TMZ + Olaparib for MGMT Hypermethylated Colorectal Cancer

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT04166435
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Temozolomide + Olaparib — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jun 17, 2020
Status verified
Aug 2023
Primary completion
Jan 6, 2022
Completion
Jun 12, 2023

Study Design

Enrollment
11 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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.

Primary Outcome Measure

Overall Response Rate [ Time Frame: Up to 1.5 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Yale New Haven HospitalNew HavenConnecticut06512-

Find similar trials in New Haven, CT

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Yale New Haven Hospital· New Haven, CT

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