Study on VS-6063 (Defactinib) for Cancers with NF2 Genetic Changes
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT04439331
This clinical trial is testing a drug called VS-6063 (defactinib) to see if it can help shrink or stop the growth of cancers that have a specific genetic change known as an NF2 mutation. The drug works by blocking a protein that may be important for cancer cell growth in these cases.
Patient Parameters
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Program Overview
The purpose of this study is to find out if the drug VS-6063 (defactinib) can effectively shrink tumors or stop their growth in patients with cancers that have an NF2 genetic mutation. This mutation may cause cancer cells to rely on a protein called FAK for growth, and defactinib aims to block this protein.
Description
The main goal of this study is to see how many patients experience a reduction in their cancer size after taking defactinib. Researchers also want to know how many patients are still alive and have not seen their cancer grow after six months of treatment. They will also look at how long it takes for the cancer to grow or for the patient to pass away. Additionally, the study will explore other factors that might predict how well the treatment works, using various tests and imaging techniques.
Participants will take defactinib pills twice a day for 28 days. This cycle will repeat every 28 days as long as the cancer does not grow and the patient can tolerate the treatment. After finishing the treatment, patients will have follow-up visits every three months for the first two years, and then every six months in the third year.
For more information about the MATCH Screening Trial, please refer to NCT02465060.
Eligibility Criteria
Inclusion Criteria
- Must meet the eligibility criteria of the Master MATCH Protocol before joining this treatment study.
- Must have a tumor with an NF2 genetic mutation.
- Must have a recent electrocardiogram (ECG) showing no serious heart rhythm issues.
- If there is a history of heart problems, a recent heart function test must show normal results.
- High blood pressure must be well-controlled with medication or diet.
Exclusion Criteria
- Cannot have allergies to defactinib or similar drugs.
- Cannot have had serious stomach or intestinal bleeding or ulcers in the past year.
- Cannot have a history of Gilbert's syndrome.
- Cannot have had a stroke in the past six months.
- Cannot have previously taken a FAK inhibitor or participated in certain related trials.
- Should avoid certain medications and foods that affect how the body processes drugs.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| ECOG-ACRIN Cancer Research Group | 19103 | Philadelphia | Pennsylvania |
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