Clinical Trials

Hormone-Refractory Prostate Cancer (HRPC) Phase II

Trial Number—AT-101-CS-205

A randomized, double-blind, placebo-controlled, multicenter, phase II study comparing AT-101 in combination with docetaxel and prednisone versus docetaxel and prednisone in men with chemotherapy-naïve metastatic HRPC

Primary Objective

• To evaluate and compare progression-free survival between the two treatment arm

Secondary Objective

• To determine the safety of oral AT-101 administered in combination with docetaxel and prednisone
• To evaluate the two treatment arms with respect to change in quality of life status and Present Pain Intensity (PPI) score
• To evaluate prostate specific antigen (PSA) and objective tumor response rate

Key Inclusion Criteria

1. Males age >/= 18 years with histologically confirmed adenocarcinoma of the prostate, which is now metastatic (eg, any T, any N, M1a-c) based on bone scan, CT scan, or MRI scan.
2. Progression of disease despite androgen deprivation (androgen ablation or surgical castration) and anti-androgen withdrawal as documented by one or more of the following.
1. Progression of measurable disease per RECIST
2. Bone scan progression, defined as the appearance of >/=2 new lesions on bone scan, attributable to prostate cancer
3. Rising PSA, as defined by increasing levels on at least two consecutive assessments, following a prior assessment taken as a reference value, where all of the following are met
1. The assessments are at least 1 week apart, with the first assessment at least 1 week later than the reference value.
2. Progressive increase in the 2 assessments after the reference value, without an intervening decrease between assessments
3. The last PSA value before study entry is >/=2 ng/mL.
3. Serum testosterone level </= 50 ng/mL post orchiectomy or while maintained on continuous or intermittent medical androgen suppression with a LHRH agonist or antagonist
4. At least 4 weeks since prior flutamide, megestrol, ketoconazole, aminoglutethimide, radiation therapy, samarium, or systemic steroids (any dose); and at least 6 weeks since prior bicalutamide or nilutamide
5. ECOG performance status </= 2
6. Able to swallow and retain oral medication

Key Exclusion Criteria

1. Received prior chemotherapy (including estramustine phosphate) for HRPC. Adjuvant chemotherapy (including docetaxel) is allowed if progression of disease occurred >/=6 months after the completion of adjuvant therapy.
2. Patients must not be receiving concurrent antiandrogen hormonal therapy for HRPC (LHRH-directed therapies are acceptable to maintain castrate levels of testosterone).
3. Known history of, or clinical evidence of, central nervous system (CNS) metastases or leptomeningeal carcinomatosis
4. Active secondary malignancy or history of other malignancy within the last 5 years
5. Prior history of radiation therapy to >=30% of the bone marrow
6. Peripheral neuropathy of >= Grade 2
7. Patients with malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel are excluded. Subjects with ulcerative colitis, inflammatory bowel disease, or partial or complete small bowel obstruction are also excluded.
8. Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
9. Known active symptomatic fungal, bacterial, and/or viral infection including active HIV. Note: screening for viruses is not required.
10. Psychiatric illness/social situations that would limit compliance with the study requirements.

Location and Contact Information

For more information on this trial, please contact Ms. Brookes or Dr. Leopold using the information provided below.

    Melissa Brookes                (610) 408-0301     mbrookes@ascenta.com
    Lance Leopold, MD         (610) 408-0301     lleopold@ascenta.com

This study is currently being conducted at several study sites within the United States and Russia.

Trial Identification Number

NCT00571675

For more information on this trial, please visit www.clinicaltrials.gov