ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety of Olaparib in Pretreated Patients With Measurable Colorectal Cancer, Stratified by Microsatellite Instability (MSI) Status

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: NCT00912743
Recruitment Status : Completed
First Posted : June 3, 2009
Results First Posted : November 9, 2016
Last Update Posted : November 9, 2016
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Colorectal Cancer
Intervention Drug: olaparib
Enrollment 33

Recruitment Details Target accrual: 54 subjects. MSI-H group: 15; non-MSI-H group: 39. Pre-planned interim analysis of the non-MSI-H cohort, after 17 patients, stopped recruitment into that cohort. Recruitment to the MSI-H cohort continued.
Pre-assignment Details Subjects with stage IV, measurable disseminated CRC incurable by surgery, with tumour progression following standard combination front-line or second-line chemotherapy, relapsed or recurrent disease within 6 months completing adjuvant or neoadjuvant chemotherapy and met all inclusion/exlusion criteria.
Arm/Group Title MSI-H Non-MSI-H
Hide Arm/Group Description MSI-H group receiving olaparib 400mg BID Non-MSI-H group receiving olaparib 400mg BID
Period Title: Overall Study
Started 13 20
Completed 0 0
Not Completed 13 20
Reason Not Completed
Adverse Event             3             1
Lack of Efficacy             9             18
Toxicity             0             1
End of treatment form was not collected             1             0
Arm/Group Title MSI-H Non-MSI-H Total
Hide Arm/Group Description MSI-H group receiving olaparib 400mg BID Non-MSI-H group receiving olaparib 400mg BID Total of all reporting groups
Overall Number of Baseline Participants 13 20 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 20 participants 33 participants
51.77  (9.37) 61.80  (11.46) 57.85  (11.65)
[1]
Measure Description: Age (years) at screening
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 20 participants 33 participants
Female
6
  46.2%
9
  45.0%
15
  45.5%
Male
7
  53.8%
11
  55.0%
18
  54.5%
[1]
Measure Description: Gender, Male/Female
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 13 participants 20 participants 33 participants
White 10 19 29
Black or African American 1 0 1
Asian 1 0 1
Other 1 1 2
[1]
Measure Description: Race
1.Primary Outcome
Title Tumour Response
Hide Description Tumour response is the number 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 From baseline, i.e. up to 28 days before first study drug dose, and then every 2 cycles (8 weeks) up to objective disease progression by RECIST, assessed up to 35 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set - all treated patients
Arm/Group Title MSI-H Non-MSI-H
Hide Arm/Group Description:
MSI-H group receiving olaparib 400mg BID
Non-MSI-H group receiving olaparib 400mg BID
Overall Number of Participants Analyzed 13 20
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
0
(0 to 25)
0
(0 to 17)
2.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 From baseline, i.e. up to 28 days before first study drug dose, and then every 2 cycles (8 weeks) up to objective disease progression by RECIST, assessed up to 35 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set - all treated patients
Arm/Group Title MSI-H Non-MSI-H
Hide Arm/Group Description:
MSI-H group receiving olaparib 400mg BID
Non-MSI-H group receiving olaparib 400mg BID
Overall Number of Participants Analyzed 13 20
Median (95% Confidence Interval)
Unit of Measure: days
61
(52 to 360)
55
(49 to 56)
3.Secondary Outcome
Title Overall Survival
Hide Description Overall survival is defined as the duration from first dose till death from any cause. 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 up to 35 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set - all treated patients
Arm/Group Title MSI-H Non-MSI-H
Hide Arm/Group Description:
MSI-H group receiving olaparib 400mg BID
Non-MSI-H group receiving olaparib 400mg BID
Overall Number of Participants Analyzed 13 20
Median (95% Confidence Interval)
Unit of Measure: days
248
(121 to 554)
290.5
(157 to 429)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MSI-H Non-MSI-H
Hide Arm/Group Description MSI-H group receiving olaparib 400mg BID Non-MSI-H group receiving olaparib 400mg BID
All-Cause Mortality
MSI-H Non-MSI-H
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
MSI-H Non-MSI-H
Affected / at Risk (%) Affected / at Risk (%)
Total   6/13 (46.15%)   3/20 (15.00%) 
