CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 20 enrolled
Drug / intervention
Evofosfamide +1 moredrug
Likely dose
Evofosfamide 480 milligramfrom 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.

Search/NCT01833546
NCT01833546Phase 1Completed
CompareCT.gov

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

Merck KGaA, Darmstadt, Germany·interventional·Posted Apr 17, 2013·Updated Oct 15, 2018

In Brief

A Phase 1 clinical trial evaluating Evofosfamide and Gemcitabine for Solid Tumor and Pancreatic Cancer. Completed, enrolled 20 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Tumor, Pancreatic Cancer
CountriesJapan
CollaboratorsThreshold Pharmaceuticals

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 17, 2013
Enrollment StartApr 18, 2013
Primary CompletionAug 31, 2015
Study CompletionJan 25, 2016
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 13.2 years ago

Interventions

Evofosfamidedrug

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.

Gemcitabinedrug

Gemcitabine 1000 mg/m\^2 on Day 1, 8 and 15 of each 28-day treatment cycle until progressive disease, unacceptable toxicity or withdrawal.