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A Cardiac Safety Study of TH-302 in Patients With Advanced Solid Tumors

NCT02020226 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-06-02

No results posted yet for this study

Summary

The Primary objective of this study is:

1\. To determine the cardiac safety of TH-302 in patients with advanced solid tumors

The Secondary objectives are:

1. To assess the pharmacokinetics (PK) of TH-302
2. To evaluate whether there is an association between plasma exposure to TH-302 and its active metabolite, Br-IPM, and effects on cardiac repolarization
3. To assess the safety and antitumor activity of TH-302 in patients with advanced solid tumors

Conditions

Interventions

DRUG

TH-302

480 mg/m2 30 min IV infusion on Days 1, 8, and 15 of a 28 day cycle

Sponsors & Collaborators

  • Threshold Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Lee Cranmer, MD, PhD · The University of Arizona Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2016-07-31
Completion
2016-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT02020226 on ClinicalTrials.gov