Trials / Completed
CompletedNCT00585195
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 MET/HGFR SELECTIVE TYROSINE KINASE INHIBITOR, ADMINISTERED ORALLY TO PATIENTS WITH ADVANCED CANCER
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 596 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
- 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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2006-04-19
- Primary completion
- 2020-07-30
- Completion
- 2022-01-19
- First posted
- 2008-01-03
- Last updated
- 2023-02-08
- Results posted
- 2021-10-14
Locations
29 sites across 4 countries: United States, Australia, Japan, South Korea
Source: ClinicalTrials.gov record NCT00585195. Inclusion in this directory is not an endorsement.