Serous ovarian cancer MedDRA version: 12.0 Level: LLT Classification code 10033128 Term: Ovarian cancer
Conditions
Interventions
Product Name: olaparib
Product Code: AZD2281, KU-0059436
Pharmaceutical Form: Capsule*
INN or Proposed INN: olaparib
CAS Number: 763113-22-0
Current Sponsor code: AZD2281 (KU-0059436)
Concentration u
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of fully informed consent prior to any study specific procedures 2. Patients must be > 18 years of age. 3. Histologically or cytologically diagnosed serous ovarian cancer or recurrent serous ovarian cancer including primary peritoneal and fallopian tube cancer stage IIIB/IIIC/IV. This includes patients who have developed recurrent ovarian cancer with macroscopic peritoneal metastases outside the pelvis or distant metastases. 4. Patients who have received > one previous platinum containing regimen and were progression free for a minimum of 6 months following completion of their last platinum containing regimen, prior to enrolment on the study. 5. At least one lesion, not previously irradiated, that can be accurately measured at baseline as = 10 mm in the longest diameter (except lymph nodes which must have short axis = 15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and which is suitable for accurate repeated measurements. 6. Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment. 7. ECOG performance status = 2 (see Appendix F) 8. Patients must have a life expectancy = 24 weeks. 9. Evidence of non-childbearing status for women of childbearing potential, or postmenopausal status: negative urine or serum pregnancy test within 28 days of study treatment, confirmed prior to treatment on day 1. 10. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients receiving any systemic anticancer chemotherapy, radiotherapy (except for palliative reasons), within 2 weeks from the last dose prior to study treatment (or a longer period depending on the defined characteristics of the agents used). The patient can receive a stable dose of bisphosphonates for bone metastases, before and during the study as long as these were started at least 4 weeks prior to treatment. 2. Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, Ductal Carcinoma in Situ (DCIS), stage 1 grade 1 endometrial carcinoma, or other solid tumours including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for = 5 years. 3. Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required. The patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 4 weeks prior to treatment. 4. Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery. 5. Patients with severe hypersensitivity reactions to paclitaxel, macrogolglycerol ricinoleate (polyoxyl castor oil) or to any of the excipients in paclitaxel. 6. Patients with a known hypersensitivity to olaparib or any of the excipients of the products 7. Patients with a history of severe allergic reaction to carboplatin or other platinum containing compounds. 8. Hypersensitivity to pre-medications required for treatment with carboplatin / paclitaxel . 9. Any previous treatment with a PARP inhibitor, including olaparib. 10. Patients receiving the following classes of inhibitors of CYP3A4 (see Section 5.6.1 for guidelines and wash out periods). 11. Persisting toxicities (>CTCAE grade 2) caused by previous cancer therapy. 12. Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent. 13. Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication. 14. Breast feeding women. 15. Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV). 16. Patients with known active hepatic disease (i.e., Hepatitis B or C). 17. Patients with uncontrolled seizures. 18. Previous randomisation in the present study. 19. Participation in another clinical study with an investigational product during the last 14 days. 20. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: The secondary objectives of this study are to: - compare the efficacy of oral olaparib in combination with carboplatin and paclitaxel versus carboplatin and paclitaxel alone by assessment of progression free survival rate (PFS) at 18 weeks, objective response rate (ORR), CA 125 response rate, and percentage change in CA-125. - compare the safety and tolerability of oral olaparib in combination with carboplatin and paclitaxel versus carboplatin and paclitaxel alone. ;Primary end point(s): Outcome variable(s): Efficacy · Primary outcome variable: Percentage change in total tumour size · Secondary outcome variables: - Progression Free Survival Rate at 18 weeks - Objective response rate - CA 125 response rate (Gynaecologic Cancer InterGroup [GCIG] criteria) - Percentage change in CA-125 Safety - Adverse events - Laboratory findings (clinical chemistry, haematology) - Vital signs (BP, pulse rate) - Cardiology (ECG) - Physical examination ;Main Objective: The primary objective of this study is to compare the efficacy of oral olaparib in combination with carboplatin and paclitaxel versus carboplatin and paclitaxel alone, as measured by % change in tumour size. | — |
Countries
Belgium, Czech Republic, Germany, Italy, Netherlands, Spain, United Kingdom
Outcome results
None listed