Study on Whether Cancers with Specific Mutations Respond Better to the Drug Telaglenastat Hydrochloride (BeGIN Study)
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT03872427
This clinical trial is testing a drug called telaglenastat hydrochloride to see if it can effectively treat patients with certain genetic mutations and advanced cancers that have spread or cannot be removed by surgery.
Patient Parameters
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Program Overview
This study is exploring how well a drug called telaglenastat hydrochloride works in treating patients with specific genetic mutations and advanced cancers, including solid tumors and malignant peripheral nerve sheath tumors. These cancers have either spread to other parts of the body or cannot be surgically removed. Telaglenastat hydrochloride works by blocking a process that cancer cells need to grow, potentially stopping their growth and causing them to die. The study focuses on patients with certain genetic mutations, such as NF1, KEAP1/NRF2, or STK11/LKB1, to see if the drug can effectively stop tumor growth.
Description
The main goal of this study is to see how well telaglenastat hydrochloride can reduce cancer in patients with specific genetic mutations within six months of treatment. Researchers will also look at the safety of the drug, how long patients live without the cancer getting worse, and overall survival rates. They will study how quickly patients respond to the treatment and the overall benefits. Additionally, the study will explore how the drug affects certain biological markers and how these changes relate to treatment response and disease progression.
Patients will take telaglenastat hydrochloride by mouth twice a day in 28-day cycles, as long as the cancer does not progress or cause unacceptable side effects. They will also undergo various scans and provide blood samples during the study.
After finishing the treatment, patients will have follow-up visits every three months to monitor their health and any changes in their condition.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of advanced cancer that has spread or cannot be removed by surgery.
- Have specific genetic mutations, such as NF1, KEAP1/NRF2, or STK11/LKB1, confirmed by a certified lab.
- No standard treatments available.
- Be 18 years or older.
- Weigh at least 40 kg for certain groups.
- At least four weeks since any prior surgery or radiotherapy.
- Women of childbearing potential must have a negative pregnancy test before starting treatment.
- Have measurable disease that can be tracked using standard criteria.
- Treated brain metastases must be stable for at least four weeks.
- HIV-positive patients must have an undetectable viral load.
- Be in good overall health with a performance status of 0 to 2.
- Meet specific blood count and organ function criteria.
- Agree to use effective contraception during the study and for a period after treatment.
- Understand and agree to sign informed consent.
Exclusion Criteria
- Recent chemotherapy or radiotherapy within the last four weeks.
- Not fully recovered from side effects of previous cancer treatments.
- Currently taking other investigational drugs.
- Allergic reactions to similar drugs.
- Have glioma or a history of hepatitis B or C.
- Taking medications that interact with telaglenastat hydrochloride.
- Have uncontrolled illnesses or conditions that could interfere with the study.
- Pregnant or breastfeeding women are excluded due to potential risks to the baby.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | 35233 | Birmingham | Alabama |
| UM Sylvester Comprehensive Cancer Center at Aventura | 33180 | Aventura | Florida |
| UM Sylvester Comprehensive Cancer Center at Coral Gables | 33146 | Coral Gables | Florida |
| UM Sylvester Comprehensive Cancer Center at Deerfield Beach | 33442 | Deerfield Beach | Florida |
| University of Miami Miller School of Medicine-Sylvester Cancer Center | 33136 | Miami | Florida |
| UM Sylvester Comprehensive Cancer Center at Kendall | 33176 | Miami | Florida |
| UM Sylvester Comprehensive Cancer Center at Plantation | 33324 | Plantation | Florida |
| Moffitt Cancer Center-International Plaza | 33607 | Tampa | Florida |
| Moffitt Cancer Center - McKinley Campus | 33612 | Tampa | Florida |
| Moffitt Cancer Center | 33612 | Tampa | Florida |
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