A Study Of Oral PF-02341066, A C-Met/Hepatocyte Growth Factor Tyrosine Kinase Inhibitor, In Patients With Advanced Cancer (PROFILE 1001)

Pfizer

Status and phase: Completed; Phase 1

Conditions: Systemic Anaplastic Large-Cell Lymphoma; Advanced Malignancies Except Leukemia; Non-Small Cell Lung Cancer c-Met Dependent; Non-Small Cell Lung Cancer ALK-positive; Non-Small Cell Lung Cancer ROS Marker Positive

Treatments: Drug: Itraconazole; Drug: Rifampin; Drug: PF-02341066

Study type: Interventional

Funder types: Industry

Identifiers

NCT00585195

PROFILE 1001 (Other Identifier)

A8081001

Details and patient eligibility

About

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.

Enrollment: 596 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Parallel Assignment

Masking: None (Open label)

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596 participants in 1 patient group

1

Experimental group

Treatment:

Drug: Itraconazole

Drug: Rifampin

Drug: PF-02341066