NCT01992874

Relative Bioavailability of Pimasertib in Cancer Patients

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: EMD Serono · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Neoplasms

Interventions

Type	Name	Description
DRUG	Pimasertib Capsule (Part A)	Pimasertib capsule administration at a single dose of 60 milligram (mg) orally on Day 1 in Part A.
DRUG	Pimasertib Tablet (Part A)	Pimasertib tablet administration at a single dose of 60 mg orally on Day 3 in Part A.
DRUG	Pimasertib Tablet (Part A)	Pimasertib tablet administration at a single dose of 60 mg orally on Day 1 in Part A.
DRUG	Pimasertib Capsule (Part A)	Pimasertib capsule administration at a single dose of 60 mg orally on Day 3 in Part A.
DRUG	Pimasertib Capsule (Part B and trial extension phase)	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.

Timeline

• Start date: 2013-11-30
• Primary completion: 2014-05-31
• Completion: 2015-02-28
• First posted: 2013-11-25
• Last updated: 2017-08-15
• Results posted: 2016-05-11

Locations

1 site across 1 country: United States