| December 29, 2007 |
| February 10, 2010 |
| May 2006 |
| December 2010 (final data collection date for primary outcome measure) |
- To test the safety of PF-02341066 when taken by people who have cancer [ Time Frame: 2.5 years ] [ Designated as safety issue: Yes ]
- To assess how the body handles blood concentrations of PF-02341066 [ Time Frame: 2.0 years ] [ Designated as safety issue: No ]
- To find the dose of PF-02341066 that should be used in future clinical trials [ Time Frame: 2.5 years ] [ Designated as safety issue: Yes ]
|
| Same as current |
| Complete list of historical versions of study NCT00585195 on ClinicalTrials.gov Archive Site |
| Anti-tumor activity [ Time Frame: 4.0 years ] [ Designated as safety issue: No ] |
| Anti-tumor activity [ Time Frame: 2.0 years ] [ Designated as safety issue: Yes ] |
| |
| 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. This research study is the first time PF-02341066 will be given to people. PF-02341066 is taken by mouth daily. |
| |
| Phase I |
| Interventional |
| Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study |
- Systemic Anaplastic Large-Cell Lymphoma
- Neoplasms
- Anaplastic Lymphoma Kinase, Human
|
| 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. |
| 1: Experimental
Intervention: Drug: PF-02341066 |
| |
| |
| Recruiting |
| 175 |
| December 2010 |
| December 2010 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Advanced malignancies (except leukemias), histologically proven at diagnosis which is refractory to standard of care therapy, or for whom no standard of care therapy is available
- Solid tumors must have measurable disease
- 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 dose level
- Prior stem cell transplant except of patients with lymphoma or myeloma
- Active or unstable cardiac disease or heart attack within 12 months of starting study treatment
|
| Both |
| 18 Years and older |
| No |
|
|
| United States, Australia, Korea, Republic of |
| |
| NCT00585195 |
| Director, Clinical Trial Disclosure Group, Pfizer Inc |
| A8081001 |
| Pfizer |
|
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
|
| Pfizer |
| February 2010 |
