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Tesetaxel in Chemotherapy-naive Patients With Progressive, Castration-resistant Prostate Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2012 by Genta Incorporated
Sponsor:
Information provided by (Responsible Party):
Genta Incorporated
ClinicalTrials.gov Identifier:
NCT01296243
First received: February 10, 2011
Last updated: July 20, 2012
Last verified: July 2012

February 10, 2011
July 20, 2012
February 2011
August 2012   (final data collection date for primary outcome measure)
Progression-free survival [ Time Frame: 6 months from the start of treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01296243 on ClinicalTrials.gov Archive Site
  • Response rate (RECIST 1.1) among patients with measurable disease [ Time Frame: 6 months from the start of treatment ] [ Designated as safety issue: No ]
  • Duration of response among patients with measurable disease [ Time Frame: 12 months from the start of treatment ] [ Designated as safety issue: No ]
  • Durable response among patients with measurable disease [ Time Frame: 12 months from the start of treatment ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 3 years following enrollment of the last subject ] [ Designated as safety issue: No ]
  • Disease-control rate [ Time Frame: 6 months from the start of treatment ] [ Designated as safety issue: No ]
  • PSA response rate [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: 12 months from the start of treatment ] [ Designated as safety issue: No ]
  • No. (percentage) of subjects with adverse events [ Time Frame: Through 30 days after the last dose of tesetaxel ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Tesetaxel in Chemotherapy-naive Patients With Progressive, Castration-resistant Prostate Cancer
A Phase II Study of Single-agent Tesetaxel in Chemotherapy-naive Patients Who Have Progressive, Castration-resistant Prostate Cancer

Given the activity of docetaxel in patients with progressive, metastatic castration-resistant prostate cancer, this study is being undertaken to evaluate the activity of tesetaxel, an orally bioavailable taxane, in chemotherapy-naive and chemotherapy-exposed patients.

Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
Drug: 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 Name: DJ-927
Experimental: Tesetaxel once every 3 weeks
Intervention: Drug: Tesetaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
57
February 2015
August 2012   (final data collection date for primary outcome measure)

Key Inclusion Criteria:

  • At least 18 years of age
  • 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

Key Exclusion Criteria:

  • History or presence of brain metastasis or leptomeningeal disease
  • 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
Male
18 Years and older
No
United States
 
NCT01296243
TOP205, PCCTC LOI # c10-071
No
Genta Incorporated
Genta Incorporated
Not Provided
Principal Investigator: Michael J Morris, MD Memorial Sloan-Kettering Cancer Center
Genta Incorporated
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP