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PARP Inhibitor
Temozolomide + Olaparib for 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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1.5 years
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 • NCT0416643567%
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
1,922 Previous Clinical Trials
3,031,531 Total Patients Enrolled
Michael Cecchini, MDPrincipal InvestigatorAssistant Professor of Medicine (Medical Oncology) Yale University
1 Previous Clinical Trials
50 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with advanced colorectal cancer that has not responded to previous treatments and has specific genetic characteristics.You are allergic to temozolomide or olaparib or any of their ingredients.You are allergic to the medication being used in the clinical trial.If a patient declines to participate in the optional exploratory genetic research or the optional biomarker research, there will be no penalty or loss of benefit to the patientIndividuals who are not currently experiencing any health problems and who have passed a medical evaluation including a medical history, physical examination, laboratory tests, and cardiac monitoring.Haemoglobin levels of 10.0 g/dL or more, without any blood transfusions in the past 28 days.A person is capable of giving their consent if they can understand the information given to them, including the risks and benefits of participating in the study, and they can make a decision on whether or not to participateYou are currently breastfeeding a baby.The participant will be given a written informed consent form to sign before any study specific procedures, sampling, or analyses are conducted.DNA from research participants is now required by many institutions, but a recent study showed that almost half the subjects who provided consent did not understand the nature of the consent form they had signedThe MGMT gene promoter is hypermethylated on pre-screening in a significant percentage of tumors.with ANC decline of ≥30% from baseline over any 7 day period ANC decline ≥ 30% from nadir
Absolute neutrophil count (ANC) ≥ 1.You have already tried at least two different types of standard treatment for your advanced cancer and it did not work or you could not tolerate it. If you have used all chemotherapy drugs together before, one prior treatment is acceptable after talking with the main doctor. If your cancer came back within six months of finishing your first treatment, it counts as one line of treatment.You have had cancer in the past, but it must have been treated successfully without any signs of the disease for at least 5 years. Exceptions are made for certain types of cancer that were treated successfully, such as skin or cervical cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Temozolomide + Olaparib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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