Recent Updates
Recently added Catalysts

PF-04691502

Phase 1

Cancer | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Aug 12, 2014

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment37
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00927823A Trial To Assess Safety And Tolerability Of PF-04691502 In Cancer PatientsPHASE1 COMPLETED 37Dec 1, 2009Apr 1, 2012Aug 12, 20147 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Baseline up to 28 days after the last dose

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.

Number of Participants With Dose Limiting Toxicities (DLTs)
Baseline up to Cycle 1 Day 21

DLT was classified as per common terminology criteria for adverse events (CTCAE) version 4.0 and defined as any of the following events occurring after first dose of study medication and considered at least possibly-related to study medication. Hematological: grade 4 neutropenia (absolute neutrophil count \[ANC\] \<500 cells per cubic millimeter \[cells/mm\^3\]) for 1 week or greater, febrile neutropenia (fever \>=38.5 degree celsius with ANC \<1000/mm\^3), grade 3 (50,000 cells/mm\^3) and grade 4 (\<25,000 cells/mm\^3) thrombocytopenia; Non-Hematologic: grade 3 or 4 nausea, vomiting, or diarrhea and any clinically significant grade 3 or greater non-hematologic toxicity, despite the use of adequate/maximal medical intervention and/or prophylaxis, and any persistent, intolerable PF-04691502 related toxicity which delayed retreatment for \>14 days.

Recommended Phase-2 Dose (RP2D)
Baseline up to Cycle 1 Day 21

RP2D was determined based on the safety profile and pharmacodynamic findings, as per investigator's discretion.

Secondary Endpoints
Maximum Observed Plasma Concentration (Cmax)
Pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24, 48, 72, 96 hours post-dose in Lead-in period; pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24 hours post-dose on Cycle 1 Day 21 (C1D21)
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24, 48, 72, 96 hours post-dose in Lead-in period; pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24 hours post-dose on C1D21
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24, 48, 72, 96 hours post-dose in Lead-in period
Unlock Study Endpoints
Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PF-04691502 TreatmentEXPERIMENTAL -
Interventions
NameTypeDescription
PF-04691502DRUGOnce daily continuous dosing. Dose escalation to Maximally tolerated dose (MTD) until progression or discontinuation.
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Patients with a histologically or cytologically confirmed malignant solid tumor for which there is no currently approved treatment or which is unresponsive to currently approved therapies. * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1 * Female patient...

Countries:United States
Unlock Eligibility Criteria