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Tyrosine

500 mg twice daily, a small-molecule inhibitor of the type III receptor tyrosine kinases. Tandutinib (MLN518) previously known as CT53518.

500 mg twice daily every day with doses taken approximately 12 hours apart, 28 day cycle.

Tandutinib

Paul Mathew, MD

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.

OBJECTIVES:

Primary

* Determine the time to progression in patients with progressive androgen-independent prostate cancer with bone metastases treated with tandutinib.

Secondary

* Determine the prostate-specific antigen (PSA) decline rate by 50% (PSA response), using the PSA Working Group Criteria, in patients treated with this regimen .
* Evaluate modulation of bone pain and bone markers in patients treated with this regimen.
* Determine the objective tumor response by RECIST (Response Evaluation Criteria In Solid Tumors) criteria in patients treated with this regimen.
* Determine the qualitative and quantitative toxicity of this regimen in these patients.

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.

Tandutinib in Treating Patients With Progressive Prostate Cancer and Bone Metastases

A Phase II Study of Tandutinib (MLN518) in Androgen-Independent Prostate Cancer With Bone Metastases

Simon 2 stage design for freedom from progression at 8 weeks where time-to-progression defined as time of initiation of therapy to first determination of progression of disease by clinical, radiological or serological criteria: Frequency of p-PDGFR (phosphorylated platelet-derived growth factor receptor) expression in bone marrow biopsy specimens, prostate-specific antigen (PSA) declines by 50% sustained for 4 weeks, measurable disease outcomes by RECIST (Response Evaluation Criteria In Solid Tumors) criteria, and quantitative/qualitative toxicities assessed.

National Cancer Institute (NCI)

The following scale grades adverse events by common features: Grade 1 = Mild Severity; Grade 2 = Moderate Severity; Grade 3 = Serious Severity.

500 mg twice daily, a small-molecule inhibitor of the type III receptor tyrosine kinases

Tandutinib (MLN518)

Age, Customized

Sex: Female, Male

United States

Region of Enrollment

The study was closed to further accrual per design specifications.

Quality Assurance Specialist

Participants Progression Free at 8 Weeks

Evaluable Participants at 8 Weeks

Analysis was per protocol; Of 18 participants, only 15 were evaluable for efficacy.

8-week Freedom-From-Progression (FFP)

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Tandutinib in Treating Patients With Progressive Prostate Cancer and Bone Metastases	NCT00390468	Metastatic Canc... Pain Prostate Cancer	Tandutinib	18 Years -	National Cancer Institute (NCI)
Tandutinib in Treating Patients With Progressive Prostate Cancer and Bone Metastases	NCT00390468	Metastatic Canc... Pain Prostate Cancer	Tandutinib	18 Years -	National Cancer Institute (NCI)

Spots Global Cancer Trial Database for mln518

Every month we try and update this database with for mln518 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for mln518

Every month we try and update this database with for mln518 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for mln518 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.