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| ID | Type | Description | Link |
|---|---|---|---|
| AGICC 09CRC01 |
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This study is being carried out to see if the new drug, olaparib (AZD2281), can effectively and safely treat advanced large bowel cancer. The primary goal of this clinical trial is to determine whether olaparib will have a beneficial effect on the patient's cancer by causing a response and increasing the time it takes for the cancer to progress.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | MSI - H arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| olaparib | Drug | 400 mg po bid continuously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tumour Response | 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) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lawrence P Leichman, MD | Aptium Oncology Gastrointestinal Cancer Consortium | Principal Investigator |
| Bert H O'Neil, MD | Aptium Oncology Gastrointestinal Cancer Consortium | Principal Investigator |
| Jane Robertson, BSc, MBCHB, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Los Angeles | California | United States | |||
| Research Site |
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| Label | URL |
|---|---|
| CSR\_Synopsis\_D9010C00008 | View source |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | MSI-H | MSI-H group receiving olaparib 400mg BID |
| FG001 | Non-MSI-H | Non-MSI-H group receiving olaparib 400mg BID |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Overall Survival | 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 | 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 |
| Palm Springs |
| California |
| United States |
| Research Site | Aurora | Colorado | United States |
| Research Site | Newark | Delaware | United States |
| Research Site | New York | New York | United States |
| Research Site | Philadelphia | Pennsylvania | United States |
| Research Site | Nashville | Tennessee | United States |
| Research Site | Seattle | Washington | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MSI-H | MSI-H group receiving olaparib 400mg BID |
| BG001 | Non-MSI-H | Non-MSI-H group receiving olaparib 400mg BID |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age (years) at screening | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Gender, Male/Female | Count of Participants | Participants |
| |||||||||||||||
| Race/Ethnicity, Customized | Race | Number | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Tumour Response | 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) | Full analysis set - all treated patients | Posted | Number | 95% Confidence Interval | Percentage of Participants | 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 |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Progression Free Survival | 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. | Full analysis set - all treated patients | Posted | Median | 95% Confidence Interval | days | 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 |
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| Secondary | Overall Survival | 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 | Full analysis set - all treated patients | Posted | Median | 95% Confidence Interval | days | 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 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MSI-H | MSI-H group receiving olaparib 400mg BID | 6 | 13 | 12 | 13 | ||
| EG001 | Non-MSI-H | Non-MSI-H group receiving olaparib 400mg BID | 3 | 20 | 20 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders |
| |||
| Nodal rhythm | Cardiac disorders |
| |||
| Abdominal pain | Gastrointestinal disorders |
| |||
| Ascites | Gastrointestinal disorders |
| |||
| Gastrointestinal haemorrhage | Gastrointestinal disorders |
| |||
| Intestinal obstruction | Gastrointestinal disorders |
| |||
| Small intestinal obstruction | Gastrointestinal disorders |
| |||
| Mucosal inflammation | General disorders |
| |||
| Oedema peripheral | General disorders |
| |||
| Urinary tract infection | Infections and infestations |
| |||
| Vena cava injury | Injury, poisoning and procedural complications |
| |||
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| Headache | Nervous system disorders |
| |||
| Hydronephrosis | Renal and urinary disorders |
| |||
| Renal failure acute | Renal and urinary disorders |
| |||
| Ureteric obstruction | Renal and urinary disorders |
| |||
| Vaginal haemorrhage | Reproductive system and breast disorders |
| |||
| Pleural effusion | Respiratory, thoracic and mediastinal disorders |
| |||
| Deep vein thrombosis | Vascular disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders |
| |||
| Neutropenia | Blood and lymphatic system disorders |
| |||
| Thrombocytopenia | Blood and lymphatic system disorders |
| |||
| Abdominal pain | Gastrointestinal disorders |
| |||
| Constipation | Gastrointestinal disorders |
| |||
| Diarrhoea | Gastrointestinal disorders |
| |||
| Dyspepsia | Gastrointestinal disorders |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Vomiting | Gastrointestinal disorders |
| |||
| Fatigue | General disorders |
| |||
| Oedema peripheral | General disorders |
| |||
| Blood creatinine increased | Investigations |
| |||
| Haemoglobin decreased | Investigations |
| |||
| Anorexia | Metabolism and nutrition disorders |
| |||
| Dizziness | Nervous system disorders |
| |||
| Dysgeusia | Nervous system disorders |
| |||
| Headache | Nervous system disorders |
| |||
| Insomnia | Psychiatric disorders |
| |||
| Cough | Respiratory, thoracic and mediastinal disorders |
| |||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders |
| |||
| Rash | Skin and subcutaneous tissue disorders |
| |||
| Leukopenia | Blood and lymphatic system disorders |
| |||
| Abdominal distension | Gastrointestinal disorders |
| |||
| Ascites | Gastrointestinal disorders |
| |||
| Small intestinal obstruction | Gastrointestinal disorders |
| |||
| Stomatitis | Gastrointestinal disorders |
| |||
| Chills | General disorders |
| |||
| Oedema | General disorders |
| |||
| Pyrexia | General disorders |
| |||
| Urinary tract infection | Infections and infestations |
| |||
| Abnormal loss of weight | Metabolism and nutrition disorders |
| |||
| Decreased appetite | Metabolism and nutrition disorders |
| |||
| Dehydration | Metabolism and nutrition disorders |
| |||
| Hypercalcaemia | Metabolism and nutrition disorders |
| |||
| Hyperkalaemia | Metabolism and nutrition disorders |
| |||
| Arthralgia | Musculoskeletal and connective tissue disorders |
| |||
| Back pain | Musculoskeletal and connective tissue disorders |
| |||
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders |
| |||
| Myalgia | Musculoskeletal and connective tissue disorders |
| |||
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| Neuropathy peripheral | Nervous system disorders |
| |||
| Anxiety | Psychiatric disorders |
| |||
| Haematuria | Renal and urinary disorders |
| |||
| Hydronephrosis | Renal and urinary disorders |
| |||
| Nocturia | Renal and urinary disorders |
| |||
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders |
| |||
| Pleural effusion | Respiratory, thoracic and mediastinal disorders |
| |||
| Erythema | Skin and subcutaneous tissue disorders |
| |||
| Deep vein thrombosis | Vascular disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Angela Sawyer, Clinical Delivery Director | Astra Zeneca LLP | +44 1625 512397 | angele.sawyer@astrazeneca.com |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| C531550 | olaparib |
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| Male |
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| Black or African American |
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| Asian |
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| Other |
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