NCT02076230

A Phase 1 TH-302 Mass Balance Trial

A Phase I, Open-Label, Two-Center Trial to Investigate the Mass Balance and Metabolite Profile of TH-302 in Cancer Patients With Locally Advanced or Metastatic Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: Male
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, Phase 1, two-center trial to evaluate the mass balance and metabolite profile of carbon 14 \[14C\]-labeled TH-302 (Label 1 and Label 2) followed by subsequent treatment with unlabeled TH-302 in cancer subjects with locally advanced or metastatic solid tumors.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	[14C] TH-302 (Label 1)	\[14C\]-labeled TH-302 (Label 1) will be administered as intravenous infusion over 30 minutes on Day 1 of Part A.
DRUG	[14C] TH-302 (Label 2)	\[14C\]-labeled TH-302 (Label 2) will be administered as intravenous infusion over 30 minutes on Day 1 of Part A.
DRUG	Unlabeled TH-302	Unlabeled TH-302 will be administered along with labeled TH-302 at the dose of 340 milligram per square meter (mg/m\^2) as intravenous infusion over 30 minutes on Day 1 of Part A, followed by recommended Phase 2 dose (RP2D) of 480 mg/m\^2 as monotherapy infusion over 30 minutes on Days 8 and 15 of Part A; and on Days 1, 8 and 15 of Part B, until progression of the disease, unacceptable toxicity, withdrawal of consent by the subject, loss to follow up, or death.

Timeline

• Start date: 2014-02-01
• Primary completion: 2014-09-01
• Completion: 2016-03-01
• First posted: 2014-03-03
• Last updated: 2016-06-10

Locations

1 site across 1 country: Germany