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PF-04554878

Phase 1

Cancer | Small molecule | Oncology |Verastem, Inc.|Last Updated: Jan 25, 2017

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment46

FDA Designations

No designations recorded

Clinical trial landscape

PF-04554878 · 1 trial · 1 indication

Phase 1 1
NCT00787033A Study Of PF-04554878 In Patients With Advanced Non-Hematologic MalignanciesCancer
COMPLETED46 Analytics
PHASE1COMPLETED
A Study Of PF-04554878 In Patients With Advanced Non-Hematologic Malignancies
CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Recommended Phase 2 Dose
18 months
Overall safety profile of PF-04554878, including Dose-Limiting Toxicity (DLT)
18 months

Secondary Endpoints

Tumor metabolic response
18 months
PF-04554878 pharmacokinetic (PK) parameters and Midazolam PK parameters
18 months
FAK-related biomarkers in tumor biopsies and blood
18 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALDose escalation study with Expansion Cohorts at RP2D and Schedule

Interventions

NameTypeDescription
PF-04554878DRUGOral pills at increasing dose twice daily, 21 day cycle, continuous treatment schedule until progression of disease, unacceptable toxicity, or patient request. Some patients will undergo serial biopsy and/or FDG-PET imaging
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Patients with advanced non-hematologic malignancies. * Adequate organ function, including bilirubin less than 1.5 x ULN, and ECOG (Eastern Cooperative Oncology Group) performance status of 0-2. Exclusion Criteria: * Clinically significant gastrointestinal abnormalities, requ...

Countries:United StatesCanada
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Frequently asked questions about PF-04554878

What is PF-04554878 used for?

PF-04554878 is an investigational small molecule being developed for the treatment of cancer. It is currently in Phase 1 clinical development, and it has been studied in patients with advanced non-hematologic malignancies. The drug is not yet approved and remains under investigation.

Who makes PF-04554878?

PF-04554878 is being developed by Verastem, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol VSTM. The company is conducting clinical research to evaluate the safety and efficacy of this investigational oncology drug.

What phase is PF-04554878 in?

PF-04554878 is in Phase 1 clinical development. It has completed one Phase 1 trial, which was an uncontrolled, non-randomized study. The drug is still investigational and has not been approved by regulatory authorities for any indication.

What clinical trials is PF-04554878 in?

PF-04554878 has been studied in one completed clinical trial, identified as NCT00787033. This Phase 1 study, titled 'A Study Of PF-04554878 In Patients With Advanced Non-Hematologic Malignancies,' enrolled 46 patients with cancer in the United States and Canada. The trial was open to adults aged 18 years and older.

Is PF-04554878 the same as any other drug?

PF-04554878 is the primary name for this investigational drug, and no alternative names have been reported. It is a small molecule being developed by Verastem, Inc. for oncology indications, and it is currently in Phase 1 clinical development.