Olaparib in Treating Patients With Stage IV Pancreatic Cancer

NCT02677038 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 2015-0503NCI-2016-00351
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metastatic Pancreatic Adenocarcinoma; Pancreatic Ductal Adenocarcinoma; Stage IV Pancreatic Cancer AJCC v6 and v7

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  The primary endpoint was the objective response rate assessed by the investigator using the modified RECIST v1.1 criteria.

  5 years 8 months

Secondary Outcomes (2)

• Progression Free Survival

  5 years 8 months

• Overall Survival

  5 years 8 months

Study Arms (1)

Treatment (olaparib)

EXPERIMENTAL

Patients receive olaparib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: Olaparib

Interventions

Olaparib DRUG

Given PO

Also known as: AZD 2281, AZD-2281, AZD2281, KU-0059436, Lynparza, PARP Inhibitor AZD2281

Treatment (olaparib)

Eligibility Criteria

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

You may qualify if:

• 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 \< 1.5 x institutional upper limit of normal (IULN)
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 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

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
• Patients whose tumors are deemed to be platinum-refractory will be excluded from the trial
• 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
• Major bleeding in the last 4 weeks prior to study entry
• Concomitant use of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors
• Resting electrocardiogram (ECG) with corrected QT interval (QTc) \> 470 msec (Fridericia's scale)

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• AstraZeneca: collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Interventions

olaparib

Results Point of Contact

• Title: Dr. Milind Javle
• Organization: M D Anderson Cancer Center

mjavle@mdanderson.org

713-792-5434

Study Officials

• Milind Javle

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: February 4, 2016
• First Posted: February 9, 2016
• Study Start: November 11, 2016
• Primary Completion: July 18, 2022
• Study Completion: July 18, 2022
• Last Updated: October 1, 2024
• Results First Posted: October 1, 2024

Record last verified: 2024-09

Locations

US (1)