Phase 2
N=24
Olaparib in Treating Patients With Stage IV Pancreatic Cancer
Metastatic Pancreatic Adenocarcinoma · Pancreatic Ductal Adenocarcinoma · Stage IV Pancreatic Cancer AJCC v6 and v7
Bottom Line
View on ClinicalTrials.gov: NCT02677038 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Objective Response Rate — 1; 15 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Olaparib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate |
1; 15 | — |
| SECONDARY Progression Free Survival |
4.83 | — |
| SECONDARY Overall Survival |
16.1 | — |
Summary
This phase II trial studies how well olaparib works in treating patients with stage IV pancreatic cancer. Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Eligibility Criteria
Inclusion Criteria
- Patients with histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas
- Family history: one or more close blood relative with ovarian carcinoma at any age or breast cancer age 50 or younger or two relatives with breast, pancreatic or prostate cancer (Gleason 7 or higher) at any age, or patients with Ashkenazi Jewish ancestry; however, patients with previously identified genetic aberrations that are associated with homologous recombination deficiency (HRD) will be eligible even in the absence of family history (e.g. somatic BRCA mutation, Fanconi anemia gene, ATM or RAD51 mutations)
- Patients must be germline BRCA 1 or 2 negative; (Note: if BRCA status was previously determined, that result is acceptable but documentation of status must be available; subjects with unknown status will be referred to genetic counselling for BRCA testing as per standard of care) and/or patients with previously identified genetic aberrations that are associated with HRD will be eligible even in the absence of family history (e.g. somatic BRCA mutation, Fanconi Anemia gene, ATM or RAD51 mutations)
- Patients must have received at least one prior therapy for metastatic disease to be eligible
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan
- All treated patients have the option to undergo pre-treatment biopsy (liver, omentum, lung or lymph node) to be eligible
- Patients with prior malignancy and treated with no evidence of active disease, and more than 2 years from initial diagnosis are eligible
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Karnofsky > 70)
- Leukocytes >= 3,000 cells/mm^3
- Absolute neutrophil count >= 1,500 cells/mm^3
- Platelets >= 75,000 cells/mm^3
- Hemoglobin >= 9 g/dl (no blood transfusions within 4 weeks prior to enrollment)
- Total bilirubin = 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
- International normalized ratio (INR) 470 msec (Fridericia's scale)
Data sourced from ClinicalTrials.gov (NCT02677038). 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.