Dose-Escalation Study of TH-302 in Combination With Sunitinib to Treat Patients With Advanced Renal Cell Carcinoma,Gastrointestinal Stromal Tumors and Pancreatic Neuroendocrine Tumors (TH-CR-410)
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|ClinicalTrials.gov Identifier: NCT01381822|
Recruitment Status : Unknown
Verified April 2014 by Threshold Pharmaceuticals.
Recruitment status was: Active, not recruiting
First Posted : June 27, 2011
Last Update Posted : April 21, 2014
The primary objectives are:
1. To determine the MTD and DLT(s) of TH-302 when used in combination with sunitinib.
- To make a preliminary assessment of the efficacy of TH-302 in combination with sunitinib as determined by the response rate and the progression-free survival in subjects with advanced RCC treated at the RP2D
- To assess the safety of TH-302 in combination with sunitinib and determine a recommended Phase 2 dose of the combination.
The secondary objectives are:
1. To make a preliminary assessment of the efficacy of TH-302 in combination with sunitinib as determined by stable disease or better rate, duration of response and overall survival in subjects with advanced RCC treated at the RP2D.
The exploratory objective is:
1. To explore the association of serum hypoxia biomarkers with efficacy endpoints.
|Condition or disease||Intervention/treatment||Phase|
|Advanced Renal Cell Carcinoma Gastrointestinal Stromal Tumors Pancreatic Neuroendocrine Tumors||Drug: TH-302||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||58 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Dose-Escalation Study to Determine the Safety of TH-302 in Combination With Sunitinib in Patients With Advanced Renal Cell Carcinoma,Gastrointestinal Stromal Tumors and Pancreatic Neuroendocrine Tumors|
|Study Start Date :||June 2011|
|Estimated Primary Completion Date :||June 2014|
|Estimated Study Completion Date :||June 2014|
Experimental: TH-302 Dose escalation
The initial dose of TH-302 will be 240 mg/m2. A Dose Level minus 1 and 2 will be built into the study in the event that subjects experience excessive toxicity at Dose Level 1. Dose escalation will continue with approximately 40% increases from the previous dose level; however lower dose increases of 20-39% may be implemented after consultation between the Investigators, Medical Monitor and Sponsor with the percent increase dependent on the current dose level and the cumulative safety data.
TH-302: administered by IV infusion over 30 or 60 minutes on Days 8, 15 and 22 of a 42 day cycle.
- To determine the MTD and DLT(s) of TH-302 when used in combination with sunitinib. [ Time Frame: Two years ]
- To make a preliminary assessment of the efficacy of TH-302 in combination with sunitinib as determined by the response rate and the progression-free survival in subjects with advanced RCC treated at the RP2D. [ Time Frame: Two years ]
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): NCT01381822
|United States, Indiana|
|IU Health Goshen Center for Cancer Care|
|Goshen, Indiana, United States, 46526|
|United States, Iowa|
|University of Iowa|
|Iowa City, Iowa, United States, 52242|
|Principal Investigator:||Alexander Starodub, MD||IU Health Goshen Center for Cancer Care|
|Principal Investigator:||Mohammed Milhem, MD||University of Iowa|