Relative Bioavailability of Pimasertib in Cancer Patients
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
1 other identifier
interventional
38
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Nov 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 8, 2013
CompletedFirst Posted
Study publicly available on registry
November 25, 2013
CompletedStudy Start
First participant enrolled
November 30, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2015
CompletedResults Posted
Study results publicly available
May 11, 2016
CompletedAugust 15, 2017
July 1, 2017
6 months
November 8, 2013
April 5, 2016
July 6, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Maximum Observed Plasma Concentration (Cmax)
Maximum observed plasma concentration (Cmax) was calculated for Part A Pimasertib 60 mg Capsule and tablet.
Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3
Area Under the Plasma Concentration-time Curve From Zero to the Last Quantifiable Concentration (AUC 0-t)
Area under the plasma concentration-time curve from time zero to the last sampling time (AUC0-t) at which the concentration was at or above the lower limit of quantification.
Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3
Secondary Outcomes (11)
Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUC0-inf)
Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3
Apparent Terminal Half-life (t1/2)
Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3
Apparent Total Body Clearance (CL/f)
Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3
Apparent Volume of Distribution (Vz/f)
Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3
- +6 more secondary outcomes
Study Arms (2)
Pimasertib Capsule/Pimasertib Tablet
EXPERIMENTALPimasertib Tablet/Pimasertib Capsule
EXPERIMENTALInterventions
Pimasertib capsule administration at a single dose of 60 milligram (mg) orally on Day 1 in Part A.
Pimasertib tablet administration at a single dose of 60 mg orally on Day 3 in Part A.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- EMD Seronolead
Study Sites (1)
Please Contact U.S. Medical Information Located in
Rockland, Massachusetts, United States
Related Publications (1)
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.
PMID: 28289865RESULT
MeSH Terms
Conditions
Interventions
Results Point of Contact
- Title
- Merck KGaA Communication Center
- Organization
- Merck KGaA
Study Officials
- STUDY DIRECTOR
Medical Responsible
EMD Serono, Inc., Rockland MA, a subsidiary of Merck KGaA, Darmstadt, Germany
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 8, 2013
First Posted
November 25, 2013
Study Start
November 30, 2013
Primary Completion
May 31, 2014
Study Completion
February 28, 2015
Last Updated
August 15, 2017
Results First Posted
May 11, 2016
Record last verified: 2017-07