Phase 3
N=154
Olaparib in gBRCA Mutated Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum-Based Chemotherapy
Germline BRCA1/2 Mutations and · Metastatic Adenocarcinoma of the Pancreas
Bottom Line
View on ClinicalTrials.gov: NCT02184195 ↗Enrolled (actual)
154
Serious AEs
25.2%
Results posted
Jan 2020
Primary outcome: Primary: Progression-free Survival (PFS) by Blinded Independent Central Review (BICR) Using Modified Response Evaluation Criteria in Solid Tumours. This Study Used Modified RECIST Version (v) 1.1 (RECIST v1.1) — 7.4; 3.8 Months — p=0.0038
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Olaparib (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival (PFS) by Blinded Independent Central Review (BICR) Using Modified Response Evaluation Criteria in Solid Tumours. This Study Used Modified RECIST Version (v) 1.1 (RECIST v1.1) |
7.4; 3.8 | 0.0038 sig |
| SECONDARY Overall Survival (OS) |
19.0; 19.2 | 0.3487 |
| SECONDARY Time From Randomisation to Second Progression (PFS2) |
16.9; 9.3 | 0.0613 |
| SECONDARY Time From Randomisation to Second Subsequent Therapy or Death (TSST) |
14.9; 9.6 | 0.0111 sig |
| SECONDARY Time From Randomisation to First Subsequent Therapy or Death (TFST) |
9.0; 5.4 | <0.0001 sig |
| SECONDARY Time From Randomisation to Study Treatment Discontinuation or Death (TDT) |
7.5; 3.8 | <0.0001 sig |
| SECONDARY Number of Participants With Objective Response Rate (ORR) by BICR Using Modified RECIST 1.1 |
22; 11 | 0.3273 |
| SECONDARY Disease Control Rate (DCR) by BICR Using Modified RECIST 1.1 |
51; 24; 34; 34; 7; 4 | — |
| SECONDARY Adjusted Mean Change From Baseline up to 6 Months in Global Quality of Life (QoL) Score From the EORTC-QLQ-C30 Questionnaire |
-1.03; 1.18 | 0.355 |
| SECONDARY Number of Participants With Adverse Events (AEs) |
89; 56; 44; 15; 1; 0 | — |
Summary
A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Maintenance Olaparib Monotherapy in Patients with gBRCA Mutated Metastatic Pancreatic Cancer whose Disease Has Not Progressed on First Line Platinum Based Chemotherapy
Eligibility Criteria
Key Inclusion Criteria
- Histologically or cytologically confirmed pancreas adenocarcinoma receiving initial chemotherapy for metastatic disease and without evidence of disease progression on treatment
- Patients with measurable disease and/or non-measurable or no evidence of disease assessed at baseline by CT (or MRI where CT is contraindicated) will be entered in this study.
- Documented mutation in gBRCA1 or gBRCA2 that is predicted to be deleterious or suspected deleterious
- Patients are on treatment with a first line platinum-based (cisplatin, carboplatin or oxaliplatin) regimen for metastatic pancreas cancer, have received a minimum of 16 weeks of continuous platinum treatment and have no evidence of progression based on investigator's opinion.
- Patients who have received platinum as potentially curative treatment for a prior cancer (eg ovarian cancer) or as adjuvant/neoadjuvant treatment for pancreas cancer are eligible provided at least 12 months have elapsed between the last dose of platinum-based treatment and initiation of the platinum-based chemotherapy for metastatic pancreas cancer.
Major Exclusion Criteria:
- gBRCA1 and/or gBRCA2 mutations that are considered to be non detrimental (eg, "Variants of uncertain clinical significance" or "Variant of unknown significance" or "Variant, favour polymorphism" or "benign polymorphism" etc.)
- Progression of tumour between start of first line platinum based chemotherapy for metastatic pancreas cancer and randomisation.
- Cytotoxic chemotherapy or non-hormonal targeted therapy within 28 days of Cycle
1 Day 1 is not permitted.
- Exposure to an investigational product within 30 days or 5 half lives (whichever is longer) prior to randomisation
- Any previous treatment with a PARP inhibitor, including Olaparib
Data sourced from ClinicalTrials.gov (NCT02184195). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.