Efficacy and Safety of PARPi to Treat Pancreatic Cancer

NCT02511223 | Completed Phase 2

• 1 other identifier: SHEBA-14-2358-TG-CTIL
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open label, single arm, phase II trial of Olaparib for (PDAC) pancreatic ductal adenocarcinoma patients with BRCAness (breast cancer gene). All study subjects will receive Olaparib in a dose of 300 mg p.o twice daily. Treatment will continue until progression, intolerable toxicity or as per patient preference. Primary objective: To determine the efficacy of Olaparib monotherapy in stage IV pancreatic ductal adenocarcinoma (PDAC)with (BRCAness) BRCA -Breast Cancer susceptibility gene.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR) by using RECIST 1.1

  Due to lack of results, study has been early terminated

  approximately- 24 months

Study Arms (1)

Single Arm

EXPERIMENTAL

Only one Arm,All patients will receive Olaparib 300 (mg) milligram bid p.o till disease progression

Drug: OLAPARIB

Interventions

OLAPARIB DRUG

Olaparib 300 (mg) twice a day per os given every day until disease progression or toxicity

Also known as: PARPi

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be male or female ≥18 years of age
• Patients with histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas.
• Patients must have tested negative for BRCA 1 or 2 germline deleterious mutation or be ineligible for BRCA testing \[as determined by their insurer\]
• Patients with previously identified Loss of ATM by IHC OR
• Family history of BRCA-associated cancers: breast, ovarian, pancreatic, gastric or prostate must be present in 2 or more first-degree relatives OR
• Patients with previously identified genetic aberrations that are associated with HRD will be eligible \[e.g. somatic BRCA mutation, Fanconi Anemia gene or RAD51 mutations\].
• Patients must have received at least one prior therapy for metastatic disease or have refused chemotherapy to be eligible
• 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. RECIST 1.1 has been modified to allow the assessment of progression due to new lesions in patients with no evidence of disease at baseline
• (ECOG) Eastern Cooperative Oncology Group: A performance status using scales and criteria to assess how a patient's disease is progressing)Performance Status 0-1 (Karnofsky \>70).
• Patients must have adequate organ and marrow function as defined below:
• Leukocytes \>3,000 cells/mm3
• Absolute neutrophil count \>1,500 cells/mm3
• Platelets \>100,000 cells/mm3
• Hemoglobin \>9 g/dl (no blood transfusions within 4 weeks prior to enrolment)
• Total bilirubin \<1.5 X institutional upper limit of normal (IULN)

You may not qualify if:

• Uncontrolled intercurrent illness including symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia and myocardial infarction (MI) within 3 months of initiation of therapy.
• Pregnancy or lactation
• Patient has active and uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
• Patient has undergone major surgical resection within 4 weeks prior to enrollment.
• Patient received radiotherapy, surgery, chemotherapy, or an investigational therapy within 2 weeks prior to study entry.
• 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
• Serious psychiatric or medical conditions that could interfere with treatment
• History of prior malignancy unless the malignancy has been treated with no evidence of active disease and more than 2 years from initial diagnosis
• Major bleeding in the last 4 weeks prior to study entry

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Centre

Ramat Gan, Israel

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

olaparib

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Talia Golan, MD

  Sheba Medical Centre, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2015
• First Posted: July 29, 2015
• Study Start: July 1, 2016
• Primary Completion: April 18, 2021
• Study Completion: April 18, 2021
• Last Updated: April 19, 2023

Record last verified: 2017-03

Locations

IL (1)