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PF-04691502

Phase 2

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

PF-04691502 development status

Highest phase Phase 2 (NCT01430585)
Phase scored for PFEPhase 1
Registered trials 3 across 1 sponsor since Jun 2009

PF-04691502 target and mechanism

Molecular targetPIK3R1, PIK3CB, PIK3CG, PIK3CA, PIK3R2, PIK3CD
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment37

FDA Designations

No designations recorded

PF-04691502 clinical trials

PF-04691502 · 1 trial · 1 indication

Phase 1 1
NCT00927823A Trial To Assess Safety And Tolerability Of PF-04691502 In Cancer PatientsCancer
COMPLETED37 Analytics
PHASE1COMPLETED
A Trial To Assess Safety And Tolerability Of PF-04691502 In Cancer Patients
CancerUnlock trial analytics

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
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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.
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Eligibility Criteria

Age Range18 Years to 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
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Competitive Landscape -Cancer 7 trials

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Frequently asked questions about PF-04691502

What is PF-04691502 used for?

PF-04691502 is an investigational small molecule being studied for the treatment of cancer. It was evaluated in a Phase 1 clinical trial in adult cancer patients. It is not approved for any indication and remains in clinical development.

What does PF-04691502 target?

PF-04691502 is a small molecule inhibitor that targets the PI3K pathway, specifically PIK3CA, PIK3CB, PIK3CG, PIK3CD, PIK3R1, and PIK3R2. By inhibiting these phosphoinositide 3-kinase targets, the drug is designed to interfere with signaling pathways involved in cancer cell growth and survival.

Who is developing PF-04691502?

PF-04691502 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the Phase 1 clinical trial evaluating the compound in cancer patients.

What phase is PF-04691502 in?

PF-04691502 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA for any indication. The Phase 1 trial has been completed.

What clinical trials is PF-04691502 in?

PF-04691502 was studied in one Phase 1 clinical trial, NCT00927823, titled A Trial To Assess Safety And Tolerability Of PF-04691502 In Cancer Patients. The trial enrolled 37 adults with cancer in the United States and is now completed.