Tesetaxel in Chemotherapy-naive Patients With Progressive, Castration-resistant Prostate Cancer
NCT ID: NCT01296243
Last Updated: 2012-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
57 participants
INTERVENTIONAL
2011-02-28
2015-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Tesetaxel once every 3 weeks
Tesetaxel
Tesetaxel capsules will be administered orally once every 21 days until progression, as defined by Prostate Cancer Working Group 2 (PCWG2) criteria. The duration of protocol therapy will not exceed 12 months. Treatment will be initiated at a dose of 27 mg/m2; dose escalation to a maximum of 35 mg/m2 is allowed in Cycle 2 depending on tolerability.
Interventions
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Tesetaxel
Tesetaxel capsules will be administered orally once every 21 days until progression, as defined by Prostate Cancer Working Group 2 (PCWG2) criteria. The duration of protocol therapy will not exceed 12 months. Treatment will be initiated at a dose of 27 mg/m2; dose escalation to a maximum of 35 mg/m2 is allowed in Cycle 2 depending on tolerability.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed prostate cancer, currently with progressive disease
* Evidence of metastatic disease
* Castrate level of testosterone (\< 50 ng/dL)
* Eastern Cooperative Oncology Group performance status 0 or 1
* Chemotherapy-naïve
* Adequate bone marrow, hepatic, and renal function
* Ability to swallow an oral solid-dosage form of medication
Exclusion Criteria
* Operable cancer
* Uncontrolled diarrhea
* Uncontrolled nausea or vomiting
* Known malabsorptive disorder
* Currently active second malignancy other than non-melanoma skin cancers
* Human immunodeficiency virus (HIV) infection based on history of positive serology
* Significant medical disease other than cancer
* Presence of neuropathy \> Grade 2 (National Cancer Institute Common Toxicity Criteria \[NCI CTC\]; v4.0)
* Need for other anticancer treatment
* Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway or P-glycoprotein activity
* Less than 2 weeks since use of a medication or ingestion of an agent, beverage, or food that is a potent inhibitor or inducer of the CYP3A pathway or P-glycoprotein activity
* Less than 4 weeks since use of another investigational agent
18 Years
MALE
No
Sponsors
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Genta Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Michael J Morris, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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University of Michigan Health System
Ann Arbor, Michigan, United States
The Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States
Countries
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Facility Contacts
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Maha Hussain, MD, FACP
Role: primary
Tina Mayer, MD
Role: primary
Michael J Morris, MD
Role: primary
Justine Bruce, MD
Role: primary
Other Identifiers
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PCCTC LOI # c10-071
Identifier Type: OTHER
Identifier Source: secondary_id
TOP205
Identifier Type: -
Identifier Source: org_study_id