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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00390468 |
RATIONALE: Tandutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well tandutinib works in treating patients with progressive prostate cancer and bone metastases.
Condition | Intervention | Phase |
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Metastatic Cancer Pain Prostate Cancer |
Drug: tandutinib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of Tandutinib (MLN518) in Androgen-Independent Prostate Cancer With Bone Metastases |
Estimated Enrollment: | 30 |
Study Start Date: | October 2006 |
Estimated Primary Completion Date: | April 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive oral tandutinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Bone pain is assessed at baseline, on day 1 of course 3, and at disease progression.
After completion of study treatment, patients are followed for 4 weeks.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the prostate
Progressive disease, as evidenced by any of the following:
Must have castrate level of testosterone (< 50 ng/mL)
PATIENT CHARACTERISTICS:
No uncontrolled intercurrent illness, including, but not limited to, the following:
PRIOR CONCURRENT THERAPY:
No other concurrent investigational agents or hormonal therapy (unless used to maintain medical castration)
United States, Texas | |
M. D. Anderson Cancer Center at University of Texas | |
Houston, Texas, United States, 77030-4009 |
Study Chair: | Paul Mathew | M.D. Anderson Cancer Center |
Study ID Numbers: | CDR0000504104, MDA-2005-0717, NCI-7409 |
Study First Received: | October 18, 2006 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00390468 |
Health Authority: | United States: Food and Drug Administration |
pain adenocarcinoma of the prostate recurrent prostate cancer stage IV prostate cancer bone metastases |
Prostatic Diseases Genital Neoplasms, Male Neoplasm Metastasis Urogenital Neoplasms Pain |
Genital Diseases, Male Adenocarcinoma Prostatic Neoplasms Recurrence |
Neoplasms Neoplastic Processes Neoplasms by Site Pathologic Processes |