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PARP Inhibitor

TMZ + Olaparib for MGMT Hypermethylated Colorectal Cancer

Phase 2
Waitlist Available
Led By Michael Cecchini, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1.5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a combination of two drugs, temozolomide and olaparib, in patients with advanced colorectal cancer that has a specific genetic change. The treatment aims to damage the cancer cells' DNA and prevent them from repairing it, leading to more effective cancer cell death. Olaparib is a drug that has been approved for use in various cancers, including ovarian and breast cancer, and has shown promise in trials for other cancers.

Eligible Conditions
  • Colorectal Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall Response Rate
Secondary study objectives
Count of Participants With Adverse Events Greater or Equal to 3
Overall Survival
Progression Free Survival

Side effects data

From 2023 Phase 2 trial • 11 Patients • NCT04166435
67%
White blood cell decreased
56%
Neutrophil count decreased
56%
Platelet count decreased
44%
Anemia
33%
Nausea
33%
Lymphocyte count decreased
22%
Fatigue
22%
Anorexia
22%
Aspartate aminotransferase increased
11%
Constipation
11%
Mucositis
11%
Alkaline phosphatase increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Temozolomide + Olaparib

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Temozolomide + OlaparibExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Temozolomide + Olaparib
2020
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,930 Previous Clinical Trials
3,033,463 Total Patients Enrolled
Michael Cecchini, MDPrincipal InvestigatorAssistant Professor of Medicine (Medical Oncology) Yale University
1 Previous Clinical Trials
50 Total Patients Enrolled

Media Library

Olaparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04166435 — Phase 2
Colorectal Cancer Research Study Groups: Temozolomide + Olaparib
Colorectal Cancer Clinical Trial 2023: Olaparib Highlights & Side Effects. Trial Name: NCT04166435 — Phase 2
Olaparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04166435 — Phase 2
~2 spots leftby Dec 2025