CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 38 enrolled
Drug / intervention
Pimasertib Capsule (Part A) +4 moredrug
Likely dose
Pimasertib Capsule (Part A) 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/NCT01992874
NCT01992874Phase 1Completed
CompareCT.gov

A Multi-Center, Open-Label, Single 60 mg Dose, Two Period, Two Sequence Cross-Over Trial to Investigate the Relative Bioavailability of Two Solid Oral Pimasertib Formulations in Cancer Patients

EMD Serono·interventional·Posted Nov 25, 2013·Updated Aug 15, 2017

In Brief

A Phase 1 clinical trial evaluating Pimasertib Capsule (Part A), Pimasertib Tablet (Part A), and 1 other intervention for Neoplasms. Completed, enrolled 38 participants across 1 site.

Detailed Summary

This is a Phase 1, multi-center, open-label, single-dose, 2 period, 2 sequence cross-over trial to investigate the relative bioavailability of 2 solid oral pimasertib formulations in cancer subjects (Part A), followed by open-label pimasertib administration (Part B and trial extension phase).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasms
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 25, 2013
Enrollment StartNov 30, 2013
Primary CompletionMay 31, 2014
Study CompletionFeb 28, 2015
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 12.6 years ago

Interventions

Pimasertib Capsule (Part A)drug

Pimasertib capsule administration at a single dose of 60 milligram (mg) orally on Day 1 in Part A.

Pimasertib Tablet (Part A)drug

Pimasertib tablet administration at a single dose of 60 mg orally on Day 3 in Part A.

Pimasertib Tablet (Part A)drug

Pimasertib tablet administration at a single dose of 60 mg orally on Day 1 in Part A.

Pimasertib Capsule (Part A)drug

Pimasertib capsule administration at a single dose of 60 mg orally on Day 3 in Part A.

Pimasertib Capsule (Part B and trial extension phase)drug

Subjects completing Part A to receive pimasertib capsule at a dose of 60 mg orally twice daily in cycles of 21 days each in Part B and trial extension phase until disease progression, intolerable toxicity, subject withdrawal, loss to follow-up or death.