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A Phase 1, Open Label, Multi-Center, Accelerated Dose-Escalation, Pharmacokinetic And Pharmacodynamic Trial Of The Oral Single Agent Aurora Kinase Inhibitor PF-03814735 In Patients With Advanced Solid Tumors For Whom No Standard Therapy Is Available


Phase 1
18 Years
N/A
Not Enrolling
Both
Solid Tumors

Thank you

Trial Information

A Phase 1, Open Label, Multi-Center, Accelerated Dose-Escalation, Pharmacokinetic And Pharmacodynamic Trial Of The Oral Single Agent Aurora Kinase Inhibitor PF-03814735 In Patients With Advanced Solid Tumors For Whom No Standard Therapy Is Available


Inclusion Criteria:



- Metastatic solid tumor resistant to standard therapy or for which no standard therapy
is available

- Adequate bone marrow, liver and kidney function

Exclusion Criteria:

- Brain metastases that are symptomatic and/or require treatment with steroids and/or
anticonvulsants, or brain metastases that have been treated within 3 months prior to
study start

- Myocardial infarction, severe/unstable angina, symptomatic congestive heart failure,
cerebrovascular accident in the previous 6 months

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants With First Cycle Dose Limiting Toxicities (DLTs) Graded According to Common Terminology Criteria Adverse Events (CTCAE), Version 3

Outcome Description:

DLT defined as any of the following during the first cycle of treatment and attributable to PF-03814735: Grade (Gr) 4 neutropenia (absolute neutrophil count [ANC] <500 cells/mm^3) for >7 days or febrile neutropenia (ANC <1000/mm^3, fever ≥38 degrees Celsius; neutropenic infection (ANC <1000/mm^3); Gr 4 thrombocytopenia (platelets <25,000 cells/mm^3); ≥Gr 3 nausea, vomiting, or diarrhea, despite optimal antiemetic, anti-diarrheal support; ≥20% decrease in left ventricular ejection fraction compared to baseline; other non-hematological toxicity; any Gr ≥3 adverse event; or failure to recover.

Outcome Time Frame:

Day 1 up to Day 21 of first cycle

Safety Issue:

Yes

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A9491001

NCT ID:

NCT00424632

Start Date:

November 2006

Completion Date:

June 2009

Related Keywords:

  • Solid Tumors
  • Neoplasms

Name

Location

Pfizer Investigational SiteBristol, Tennessee  37620