Study on Trametinib and Navitoclax for Treating Advanced or Metastatic Solid Tumors
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT02079740
This clinical trial is testing the safety and effectiveness of two drugs, trametinib and navitoclax, in treating patients with advanced or metastatic solid tumors. The study aims to find the best dose and see how well these drugs work together to stop tumor growth.
Patient Parameters
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Program Overview
This study is exploring how well the combination of trametinib and navitoclax works in treating solid tumors that have spread to other parts of the body. Trametinib may help stop tumor growth by blocking certain enzymes needed for cell growth, while navitoclax targets proteins that help cancer cells survive. The trial will determine the best dose and assess the effectiveness of this drug combination in shrinking tumors.
Description
The study is divided into two phases: Phase Ib and Phase II.
In Phase Ib, researchers will determine the highest safe doses of trametinib and navitoclax when used together. They will also study the side effects and how the body processes these drugs. In Phase II, the focus will be on how well the drug combination works in shrinking tumors in patients with specific genetic mutations (KRAS or NRAS) in their cancer.
Participants will take trametinib and navitoclax orally every day in 28-day cycles. They will undergo regular scans and provide blood samples to monitor their response to the treatment. If side effects occur, the dosage may be adjusted. After completing the treatment, participants will be followed up for 30 days to check their health.
The study aims to provide valuable insights into the potential benefits of combining trametinib and navitoclax for treating advanced solid tumors.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of advanced or metastatic solid tumor with KRAS or NRAS mutations.
- Have measurable disease that can be tracked using standard criteria.
- Have received at least one prior chemotherapy treatment and experienced progression or intolerance.
- Be willing to provide tumor tissue samples for analysis.
- Be 18 years or older.
- Have a good performance status, meaning able to carry out daily activities with minimal restrictions.
- Have a life expectancy of more than 3 months.
- Be able to swallow pills and have no significant digestive issues.
- Have recovered from any previous treatment side effects to a mild level.
- Meet specific blood count and organ function criteria.
- Agree to use effective contraception during the study and for 4 months after treatment.
- Women must have a negative pregnancy test before starting treatment.
- Be able to understand and sign a consent form.
Exclusion Criteria
- Have a history of another cancer, unless disease-free for 3 years or with certain non-threatening cancers.
- Have a history of lung disease or inflammation.
- Have had major surgery or certain treatments within the last 21 days.
- Be taking other investigational drugs or have brain metastases unless stable.
- Have allergies to the study drugs or related compounds.
- Be using prohibited medications or supplements.
- Have a history of heart problems or uncontrolled high blood pressure.
- Have active infections like hepatitis B, C, or HIV.
- Have any condition that increases bleeding risk.
- Be pregnant or breastfeeding.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Massachusetts General Hospital Cancer Center | 02114 | Boston | Massachusetts |
| Dana-Farber Cancer Institute | 02215 | Boston | Massachusetts |
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