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

Prostate Cancer Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00286793
• Other study ID #: AT-101-CS-202
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 3, 2006
• Last updated: June 27, 2011
• Start date: February 2006
• Est. completion date: November 2009

Study information

• Verified date: June 2011
• Source: Ascenta Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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,

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Rising prostate specific antigen (PSA) despite castrate levels of testosterone due to orchiectomy or luteinizing hormone-releasing hormone (LHRH) agonist therapy.

2. Patients must have metastatic disease by bone scan, computed tomography (CT) scan, or magnetic resonance imaging (MRI).

3. ECOG performance status 0 or 1

4. Adequate hematologic function

5. Adequate liver and renal function

6. Able to swallow and retain oral medication.

7. 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.

8. 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.

9. At least 4 weeks since prior flutamide, megestrol, ketoconazole, and radiotherapy, and at least 6 weeks since prior bicalutamide or nilutamide.

Exclusion Criteria:

1. Patients enrolled into Cohort A must not have received prior chemotherapy for HRPC.

2. Known history of or clinical evidence of central nervous system (CNS) metastases.

3. Active secondary malignancy or history of other malignancy within the last 5 years.

4. Prior history of radiation therapy to > 25% of the bone marrow

5. Peripheral neuropathy of > Grade 2

6. Uncontrolled concurrent illness

7. Failure to recover fully, as judged by the investigator, from prior surgical procedures.

8. Concurrent anti-cancer therapy other than docetaxel and prednisone.

9. Patients must not be receiving concurrent anti-androgen hormonal therapy for HRPC (LHRH therapies are acceptable to maintain castrate levels of testosterone)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• AT-101
Oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ascenta Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of AT-101 in combination with docetaxel and prednisone		12 months	Yes
Secondary	Preliminary efficacy of AT-101 in combination with docetaxel and prednisone		12 months	No