Study on Olaparib and AZD6738 for Tumors with IDH1 and IDH2 Mutations
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT03878095
This clinical trial is testing how well the drugs olaparib and ceralasertib (AZD6738) work in treating patients with certain types of tumors that have specific genetic mutations called IDH1 and IDH2. These drugs may help shrink tumors or stop them from growing by blocking enzymes needed for cell growth.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The purpose of this study is to see if the combination of olaparib and ceralasertib (AZD6738) can effectively treat tumors with IDH1 or IDH2 mutations. These mutations are changes in genes that can lead to cancer. The study will focus on patients with cholangiocarcinoma (a type of bile duct cancer) and other solid tumors. The drugs work by blocking certain enzymes that cancer cells need to grow.
Description
In this study, patients will take olaparib twice a day and ceralasertib once a day in 28-day cycles. The treatment will continue as long as the cancer does not progress and the side effects are manageable. Patients will have regular check-ups, including scans and blood tests, to monitor their response to the treatment. Tumor biopsies will be taken before and during the study to help understand how the treatment is working. After finishing the treatment, patients will be followed up for 30 days to check their health.
Eligibility Criteria
Inclusion Criteria
- Must understand the study and provide written consent. Patients with decision-making difficulties can participate if they have a caregiver or representative.
- Diagnosed with a solid tumor (not cholangiocarcinoma or primary brain tumor) that has worsened despite standard treatment or has no effective standard treatment.
- Tumors must have an IDH1 or IDH2 mutation confirmed by a certified lab.
- Tumors must be accessible for biopsy, and patients must agree to have biopsies taken.
- Must have measurable disease by standard criteria.
- Must have progressive cancer at the time of study entry.
- Must have recovered from previous treatments to a certain level of health.
- Must be 18 years or older.
- Must have good overall health and organ function as determined by specific medical tests.
- Women of childbearing potential must use effective contraception during and after the study.
- Men must agree to use contraception to prevent pregnancy in a partner during and after the study.
- Patients with HIV must have an undetectable viral load on treatment.
Exclusion Criteria
- Involvement in planning or conducting the study.
- Previous participation in this study.
- Participation in another study with an investigational product recently.
- Previous treatment with a PARP inhibitor or AZD6738.
- Recent chemotherapy or radiotherapy.
- Other cancers within the last 5 years, except for certain treated cancers.
- Uncontrolled heart conditions or certain medications that affect the heart.
- Severe allergies to study drugs.
- Major surgery recently.
- Serious uncontrolled medical conditions.
- Unable to swallow pills or have digestive issues affecting drug absorption.
- Pregnant or breastfeeding women.
- Recent blood transfusions.
- Receiving other investigational agents.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | 35233 | Birmingham | Alabama |
| Smilow Cancer Center/Yale-New Haven Hospital | 06510 | New Haven | Connecticut |
| Yale University | 06520 | New Haven | Connecticut |
| Smilow Cancer Hospital Care Center-Trumbull | 06611 | Trumbull | Connecticut |
| UF Health Cancer Institute - Gainesville | 32610 | Gainesville | Florida |
| Northwestern University | 60611 | Chicago | Illinois |
| Johns Hopkins University/Sidney Kimmel Cancer Center | 21287 | Baltimore | Maryland |
| Wayne State University/Karmanos Cancer Institute | 48201 | Detroit | Michigan |
| Weisberg Cancer Treatment Center | 48334 | Farmington Hills | Michigan |
| Ohio State University Comprehensive Cancer Center | 43210 | Columbus | Ohio |
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