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

Last updated on May 11, 2018

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.
Show details

- 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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MEK Inhibitor PD-325901 To Treat Advanced Breast Cancer, Colon Cancer, And Melanoma.
A Multicenter, Open-Label, Noncomparative Phase 1-2 Clinical And Pharmacokinetic Study Of Oral PD 0325901 In Patients With Advanced Cancer
MEK is a critical member of the MAPK pathway involved in growth and survival of cancer cells. PD-325901 is a new drug designed to block this pathway and kill cancer cells. The purpose of this study is to study the effectiveness of PD-325901 in patients with colon cancer, breast cancer, and melanoma. PD-325901 will be given by mouth as a pill twice a day, CT scans will be done and biopsies will be taken of a tumor before and once during treatment to measure the effects of the drug. Blood samples will be taken to measure the amount of drug in the blood.
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.
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Melanoma
  • Colonic Neoplasms
  • Breast Neoplasms
Drug: PD-0325901
Administered orally either once or twice a day; several dosing schedules evaluated; current dosing schedule is 5 days on-drug, 2-days off drug for 3 weeks in a 28-day cycle. Doses evaluated ranged from 1 mg once a day to 30 mg twice daily.
Experimental: 1
Intervention: Drug: PD-0325901
Boasberg PD, Redfern CH, Daniels GA, Bodkin D, Garrett CR, Ricart AD. Pilot study of PD-0325901 in previously treated patients with advanced melanoma, breast cancer, and colon cancer. Cancer Chemother Pharmacol. 2011 Aug;68(2):547-52. doi: 10.1007/s00280-011-1620-1. Epub 2011 Apr 24.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
79
July 2013
May 2007   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00147550
A4581001
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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