Tesetaxel in Chemotherapy-naive Patients With Progressive, Castration-resistant Prostate Cancer
This study is currently recruiting participants.
Verified July 2012 by Genta Incorporated
Sponsor:
Genta Incorporated
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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: Tesetaxel |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Single-agent Tesetaxel in Chemotherapy-naive Patients Who Have Progressive, Castration-resistant Prostate Cancer |
Resource links provided by NLM:
Further study details as provided by Genta Incorporated:
Primary Outcome Measures:
- Progression-free survival [ Time Frame: 6 months from the start of treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 57 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | February 2015 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Tesetaxel once every 3 weeks |
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01296243
Locations
| United States, Michigan | |
| University of Michigan Health System | Recruiting |
| Ann Arbor, Michigan, United States, 48109-5946 | |
| Contact: Maha Hussain, MD, FACP 734-936-8906 | |
| Principal Investigator: Maha Hussain, MD, FACP | |
| United States, New Jersey | |
| The Cancer Institute of New Jersey | Recruiting |
| New Brunswick, New Jersey, United States, 08901 | |
| Contact: Tina Mayer, MD 732-235-8157 | |
| Principal Investigator: Tina Mayer, MD | |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Michael J Morris, MD 646-422-4469 morrism@MSKCC.ORG | |
| Principal Investigator: Michael J Morris, MD | |
| United States, Wisconsin | |
| University of Wisconsin Carbone Cancer Center | Recruiting |
| Madison, Wisconsin, United States, 53705 | |
| Contact: Justine Bruce, MD 608-262-4961 | |
| Principal Investigator: Justine Y Bruce, MD | |
Sponsors and Collaborators
Genta Incorporated
Investigators
| Principal Investigator: | Michael J Morris, MD | Memorial Sloan-Kettering Cancer Center |
More Information
No publications provided
| Responsible Party: | Genta Incorporated |
| ClinicalTrials.gov Identifier: | NCT01296243 History of Changes |
| Other Study ID Numbers: | TOP205, PCCTC LOI # c10-071 |
| Study First Received: | February 10, 2011 |
| Last Updated: | July 20, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Genta Incorporated:
|
Castration-resistant prostate cancer Tesetaxel Taxanes |
Chemotherapy-naive Chemotherapy-exposed Progressive, metastatic castration-resistant prostate cancer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 22, 2013