Study of Olaparib and Durvalumab in IDH-Mutated Solid Tumors

Sponsor
University Health Network, Toronto
Study ID
NCT03991832
Phase
PHASE2
Status
Recruiting
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Conditions

  • Cholangiocarcinoma
  • Glioma
  • IDH Mutation
  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Olaparib — DRUG
    Olaparib is a drug that blocks a protein called poly (ADP-ribose) polymerase (PARP). PARP is important in the growth and spread of cancer cells. Because of this, blocking PARP from working is expected to stop the growth of or shrink cancer cells.
  • Durvalumab — DRUG
    Durvalumab is a drug that works by stopping a protein called Programmed Cell Death Ligand 1 (PD-L1) from working. PD-L1 is a protein that is thought to prevent the immune system (the body's defense against diseases) from killing cancer cells. Stopping PD-L1 from working is expected to allow the immune system to once again prevent or slow down cancer growth.

Study Details

This is a phase 2 study of the combination of drugs olaparib and durvalumab for the treatment of isocitrate dehydrogenase or (IDH) mutated solid tumors. The purpose of this study is to assess the efficacy of the drug combination via overall response rate and overall disease control rate. It is believed that giving olaparib and durvalumab together would be more useful when given to patients with IDH-mutated solid tumors than giving each drug alone.

Key Dates

Start date
Dec 31, 2019
Status verified
Jul 2024
Primary completion
Mar 31, 2025
Completion
Mar 31, 2025

Study Design

Enrollment
58 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A: IDH mutated glioma
    Olaparib, by mouth (orally), twice a day, every day. Durvalumab, by vein (intravenously), on Day 1 of every 28 day cycle.
  • Experimental: Cohort B: IDH mutated cholangiocarcinoma
    Olaparib, by mouth (orally), twice a day, every day. Durvalumab, by vein (intravenously), on Day 1 of every 28 day cycle.

Primary Outcome Measure

Overall response rate [ Time Frame: 3 years ]

Central Contacts

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