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.
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 4 weeks since ketoconazole or systemic steroids (any dose); 4 weeks since
prior flutamide, megestrol, or aminoglutethimide; and at least 6 weeks since prior
bicalutamide or nilutamide
5. At least 4 weeks since prior flutamide, megestrol, ketoconazole, aminoglutethimide, or
systemic steroids (any dose); and at least 6 weeks since prior bicalutamide or
nilutamide
6. 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.
7. ECOG performance status ≤ 2
8. 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.
Barnaul, Russian Federation; Recruiting
Vladimir Lubennikov, MD, Phone: 7 3852 77 47 55
Engels, Russian Federation; Recruiting
Olga Brichkova, MD, Phone: 7 8453 73 35 10
Kazan, Russian Federation; Recruiting
Sufia Safina, MD, Phone: 7 8432 19 26 00
Kursk, Russian Federation; Recruiting
Igor Kiselev, MD, Phone: 7 4712 54 88 52
Kuzmolovsky, Russian Federation; Recruiting
Laslo Roman, MD, Phone: 7 812 273 74 42
Lipetsk, Russian Federation; Recruiting
Sergey Shinkarev, MD, Phone: 7 474 270 6387
Moscow, Russian Federation; Recruiting
Andrey Karpin, MD, Phone: 7 495 333 90 60
Moscow, Russian Federation; Recruiting
Vsevolod Matveev, MD, Phone: 7 495 324 44 89
Moscow, Russian Federation; Recruiting
Oleg Apolikhin, MD, Phone: 7 495 164 76 60
Moscow, Russian Federation; Recruiting
Vasily Borisov, MD, Phone: 7 495 261 44 01
Moscow, Russian Federation; Recruiting
Michail Biakhov, MD, Phone: 7 495 187 74 83
Moscow, Russian Federation; Recruiting
Anatoly Makhson, MD, Phone: 8 495 561 23 12
Republic of Bashkortostan, Russian Federation; Recruiting
Oleg Lipatov, MD, Phone: 8 3472 485518
Sochi, Russian Federation; Recruiting
Dmitry Udovitsa, MD, Phone: 7 8622 61 51 90
Stavropol, Russian Federation; Recruiting
Sergey Mikhailov, MD, Phone: 7 8652 47 02 69
St. Petersburg, Russian Federation; Recruiting
Sergey Gorelov, MD, Phone: 7 812 558 92 32
St. Petersburg, Russian Federation; Recruiting
Petr Karlov, MD, Phone: 7 812 376 89 20
St. Petersburg, Russian Federation; Recruiting
Mikhail Forkampf-Laue, MD, Phone: 8 812 937 92 03
St. Petersburg, Russian Federation; Recruiting
Salman Al-Shukri, MD, Phone: 8 812 234 66 57
Voronezh, Russian Federation; Recruiting
Vadim Popov, MD, Phone: 7 4732 53 32 77
Yekaterinburg, Russian Federation; Recruiting
Irina Bulavina, MD, Phone: 7 343 376 95 46
Colorado Springs, Colorado, United States; Recruiting
Katherine Scheich, Phone: (303) 388-4876
New Port Richey, Florida, United States; Recruiting
Suzanne Jacobs, Phone: (727) 842-8411
Ocoee, Florida, United States; Recruiting
Lynn Hogue, Phone: (407) 292-3042
Fishers, Indiana, United States; Recruiting
Kathryn Lynn La Prees, Phone: (317) 964-5200
Burnsville, Minnesota, United States; Recruiting
Carol Vake, Phone: (612) 863-8585
Las Vegas, Nevada, United States; Recruiting
Elizabeth Petersen, Phone: (702) 952-3400
Albuquerque, New Mexico, United States; Recruiting
Debra Winkeljohn, RN, Phone: (505) 938-5858, Ext: 236
Helen Whitesides, Phone: (505) 938-5858, Ext: 237
Albuquerque, New Mexico, United States; Recruiting
John Pierce, RN,ONC, Phone: 505-272-0323
Las Cruces, New Mexico, United States; Recruiting
Kim Hoffman, Phone: 575-556-1748
Raleigh, North Carolina, United States; Recruiting
Diane Bracco, Phone: (919) 781-7070
Kettering, Ohio, United States; Recruiting
Michelle Owens, Phone: (937) 293-1622
Eugene, Oregon, United States; Recruiting
Jeanne Schaffer, Phone: (541) 681-4930
Spartanburg, South Carolina, United States; Recruiting
Gina Norris, Phone: (864) 699-5700
Amarillo, Texas, United States; Recruiting
John McMahan, Phone: (806) 457-2026
Arlington, Texas, United States; Recruiting
Robin Rutt, Phone: (817) 467-6092
Austin, Texas, United States; Recruiting
Gabriella Iannone, Phone: (512) 427-9467
Dallas, Texas, United States; Recruiting
Marine Fisher, Phone: (214) 370-1000
Midland, Texas, United States; Recruiting
Mary Williams, Phone: (432) 687-1949
Paris, Texas, United States; Recruiting
Sue Crumpler, Phone: (903) 785-0031
Webster, Texas, United States; Recruiting
Deborah Terry-Dettmer, Phone: (281) 332-7505
Denton, Texas, United States; Recruiting
Debra Vernon, Phone: (940) 328-1022
Fairfax, Virginia, United States; Recruiting
Denise Campbell, Phone: (703) 391-5874
Norfolk, Virginia, United States; Recruiting
Wendi Gobhardt, Phone: (757) 466-8683
Kennewick, Washington, United States; Recruiting
Cynthia Beecher, Phone: (509) 783-0144
Vancouver, Washington, United States; Recruiting
Judith Welch, Phone: (360) 944-9889
