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Open Label Study to Assess Efficacy and Safety of Olaparib in Confirmed Genetic BRCA1 or BRCA2 Mutation Pats

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: NCT01078662
Recruitment Status : Active, not recruiting
First Posted : March 2, 2010
Results First Posted : May 22, 2015
Last Update Posted : December 11, 2019
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Ovarian
Breast
Prostate
Pancreatic
Advanced Tumours
Intervention Drug: olaparib
Enrollment 299
Recruitment Details This study was conducted at 13 sites across Israel, Germany, Spain, Australia, USA, Sweden. Enrolment started in Feb 2010 and was completed in Jul 2012. In total, 318 patients of different cancer types were enrolled out of which 298 patients received olaparib.
Pre-assignment Details Patients >17 years age with histologically and/or cytologically confirmed malignant solid tumours, refractory to standard therapy for which no suitable effective/curative therapy. Patients with confirmed deleterious or suspected deleterious BRCA mutation, Eastern Co-operative Oncology Group performance status ≤2 and life expectancy of ≥12 weeks.
Arm/Group Title Breast Cancer Ovarian Cancer Pancreatic Cancer Prostate Cancer Other Cancers
Hide Arm/Group Description Patients with primary cancer site = breast. Receiving olaparib 400mg BID Patients with primary cancer site = ovary. Receiving olaparib 400mg BID Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID Patients with primary cancer site = prostate. Receiving olaparib 400mg BID Patients with other primary cancers. Receiving olaparib 400mg BID
Period Title: Overall Study
Started 62 193 23 8 12
Completed 4 25 2 1 1
Not Completed 58 168 21 7 11
Reason Not Completed
Death             41             103             18             5             8
Patients reached data cut-off             12             53             2             2             3
Withdrawal by Subject             4             11             1             0             0
Protocol Violation             0             1             0             0             0
Lost to Follow-up             1             0             0             0             0
Arm/Group Title Breast Cancer Ovarian Cancer Pancreatic Cancer Prostate Cancer Other Cancers Total
Hide Arm/Group Description Patients with primary cancer site = breast. Receiving olaparib 400mg BID Patients with primary cancer site = ovary. Receiving olaparib 400mg BID Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID Patients with primary cancer site = prostate. Receiving olaparib 400mg BID Patients with other primary cancers. Receiving olaparib 400mg BID Total of all reporting groups
Overall Number of Baseline Participants 62 193 23 8 12 298
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 62 participants 193 participants 23 participants 8 participants 12 participants 298 participants
47.6  (9.69) 57.2  (9.28) 57.1  (7.99) 66.6  (9.86) 54.9  (12.38) 55.3  (10.3)
[1]
Measure Description: Age at time of screening
Age, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 62 participants 193 participants 23 participants 8 participants 12 participants 298 participants
< 50 years 33 40 6 0 4 83
>=50 to <65 years 28 117 14 3 5 167
>= 65 years 1 36 3 5 3 48
[1]
Measure Description: Age by category
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 193 participants 23 participants 8 participants 12 participants 298 participants
Female
61
  98.4%
193
 100.0%
10
  43.5%
0
   0.0%
8
  66.7%
272
  91.3%
Male
1
   1.6%
0
   0.0%
13
  56.5%
8
 100.0%
4
  33.3%
26
   8.7%
[1]
Measure Description: Gender
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 62 participants 193 participants 23 participants 8 participants 12 participants 298 participants
White 60 183 21 8 11 283
Black or African American 0 1 1 0 0 2
Asian 1 8 1 0 1 11
Other 1 1 0 0 0 2
[1]
Measure Description: Race
1.Primary Outcome
Title Tumour Response Rate
Hide Description Tumour response rate is the proportion of patients who experienced complete or partial response at least once during the assessment period, according to the definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1).
