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MEK Inhibitor PD-325901 To Treat Advanced Breast Cancer, Colon Cancer, And Melanoma.

Last updated on March 15, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35233-2115 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Melanoma, Colonic Neoplasms, Breast Neoplasms
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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 bilirubin (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

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00147550
Pfizer
Terminated
MEK Inhibitor PD-325901 To Treat Advanced Breast Cancer, Colon Cancer, And Melanoma.

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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