CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 6 enrolled
Drug / intervention
Pimasertibdrug
Likely dose
Pimasertib 60 milligramfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01713036
NCT01713036Phase 1Completed

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

Merck KGaA, Darmstadt, Germany·interventional·Posted Oct 24, 2012·Updated Aug 15, 2017

In Brief

A Phase 1 clinical trial evaluating Pimasertib for Locally Advanced or Metastatic Solid Tumors. Completed, enrolled 6 participants across 1 site.

Detailed Summary

This is a Phase 1, open-label, single centered trial to evaluate the mass balance, bioavailability and metabolism of pimasertib in cancer subjects with locally advanced or metastatic solid tumors.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesHungary
Collaborators--

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 24, 2012
Enrollment StartNov 30, 2012
Primary CompletionJul 31, 2014
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 13.7 years ago

Interventions

Pimasertibdrug

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.