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PF-03084014

Phase 1

Neoplasms by Histologic Type | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Nov 12, 2019

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment72

FDA Designations

No designations recorded

Clinical trial landscape

PF-03084014 · 1 trial · 1 indication

Phase 1 1
NCT00878189A Trial In Patients With Advanced Cancer And LeukemiaNeoplasms by Histologic Type
COMPLETED72 Analytics
PHASE1COMPLETED
A Trial In Patients With Advanced Cancer And Leukemia
Neoplasms by Histologic TypeUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Solid Tumor Participants With First-Cycle Dose-Limiting Toxicity (DLT)
Baseline to the end of Cycle 1 (Week 4)

Any DLT event attributable to PF-03084014 during Cycle 1: non-hematologic toxicities \>= Grade 3 despite optimal care; treatment delay \>=7 days or unable to deliver at least 80% of planned dose due to treatment-related toxicities; Grade 4 neutropenia \>7 days; febrile neutropenia; neutropenic infection; Grade \>=3 thrombocytopenia with bleeding

Number of T-ALL/LBL Participants With First-Cycle DLT
Baseline to the end of Cycle 1 (Week 4)

Any DLT attributable to PF-03084014 at 1st Cycle: non-hematologic toxicities \>= Grade 3 despite optimal care; treatment delay \>=7 days; unable to deliver at least 80% of planned dose; absolute neutrophil count (ANC) \<1000/microliter (uL), or platelet count \<30,000/uL, or hemoglobin \<8 gram/deciliter (g/dL) in a bone marrow with \<5% blasts and no evidence of leukemia or abnormal dysplasia for \>42 days

Secondary Endpoints

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causality)
Baseline up to end of study (maximum of 84 months)
Number of Participants With TEAEs (Treatment-Related)
Baseline up to end of study (maximum of 84 months)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causality) by Severity (by Maximum Common Terminology Criteria for Adverse Events [CTCAE] Grade)
Baseline up to end of study (maximum of 84 months)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -

Interventions

NameTypeDescription
PF-03084014DRUG10 mg, 50 mg or 100 mg tablets. Patients dosed from 20 mg - 500 mg, twice daily
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Eligibility Criteria

Age Range16 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites10

Inclusion Criteria: * Patients with advanced cancer that is resistant to standard therapy or for which no standard therapy is available * Patients with acute T cell leukemia/lymphoblastic lymphoma that is resistant to standard therapy or for which no standard therapy is available * Men and women \>...

Countries:United StatesItaly
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Frequently asked questions about PF-03084014

What is PF-03084014 used for?

PF-03084014 is an investigational small molecule being studied for the treatment of neoplasms by histologic type, which refers to cancers classified by their tissue of origin. It is being developed by Pfizer, Inc. for oncology indications.

Who makes PF-03084014?

PF-03084014 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is an investigational small molecule in the oncology therapeutic area.

What phase is PF-03084014 in?

PF-03084014 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for the treatment of neoplasms by histologic type.

What clinical trials is PF-03084014 in?

PF-03084014 has been studied in one clinical trial, NCT00878189, titled "A Trial In Patients With Advanced Cancer And Leukemia." This Phase 1 trial was completed and enrolled 72 participants in the United States and Italy.

Is PF-03084014 FDA approved?

PF-03084014 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed trial, NCT00878189, was a Phase 1 study in patients with advanced cancer and leukemia, but approval status has not been established.