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TMZ + Olaparib for MGMT Hypermethylated Colorectal Cancer

NCT04166435 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2023-09-06

Study results available
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Summary

This is a Phase II, non-randomized, open-label study to evaluate temozolomide in combination with olaparib in patients with MGMT promoter hypermethylated advanced colorectal cancer.

Conditions

Interventions

DRUG

Temozolomide + Olaparib

Temozolomide (75 mg/m2 orally on days 1-7 every 3 weeks) + Olaparib (150 mg orally twice daily days 1-21) in a 21-day cycle.

Sponsors & Collaborators

  • Yale University

    lead OTHER

Principal Investigators

  • Michael Cecchini, MD · Assistant Professor of Medicine (Medical Oncology) Yale University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-17
Primary Completion
2022-01-06
Completion
2023-06-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT04166435 on ClinicalTrials.gov