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Relative Bioavailability of Pimasertib in Cancer Patients

NCT01992874 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2017-08-15

Study results available
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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

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.

Sponsors & Collaborators

Principal Investigators

  • Medical Responsible · EMD Serono, Inc., Rockland MA, a subsidiary of Merck KGaA, Darmstadt, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2014-05-31
Completion
2015-02-28

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01992874 on ClinicalTrials.gov