Study to Determine the Best Dose and Effectiveness of Nanvuranlat Compared to Standard Treatments in Adults with Biliary Tract Cancer
Sponsor: J-Pharma Co., Ltd.
ClinicalTrials ID:NCT07265674
This clinical trial is testing a new drug, nanvuranlat, to find the best dose and compare its effectiveness against standard treatments for adults with biliary tract cancer. Participants will receive treatment every two weeks, and their health and cancer response will be closely monitored.
Patient Parameters
| Parameter | Options |
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Program Overview
The study aims to find the best dose of nanvuranlat and compare its effectiveness to standard treatments like FOLFOX, FOLFIRI, or supportive care in adults with biliary tract cancer. Participants will be randomly assigned to different treatment groups and will receive treatment every two weeks as long as it is safe and effective. Regular health checks and scans will be conducted to monitor safety and how well the cancer responds to the treatment.
Description
This study is in two parts. In Part A, researchers will test different doses of nanvuranlat to find the best one for further study. Participants will be randomly assigned to receive one of three nanvuranlat doses or standard treatment. In Part B, participants will be randomly assigned to receive either the best dose of nanvuranlat from Part A or standard treatment. The study will include regular health checks, blood tests, and scans to monitor safety and the cancer's response to treatment. Participants will continue treatment every two weeks unless they experience side effects or their cancer worsens.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Must provide written consent to participate.
- Willing to attend scheduled visits and follow the treatment plan.
- Cancer must be advanced and not treatable with local therapies.
- Must have a confirmed diagnosis of biliary tract cancer.
- Must have received one prior platinum-based therapy for advanced cancer.
- Must have a good performance status (ECOG 0 or 1).
- Must have a life expectancy of at least 90 days.
- Must have at least one measurable tumor.
- Must have resolved significant side effects from previous treatments.
- Must have adequate blood counts and organ function.
- Women of childbearing potential must use effective contraception during and after the study.
- Men must use effective contraception if their partner is of childbearing potential.
Exclusion Criteria
- Recent treatment with other cancer therapies or investigational drugs.
- Recent radiation to metastatic sites.
- Recent major surgery without full recovery.
- Active brain metastases or meningitis.
- Significant heart disease or uncontrolled health conditions.
- Additional active cancer requiring treatment.
- Need for certain medications that interfere with the study drug.
- Positive HIV status without stable treatment.
- Active hepatitis B or C.
- Uncontrolled illness or infection.
- Pregnant or breastfeeding women.
- Known allergy to study drugs or components.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Banner MD Anderson Cancer Center (Site 106) | 85234 | Gilbert | Arizona |
| City of Hope (Site 107) | 91010 | Duarte | California |
| University of California at Irvine (Site 101) | 92868 | Orange | California |
| UCLA Medical Center (Site 117) | 90404 | Santa Monica | California |
| Norton Cancer Institute (Site 115) | 40127 | Louisville | Kentucky |
| Ochsner Medical Center (Site 120) | 70121 | New Orleans | Louisiana |
| Henry Ford Cancer Center (Site 113) | 48186 | Detroit | Michigan |
| Karmanos Cancer Center (Site 109) | 48201 | Detroit | Michigan |
| Masonic Cancer Center, University of Minnesota (Site 116) | 55455 | Minneapolis | Minnesota |
| Rutgers Cancer Institute of New Jersey (Site 103) | 08901 | New Brunswick | New Jersey |
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