At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 107 enrolled
Drug / intervention
TH-302drug
Likely dose
TH-302 180 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1/2, Multicenter, Dose-Escalation Study to Determine the Safety, Efficacy and Pharmacokinetics of TH-302 in Combination With Doxorubicin in Patients With Advanced Soft Tissue Sarcoma
In Brief
A Phase 2 clinical trial evaluating TH-302 for Soft Tissue Sarcoma. Completed, enrolled 107 participants across 9 sites.
Detailed Summary
The purpose of this study is to determine whether TH-302 in combination with Doxorubicin is safe and effective in the treatment of Advanced Soft Tissue Sarcoma.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSoft Tissue Sarcoma
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2008
First PostedAug 2008
Primary CompletionJul 2013
Study CompletionOct 2013
TodayJul 2026
First PostedAug 28, 2008
Enrollment StartAug 1, 2008
Primary CompletionJul 1, 2013
Study CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 17.8 years ago
Interventions
TH-302drug
TH-302 will be administered by IV infusion over 30-60 minutes on Days 1 and 8 of a 21-day cycle. Dose escalation dose levels: Dose level -1 (if needed): 180 mg/m2 Starting dose: 240 mg/m2