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Phase 1 Targeted Combination Trial Of PF-00299804 And CP-751,871 In Patients With Advanced Solid Tumors


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Carcinoma, Non-Small Cell, Neoplasm Metastasis

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Trial Information

Phase 1 Targeted Combination Trial Of PF-00299804 And CP-751,871 In Patients With Advanced Solid Tumors


Inclusion Criteria:



- Histologically documented advanced cancer, Eastern Cooperative Oncology Group (ECOG)
0-1;

- Platelets > 100,000, ANC > 1500;

- Ccr > 60 or serum creat. <1.5

- Non-small cell cancer cohort:

- Eastern Cooperative Oncology Group (ECOG) 0-2, prior platin, < 4 prior chemotherapy
regimen

- HgA1C <5.7%

Exclusion Criteria:

- Active Central Nervous System (CNS) metastases;

- prior IGF1-R targeted therapy

- Any history of unstable angina, myocardial infarction or symptomatic congestive heart
failure.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall safety profile characterized by type, frequency, severity (as graded using NCI CTC AE v. 3.0), timing, seriousness and relationship to trial treatment of adverse events and laboratory abnormalities.

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:

A7471004

NCT ID:

NCT00728390

Start Date:

August 2008

Completion Date:

December 2013

Related Keywords:

  • Carcinoma, Non-Small Cell
  • Neoplasm Metastasis
  • advanced cancer refractory advanced non-small cell lung cancer
  • Neoplasms
  • Carcinoma
  • Neoplasm Metastasis

Name

Location
Pfizer Investigational Site Bronx, New York  10461
Pfizer Investigational Site Houston, Texas  77030