Blood and lymphatic system disorders     
Anaemia  1/13 (7.69%)  0/20 (0.00%) 
Cardiac disorders     
Nodal rhythm  1/13 (7.69%)  0/20 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1/13 (7.69%)  0/20 (0.00%) 
Ascites  1/13 (7.69%)  0/20 (0.00%) 
Gastrointestinal haemorrhage  1/13 (7.69%)  0/20 (0.00%) 
Intestinal obstruction  1/13 (7.69%)  0/20 (0.00%) 
Small intestinal obstruction  2/13 (15.38%)  0/20 (0.00%) 
General disorders     
Mucosal inflammation  1/13 (7.69%)  0/20 (0.00%) 
Oedema peripheral  1/13 (7.69%)  0/20 (0.00%) 
Infections and infestations     
Urinary tract infection  1/13 (7.69%)  0/20 (0.00%) 
Injury, poisoning and procedural complications     
Vena cava injury  1/13 (7.69%)  0/20 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tumour pain  0/13 (0.00%)  1/20 (5.00%) 
Nervous system disorders     
Headache  0/13 (0.00%)  1/20 (5.00%) 
Renal and urinary disorders     
Hydronephrosis  2/13 (15.38%)  0/20 (0.00%) 
Renal failure acute  1/13 (7.69%)  0/20 (0.00%) 
Ureteric obstruction  1/13 (7.69%)  0/20 (0.00%) 
Reproductive system and breast disorders     
Vaginal haemorrhage  1/13 (7.69%)  0/20 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pleural effusion  1/13 (7.69%)  0/20 (0.00%) 
Vascular disorders     
Deep vein thrombosis  1/13 (7.69%)  1/20 (5.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MSI-H Non-MSI-H
Affected / at Risk (%) Affected / at Risk (%)
Total   12/13 (92.31%)   20/20 (100.00%) 
Blood and lymphatic system disorders     
Anaemia  6/13 (46.15%)  7/20 (35.00%) 
Neutropenia  1/13 (7.69%)  3/20 (15.00%) 
Thrombocytopenia  1/13 (7.69%)  4/20 (20.00%) 
Leukopenia  1/13 (7.69%)  1/20 (5.00%) 
Gastrointestinal disorders     
Abdominal pain  3/13 (23.08%)  4/20 (20.00%) 
Constipation  5/13 (38.46%)  3/20 (15.00%) 
Diarrhoea  2/13 (15.38%)  5/20 (25.00%) 
Dyspepsia  2/13 (15.38%)  3/20 (15.00%) 
Nausea  8/13 (61.54%)  15/20 (75.00%) 
Vomiting  6/13 (46.15%)  9/20 (45.00%) 
Abdominal distension  0/13 (0.00%)  2/20 (10.00%) 
Ascites  1/13 (7.69%)  1/20 (5.00%) 
Small intestinal obstruction  2/13 (15.38%)  0/20 (0.00%) 
Stomatitis  0/13 (0.00%)  2/20 (10.00%) 
General disorders     
Fatigue  5/13 (38.46%)  8/20 (40.00%) 
Oedema peripheral  2/13 (15.38%)  4/20 (20.00%) 
Chills  1/13 (7.69%)  2/20 (10.00%) 
Oedema  0/13 (0.00%)  2/20 (10.00%) 
Pyrexia  1/13 (7.69%)  2/20 (10.00%) 
Infections and infestations     
Urinary tract infection  1/13 (7.69%)  2/20 (10.00%) 
Investigations     
Blood creatinine increased  2/13 (15.38%)  2/20 (10.00%) 
Haemoglobin decreased  1/13 (7.69%)  3/20 (15.00%) 
Metabolism and nutrition disorders     
Anorexia  3/13 (23.08%)  5/20 (25.00%) 
Abnormal loss of weight  0/13 (0.00%)  2/20 (10.00%) 
Decreased appetite  1/13 (7.69%)  1/20 (5.00%) 
Dehydration  1/13 (7.69%)  2/20 (10.00%) 
Hypercalcaemia  1/13 (7.69%)  1/20 (5.00%) 
Hyperkalaemia  1/13 (7.69%)  1/20 (5.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  0/13 (0.00%)  2/20 (10.00%) 
Back pain  1/13 (7.69%)  1/20 (5.00%) 
Musculoskeletal pain  0/13 (0.00%)  2/20 (10.00%) 
Myalgia  0/13 (0.00%)  3/20 (15.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tumour pain  0/13 (0.00%)  2/20 (10.00%) 
Nervous system disorders     
Dizziness  3/13 (23.08%)  1/20 (5.00%) 
Dysgeusia  0/13 (0.00%)  4/20 (20.00%) 
Headache  2/13 (15.38%)  4/20 (20.00%) 
Neuropathy peripheral  1/13 (7.69%)  1/20 (5.00%) 
Psychiatric disorders     
Insomnia  2/13 (15.38%)  2/20 (10.00%) 
Anxiety  2/13 (15.38%)  0/20 (0.00%) 
Renal and urinary disorders     
Haematuria  0/13 (0.00%)  2/20 (10.00%) 
Hydronephrosis  3/13 (23.08%)  0/20 (0.00%) 
Nocturia  0/13 (0.00%)  2/20 (10.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  0/13 (0.00%)  4/20 (20.00%) 
Dyspnoea  1/13 (7.69%)  3/20 (15.00%) 
Dyspnoea exertional  2/13 (15.38%)  0/20 (0.00%) 
Pleural effusion  1/13 (7.69%)  1/20 (5.00%) 
Skin and subcutaneous tissue disorders     
Rash  3/13 (23.08%)  3/20 (15.00%) 
Erythema  0/13 (0.00%)  2/20 (10.00%) 
Vascular disorders     
Deep vein thrombosis  1/13 (7.69%)  1/20 (5.00%) 
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
Name/Title: Angela Sawyer, Clinical Delivery Director
Organization: Astra Zeneca LLP
Phone: +44 1625 512397
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00912743     History of Changes
Other Study ID Numbers: D9010C00008
AGICC 09CRC01
First Submitted: May 28, 2009
First Posted: June 3, 2009
Results First Submitted: January 13, 2015
Results First Posted: November 9, 2016
Last Update Posted: November 9, 2016