A Study of Single-Agent AT-101 in Men With Hormone Refractory Prostate Cancer

Hormone Refractory Prostate Cancer Clinical Trial

Official title:

An Open-Label, Multicenter, Phase I/II Study of Single-Agent AT-101 in Men With Hormone Refractory Prostate Cancer (HRPC) and Rising Prostate Specific Antigen (PSA) Levels Who Have Not Received Prior Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00286806
• Other study ID #: AT-101-CS-006
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 3, 2006
• Last updated: August 20, 2010
• Start date: December 2005
• Est. completion date: June 2007

Study information

• Verified date: August 2010
• 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 single-agent AT-101 in men with hormone-refractory prostate cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Rising PSA, as defined by increasing levels on at least two consecutive assessments

2. ECOG performance status 0 or 1

3. Adequate hematologic function

4. Adequate liver and renal function

5. Able to swallow and retain oral medication.

Exclusion Criteria:

1. Received prior chemotherapy for HRPC.

2. Concurrent therapy for the treatment of prostate cancer.

3. Clinical signs or symptoms of CNS metastases

4. Requirement for corticosteroid treatment, with the exception of topical corticosteroids or inhaled corticosteroids for reactive airway disease.

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

6. Failure to recover from toxicities related to prior therapy.

7. Uncontrolled concurrent illness.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hormone Refractory Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• AT-101

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	Number of participants with adverse events.
Secondary	Complete or partial remission of disease