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A Phase 1b Dose Escalation/Phase 2 Randomized, Non-Comparative, Multiple Center, Open Label Study Of CP 751,871 In Combination With Paclitaxel And Carboplatin And Of Paclitaxel And Carboplatin Alone As First Line Treatment For Advanced Non-Small Cell Lung Cancer


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoma, Non-Small-Cell Lung

Thank you

Trial Information

A Phase 1b Dose Escalation/Phase 2 Randomized, Non-Comparative, Multiple Center, Open Label Study Of CP 751,871 In Combination With Paclitaxel And Carboplatin And Of Paclitaxel And Carboplatin Alone As First Line Treatment For Advanced Non-Small Cell Lung Cancer


Inclusion Criteria:



- Diagnosis of advanced/metastatic lung cancer

Exclusion Criteria:

- Previous treatment with chemotherapy

- Uncontrolled diabetes

- History/active cardiovascular disease

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Maximum Tolerated Dose (MTD)of CP-751,871 in Combination With Paclitaxel and Carboplatin: Phase 1b

Outcome Description:

The maximum tolerated dose of CP-751,871 in combination with paclitaxel and carboplatin is the highest dose level below the Maximum Administered Dose (the dose level at which 2 or more out of 3 to 6 patients experience a Dose Limiting Toxicity at a dose level in Cycle 1) at which none or one out of 6 patients experience a Cycle 1 Dose Limiting Toxicity.

Outcome Time Frame:

Start of treatment (baseline) up to the end of Cycle 1 (Day 21)

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:

A4021002

NCT ID:

NCT00147537

Start Date:

February 2005

Completion Date:

August 2011

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • non-small cell lung cancer
  • chemotherapy
  • figitumumab
  • insulin-like growth 1 factor receptor
  • IGF-IR
  • monoclonal antibody
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Pfizer Investigational Site Blendora, California  91740
Pfizer Investigational Site Crestview Hills, Kentucky  41017
Pfizer Investigational Site Rochester, Minnesota  55905
Pfizer Investigational Site Bronx, New York  10461
Pfizer Investigational Site Houston, Texas  77030
Pfizer Investigational Site Flagstaff, Arizona  86001
Pfizer Investigational Site Clearwater, Florida  33761
Pfizer Investigational Site Carmel, Indiana  46032
Pfizer Investigational Site Westminster, Maryland  21157
Pfizer Investigational Site Columbia, Missouri  65201
Pfizer Investigational Site Kingston, Pennsylvania  18704-5535
Pfizer Investigational Site Bristol, Tennessee  37620
Pfizer Investigational Site Olive Branch, Mississippi  38654