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A Phase 1, Open Label, Dose Escalation Study To Evaluate Safety, Pharmacokinetics And Pharmacodynamics Of Combined Oral C- MET/ALK Inhibitor (PF- 02341066) And PAN-HER Inhibitor (PF- 00299804) In Patients With Advanced Non-Small Cell Lung Cancer


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Non Small Cell Lung Cancer

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Trial Information

A Phase 1, Open Label, Dose Escalation Study To Evaluate Safety, Pharmacokinetics And Pharmacodynamics Of Combined Oral C- MET/ALK Inhibitor (PF- 02341066) And PAN-HER Inhibitor (PF- 00299804) In Patients With Advanced Non-Small Cell Lung Cancer


Inclusion Criteria:



- advanced non small cell lung cancer (dose escalation phase)

- acquired resistance to erlotinib or gefitinib (expansion phase)

- mandatory entrance biopsy (expansion phase)

Exclusion Criteria:

- interstitial lung disease

- unstable brain metastases

- leptomeningeal disease

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall safety profile of combined PF 02341066 plus PF 00299804 including adverse events (AE), as defined and graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], and first cycle Dose Limiting Toxicity.

Outcome Time Frame:

18 months

Safety Issue:

Yes

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A8081006

NCT ID:

NCT01121575

Start Date:

August 2010

Completion Date:

August 2013

Related Keywords:

  • Non Small Cell Lung Cancer
  • Phase 1 acquired resistance to erlotinib or gefitinib cMET inhibitor EGFR inhibitor panHER inhibitor combination trial Crizotinib
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Pfizer Investigational SiteAurora, Colorado  80012
Pfizer Investigational SiteWestminster, Maryland  21157
Pfizer Investigational SiteNorth Adams, Massachusetts  01247