Oral Bioavailability and Mass Balance Trial With Pimasertib

PHASE1CompletedINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

November 30, 2012

Primary Completion Date

July 31, 2014

Study Completion Date

July 31, 2014

Conditions
Locally Advanced or Metastatic Solid Tumors
Interventions
DRUG

Pimasertib

Part A: Subjects will receive unlabeled pimasertib capsules orally at a single dose of 60 milligram (mg) on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kilobecquerel (kBq) \[14C\] pimasertib will be administered as a bolus injection. On Days 3-21 (except Day 8), subjects will receive unlabeled pimasertib capsules orally at a dose of 60 mg twice daily (BID). In the morning of Day 8, subjects will receive 60 mg unlabeled pimasertib capsules spiked with a dose of 2.6 megabecquerel (MBq) (70 microcuries \[mcgCi\]) of \[14C\] pimasertib orally. In the evening of Day 8, subjects will receive the evening dose of 60 mg pimasertib as unlabeled pimasertib capsules orally. Part B : Subjects will be administered with 60 mg BID unlabeled pimasertib as oral capsules continuously in cycles of 21 days until progression of the disease, unacceptable toxicity, withdrawal of consent by the subject, loss to follow-up or death.

Trial Locations (1)

Unknown

Research Site, Budapest

All Listed Sponsors
lead

Merck KGaA, Darmstadt, Germany

INDUSTRY

NCT01713036 - Oral Bioavailability and Mass Balance Trial With Pimasertib | Biotech Hunter | Biotech Hunter