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A Phase 1 Safety And Pharmacokinetic Study Of SU011248 In Combination With Docetaxel In Patients With Advanced Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Solid Tumors, Non Small Cell Lung Cancer

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Trial Information

A Phase 1 Safety And Pharmacokinetic Study Of SU011248 In Combination With Docetaxel In Patients With Advanced Solid Tumors


Inclusion Criteria:



Advanced solid tumor malignancy ECOG 0 or 1

Exclusion Criteria:

Prior treatment with with high-dose chemotherapy requiring stem cell rescue Prior
irradiation to ≥25% of the bone marrow (e.g. whole pelvis=25%) Patients with centrally
located lung lesions unless recently treated with radiotherapy

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:

Type, incidence, severity, timing, seriousness, and relatedness of adverse events and laboratory abnormalities

Outcome Time Frame:

November 2007

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:

A6181035

NCT ID:

NCT00712504

Start Date:

July 2004

Completion Date:

November 2007

Related Keywords:

  • Advanced Solid Tumors
  • Non Small Cell Lung Cancer
  • advanced solid tumors, non small cell lung cancer, pulmonary neoplasms, sunitinib (SUTENT), docetaxel (Taxotere), Angiogenesis Inhibitors
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Neoplasms

Name

Location
Pfizer Investigational Site Birmingham, Alabama  35205
Pfizer Investigational Site Milwaukee, Wisconsin  53215
Pfizer Investigational Site Bristol, Tennessee  37620