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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00712504
First received: July 7, 2008
Last updated: November 7, 2008
Last verified: November 2008
  Purpose

This 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.


Condition Intervention Phase
Advanced Solid Tumors
Non Small Cell Lung Cancer
Drug: sunitinib
Drug: docetaxel
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Safety And Pharmacokinetic Study Of SU011248 In Combination With Docetaxel In Patients With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Type, incidence, severity, timing, seriousness, and relatedness of adverse events and laboratory abnormalities [ Time Frame: November 2007 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetic parameters of SU011248 (and its active metabolite, SU012662), and docetaxel. [ Time Frame: November 2007 ] [ Designated as safety issue: No ]
  • Objective disease response [ Time Frame: November 2007 ] [ Designated as safety issue: No ]

Enrollment: 49
Study Start Date: July 2004
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
SU011248 in combination with docetaxel
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00712504

Locations
United States, Alabama
Pfizer Investigational Site
Birmingham, Alabama, United States, 35233
Pfizer Investigational Site
Birmingham, Alabama, United States, 35233-2115
Pfizer Investigational Site
Birmingham, Alabama, United States, 35294
United States, Tennessee
Pfizer Investigational Site
Nashville, Tennessee, United States, 37232
United States, Wisconsin
Pfizer Investigational Site
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00712504     History of Changes
Other Study ID Numbers: A6181035
Study First Received: July 7, 2008
Last Updated: November 7, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
advanced solid tumors, non small cell lung cancer, pulmonary neoplasms, sunitinib (SUTENT), docetaxel (Taxotere), Angiogenesis Inhibitors

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Docetaxel
Sunitinib
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antimitotic Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 25, 2014