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A Multicenter, Open-Label, Noncomparative Phase 1-2 Clinical And Pharmacokinetic Study Of Oral PD 0325901 In Patients With Advanced Cancer


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Melanoma, Colonic Neoplasms, Breast Neoplasms

Thank you

Trial Information

A Multicenter, Open-Label, Noncomparative Phase 1-2 Clinical And Pharmacokinetic Study Of Oral PD 0325901 In Patients With Advanced Cancer


The study prematurely discontinued on March 15, 2007 due to a safety concern, specifically
ocular and neurological toxicity presented at 10 mg twice-a-day and higher doses.


Inclusion Criteria:



- Age >= 18 years old

- Tumor accessible for biopsy and willingness to undergo baseline and 1 post treatment
biopsy

- Biopsiable, histologically or cytologically confirmed metastatic or inoperable breast
cancer, colon cancer, or melanoma. Prior treatment requirement : i) no more than 2
prior cytotoxic chemotherapy regimens for metastatic disease for patients with breast
or colon cancers; ii) No prio cytotoxic therapy for patients with melanoma, or iii)
measurable lesion (s) that have not been irradiated.

- Adequate renal, liver, and bone marrow function, determined within 2 weeks prior to
the first treatment, defined as the following: Serum creatinine <1.5 x ULN, total
bilirubin <2 x ULN, aspartate aminotransferase (AST) or alanine aminotransferase
(ALT) <3 x ULN (<5 x ULN for patients with liver involvement); absolute neutrophil
count (ANC) >1500/ul; and platelet >100,000/ul

- Hemoglobin >9.0 g/dL. Treatment with transfusions or erythropoietin to elevate the
hemoglobin level for eligibility purposes is not permitted. Patients must have
discontinued erythropoietin at least 2 weeks prior to the first dose of study
medication

- Serum calcium <1 x ULN and phosphorus <1 x ULN

- Patients having reproductive potential must use adequate method of birth control.
Patients may not be pregnant or breastfeeding.

- ECOG Status of 0,1, or 2.

- Must be able to swallow intact study medication and have no gastrointestinal
disorders that may affect absorption of the drug

- Must be able to follow instructions or protocol specified procedures, or have a daily
care giver who will be responsible for administering study medication.

- Must be able to give written informed consent.

Exclusion Criteria:

- No parathyroid disorder or history of malignancy associated hypercalcemia

- No ongoing radiation therapy or radio-cytotoxic therapy within prior 4 weeks; No
immunotherapy, biologic therapy, hormonal, or molecular targeted therapy within prior
2 weeks

- No concurrent serious infection or life-threatening illness (unrelated to tumor)

- No history of any cancer other than the present condition (except nonmelanoma skin
cancer or carcinoma in situ of the cervix), unless in complete remission and off all
therapy for that disease for a minimum of 3 years

- No untreated brain metastases.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Objective Response Rate, Safety.

Outcome Time Frame:

duration of trial

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:

A4581001

NCT ID:

NCT00147550

Start Date:

February 2004

Completion Date:

July 2013

Related Keywords:

  • Melanoma
  • Colonic Neoplasms
  • Breast Neoplasms
  • Breast Neoplasms
  • Neoplasms
  • Colonic Neoplasms
  • Melanoma

Name

Location

Pfizer Investigational SiteBirmingham, Alabama  35205
Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteDetroit, Michigan  48201
Pfizer Investigational SiteRochester, Minnesota  55905
Pfizer Investigational SiteCincinnait, Ohio  45236
Pfizer Investigational SiteBronx, New York  10461
Pfizer Investigational SiteClearwater, Florida  33761