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OLAParib COmbinations

NCT02576444 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2022-12-28

Study results available
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Summary

The primary objective of this phase II trial is to determine tumor overall response rate (ORR) in molecularly selected patients with measurable disease as assessed by the Response Evaluation Criteria in Solid Tumors (RECIST), before versus after 16 weeks of treatment across tumor types in each arm of the study.

Conditions

Interventions

DRUG

AZD2281

Patients will be administered olaparib orally twice daily (bid) at 300 mg. Two (2) x 150 mg olaparib tablets should be taken at the same times each morning and evening of each day, approximately 12 hours apart with approximately 240 mL of water.

DRUG

AZD5363

Patients will be administered AZD5363 at 640 mg twice daily for two days on/five days off (2/7) schedule. Two (2) 200 mg tablets and three (3) 80 mg tablets should be taken twice daily.

DRUG

AZD1775

The recommended dose will be available no earlier than March 2016.

DRUG

AZD6738

Patients will be administered AZD6738 at 160 mg daily for days 1-7 of a 28-day cycle (7/28) schedule. AZD6738 is available as 100, 20, and 10 mg tablets. Tablets should be taken daily.

Sponsors & Collaborators

  • Dana-Farber Cancer Institute

    collaborator OTHER

  • Vanderbilt-Ingram Cancer Center

    collaborator OTHER

  • The Cleveland Clinic

    collaborator OTHER

  • Joseph Paul Eder

    lead OTHER

Principal Investigators

  • Joseph P Eder, MD · Yale University Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2019-11-18
Completion
2019-11-18

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02576444 on ClinicalTrials.gov