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Phase I, Open-Label, Multi-Center, Accelerated Dose Escalation Study Of The Anti-Angiogenesis Agent PF-00337210 In Patients With Advanced Solid Tumors

Phase 1
18 Years
Not Enrolling

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Trial Information

Phase I, Open-Label, Multi-Center, Accelerated Dose Escalation Study Of The Anti-Angiogenesis Agent PF-00337210 In Patients With Advanced Solid Tumors

Inclusion Criteria:

- Histologically or cytologically confirmed advanced solid tumors un-responsive to
currently available therapies or for which there is no standard therapy.

- At least 1 measurable disease site as defined by Response Evaluation Criterion in
Solid Tumors [RECIST].

- Adequate bone marrow, liver function and renal function as defined by protocol.

- Blood pressure Requirements During dose escalation - no evidence of pre-existing
hypertension and no antihypertensive medications at baseline.

During dose expansion - patient's whose hypertension is controlled by antihypertensive

Exclusion Criteria:

- Chemotherapy, radiotherapy or any investigational therapy within 4 weeks of study

- Current use or anticipated need for drugs that are known CYP34 inhibitors or

- Patients with carcinomatous meningitis or un-treated brain metastases.

- Any acute cardiovascular incident within the past 12 months.

- Patients with active gastrointestinal bleeding or significant gastrointestinal
abnormalities as defined by protocol

- Patients with no evidence of the following for 5 years: malignancy or metastatic
disease of skin cancer (except melanoma), in situ cervical cancer or breast cancer or
T1C prostate cancer.

Type of Study:


Study Design:

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

Outcome Measure:

Number of Participants With Dose-limiting Toxicities (DLTs)

Outcome Description:

DLTs included events occurring in Cycle 1: blood pressure of 180/110 millimeters of mercury (mmHg) or higher for 3 readings over 3 hours regardless of use of anti-hypertensive drugs or greater than (>) 160/100 mmHg for 3 readings over 3 days on maximum anti-hypertensive drugs; afebrile Grade 4 neutropenia for greater than or equal to (>=) 7 days or >=Grade 3 neutropenia associated with fever (1 reading of oral temperature >38.5 degree Celsius [degree C] or 3 readings of oral temperature >38.0 degree C in 24-hour period); Grade 4 thrombocytopenia; hemoptysis of >1/2 teaspoon of bright red blood per day; proteinuria of >=2 grams/24 hours; inability to resume PF-00337210 dosing at current dose level within 14 days of stopping due to treatment-related toxicity; >=Grade 3 nonhematological toxicities (except alopecia and blood pressure/hypertension); Grade 3 nonhematological toxicities that could be controlled to Grade 2 or less with appropriate treatment were not considered dose limiting.

Outcome Time Frame:

Baseline up to Day 28

Safety Issue:


Principal Investigator

Pfizer Call Center

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

May 2006

Completion Date:

September 2011

Related Keywords:

  • Neoplasm
  • VGEF inhibitor
  • Anti angiogenesis
  • Advanced Solid Tumors
  • Neoplasms



Pfizer Investigational Site Detroit, Michigan  48201
Pfizer Investigational Site Milwaukee, Wisconsin  53215