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A Study Of Oral PF-02341066, A C-Met/Hepatocyte Growth Factor Tyrosine Kinase Inhibitor, In Patients With Advanced Cancer

Last updated on March 25, 2018

FOR MORE INFORMATION
Study Location
University of California, Irvine Medical Center
Orange, California, 92868 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non-Small Cell Lung Cancer ALK-positive, Non-Small Cell Lung Cancer c-Met Dependent, Non-Small Cell Lung Cancer ROS Marker Positive, Systemic Anaplastic Large-Cell Lymphoma, Advanced Malignancies Except Leukemia
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

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

- 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 3 months of starting study
treatment

NCT00585195
Pfizer
Recruiting
A Study Of Oral PF-02341066, A C-Met/Hepatocyte Growth Factor Tyrosine Kinase Inhibitor, In Patients With Advanced Cancer

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A Study Of Oral PF-02341066, A C-Met/Hepatocyte Growth Factor Tyrosine Kinase Inhibitor, In Patients With Advanced Cancer
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
PF-02341066 may work in cancer by blocking the cell growth, migration and invasion of tumor cells. PF-02341066 is a new class of drugs called c-Met/Hepatocyte growth factor receptor tyrosine kinase inhibitors. This compound is also an inhibitor of the anaplastic lymphoma kinase (called ALK) tyrosine kinase and ROS receptor tyrosine kinases. This research study is the first time PF-02341066 will be given to people. PF-02341066 is taken by mouth daily.
Not Provided
Interventional
Phase 1
Masking: None (Open Label)
Primary Purpose: Treatment
  • Non-Small Cell Lung Cancer ALK-positive
  • Non-Small Cell Lung Cancer c-Met Dependent
  • Non-Small Cell Lung Cancer ROS Marker Positive
  • Systemic Anaplastic Large-Cell Lymphoma
  • Advanced Malignancies Except Leukemia
  • Drug: PF-02341066
    Escalating doses of PF-02341066 will be administered orally on a continuous dosing schedule. Doses to be evaluated will range from 50 mg to 2000 mg/day administered either once or twice a day. A treatment cycle is considered to be 28 days (or 21 days depending on the cohort).
  • Drug: Rifampin
    600 mg QD administered from Cycle 1, Day 16 to Cycle 2, Day 1 (14 days of dosing) in combination with PF-02341066.
  • Drug: Itraconazole
    Multiple Dose Design: 200 mg QD administered from Cycle 1, Day 1 to Cycle 1, Day 16 (16 days) in combination with PF-02341066.
Experimental: 1
Interventions:
  • Drug: PF-02341066
  • Drug: Rifampin
  • Drug: Itraconazole


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
November 2019
January 2018   (Final data collection date for primary outcome measure)

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 3 months of starting study treatment
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Australia,   Japan,   Korea, Republic of,   United States
United Kingdom
 
NCT00585195
A8081001
PROFILE 1001 ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

ICMJE     Data element required by the

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

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