A Study Comparing AT-101 in Combination With Docetaxel and Prednisone Versus Docetaxel and Prednisone in Men With Chemotherapy-Naïve Metastatic Hormone Refractory Prostate Cancer (HRPC)

NCT ID: NCT00571675

Last Updated: 2010-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2010-09-30

Brief Summary

This is a randomized, double-blind, placebo-controlled, multinational Phase 2 study to evaluate and compare oral AT-101 in combination with docetaxel and prednisone versus docetaxel and prednisone plus placebo in the treatment of chemotherapy-naïve metastatic hormone-refractory prostate cancer, who have received hormonal therapy but not chemotherapy.

Detailed Description

Further Study Details provided by Ascenta.

Conditions

Hormone Refractory Prostate Cancer

Keywords

Prostate Cancer; Hormone Refractory Prostate Cancer; HRPC; Docetaxel; Taxotere; Prednisone; Metastatic (Stage IV) Disease; Chemotherapy-naïve metastatic Hormone Refractory Prostate Cancer (HRPC)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

AT-101, prednisone and docetaxel

Group Type: EXPERIMENTAL

AT-101, prednisone and docetaxel

Intervention Type: DRUG

docetaxel (75mg/m2 intravenously over 1 hour on day 1, every 21 days \[one cycle\]), oral prednisone (5mg BID on days 1-21), and oral AT-101 on cycle days 1-3

2

Placebo, prednisone and docetaxel

Group Type: PLACEBO_COMPARATOR

placebo, prednisone and docetaxel

Intervention Type: DRUG

docetaxel (75mg/m2 intravenously over 1 hour every 21 days \[one cycle\]), oral prednisone (5mg BID on days 1-21), and oral placebo on cycle days 1-3

Interventions

AT-101, prednisone and docetaxel

docetaxel (75mg/m2 intravenously over 1 hour on day 1, every 21 days \[one cycle\]), oral prednisone (5mg BID on days 1-21), and oral AT-101 on cycle days 1-3

Intervention Type: DRUG

placebo, prednisone and docetaxel

docetaxel (75mg/m2 intravenously over 1 hour every 21 days \[one cycle\]), oral prednisone (5mg BID on days 1-21), and oral placebo on cycle days 1-3

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Males age ≥ 18 years with histologically confirmed adenocarcinoma of the prostate, which is now metastatic (e.g. 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.

• Progression of measurable disease per RECIST
• Bone scan progression, defined as the appearance of ≥ 2 new lesions on bone scan, attributable to prostate cancer
• 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:

• The assessments are at least one week apart, with the first assessment at least one week later than the reference value
• Progressive increase in the two assessments after the reference value, without an intervening decrease between assessments.
• The last value prior to study entry is ≥ 2 ng/mL

3. Serum testosterone level ≤ 50 ng/dL post orchiectomy or while maintained on continuous or intermittent medical androgen suppression with a LHRH agonist or antagonist.

4. At least 2 weeks since ketoconazole or systemic steroids (any dose); 2 weeks since prior flutamide, megestrol, or aminoglutethimide; and at least 2 weeks since prior bicalutamide or nilutamide

5. Radiation therapy and/or therapy with samarium must have been completed 4 weeks prior to first dose of therapy. Strontium therapy must have been completed at least 12 weeks prior to the first dose of therapy. The patient must have recovered from all treatment-related toxicities.

6. ECOG performance status ≤ 2

7. Able to swallow and retain oral medication

Exclusion Criteria

1. Received prior chemotherapy (including estramustine phosphate [Estracyt]) for HRPC. Adjuvant chemotherapy (including docetaxel) is allowed provided that progression of disease occurred ≥ 6 months after the completion of adjuvant therapy.

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

3. Treatment with monoclonal antibody (e.g., VEGF targeting antibody) or prostate cancer vaccine within 45 days prior to the first dose of study treatment. Acute toxicities from prior therapy must have resolved to Grade ≤ 1.

4. Known history of or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis

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

6. Prior history of radiation therapy to ≥ 30% of the bone marrow

7. Peripheral neuropathy of ≥ Grade 2

8. 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.

9. Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification

10. Known active symptomatic fungal, bacterial and/or viral infection including active HIV. Note: screening for viruses is not required.

11. Psychiatric illness/social situations that would limit compliance with the study requirements.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ascenta Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Ascenta Therapeutics

Principal Investigators

Lance Leopold, MD

Role: STUDY_DIRECTOR

Ascenta Therapeutics

Locations

Colorado Springs, Colorado, United States

New Port Richey, Florida, United States

Ocoee, Florida, United States

Fishers, Indiana, United States

Burnsville, Minnesota, United States

Las Vegas, Nevada, United States

Albuquerque, New Mexico, United States

Las Cruces, New Mexico, United States

Raleigh, North Carolina, United States

Kettering, Ohio, United States

Eugene, Oregon, United States

Spartanburg, South Carolina, United States

Amarillo, Texas, United States

Arlington, Texas, United States

Austin, Texas, United States

Dallas, Texas, United States

Denton, Texas, United States

Midland, Texas, United States

Paris, Texas, United States

Webster, Texas, United States

Fairfax, Virginia, United States

Norfolk, Virginia, United States

Kennewick, Washington, United States

Vancouver, Washington, United States

Barnaul, , Russia

Engel's, , Russia

Kazan', , Russia

Kursk, , Russia

Kuzmolovsky, , Russia

Moscow, , Russia

Saint Petersburg, , Russia

Sochi, , Russia

Stavropol, , Russia

Voronezh, , Russia

Yekaterinburg, , Russia

Countries

United States; Russia

References

O'Neill AJ, Prencipe M, Dowling C, Fan Y, Mulrane L, Gallagher WM, O'Connor D, O'Connor R, Devery A, Corcoran C, Rani S, O'Driscoll L, Fitzpatrick JM, Watson RW. Characterisation and manipulation of docetaxel resistant prostate cancer cell lines. Mol Cancer. 2011 Oct 7;10:126. doi: 10.1186/1476-4598-10-126.

Reference Type: DERIVED

PMID: 21982118 (View on PubMed)

Other Identifiers

AT-101-CS-205

Identifier Type: -

Identifier Source: org_study_id