Study on ASTX660 for Patients with Advanced Solid Tumors and Lymphomas
Sponsor: Taiho Oncology, Inc.
ClinicalTrials ID:NCT02503423
This clinical trial is testing the safety and effectiveness of a new drug, ASTX660, in adults with advanced solid tumors or lymphomas who have no other standard treatment options available. The study aims to find the best dose and gather early data on how well the drug works.
Patient Parameters
| Parameter | Options |
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Program Overview
This study is exploring a new treatment called ASTX660 for adults with advanced solid tumors or lymphomas that cannot be treated with standard therapies. The trial will determine the safest and most effective dose of ASTX660 and gather initial information on its ability to fight cancer. Participants will continue treatment until their cancer progresses, they experience unacceptable side effects, or the study ends.
Description
ASTX660 is a new drug designed to help kill cancer cells and stop tumor growth. It works by blocking certain proteins that prevent cancer cells from dying. The study is divided into two phases. The first phase, which is already completed, determined the safest dose of ASTX660. The second phase will test how well the drug works in specific types of cancer. Participants will receive ASTX660 until their cancer worsens, they experience severe side effects, or the study concludes. The study will also collect information on how the drug is processed in the body and its effects on cancer cells.
Eligibility Criteria
Inclusion Criteria
- Able to understand the study and agree to participate.
- Men and women aged 18 or older.
- Have advanced solid tumors or lymphomas that cannot be treated with standard therapies.
- For certain groups, must have specific types of T-cell lymphoma and have tried at least two previous treatments.
- Must have measurable cancer that can be tracked during the study.
- Good overall health with an ECOG performance status of 0, 1, or 2.
- Acceptable organ function based on specific blood tests.
- Women of childbearing potential must not be pregnant or breastfeeding and must use effective birth control during the study and for three months after.
- Men with partners of childbearing potential must also use effective birth control during the study and for three months after.
Exclusion Criteria
- Allergic to ASTX660 or its ingredients.
- Have serious health conditions that could affect safety or study results.
- Have heart problems or are at risk for heart disease.
- Have active infections like HIV, hepatitis B, or hepatitis C.
- Have significant nerve damage.
- Have untreated or unstable brain metastases.
- Have mental health or substance abuse issues that could affect participation.
- Have had recent cancer treatments that could interfere with the study.
- Have another active cancer requiring treatment.
- Have a history of severe graft-versus-host disease from a transplant.
- Are taking high doses of steroids or other medications that could interfere with the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham | 35294 | Birmingham | Alabama |
| HonorHealth Research Institute | 852558 | Scottsdale | Arizona |
| USC/Norris Comprehensive Cancer Center | 90033 | Los Angeles | California |
| Cedars-Sinai Medical Center | 90048 | Los Angeles | California |
| UC Davis Medical Center | 95817 | Sacramento | California |
| Simlow Cancer Hospital at Yale | 06510 | New Haven | Connecticut |
| Emory University winship Cancer Institute | 30322 | Atlanta | Georgia |
| Robert H. Lurie Comprehensive Cancer Center of Northwestern University | 60611 | Chicago | Illinois |
| The Sidney Kimmel Comprehensive Cancer Center at John Hopkins | 21287 | Baltimore | Maryland |
| Tufts Medical Center | 02111 | Boston | Massachusetts |
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