Time Frame Tumour assessments carried out at baseline ie 28 days before first study drug dose and then every 8 weeks up to 6 months after starting study treatment, then every 12 weeks until objective disease progression, assessed maximum up to 29 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set - all treated patients
Arm/Group Title Breast Cancer Ovarian Cancer Pancreatic Cancer Prostate Cancer Other Cancers All Patients
Hide Arm/Group Description:
Patients with primary cancer site = breast. Receiving olaparib 400mg BID
Patients with primary cancer site = ovary. Receiving olaparib 400mg BID
Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID
Patients with primary cancer site = prostate. Receiving olaparib 400mg BID
Patients with other primary cancers. Receiving olaparib 400mg BID
Patients of different cancer types
Overall Number of Participants Analyzed 62 193 23 8 12 298
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
12.9
(5.74 to 23.85)
31.1
(24.64 to 38.13)
21.7
(7.46 to 43.7)
50
(15.7 to 84.3)
8.3
(0.21 to 38.48)
26.2
(21.27 to 31.55)
2.Secondary Outcome
Title Objective Response Rate
Hide Description Objective response rate is the proportion of patients with at least one measurable lesion at baseline, who experienced complete or partial response at least once during the assessment period, according to the definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1).
Time Frame Tumour assessments carried out at baseline ie 28 days before first study drug dose and then every 8 weeks up to 6 months after starting study treatment, then every 12 weeks until objective disease progression, assessed maximum up to 29 months
Hide Outcome Measure Data
Hide Analysis Population Description
Measurable disease analysis set - all treated patients having at least one measurable lesion at baseline
Arm/Group Title Breast Cancer Ovarian Cancer Pancreatic Cancer Prostate Cancer Other Cancers All Patients
Hide Arm/Group Description:
Patients with primary cancer site = breast. Receiving olaparib 400mg BID
Patients with primary cancer site = ovary. Receiving olaparib 400mg BID
Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID
Patients with primary cancer site = prostate. Receiving olaparib 400mg BID
Patients with other primary cancers. Receiving olaparib 400mg BID
Patients of different cancer types
Overall Number of Participants Analyzed 58 167 23 7 11 266
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
13.8
(6.15 to 25.38)
35.9
(28.66 to 43.7)
21.7
(7.46 to 43.7)
57.1
(18.41 to 90.1)
9.1
(0.23 to 41.28)
29.3
(23.92 to 35.19)
3.Secondary Outcome
Title Progression Free Survival
Hide Description Progression free survival is defined as the duration from first dose till objective progression or death. In absence of progression or death, the time is calculated from first dose till last evaluable scanning visit.
Time Frame Tumour assessments are carried out at baseline ie 28 days before first study drug dose and then every 8 weeks up to 6 months after starting study treatment, then every 12 weeks until objective disease progression, assessed maximum up to 29 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set - all treated patients. The Other cancer group was not analysed in accordance with the protocol.
Arm/Group Title Breast Cancer Ovarian Cancer Pancreatic Cancer Prostate Cancer
Hide Arm/Group Description:
Patients with primary cancer site = breast. Receiving olaparib 400mg BID
Patients with primary cancer site = ovary. Receiving olaparib 400mg BID
Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID
Patients with primary cancer site = prostate. Receiving olaparib 400mg BID
Overall Number of Participants Analyzed 62 193 23 8
Median (Inter-Quartile Range)
Unit of Measure: months
3.68
(1.76 to 7.52)
7.03
(3.65 to 11.24)
4.55
(1.81 to 8.21)
7.15
(2.63 to 17.45)
4.Secondary Outcome
Title Overall Survival
Hide Description Overall survival is defined as the duration from first dose till death. In absence of death, the time is calculated from first dose till the date subject last known to be alive.
Time Frame Survival follow-up from first dose till death of the patient or till end of study in absence of death, assessed maximum up to 29 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set - all treated patients. The Other cancer group was not analysed in accordance with the protocol.
Arm/Group Title Breast Cancer Ovarian Cancer Pancreatic Cancer Prostate Cancer
Hide Arm/Group Description:
Patients with primary cancer site = breast. Receiving olaparib 400mg BID
Patients with primary cancer site = ovary. Receiving olaparib 400mg BID
Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID
Patients with primary cancer site = prostate. Receiving olaparib 400mg BID
Overall Number of Participants Analyzed 62 193 23 8
Median (Inter-Quartile Range)
Unit of Measure: months
11.01
(5.68 to 24.18)
16.62 [1] 
(9.43 to NA)
9.81
(3.84 to 16.62)
18.38
(6.24 to 25.46)
[1]
No enough data to calculate upper limit
5.Secondary Outcome
Title Overall Survival Rate at 12 Months
Hide Description Overall survival rate at 12 months is defined as the proportion of patients who are alive 12 months after date of first dose
Time Frame Survival follow-up from first dose till death of the patient or till end of study in absence of death, assessed maximum up to 29 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set - all treated patients. The Other cancer group was not analysed in accordance with the protocol.
