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Study Of SU011248 In Combination With Paclitaxel/Carboplatin In Patients With Advanced Solid Tumors

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NCT00511849

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Detroit, Michigan, 48201 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Neoplasms
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00511849
Pfizer
Completed
Study Of SU011248 In Combination With Paclitaxel/Carboplatin In Patients With Advanced Solid Tumors

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Pfizer Clinical Trials Contact Center

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[email protected]

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Study Of SU011248 In Combination With Paclitaxel/Carboplatin In Patients With Advanced Solid Tumors
Phase I Study Of SU011248 In Combination With Paclitaxel/Carboplatin In Patients With Advanced Solid Malignancies
The purpose of this study is to test SU011248 (sunitinib) in combination with paclitaxel/carboplatin. This combination regimen will be tested for safety and antitumor activity.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Neoplasms
Drug: carboplatin + SU011248 (sunitinib) + paclitaxel
AUC of 6 mg*min/mL administered as a 30-minute infusion, every 21 days for 4 cycles or until progression/unacceptable toxicity. 25 mg, 37.5 mg, or 50 mg (depending on the dose level assigned) orally taken every day or for 2 weeks and 1 week off without for 4 cycles or until progression/unacceptable toxicity. 175 mg/m2, 200 mg/m2, or 225 mg/m2 (depending on the dose level assigned), administered as a 3-hour infusion every 21 days for 4 cycles or until progression/unacceptable toxicity.
Other Name: Paraplatin; SUTENT; Taxol
Experimental: 1
Intervention: Drug: carboplatin + SU011248 (sunitinib) + paclitaxel
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
February 2009
February 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00511849
A6181050
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

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