Relative Bioavailability of Pimasertib in Cancer Patients

Merck KGaA (EMD Serono)

Status and phase: Completed; Phase 1

Conditions: Neoplasms

Treatments: Drug: Pimasertib Capsule (Part B and trial extension phase); Drug: Pimasertib Capsule (Part A); Drug: Pimasertib Tablet (Part A)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01992874

200066-013

Details and patient eligibility

About

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).

Enrollment: 38 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

Pimasertib Capsule/Pimasertib Tablet

Experimental group

Treatment:

Drug: Pimasertib Tablet (Part A)

Drug: Pimasertib Capsule (Part A)

Drug: Pimasertib Capsule (Part B and trial extension phase)

Drug: Pimasertib Tablet (Part A)

Drug: Pimasertib Capsule (Part A)

Pimasertib Tablet/Pimasertib Capsule

Experimental group

Treatment:

Drug: Pimasertib Tablet (Part A)

Drug: Pimasertib Capsule (Part A)

Drug: Pimasertib Capsule (Part B and trial extension phase)

Drug: Pimasertib Tablet (Part A)

Drug: Pimasertib Capsule (Part A)