A Cardiac Safety Study of TH-302 in Patients With Advanced Solid Tumors
The Primary objective of this study is:
1. To determine the cardiac safety of TH-302 in patients with advanced solid tumors
The Secondary objectives are:
- To assess the pharmacokinetics (PK) of TH-302
- To evaluate whether there is an association between plasma exposure to TH-302 and its active metabolite, Br-IPM, and effects on cardiac repolarization
- To assess the safety and antitumor activity of TH-302 in patients with advanced solid tumors
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Cardiac Safety Study of TH-302 in Patients With Advanced Solid Tumors|
- Evaluate the potential for QT/QTc interval prolongation of TH-302 in patients with solid tumors [ Time Frame: 2 years ]
- Evaluate association between plasma exposure to TH-302 and its active metabolite, Br-IPM, and effects on cardiac repolarization [ Time Frame: 2 years ]
- Safety and antitumor activity of TH-302 in patients with advanced solid tumors [ Time Frame: 2 years ]
|Study Start Date:||November 2013|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
480 mg/m2 by IV infusion over 30 minutes on Days 1, 8, and 15 of each 28-day cycle
480 mg/m2 30 min IV infusion on Days 1, 8, and 15 of a 28 day cycle
This is an open-label study in patients with advanced solid tumors treated with TH-302 to assess safety, pharmacokinetics, and potential effects on cardiac repolarization and antitumor activity in patients with advanced solid tumors.
A dose of 480 mg/m2 of TH 302 will be administered by IV infusion over 30 minutes on Days 1, 8 and 15 of each 28-day cycle. Evaluations of safety, PK, and ECG parameters of cardiac repolarization will be performed on Study Day 1 and Day 2 of Cycle 1.
Cycles will be repeated every 28 days, until toxicity, progressive disease, patient or investigator decision to discontinue treatment, or until a maximum of six treatment cycles. Patients who are clearly benefitting from the treatment based on anti-cancer disease control and tolerability will be able to continue to receive drug past 6 cycles after discussion with the Sponsor. Tumor assessments will be performed after every 2 cycles during treatment.
The rationale for conducting this study is based on (a) prior data demonstrating the clinical benefit in advanced solid tumors as defined by tumor response or stable disease for at least 4 months, (b) tolerability of TH-302 at the proposed dose, and (c) a requirement to perform a dedicated ECG study to address the clinical evaluation of the potential for QT/QTc interval prolongation of TH-302.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02020226
|United States, Arizona|
|The University of Arizona Cancer Center|
|Tucson, Arizona, United States, 85719|
|Yuma Regional Cancer Center|
|Yuma, Arizona, United States, 85364|
|Principal Investigator:||Lee Cranmer, MD, PhD||The University of Arizona Cancer Center|