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Prostatic Neoplasms

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Genital Diseases, Male

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All Drugs and Chemicals

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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

Blood and Lymph Conditions

Rare Diseases

Syndrome

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Preleukemia

Myelodysplastic Syndromes

Neoplasms by Histologic Type

Hematologic Diseases

Bone Marrow Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

CT53518

This is the first study of the drug CT53518 when given to humans. The purpose of this study is to determine the highest dose of CT53518 that can safely be given to patients with Acute Myelogenous Leukemia (AML) and to identify the side effects associated with taking the drug. The study will evaluate how CT53518 is absorbed, broken down, and eliminated by the body. Additionally, the study will evaluate the effects of the drug on a specific type of cell in bone marrow and blood, known as a blast.

This is a Phase 1, open label, dose escalating study at five clinical sites to determine dose limiting toxicity (DLT), maximum tolerated dose (MTD), pharmacokinetics, and the effect on the peripheral and bone marrow blast count of an oral 28-day course of CT53518 in patients with Acute Myelogenous Leukemia (AML) and myelodysplastic syndrome. This study will confirm the tolerability and assess the effects on the peripheral and bone marrow blast count of an oral 28-day course of CT53518 at or near the maximum tolerated dose in patients with AML displaying a specified mutation of the FLT-3 gene, internal tandem duplication (ITD).

Safety and Tolerance Study of Oral Doses of CT53518 to Treat Patients With Acute Myelogenous Leukemia (AML)

Tolerability and PK/PD of Multiple Oral Doses of CT53518 in Patients With Acute Myelogenous Leukemia

Millennium Pharmaceuticals, Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Tandutinib in Treating Patients With Progressive Prostate Cancer and Bone Metastases	NCT00390468	Metastatic Canc... Pain Prostate Cancer	Tandutinib	18 Years -	National Cancer Institute (NCI)
Safety and Tolerance Study of Oral Doses of CT53518 to Treat Patients With Acute Myelogenous Leukemia (AML)	NCT00064584	Acute Myelogeno... Myelodysplastic...	CT53518	18 Years -	Millennium Pharmaceuticals, Inc.
Safety and Tolerance Study of Oral Doses of CT53518 to Treat Patients With Acute Myelogenous Leukemia (AML)	NCT00064584	Acute Myelogeno... Myelodysplastic...	CT53518	18 Years -	Millennium Pharmaceuticals, Inc.
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 ct53518

Every month we try and update this database with for ct53518 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 ct53518

Every month we try and update this database with for ct53518 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 ct53518 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.