Arm/Group Title Breast Cancer Ovarian Cancer Pancreatic Cancer Prostate Cancer
Hide Arm/Group Description:
Patients with primary cancer site = breast. Receiving olaparib 400mg BID
Patients with primary cancer site = ovary. Receiving olaparib 400mg BID
Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID
Patients with primary cancer site = prostate. Receiving olaparib 400mg BID
Overall Number of Participants Analyzed 62 193 23 8
Measure Type: Number
Unit of Measure: Percentage of participants
44.7 64.4 40.9 50
6.Secondary Outcome
Title Duration of Response
Hide Description Duration of response is calculated from the date of first documented response (complete or partial) until date of documented progression (as defined by RECIST 1.1) or death (by any cause) in the absence of disease progression.
Time Frame From onset of first occurrence of complete or partial response till documented progression or death by any cause in the absence of progression, assessed maximum up to 29 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set - all treated patients who had at least one complete or partial response during the assessment period.
Arm/Group Title Breast Cancer Ovarian Cancer Pancreatic Cancer Prostate Cancer Other Cancers All Patients
Hide Arm/Group Description:
Patients with primary cancer site = breast. Receiving olaparib 400mg BID
Patients with primary cancer site = ovary. Receiving olaparib 400mg BID
Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID
Patients with primary cancer site = prostate. Receiving olaparib 400mg BID
Patients with other primary cancers. Receiving olaparib 400mg BID
Patients of different cancer types
Overall Number of Participants Analyzed 8 60 5 4 1 78
Median (Inter-Quartile Range)
Unit of Measure: days
204
(149.5 to 405)
225
(143 to 410)
134
(131 to 141)
326.5
(164 to 476)
165
(165 to 165)
208
(134 to 410)
7.Secondary Outcome
Title Disease Control Rate at Week 16
Hide Description Disease control rate is the proportion of patients with best response of complete or partial response or stable disease according to definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) till week 16.
Time Frame Tumour assessments carried out at baseline ie 28 days before first study drug dose and then at week 8 and week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set - all treated patients
Arm/Group Title Breast Cancer Ovarian Cancer Pancreatic Cancer Prostate Cancer Other Cancers All Patients
Hide Arm/Group Description:
Patients with primary cancer site = breast. Receiving olaparib 400mg BID
Patients with primary cancer site = ovary. Receiving olaparib 400mg BID
Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID
Patients with primary cancer site = prostate. Receiving olaparib 400mg BID
Patients with other primary cancers. Receiving olaparib 400mg BID
Patients of different cancer types
Overall Number of Participants Analyzed 62 193 23 8 12 298
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
37.1
(25.16 to 50.31)
58
(50.73 to 65.08)
47.8
(26.82 to 69.41)
62.5
(24.49 to 91.48)
33.3
(9.92 to 65.11)
52
(46.18 to 57.81)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title OLAPARIB
