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A Phase 1, Open-Label, Dose Escalation Study To Evaluate Safety, Pharmacokinetics And Pharmacodynamics Of PF-00562271 In Patients With Advanced Non-Hematologic Malignancies


Phase 1
18 Years
N/A
Not Enrolling
Both
Head and Neck Neoplasm, Prostatic Neoplasm, Pancreatic Neoplasm

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Trial Information

A Phase 1, Open-Label, Dose Escalation Study To Evaluate Safety, Pharmacokinetics And Pharmacodynamics Of PF-00562271 In Patients With Advanced Non-Hematologic Malignancies


Inclusion Criteria:



- Pancreatic, head and neck, and prostatic neoplasms, and patients with non-hematologic
malignancies who have tumor appropriate for serial biopsy.

- Adequate organ function, including bilirubin less than 1.5 x ULN, and [Eastern
Cooperative Oncology Group] ECOG performance status of 0-2.

Exclusion Criteria:

- Clinically significant gastrointestinal abnormalities, requirement for systemic
anticoagulants or potent CYP 3A4 inhibitors, and history of clinically significant
cardiac or pulmonary disorders.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants With First Cycle Dose Limiting Toxicities (DLTs)

Outcome Description:

At least possibly attributable to study treatment (Tx): Grade (Gr) 4 neutropenia (absolute neutrophil count [ANC] <500 cells/mm^3) for >7 days or Gr 3 febrile neutropenia (ANC <1000/mm^3, fever ≥38 degrees Celsius; Gr 4 thrombocytopenia (platelets <25,000 cells/mm^3); Gr ≥3 non-hematologic toxicity despite adequate medical intervention; Gr ≥3 confirmed prolonged QTc interval (>500 milliseconds [msec]); confirmed cardiac troponin I ≥99 percentile of reference range; Tx related toxicities with failure to receive ≥18 days Tx in 21-day cycle or inability to resume current dose level ≤14 days.

Outcome Time Frame:

Baseline up to Cycle 1 Day 21 (C1.D21)

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A8031001

NCT ID:

NCT00666926

Start Date:

December 2005

Completion Date:

April 2009

Related Keywords:

  • Head and Neck Neoplasm
  • Prostatic Neoplasm
  • Pancreatic Neoplasm
  • Pancreatic Neoplasm
  • Head and Neck neoplasm
  • Prostatic neoplasms; Focal Adhesion Kinase
  • Phase 1
  • Pharmacodynamics
  • FDG-PET
  • Neoplasms
  • Head and Neck Neoplasms
  • Pancreatic Neoplasms
  • Prostatic Neoplasms

Name

Location

Pfizer Investigational SiteAurora, Colorado  80012
Pfizer Investigational SiteBristol, Tennessee  37620