Dose-defining Study of Tirapazamine Combined With Embolization in Liver Cancer

Part of paid clinical trials in Palo Alto, California.

Sponsor
Teclison Ltd.
Study ID
NCT02174549
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Tirapazamine — DRUG
    Intra-arterial injection into the tumor feeding artery
  • Conventional Transarterial Embolization (TAE) — PROCEDURE
    Lipiodol and Gelfoam used to embolize tumor vessels and induce tumor hypoxia

Study Details

This phase 1 study is to determine the optimal dose and tolerability of a hypoxia-activating agent, tirapazamine, when it is combined with embolization in liver cancer. Liver cancer patients who are Child-Pugh score A, suitable for embolization with tumor no more than 4 nodules are eligible. Tirapazamine will be given by intra-arterial injection before embolization. Treatment effect is evaluated by MRI based on mRECIST criteria. Repeat treatment is necessary only if disease progression. Dose escalation cohort has been completed. Expansion cohort is open for metastatic liver dominant neuroendocrine tumor.

Key Dates

Start date
Sep 30, 2014
Status verified
Apr 2026
Primary completion
Mar 31, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tirapazamine
    Intra-arterial administration with tirapazamine before embolization to evaluate the response in metastatic liver lesions of NET

Primary Outcome Measure

Overall Response rate (ORR) by RECIST [ Time Frame: 2 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Stanford UniversityPalo AltoCalifornia94305
Mikayla Easterling
[email protected]
650-724-3698
University of PennsylvaniaPhiladelphiaPennsylvania19104
Veronica Faris
[email protected]
215-573-9765

Find similar trials in Palo Alto, CA

By condition
Liver cancerNeuroendocrine tumors
By specialty
OncologyGI oncologyHepatology
By research site
Stanford University· Palo Alto, CAUniversity of Pennsylvania· Philadelphia, PA

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