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A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 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)


Phase 2
18 Years
N/A
Not Enrolling
Both
Hormone Refractory Prostate Cancer

Thank you

Trial Information

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 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)


Further Study Details provided by Ascenta.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

To evaluate and compare the two treatment arms with respect to overall survival (OS)

Outcome Time Frame:

33 months

Safety Issue:

No

Principal Investigator

Lance Leopold, MD

Investigator Role:

Study Director

Investigator Affiliation:

Ascenta Therapeutics

Authority:

United States: Food and Drug Administration

Study ID:

AT-101-CS-205

NCT ID:

NCT00571675

Start Date:

October 2007

Completion Date:

September 2010

Related Keywords:

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

Name

Location

Alexandria, Minnesota  56308
Miami, Florida  33176
Cleveland, Ohio  44195
Austin, Texas  78705
Seattle, Washington  98195
McLean, Virginia  22101
Albuquerque, New Mexico  87131-5636
Denver, Colorado  
Charlotte, North Carolina  
Eugene, Oregon  
Indianapolis, Indiana  
Charleston, South Carolina  
Las Vegas, Nevada  89109