Randomized Phase 1/2 Open-Label Trial of PR104 and Sorafenib in Patients With Advanced Hepatocellular Carcinoma (HCC)
Public ClinicalTrials.gov record NCT00862082. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized Phase I/II, Multi-Center, Open-Label Trial of PR104 and Sorafenib in Patients With Advanced Hepatocellular Carcinoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The current understanding of PR104 justifies the evaluation of PR104 with sorafenib in patients with hepatocellular carcinoma. These include: * Hypoxia. Hepatocellular Carcinoma (HCC) is likely to demonstrate a level of hypoxia sufficient to activate PR104 to its active metabolites PR104H and PR104M. In addition, in preclinical models, sorafenib has been demonstrated to increase the degree of hypoxia in tumors following treatment. * Non-overlapping toxicity. PR104 and sorafenib do not share major toxicities. It is anticipated that both drugs can be administered at their full single agent dose when used in combination. * Aldo-keto reductase 1C3 (AKR1C3). HCC has been shown to express high levels of AKR1C3 which should lead to selective activation of PR104 within both hypoxic and oxic HCC cells. * Preclinical data. The use of sorafenib and PR104 alone and in combination in a hepatocellular carcinoma model demonstrates activity of PR104 as a single agent and increased activity when PR104 and sorafenib are used in combination. The current study will provide an estimate of the activity of PR104 in subjects with HCC. This information will prove valuable in defining the future clinical development of PR104, and in determining if PR104 has sufficient activity in HCC to warrant a larger phase III registration study in this indication. Primary objectives * Phase I: Determine the maximum tolerated dose (MTD) of PR104 when used in combination with standard dose sorafenib * Phase II: Estimate the response rate (RR) of PR104/sorafenib \[Note: Phase II was never initiated\] Secondary objectives * Evaluate survival * Evaluate Progression Free Survival (PFS) * Evaluate time to progression (TTP) * Evaluate safety * Evaluate the pharmacokinetics (PK) of sorafenib, PR104 and PR104 metabolites * Collect diagnostic biopsy samples for the determination of aldo-keto reductase 1C3 * Collect plasma samples for assessment of potential biomarkers of tumor hypoxia
Study identification
- NCT ID
- NCT00862082
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 14 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 28, 2009
- Primary completion
- Dec 31, 2009
- Completion
- Apr 30, 2010
- Last update posted
- Aug 22, 2013
2009 – 2010
United States locations
- U.S. sites
- 9
- U.S. states
- 6
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Arizona | Tucson | Arizona | 85724 | — |
| Moores UCSD Cancer Center | La Jolla | California | 92093 | — |
| University of California, Irvine | Orange | California | 92868 | — |
| Sharp Clinical Oncology Research | San Diego | California | 92123 | — |
| Pacific Oncology/Hematology | San Francisco | California | 94115 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| Indiana University Simon Cancer Center | Indianapolis | Indiana | 46202 | — |
| Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins | Baltimore | Maryland | 21231 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 8 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00862082, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 22, 2013 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00862082 live on ClinicalTrials.gov.