Relative Bioavailability of Pimasertib in Cancer Patients

• Status: Completed
• Trial end date: 2015-02-28
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EMD Serono
• Treatments: Niacinamide

Criteria

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 Response Evaluation Criteria in Solid Tumors (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