Clinical Trials /

Olaparib in Treating Patients With Stage IV Pancreatic Cancer

NCT02677038

Description:

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.

Related Conditions:
  • Pancreatic Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Olaparib for BRCAness Phenotype in Pancreatic Cancer
  • Official Title: Olaparib for BRCAness Phenotype in Pancreatic Cancer: Phase II Study

Clinical Trial IDs

  • ORG STUDY ID: 2015-0503
  • SECONDARY ID: NCI-2016-00351
  • NCT ID: NCT02677038

Conditions

  • Pancreatic Cancer

Interventions

DrugSynonymsArms
OlaparibLynparzaOlaparib

Purpose

The goal of this clinical research study is to learn if olaparib can help to control metastatic pancreatic cancer. The safety of this drug will also be studied. This is an investigational study. Olaparib is FDA approved and commercially available for the treatment of ovarian cancer. Its use in this study is investigational. The study doctor can explain how the study drug is designed to work. Up to 34 participants will be enrolled in this study. All will take part at MD Anderson.

Trial Arms

NameTypeDescriptionInterventions
OlaparibExperimentalParticipants receive Olaparib tablets in a dose of 300 mg orally (p.o.) twice daily. Treatment continues until progression, intolerable toxicity or as per participant's preference. Each treatment cycle is 28 days long.
  • Olaparib

Eligibility Criteria

        Inclusion Criteria:

          1. Patients with histologically or cytologically confirmed metastatic adenocarcinoma of
             the pancreas.

          2. 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 HRD will be eligible even in the absence of family history [e.g. somatic BRCA
             mutation, Fanconi Anemia gene, ATM or RAD51 mutations].

          3. 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].

          4. Patients must have received at least one prior therapy for metastatic disease to be
             eligible.

          5. 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 CT scan.

          6. All treated patients have the option to undergo pre-treatment biopsy (liver, omentum,
             lung or lymph node) to be eligible.

          7. Patients with prior malignancy and treated with no evidence of active disease, and
             more than 2 years from initial diagnosis are eligible.

          8. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 (Karnofsky >70).

          9. Patients must have adequate organ and marrow function as defined below: 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 < 1.5 X institutional upper limit of normal (IULN);
             AST(SGOT)/ALT(SGPT) </= 2.5 X IULN without liver metastasis; </= 5 X IULN for patients
             with liver metastasis; creatinine not greater than Upper Institutional limits OR
             creatinine clearance >/= 60 mL/min/1.73 m^2 for patients with creatinine levels above
             institutional normal.

         10. International Normalized Ratio (INR) < 1.5.

         11. Patients must be >/= 18 years of age.

         12. Women of childbearing potential (defined as not post-menopausal for 12 months or no
             previous surgical sterilization) and fertile men must agree to use two highly
             effective forms of contraception while they are receiving study treatment and for 30
             days after last dose of study drug. Male subjects must agree to refrain from sperm
             donation during the study and for 30 days after the last dose of study drugs.

         13. Ability to understand and the willingness to sign a written informed consent document.
             Signed informed consent form must be obtained prior to initiation of study evaluations
             and/or activities.

        Exclusion Criteria:

          1. Uncontrolled intercurrent illness including symptomatic congestive heart failure,
             unstable angina pectoris, cardiac arrhythmia and myocardial infarction (MI) within 3
             months of initiation of therapy.

          2. Patients whose tumors are deemed to be platinum-refractory will be excluded from the
             trial.

          3. Pregnancy or lactation.

          4. Patient has active and uncontrolled bacterial, viral, or fungal infection(s) requiring
             systemic therapy.

          5. Patient has undergone major surgical resection within 4 weeks prior to enrollment.

          6. Patient received radiotherapy, surgery, chemotherapy, or an investigational therapy
             within 2 weeks prior to study entry.

          7. Patient has serious medical risk factors involving any of the major organ systems such
             that the investigator considers it unsafe for the patient to receive an experimental
             research drug.

          8. Serious psychiatric or medical conditions that could interfere with treatment.

          9. Major bleeding in the last 4 weeks prior to study entry.

         10. Concomitant use of CYP3A4 inhibitors.

         11. Resting electrocardiogram (ECG) with corrected QT interval (QTc) > 470msec.
             (Fredericia's scale).
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective Tumor Response Rate of Olaparib in Participants with Pancreatic Cancer
Time Frame:8 weeks
Safety Issue:
Description:Objective tumor response assessment based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria of response: complete response (CR), partial response (PR), stable disease (SD), progression of disease (PD), no evidence of disease (NED) and not evaluable (NE).

Secondary Outcome Measures

Measure:Efficacy of Olaparib in Participants with Pancreatic Cancer
Time Frame:8 weeks
Safety Issue:
Description:Efficacy assessed by objective tumor assessments until objective radiological disease progression as defined by RECIST.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:M.D. Anderson Cancer Center

Trial Keywords

  • Pancreatic Cancer
  • Stage IV pancreatic ductal adenocarcinoma (PDAC) with BRCAness
  • PDAC
  • Metastatic adenocarcinoma of the pancreas
  • Family history of breast cancer
  • Family history of ovarian cancer
  • Family history of pancreatic cancer
  • Family history of gastric cancer
  • Family history of prostate cancer
  • Olaparib
  • Lynparza

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