Combination Study Of CP-751,871 With Paclitaxel And Carboplatin In Advanced Lung Cancer

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Pfizer

Status and phase

Completed
Phase 2
Phase 1

Conditions

Carcinoma, Non-Small-Cell Lung

Treatments

Drug: erlotinib
Drug: paclitaxel
Drug: carboplatin
Drug: CP-751,871

Study type

Interventional

Funder types

Industry

Identifiers

NCT00147537
A4021002

Details and patient eligibility

About

Phase 1b Dose Excalation/Expansion: Identify and characterize safety and tolerability of recommended phase 2 dose of CP-751,871 when administered with paclitaxel and carboplatin Phase 1b Erlotinib Extension: To characterize the safety and tolerability of CP751,871 when administered with paclitaxel, carboplatin and erlotinib. Phase 2: To test the efficacy of CP-751,871 combined with paclitaxel and carboplatin in the treatment of advanced non-small cell lung cancer

Enrollment

282 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of advanced/metastatic lung cancer

Exclusion criteria

  • Previous treatment with chemotherapy
  • Uncontrolled diabetes
  • History/active cardiovascular disease

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

282 participants in 2 patient groups

Phase 2 (Arms A & B)
Experimental group
Description:
CP-751,871 + paclitaxel + carboplatin
Treatment:
Drug: CP-751,871
Drug: carboplatin
Drug: paclitaxel
Phase 1b
Experimental group
Description:
Phase 1b Dose Escalation /Expansion: CP-751,871 + paclitaxel + carboplatin Phase 1b Erlotinib Extension: CP-751,871 + paclitaxel + carboplatin + erlotinib
Treatment:
Drug: CP-751,871
Drug: carboplatin
Drug: paclitaxel
Drug: erlotinib

Trial contacts and locations

31

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Data sourced from clinicaltrials.gov

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