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Study Of SU011248 In Combination With Docetaxel In Patients With Advanced Cancer

Last updated on November 13, 2019

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Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35233-2115 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Advanced Solid Tumors, Non Small Cell Lung Cancer
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

Advanced solid tumor malignancy ECOG 0 or 1

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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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

NCT00712504
Pfizer
Completed
Study Of SU011248 In Combination With Docetaxel In Patients With Advanced Cancer

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Descriptive Information
Brief Title  ICMJE Study Of SU011248 In Combination With Docetaxel In Patients With Advanced Cancer
Official Title  ICMJE A Phase 1 Safety And Pharmacokinetic Study Of SU011248 In Combination With Docetaxel In Patients With Advanced Solid Tumors
Brief SummaryThis study is determining the maximum tolerated dose and safety of SU011248 (sunitinib malate, SUTENT) in combination with docetaxel (Taxotere). Several dosing regimens will be tested in patients with advanced solid tumors, including non small cell lung cancer.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Advanced Solid Tumors
  • Non Small Cell Lung Cancer
Intervention  ICMJE
  • Drug: sunitinib
    25, 37.5 and 50 mg/day, oral, administered on an outpatient basis in two different dosing regimens: schedule 2/1 (2 weeks on, 1 week off) and schedule 4/2 (4 weeks on, 2 weeks off)
  • Drug: docetaxel
    60, 75, and 100 mg/m2 docetaxel administered every 21 days as a 1-hr IV infusion
Study Arms  ICMJE Experimental: 1
SU011248 in combination with docetaxel
Interventions:
  • Drug: sunitinib
  • Drug: docetaxel
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 4, 2008)
49
Original Actual Enrollment  ICMJE
 (submitted: July 7, 2008)
50
Actual Study Completion Date  ICMJE November 2007
Actual Primary Completion DateNovember 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00712504
Other Study ID Numbers  ICMJE A6181035
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateNovember 2008

ICMJE     Data element required by the

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

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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