NCT01833546

A Japanese Phase 1 Trial of TH-302 in Subjects With Solid Tumors and Pancreatic Cancer

A Japanese Single Center, Open-label, Phase I Trial of TH-302 Given Intravenously to Subjects With Solid Tumors as Monotherapy or to Subjects With Advanced Pancreatic Cancer in Combination With Gemcitabine

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This is a Japanese Phase 1, open-label, and dose-escalating trial of TH-302 as monotherapy in subjects with solid tumors and in combination with gemcitabine in subjects with pancreatic cancer.

Conditions

• Solid Tumor
• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Evofosfamide	Evofosfamide infusion intravenously at an escalated dose of 240, 340 or 480 milligram per square meter (mg/m\^2) on Day 1, 8 and 15 of each 28-day treatment cycle until progressive disease, unacceptable toxicity or withdrawal.
DRUG	Gemcitabine	Gemcitabine 1000 mg/m\^2 on Day 1, 8 and 15 of each 28-day treatment cycle until progressive disease, unacceptable toxicity or withdrawal.

Timeline

• Start date: 2013-04-18
• Primary completion: 2015-08-31
• Completion: 2016-01-25
• First posted: 2013-04-17
• Last updated: 2018-10-15
• Results posted: 2018-10-15

Locations

2 sites across 1 country: Japan