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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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8 April 2013 |
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Main ID: |
NCT00585195 |
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Date of registration:
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29/12/2007 |
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Primary sponsor: |
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Public title:
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A Study Of Oral PF-02341066, A c-Met/Hepatocyte Growth Factor Tyrosine Kinase Inhibitor, In Patients With Advanced Cancer
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Scientific title:
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Phase 1 Safety, Pharmacokinetic And Pharmacodynamic Study Of PF-02341066, A c-Met/HGFR Selective Tyrosine Kinase Inhibitor, Administered Orally To Patients With Advanced Cancer |
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Date of first enrolment:
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April 2006 |
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Target sample size:
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475 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00585195 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Australia
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Korea, Republic of
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United States
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Contacts
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Name:
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Pfizer CT.gov Call Center |
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Address:
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Telephone:
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1-800-718-1021 |
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Email:
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Affiliation:
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Name:
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Pfizer CT.gov Call Center |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pfizer |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Advanced malignancies (except leukemias), histologically proven at diagnosis;
Histologically confirmed advanced malignancies that are known to be sensitive to
PF-03241066 inhibition, e.g. ALK, c-MET and ROS
- Solid tumors must have measurable disease (Recommended Phase 2 Dose Cohort patients
with non-measurable disease may enter on a case-by-case basis); not required for DDI
sub-studies.
- Adequate blood cell counts, kidney function, liver function and Eastern Cooperative
Oncology Group (ECOG) score of 0 or 1 (for the Recommended Phase 2 Cohort, a ECOG
score of 2 may be allowed on a case-by-case basis)
Exclusion Criteria:
- Major surgery, radiation therapy or anti-cancer therapy within 2 to 4 weeks of
starting study treatment, depending on the patient cohort
- Prior stem cell transplant except of patients with neuroblastoma, lymphoma or myeloma
- Active or unstable cardiac disease or heart attack within 6 months of starting study
treatment
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Anaplastic Lymphoma Kinase, Human
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Neoplasms
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NSCLC
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Systemic Anaplastic Large-Cell Lymphoma
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Intervention(s)
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Drug: Ketoconazole
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Drug: PF-02341066
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Drug: Rifampin
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Primary Outcome(s)
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To assess how the body handles blood concentrations of PF-02341066
[Time Frame: 2.0 years]
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To find the dose of PF-02341066 that should be used in future clinical trials
[Time Frame: 2.5 years]
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To test the safety of PF-02341066 when taken by people who have cancer
[Time Frame: 2.5 years]
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Secondary Outcome(s)
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Anti-tumor activity
[Time Frame: 4.0 years]
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To assess how the body handles blood concentrations of PF-02341066 in the presence of another drug, ketoconazole
[Time Frame: 3.0 years]
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To assess how the body handles blood concentrations of PF-02341066 in the presence of another drug, rifampin
[Time Frame: 2.0 years]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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