Relative Bioavailability of Pimasertib in Cancer Patients

NCT ID: NCT01992874

Last Updated: 2017-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2015-02-28

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).

Conditions

Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pimasertib Capsule/Pimasertib Tablet

Group Type: EXPERIMENTAL

Pimasertib Capsule (Part A)

Intervention Type: DRUG

Pimasertib capsule administration at a single dose of 60 milligram (mg) orally on Day 1 in Part A.

Pimasertib Tablet (Part A)

Intervention Type: DRUG

Pimasertib tablet administration at a single dose of 60 mg orally on Day 3 in Part A.

Pimasertib Capsule (Part B and trial extension phase)

Intervention Type: DRUG

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.

Pimasertib Tablet/Pimasertib Capsule

Group Type: EXPERIMENTAL

Pimasertib Tablet (Part A)

Intervention Type: DRUG

Pimasertib tablet administration at a single dose of 60 mg orally on Day 1 in Part A.

Pimasertib Capsule (Part A)

Intervention Type: DRUG

Pimasertib capsule administration at a single dose of 60 mg orally on Day 3 in Part A.

Pimasertib Capsule (Part B and trial extension phase)

Intervention Type: DRUG

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.

Interventions

Pimasertib Capsule (Part A)

Pimasertib capsule administration at a single dose of 60 milligram (mg) orally on Day 1 in Part A.

Intervention Type: DRUG

Pimasertib Tablet (Part A)

Pimasertib tablet administration at a single dose of 60 mg orally on Day 3 in Part A.

Intervention Type: DRUG

Pimasertib Tablet (Part A)

Pimasertib tablet administration at a single dose of 60 mg orally on Day 1 in Part A.

Intervention Type: DRUG

Pimasertib Capsule (Part A)

Pimasertib capsule administration at a single dose of 60 mg orally on Day 3 in Part A.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

AS703026; MSC1936369B; AS703026; MSC1936369B; AS703026; MSC1936369B; AS703026; MSC1936369B; AS703026; MSC1936369B

Eligibility 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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EMD Serono

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Responsible

Role: STUDY_DIRECTOR

EMD Serono, Inc., Rockland MA, a subsidiary of Merck KGaA, Darmstadt, Germany

Locations

Please Contact U.S. Medical Information Located in

Rockland, Massachusetts, United States

Countries

United States

References

Mahadevan D, Mita M, Richards D, McClay E, Heist RS, Kumar A, Sundararajan S, Naing A. Phase I single dose, two-period and two-sequence cross-over trial to evaluate the relative bioavailability of two oral pimasertib formulations in advanced cancer patients. Cancer Chemother Pharmacol. 2017 Apr;79(4):681-688. doi: 10.1007/s00280-017-3258-0. Epub 2017 Mar 13.

Reference Type: RESULT

PMID: 28289865 (View on PubMed)

Other Identifiers

200066-013

Identifier Type: -

Identifier Source: org_study_id