
Last Update Posted: August 1, 2019