Conditions: Neoplasms
Keywords: Neoplasms Pimasertib Cancer
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 38
Healthy volunteers: no

Brief 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).

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Pimasertib Capsule (Part A) intervention 2: Pimasertib Tablet (Part A) intervention 3: Pimasertib Tablet (Part A) intervention 4: Pimasertib Capsule (Part A) intervention 5: Pimasertib Capsule (Part B and trial extension phase)
Intervention descriptions: intervention 1: Pimasertib capsule administration at a single dose of 60 milligram (mg) orally on Day 1 in Part A. intervention 2: Pimasertib tablet administration at a single dose of 60 mg orally on Day 3 in Part A. intervention 3: Pimasertib tablet administration at a single dose of 60 mg orally on Day 1 in Part A. intervention 4: Pimasertib capsule administration at a single dose of 60 mg orally on Day 3 in Part A. intervention 5: 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.

Protocol document: