Dose-defining Study of Tirapazamine Combined With Embolization in Liver Cancer
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|ClinicalTrials.gov Identifier: NCT02174549|
Recruitment Status : Active, not recruiting
First Posted : June 25, 2014
Last Update Posted : May 2, 2022
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma Gastrointestinal Cancer Metastatic Neuroendocrine Tumors||Drug: Tirapazamine Procedure: Transarterial embolization (TAE)||Phase 1 Phase 2|
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. 5.0 and efficacy is evaluated by MRI using modified RECIST criteria and RECIST criteria.
The dose escalation part has been completed. Only the third cohort or neuroendocrine tumor remains active for future patient enrollment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open label, dose escalation 3+3 design; 3 expansion cohorts: hepatocellular carcinoma, advanced solid tumors and neuroendocrine tumor.|
|Masking:||None (Open Label)|
|Official Title:||Phase I Dose-Escalating Study of Combining Intravenous Tirapazamine and Transarterial Embolization (TAE) in Liver Cancer|
|Study Start Date :||September 2014|
|Estimated Primary Completion Date :||December 31, 2023|
|Estimated Study Completion Date :||December 31, 2023|
Administration with dose escalated tirapazamine before embolization until maximally tolerated dose achieved.
Intra-arterial injection into the tumor feeding artery
Procedure: Transarterial embolization (TAE)
Lipiodol and Gelfoam used to embolize tumor vessels and induce tumor hypoxia
Other Name: Lipiodol and Gelfoam as the standard embolizing agents.
- determine the recommended phase 2 dose [ Time Frame: 2 years ]future dose used for randomzied trials
- Complete Response (CR) rate [ Time Frame: 2 years ]mRECIST based on mRECIST
- Duration of response [ Time Frame: 2 years ]From randomization to progression
- Area under the plasma concentration versus time curve (AUC) [ Time Frame: 2 years ]PK parameter
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02174549
|United States, California|
|University of California Irvine Medical Center|
|Orange, California, United States, 92868|
|Univ. of California, San Francisco|
|San Francisco, California, United States, 94143|
|Principal Investigator:||Nadine Abi-Jaoudeh, MD||Univ. of California, Irvine|