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Completed

NCT Number: NCT00712504

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

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.

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Key information

Conditions

Advanced Solid Tumors Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Non Small Cell Lung Cancer Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sunitinib

Drug

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)

docetaxel

Drug

60, 75, and 100 mg/m2 docetaxel administered every 21 days as a 1-hr IV infusion

Primary outcomes

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

    Time frame: November 2007

Secondary outcomes

  1. Pharmacokinetic parameters of SU011248 (and its active metabolite, SU012662), and docetaxel.

    Time frame: November 2007

  2. Objective disease response

    Time frame: November 2007

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Jul 10, 2008
Registry last updated
Nov 11, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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