MedTrace Logo

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

NCT01833546 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2018-10-15

Study results available
· View outcomes & findings →

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

Interventions

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.

Sponsors & Collaborators

  • Threshold Pharmaceuticals

    collaborator INDUSTRY

  • Merck KGaA, Darmstadt, Germany

    lead INDUSTRY

Principal Investigators

  • Medical Responsible · Merck Serono Co., Ltd., Japan

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-18
Primary Completion
2015-08-31
Completion
2016-01-25

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01833546 on ClinicalTrials.gov