Clinical trialPhase 1 / Phase 2Completed
Dose-Escalation Study of TH-302 in Combination With A) Gemcitabine or B) Docetaxel or C) Pemetrexed to Treat Advanced Solid Tumors
A Phase 1/2, Multicenter, Dose-Escalation Study to Determine the Safety, Efficacy and Pharmacokinetics of TH-302 in Combination With A) Gemcitabine or B) Docetaxel or C) Pemetrexed in Patients With Advanced Solid Tumors
- Outcome
- Finished, no results posted
- Phase
- Phase 1 / Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- August 2008
- Expected end
- March 2014
- Enrollment
- 71 participants
- Sites
- 11
- Primary outcomes
- To determine the MTD and DLT(s) of TH-302 when used in combination with A) Gemcitabine or B) Docetaxel or C) Pemetrexed in patients with advanced solid tumors
- Sponsor
- Industry
- Results posted
- No
- Last update
- 7 May 2015
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Source text
Brief summary public domain (ClinicalTrials.gov)
The purpose of this study is to determine if TH-302, in combination with A) Gemcitabine, or B) Docetaxel or C) Pemetrexed methotrexate, are safe and effective in the treatment of Pancreatic Cancer, Castrate-resistant Prostate Cancer, and Non-small Cell Lung Cancer, respectively.
Detailed description public domain (ClinicalTrials.gov)
A broad range of tumors have been shown to contain significant numbers of hypoxic cells and hypoxia has been shown to be associated with a poor prognosis and an increase in resistance to chemotherapy and radiotherapy (Brizel 1997, Vaupel 2007, Shannon 2003). It is likely that an agent that could effectively target hypoxic regions in tumors would improve efficacy when combined with standard chemotherapy or radiotherapy. TH-302 is activated at lower oxygen concentrations than other bioreductive prodrugs (Duan 2008) and tirapazamine, a hypoxic cytotoxin that has been extensively studied in both preclinical and clinical studies. This should result in an improved therapeutic ratio (tumor vs normal tissue toxicity) as compared with other bioreductive agents. Because TH-302 is expected to be minimally toxic to aerobic cancer cells, optimal efficacy would be expected when TH-302 is combined with treatments that are most effective under aerobic conditions such as radiotherapy and cytotoxic chemotherapy. Preclinical data have shown at least additive efficacy when TH-302 is combined with either docetaxel or gemcitabine. In order to minimize the risk of additive toxicity, TH-302 is not being evaluated in combination with alkylating agents.
Papers 1
- Registry-listed results paperRandomized Phase II Trial of Gemcitabine Plus TH-302 Versus Gemcitabine in Patients With Advanced Pancreatic Cancer. DOI 10.1200/jco.2014.55.7504↗
The registry lists these as results papers; in a hand check of 27 such links about 78% reported the trial’s results, so read the paper before treating it as the outcome.