Safety and Efficacy Study of AT-101 in Combination With Docetaxel and Prednisone in Men With HRPC

Sponsor

Ascenta Therapeutics (Industry)

Overall Status

Completed

CT.gov ID

NCT00286793

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

5.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is an open-label, multicenter Phase I/II study to evaluate the safety and efficacy of AT-101 in combination with docetaxel and prednisone in men with hormone-refractory prostate cancer that are either chemotherapy naive or have received and progressed on a docetaxel containing regimen,

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: AT-101	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

76 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open-label, Multicenter, Phase I/II Study of AT-101 in Combination With Docetaxel and Prednisone in Men With Hormone Refractory Prostate Cancer (HRPC)

Study Start Date :

Feb 1, 2006

Actual Primary Completion Date :

Nov 1, 2009

Actual Study Completion Date :

Nov 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SIngle Arm Study of AT-101 in combination with Docetaxel	Drug: AT-101 Oral

Arm

Intervention/Treatment

Experimental: SIngle Arm Study of AT-101 in combination with Docetaxel

Drug: AT-101

Oral

Outcome Measures

Primary Outcome Measures

Safety of AT-101 in combination with docetaxel and prednisone [12 months]

Secondary Outcome Measures

Preliminary efficacy of AT-101 in combination with docetaxel and prednisone [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

Rising prostate specific antigen (PSA) despite castrate levels of testosterone due to orchiectomy or luteinizing hormone-releasing hormone (LHRH) agonist therapy.
Patients must have metastatic disease by bone scan, computed tomography (CT) scan, or magnetic resonance imaging (MRI).
ECOG performance status 0 or 1
Adequate hematologic function
Adequate liver and renal function
Able to swallow and retain oral medication.
Patients enrolled into Cohort B must have documented progression of disease during treatment with a docetaxel-containing regimen by meeting one or more of the following criteria- rising PSA, progression of disease per RECIST, or >2 new lesions on bone scan.
Patients enrolled into Cohort B must have received at least two cycles of docetaxel. Minimum doses of prior docetaxel permitted are 60 mg/m2 on a q 3 week schedule or 20 mg/m2 on a weekly schedule.
At least 4 weeks since prior flutamide, megestrol, ketoconazole, and radiotherapy, and at least 6 weeks since prior bicalutamide or nilutamide.

Exclusion Criteria:

Patients enrolled into Cohort A must not have received prior chemotherapy for HRPC.
Known history of or clinical evidence of central nervous system (CNS) metastases.
Active secondary malignancy or history of other malignancy within the last 5 years.
Prior history of radiation therapy to > 25% of the bone marrow
Peripheral neuropathy of > Grade 2
Uncontrolled concurrent illness
Failure to recover fully, as judged by the investigator, from prior surgical procedures.
Concurrent anti-cancer therapy other than docetaxel and prednisone.
Patients must not be receiving concurrent anti-androgen hormonal therapy for HRPC (LHRH therapies are acceptable to maintain castrate levels of testosterone)

Contacts and Locations

Locations

	City	State	Country
1	Hot Springs	Arkansas	United States
2	Fort Meyers	Florida	United States
3	Chicago	Illinois	United States
4	Fridley	Minnesota	United States
5	Albuquerque	New Mexico	United States
6	Syracuse	New York	United States
7	Wilmington	North Carolina	United States
8	Portland	Oregon	United States
9	Hilton Head Island	South Carolina	United States
10	Germantown	Tennessee	United States
11	Memphis	Tennessee	United States
12	Nashville	Tennessee	United States
13	Richardson	Texas	United States