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
OLAPARIB
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
OLAPARIB
Affected / at Risk (%) # Events
Total   90/298 (30.20%)    
Blood and lymphatic system disorders   
ANAEMIA  1  13/298 (4.36%)  14
THROMBOCYTOPENIA  1  3/298 (1.01%)  3
FEBRILE NEUTROPENIA  1  2/298 (0.67%)  2
LEUKOPENIA  1  1/298 (0.34%)  1
NEUTROPENIA  1  3/298 (1.01%)  3
Cardiac disorders   
PERICARDIAL EFFUSION  1  2/298 (0.67%)  3
Ear and labyrinth disorders   
VERTIGO  1  1/298 (0.34%)  1
Eye disorders   
DIPLOPIA  1  1/298 (0.34%)  1
RETINAL DETACHMENT  1  1/298 (0.34%)  1
Gastrointestinal disorders   
ENTERITIS  1  1/298 (0.34%)  1
INTESTINAL MASS  1  1/298 (0.34%)  1
INTESTINAL OBSTRUCTION  1  7/298 (2.35%)  8
LARGE INTESTINAL OBSTRUCTION  1  1/298 (0.34%)  1
OBSTRUCTION GASTRIC  1  1/298 (0.34%)  1
ABDOMINAL HERNIA  1  1/298 (0.34%)  1
ABDOMINAL PAIN  1  11/298 (3.69%)  12
ASCITES  1  1/298 (0.34%)  1
CONSTIPATION  1  1/298 (0.34%)  1
DYSPHAGIA  1  3/298 (1.01%)  4
GASTROINTESTINAL OBSTRUCTION  1  2/298 (0.67%)  2
GASTROINTESTINAL PERFORATION  1  1/298 (0.34%)  1
ILEUS  1  1/298 (0.34%)  1
NAUSEA  1  1/298 (0.34%)  1
OESOPHAGEAL STENOSIS  1  1/298 (0.34%)  1
PANCREATITIS  1  1/298 (0.34%)  1
RECTAL HAEMORRHAGE  1  1/298 (0.34%)  1
SMALL INTESTINAL OBSTRUCTION  1  7/298 (2.35%)  9
VOMITING  1  5/298 (1.68%)  6
General disorders   
DEVICE OCCLUSION  1  1/298 (0.34%)  1
FATIGUE  1  1/298 (0.34%)  1
NON-CARDIAC CHEST PAIN  1  1/298 (0.34%)  1
PYREXIA  1  3/298 (1.01%)  3
Hepatobiliary disorders   
CHOLANGITIS  1  1/298 (0.34%)  1
Infections and infestations   
DEVICE RELATED SEPSIS  1  1/298 (0.34%)  1
GASTROENTERITIS  1  2/298 (0.67%)  2
STAPHYLOCOCCAL SEPSIS  1  1/298 (0.34%)  1
URINARY TRACT INFECTION  1  2/298 (0.67%)  2
ABDOMINAL ABSCESS  1  1/298 (0.34%)  1
BACTERAEMIA  1  1/298 (0.34%)  1
DEVICE RELATED INFECTION  1  1/298 (0.34%)  1
ENTEROBACTER SEPSIS  1  1/298 (0.34%)  1
INFECTION  1  1/298 (0.34%)  1
PNEUMONIA  1  4/298 (1.34%)  4
POSTOPERATIVE WOUND INFECTION  1  1/298 (0.34%)  2
SEPSIS  1  1/298 (0.34%)  1
UPPER RESPIRATORY TRACT INFECTION  1  1/298 (0.34%)  1
UPPER RESPIRATORY TRACT INFECTION BACTERIAL  1  1/298 (0.34%)  1
Injury, poisoning and procedural complications   
TOXICITY TO VARIOUS AGENTS  1  1/298 (0.34%)  1
WOUND DEHISCENCE  1  1/298 (0.34%)  1
HIP FRACTURE  1  1/298 (0.34%)  1
PROCEDURAL HAEMORRHAGE  1  1/298 (0.34%)  1
Investigations   
HAEMOGLOBIN DECREASED  1  2/298 (0.67%)  2
NEUTROPHIL COUNT DECREASED  1  1/298 (0.34%)  1
PLATELET COUNT DECREASED  1  1/298 (0.34%)  1
WHITE BLOOD CELL COUNT DECREASED  1  1/298 (0.34%)  1
Metabolism and nutrition disorders   
HYPONATRAEMIA  1  1/298 (0.34%)  1
HYPERKALAEMIA  1  1/298 (0.34%)  1
HYPOKALAEMIA  1  1/298 (0.34%)  1
Musculoskeletal and connective tissue disorders   
GROIN PAIN  1  1/298 (0.34%)  1
HAEMARTHROSIS  1  1/298 (0.34%)  1
MUSCULAR WEAKNESS  1  2/298 (0.67%)  2
OSTEONECROSIS OF JAW  1  1/298 (0.34%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
ACUTE LEUKAEMIA  1  1/298 (0.34%)  1
ACUTE MYELOID LEUKAEMIA  1  1/298 (0.34%)  1
GASTRIC CANCER  1  1/298 (0.34%)  1
