Relative Bioavailability of Pimasertib in Cancer Patients

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01992874
• Other study ID #: 200066-013
• Status: Completed
• Phase: Phase 1
• First received: November 8, 2013
• Last updated: April 17, 2015
• Start date: November 2013
• Est. completion date: February 2015

Study information

• Verified date: April 2015
• Source: EMD Serono
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: February 2015
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• Pimasertib Capsule (Part A)
Pimasertib capsule will be administered at a single dose of 60 milligram (mg) orally on Day 1 in Part A.
• Pimasertib Tablet (Part A)
Pimasertib tablet will be administered at a single dose of 60 mg orally on Day 3 in Part A.
• Pimasertib Tablet (Part A)
Pimasertib tablet will be administered at a single dose of 60 mg orally on Day 1 in Part A.
• Pimasertib Capsule (Part A)
Pimasertib capsule will be administered at a single dose of 60 mg orally on Day 3 in Part A.
• Pimasertib Capsule (Part B and trial extension phase)
Subjects who complete Part A will 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.

Locations

Country	Name	City	State
United States	Please Contact U.S. Medical Information Located in	Rockland	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
EMD Serono

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics parameters: Cmax and AUC (0-t)		Days 1 and 3	No
Secondary	Pharmacokinetics parameters: AUC (0-infinity), tmax, lambda_z, t1/2, CL/f, and Vz/f		Days 1 and 3	No
Secondary	Number of Subjects With Treatment-Emergent Adverse Events (TEAEs)		Baseline up to 30 days after the last dose of study treatment	Yes
Secondary	Number of Subjects With Complete Response (CR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)		Day 1 of Cycle 3, Cycle 5 and thereafter Day 1 of every fourth cycle until disease progression, intolerable toxicity, withdrawal of consent or before start of a new anti-cancer therapy, assessed up to 200 days	No
Secondary	Number of Subjects With Partial Response (PR) according to RECIST v1.1		Day 1 of Cycle 3, Cycle 5 and thereafter Day 1 of every fourth cycle until disease progression, intolerable toxicity, withdrawal of consent or before start of a new anti-cancer therapy, assessed up to 200 days	No
Secondary	Number of Subjects With Stable Disease (SD) according to RECIST v1.1		Day 1 of Cycle 3, Cycle 5 and thereafter Day 1 of every fourth cycle until disease progression, intolerable toxicity, withdrawal of consent or before start of a new anti-cancer therapy, assessed up to 200 days	No
Secondary	Number of Subjects With Progressive Disease (PD) according to RECIST v1.1		Day 1 of Cycle 3, Cycle 5 and thereafter Day 1 of every fourth cycle until disease progression, intolerable toxicity, withdrawal of consent or before start of a new anti-cancer therapy, assessed up to 200 days	No