Study on Adding Navitoclax to Dabrafenib and Trametinib for Treating BRAF Mutant Melanoma
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT01989585
This clinical trial is testing a new combination of drugs, including navitoclax, dabrafenib, and trametinib, to see if they can effectively treat melanoma with a specific BRAF mutation that has spread or cannot be surgically removed.
Patient Parameters
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Program Overview
The purpose of this study is to find out if adding navitoclax to the existing treatment of dabrafenib and trametinib can help shrink tumors in patients with BRAF mutant melanoma or other solid tumors that have spread or cannot be removed by surgery. Dabrafenib and trametinib work by blocking certain enzymes needed for tumor growth, while navitoclax targets a protein that helps tumor cells survive.
Description
This study is divided into two phases. In Phase I, researchers will determine the safest dose of navitoclax when combined with dabrafenib and trametinib, and assess any side effects. In Phase II, the study will compare the effectiveness of the combination treatment against the standard treatment of dabrafenib and trametinib alone.
Participants in Phase I will receive navitoclax for a short period before starting the full combination treatment. They will continue to take all three drugs in 28-day cycles, with regular health checks and scans to monitor their progress.
In Phase II, participants will be randomly assigned to one of two groups. One group will receive the standard treatment of dabrafenib and trametinib, while the other group will receive the combination of all three drugs. Both groups will undergo regular health checks, scans, and blood tests to evaluate the treatment's effectiveness and safety.
After completing the study treatment, participants will have follow-up visits to monitor their health and any changes in their condition.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of BRAF-mutant melanoma that has spread or cannot be removed by surgery.
- Must have measurable disease, meaning at least one tumor that can be accurately measured by scans or physical exam.
- Must be 18 years or older.
- Must have good overall health, with a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Must have adequate blood cell counts and organ function, including liver and kidney function.
- Must agree to use effective contraception during the study and for four months after treatment.
- Must be able to swallow pills and not have any significant digestive issues that could affect medication absorption.
- Must be willing to sign an informed consent document and comply with study procedures.
Exclusion Criteria
- Cannot have received navitoclax before, except under specific conditions in Phase I.
- Cannot have had recent cancer treatments, such as chemotherapy or immunotherapy, within a specified time before starting the study.
- Cannot have untreated or unstable brain metastases.
- Cannot have a history of severe allergic reactions to similar drugs.
- Cannot have uncontrolled health conditions, such as serious infections or heart problems.
- Cannot be pregnant or breastfeeding.
- Cannot be taking certain medications that may interact with the study drugs.
- Cannot have a history of other cancers, except under specific conditions.
- Cannot have a history of lung disease or eye conditions that increase the risk of certain complications.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Mayo Clinic Hospital in Arizona | 85054 | Phoenix | Arizona |
| Mayo Clinic in Arizona | 85259 | Scottsdale | Arizona |
| Los Angeles General Medical Center | 90033 | Los Angeles | California |
| USC / Norris Comprehensive Cancer Center | 90033 | Los Angeles | California |
| USC Norris Oncology/Hematology-Newport Beach | 92663 | Newport Beach | California |
| UC Irvine Health/Chao Family Comprehensive Cancer Center | 92868 | Orange | California |
| University of California Davis Comprehensive Cancer Center | 95817 | Sacramento | California |
| UCHealth University of Colorado Hospital | 80045 | Aurora | Colorado |
| UM Sylvester Comprehensive Cancer Center at Aventura | 33180 | Aventura | Florida |
| UM Sylvester Comprehensive Cancer Center at Coral Gables | 33146 | Coral Gables | Florida |
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