Relative Bioavailability of Pimasertib in Cancer Patients



Status:Completed
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 80
Updated:5/5/2014
Start Date:November 2013
End Date:October 2014
Contact:US Medical Information
Phone:888-275-7376

Use our guide to learn which trials are right for you!

Trial Summary
Trial Overview
Inclusion Criteria

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

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).


Inclusion Criteria:

- Pathologically confirmed solid tumors, either refractory to standard therapy or for
which no effective standard therapy is available, with a measurable disease as
defined by RECIST v1.1

- An Eastern Cooperative Oncology Group Performance Status (ECOG PS) of less than or
equal to 1

- Other protocol defined inclusion criteria could apply

Exclusion Criteria:

- Disease conditions or concomitant medication that may significantly influence the
conduct of the trial or an abnormal electrocardiogram (ECG) or blood pressure at
Screening as defined in the protocol

- Treatment with strong inhibitors or inducers of cytochrome P450 2C19 (CYP2C19) and
CYP3A4 including fruit juices or beverages containing these substances

- History of prior mitogen-activated protein kinase/extracellular signal-regulated
kinase (MAPK/ERK) kinase (MEK) inhibitor exposure (including, pimasertib) or
progression of disease on MEK inhibitors

- Evidence of a retinal vein occlusion (RVO) on fluorescein angiogram or a history of
RVO

- Life expectancy of less than 12 weeks

- Other protocol defined exclusion criteria could apply
We found this trial at
1
site
Please Contact U.S. Medical Information Located in
Rockland, Massachusetts
?
mi
from
Rockland, MA
Click here to add this to my saved trials