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

Sponsor

Genta Incorporated (Industry)

Overall Status

Unknown status

CT.gov ID

NCT01296243

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

14.3

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: Tesetaxel	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

57 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Feb 1, 2011

Anticipated Primary Completion Date :

Aug 1, 2012

Anticipated Study Completion Date :

Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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 Names: DJ-927

Arm

Intervention/Treatment

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 Names:

DJ-927

Outcome Measures

Primary Outcome Measures

Progression-free survival [6 months from the start of treatment]

Secondary Outcome Measures

Response rate (RECIST 1.1) among patients with measurable disease [6 months from the start of treatment]
Duration of response among patients with measurable disease [12 months from the start of treatment]
Durable response among patients with measurable disease [12 months from the start of treatment]
Overall survival [3 years following enrollment of the last subject]
Disease-control rate [6 months from the start of treatment]
PSA response rate [Week 12]
Progression-free survival [12 months from the start of treatment]
No. (percentage) of subjects with adverse events [Through 30 days after the last dose of tesetaxel]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan Health System	Ann Arbor	Michigan	United States	48109-5946
2	The Cancer Institute of New Jersey	New Brunswick	New Jersey	United States	08901
3	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10065
4	University of Wisconsin Carbone Cancer Center	Madison	Wisconsin	United States	53705