NCT02076230 - A Phase 1 TH-302 Mass Balance Trial | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

February 28, 2014

Primary Completion Date

September 30, 2014

Study Completion Date

March 31, 2016

Conditions

Solid Tumor

Interventions

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.

Trial Locations (1)

Unknown

Please contact the Merck KGaA Communication Center located in, Darmstadt