Nervous system disorders   
CEREBRAL ISCHAEMIA  1  1/298 (0.34%)  1
CEREBROVASCULAR ACCIDENT  1  2/298 (0.67%)  3
SYNCOPE  1  2/298 (0.67%)  2
Psychiatric disorders   
ANXIETY  1  1/298 (0.34%)  1
SUICIDE ATTEMPT  1  1/298 (0.34%)  1
Renal and urinary disorders   
RENAL FAILURE ACUTE  1  1/298 (0.34%)  1
URINARY RETENTION  1  1/298 (0.34%)  1
Reproductive system and breast disorders   
VAGINAL HAEMORRHAGE  1  1/298 (0.34%)  1
Respiratory, thoracic and mediastinal disorders   
COUGH  1  1/298 (0.34%)  1
CHRONIC OBSTRUCTIVE PULMONARY DISEASE  1  1/298 (0.34%)  1
DYSPNOEA  1  4/298 (1.34%)  4
PLEURAL EFFUSION  1  4/298 (1.34%)  4
PULMONARY EMBOLISM  1  4/298 (1.34%)  4
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
OLAPARIB
Affected / at Risk (%) # Events
Total   290/298 (97.32%)    
Blood and lymphatic system disorders   
ANAEMIA  1  90/298 (30.20%)  120
THROMBOCYTOPENIA  1  28/298 (9.40%)  36
LEUKOPENIA  1  23/298 (7.72%)  35
Gastrointestinal disorders   
DRY MOUTH  1  19/298 (6.38%)  20
DYSPEPSIA  1  52/298 (17.45%)  54
ABDOMINAL DISTENSION  1  33/298 (11.07%)  35
ABDOMINAL PAIN  1  66/298 (22.15%)  85
ABDOMINAL PAIN UPPER  1  25/298 (8.39%)  27
CONSTIPATION  1  42/298 (14.09%)  53
DIARRHOEA  1  81/298 (27.18%)  103
FLATULENCE  1  23/298 (7.72%)  28
NAUSEA  1  176/298 (59.06%)  218
VOMITING  1  109/298 (36.58%)  158
General disorders   
ASTHENIA  1  25/298 (8.39%)  33
FATIGUE  1  176/298 (59.06%)  199
OEDEMA PERIPHERAL  1  41/298 (13.76%)  48
PYREXIA  1  37/298 (12.42%)  51
Infections and infestations   
NASOPHARYNGITIS  1  23/298 (7.72%)  26
UPPER RESPIRATORY TRACT INFECTION  1  23/298 (7.72%)  29
URINARY TRACT INFECTION  1  30/298 (10.07%)  44
Investigations   
BLOOD CREATININE INCREASED  1  21/298 (7.05%)  21
WEIGHT DECREASED  1  26/298 (8.72%)  26
Metabolism and nutrition disorders   
DECREASED APPETITE  1  62/298 (20.81%)  67
Musculoskeletal and connective tissue disorders   
MUSCULOSKELETAL PAIN  1  17/298 (5.70%)  18
ARTHRALGIA  1  27/298 (9.06%)  33
BACK PAIN  1  37/298 (12.42%)  43
MUSCLE SPASMS  1  27/298 (9.06%)  31
MUSCULOSKELETAL CHEST PAIN  1  15/298 (5.03%)  16
PAIN IN EXTREMITY  1  25/298 (8.39%)  26
Nervous system disorders   
DIZZINESS  1  34/298 (11.41%)  34
DYSGEUSIA  1  47/298 (15.77%)  47
HEADACHE  1  48/298 (16.11%)  60
Psychiatric disorders   
ANXIETY  1  17/298 (5.70%)  17
DEPRESSION  1  19/298 (6.38%)  19
INSOMNIA  1  22/298 (7.38%)  22
Respiratory, thoracic and mediastinal disorders   
OROPHARYNGEAL PAIN  1  16/298 (5.37%)  18
COUGH  1  42/298 (14.09%)  52
DYSPNOEA  1  36/298 (12.08%)  44
DYSPNOEA EXERTIONAL  1  15/298 (5.03%)  15
Skin and subcutaneous tissue disorders   
RASH  1  15/298 (5.03%)  16
Vascular disorders   
HOT FLUSH  1  19/298 (6.38%)  20
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Anitra Fielding
Organization: AstraZeneca
Phone: +44 1625 517178
EMail: aztrial_results_posting@astrazeneca.com
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01078662    
Other Study ID Numbers: D0810C00042
First Submitted: March 1, 2010
First Posted: March 2, 2010
Results First Submitted: January 13, 2015
Results First Posted: May 22, 2015
Last Update Posted: December 11, 2019