Dose-defining Study of Tirapazamine Combined With Embolization in Liver Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 50
Summary
- Conditions
- Gastrointestinal Cancer Metastatic
- Hepatocellular Carcinoma
- Neuroendocrine Tumors
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Open label, dose escalation 3+3 design; 3 expansion cohorts: hepatocellular carcinoma, advanced solid tumors and neuroendocrine tumor.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 20 years and 80 years
- Gender
- Both males and females
Description
The study is a 3+3 design for dose escalation. Each cohort will have 3-6 patients based on tolerability. Patients will receive escalated doses of tirapazamine until maximally tolerated dose. Embolization is performed per standard practice using Lipiodol and Gelfoam under X-ray guidance. Once a suita...
The study is a 3+3 design for dose escalation. Each cohort will have 3-6 patients based on tolerability. Patients will receive escalated doses of tirapazamine until maximally tolerated dose. Embolization is performed per standard practice using Lipiodol and Gelfoam under X-ray guidance. Once a suitable dose is determined, an expansion cohort of 15 patients will be treated with the recommended phase 2 dose to determine preliminary efficacy. Expansion cohorts include (1) hepatocellular carcinoma, (2) metastatic solid tumors with liver metastasis, and (3) neuroendocrine tumor. Adverse events are evaluated by CTCAE vs. 4.0 and efficacy is evaluated by MRI using modified RECIST criteria and RECIST criteria.
Tracking Information
- NCT #
- NCT02174549
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Nadine Abi-Jaoudeh, MD Univ. of California, Irvine
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