Recent Updates
Recently added Catalysts

Trametinib pediatric formulation

Phase 1

Cancer | Small molecule | Oncology |GSK plc|Last Updated: Nov 13, 2017

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment18

FDA Designations

No designations recorded

Clinical trial landscape

Trametinib pediatric formulation · 1 trial · 1 indication

Phase 1 1
NCT01647659Relative Bioavailibilty for Pediatric Powder for Suspension (PfOS) FormulationCancer
COMPLETED18 Analytics
PHASE1COMPLETED
Relative Bioavailibilty for Pediatric Powder for Suspension (PfOS) Formulation
Cancer
NCT0164765918
Unlock trial analytics

Study Endpoints

Primary Endpoints

Evaluate the relative bioavailability of a PfOS formulation relative to the commercial GSK1120212 tablet formulation in adult subjects with solid tumors
168 hours X 2

Secondary Endpoints

Safety and tolerability as determined by the number of patients with adverse events, serious adverse events, and changes in lab values and vital signs from baseline
Day 1 of each dosing session and followup
Evaluate the palatability (bitterness, sweetness, overall taste and aroma) of the pediatric formulation of GSK1120212
Day 1
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
GSK1120212 tabletEXPERIMENTALGSK1120212 tablet
GSK1120212 powder for oral solutionEXPERIMENTALGSK1120212 powder for oral solution

Interventions

NameTypeDescription
Trametinib tabletDRUG2 mg, orally, on Day 1 of the dosing period
Trametinib pediatric formulationDRUG2 mg, orally, on Day 1 of the dosing period
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Male or female, 18 years of age or older, at the time of signing the informed consent. * Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. * Able to swallow and retain oral medication. * His...

Countries:United States
Unlock Eligibility Criteria

Competitive Landscape -Cancer 5 trials

CompanyTickerTrialsLead PhaseDrugs
GE Healthcare Technologies Inc.GEHC1PHASE1GEH200520/ GEH200521- Part A
Zimmer Biomet Holdings, Inc.ZBH1 - Undisclosed
Ascentage Pharma Group International Unsponsored ADRAAPG1PHASE1Olverembatinib
Unlock Competitive Intelligence