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Phase I Study Of SU011248 In Combination With Paclitaxel/Carboplatin In Patients With Advanced Solid Malignancies


Phase 1
18 Years
N/A
Not Enrolling
Both
Neoplasms

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Trial Information

Phase I Study Of SU011248 In Combination With Paclitaxel/Carboplatin In Patients With Advanced Solid Malignancies


Inclusion Criteria:



- Histologically or cytologically proven diagnosis of any advanced solid malignancy
that is not amenable to treatment with curative intent

- Candidates for treatment with carboplatin and paclitaxel with maximum of 2 prior
chemotherapy regimens

- ECOG performance status 0 or 1

Exclusion Criteria:

- Prior chemotherapy, radiation therapy or surgery within 4 weeks prior to study entry
except palliative radiotherapy to non-target, metastatic lesions

- Diagnosis of any second malignancy within the past 3 years

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Determination of the maximum tolerated dose (MTD) and overall safety of SU011248 when administered in combination with paclitaxel/carboplatin in patients with advanced solid tumors (ongoing)

Outcome Time Frame:

3 yrs

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A6181050

NCT ID:

NCT00511849

Start Date:

November 2005

Completion Date:

February 2009

Related Keywords:

  • Neoplasms
  • Neoplasms

Name

Location

Pfizer Investigational Site Detroit, Michigan  48201
Pfizer Investigational Site Houston, Texas  77030
Pfizer Investigational Site Kingston, Pennsylvania  18704-5535
Pfizer Investigational Site Milwaukee, Wisconsin  53215