Recruiting
Phase 2

Tesetaxel

Sponsor:

Genta Incorporated

Code:

NCT01296243

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tesetaxel

Study Details

Brief summary:

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.

Conditions

Prostate Cancer

Study ID

NCT01296243

Start date

Feb, 2011

Status verified date

Jul, 2012

Completion date

Feb, 2015

Anticipated

Primary completion date

Aug, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

57 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Tesetaxel once every 3 weeks

Interventions

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.

Primary outcome measure

  • Progression-free survival [ Time Frame: 6 months from the start of treatment ]

Central Contacts and Locations

Locations

University of Michigan Health System

Recruiting

Ann Arbor, Michigan, United States, 48109-5946

Contacts

Maha Hussain, MD, FACP

734-936-8906

Principal Investigator:

Maha Hussain, MD, FACP

The Cancer Institute of New Jersey

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

Tina Mayer, MD

732-235-8157

Principal Investigator:

Tina Mayer, MD

Memorial Sloan-Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Michael J Morris, MD

646-422-4469morrism@MSKCC.ORG

Principal Investigator:

Michael J Morris, MD

University of Wisconsin Carbone Cancer Center

Recruiting

Madison, Wisconsin, United States, 53705

Contacts

Justine Bruce, MD

608-262-4961

Principal Investigator:

Justine Y Bruce, MD

More Information

Sponsor

Genta Incorporated

Last update posted

Jul 24, 2012

Last verified

Jul, 2012

Keywords

  • Castration-resistant prostate cancer
  • Tesetaxel
  • Taxanes
  • Chemotherapy-naive
  • Chemotherapy-exposed
  • Progressive, metastatic castration-resistant prostate cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Genta Incorporated on 2012-07-24.