NCT02255110

A Japanese Trial of TH-302 in Subjects With Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma

A Phase II, Single-arm, Japanese Multicenter Trial of TH-302 in Combination With Doxorubicin in Subjects With Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2, single-arm, Japanese multicenter trial to evaluate the safety, tolerability, and efficacy of TH-302 in combination with doxorubicin in subjects with locally advanced unresectable or metastatic soft tissue sarcoma (STS).

Conditions

• Soft Tissue Sarcoma

Interventions

Type	Name	Description
DRUG	TH-302	TH-302 will be administered at a dose of 300 milligram per square meter (mg/m\^2) by intravenous infusion over 30 minutes on Days 1 and 8 of every 21-day cycle until the evidence of significant treatment-related toxicity or progressive disease.
DRUG	Doxorubicin	Doxorubicin will be administered at a dose of 75 mg/m\^2 by intravenous injection (over at least 5 minutes) or by intravenous infusion over 6-96 hours on Day 1 of every 21-day cycle starting 2 to 4 hours after completion of TH-302 administration until the evidence of significant treatment-related toxicity or progressive disease.

Timeline

• Start date: 2014-12-10
• Primary completion: 2016-01-12
• Completion: 2016-01-12
• First posted: 2014-10-02
• Last updated: 2018-12-14
• Results posted: 2018-12-14

Locations

2 sites across 1 country: Japan