A 2 Part, Phase 2 Trial of Galeterone in the Treatment of Castration Resistant Prostate Cancer



Status:Completed
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/5/2018
Start Date:December 2012
End Date:September 2016

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ARMOR2: A 2 Part, Phase 2 Trial of Galeterone in the Treatment of Castration Resistant Prostate Cancer

A Phase 2, 2 part trial to evaluate the safety and efficacy of galeterone in castration
resistant prostate cancer (CRPC) patients.

This trial will be split into two parts. The purpose of Part 1 will be to confirm dose and
target patient population and Part 2 will be expansion of the dose and patient population
selected in Part 1. For eligible patients, there will be an optional extension dosing
following the completion of Part 1 or Part 2 of the trial.

Obtaining of informed consent and screening may be performed up to 28 days prior to
enrollment. Each patient will be able to receive his specified regimen for 3 consecutive
cycles. Each cycle consists of 28 days (approximately 1 mo.). End of Cycle 3 visit
assessments will be used to determine outcome and dosing may continue up to an additional 2
weeks until the results of all assessments are obtained. Eligible patients may continue
treatment in an optional extension period following the completion of the primary parts of
this trial.

Inclusion Criteria:

1. Histologically or cytologically confirmed adenocarcinoma of the prostate

2. Ongoing androgen blockade demonstrated by serum testosterone concentration of less
than 50 ng/dL

3. Demonstration of progression while on androgen blockade

4. Eastern Cooperative Oncology Group (ECOG) Performance Status <2

Exclusion Criteria:

1. Depending upon patient prior treatment the following apply:

- Prior treatment with CYP17 inhibitors or AR antagonists (e.g. abiraterone,
TAK-700, ARN-509, ketoconazole*, enzalutamide, or galeterone) - Treatment naïve
only

- Prior treatment with CYP17 inhibitors (e.g. TAK-700, ketoconazole*) or AR
antagonists (e.g. enzalutamide, ARN-509,) or galeterone - abiraterone refractory
only

- Prior treatment with CYP17 inhibitors (e.g. abiraterone, TAK-700, ketoconazole*)
or AR antagonists (e.g. ARN -509) or galeterone - enzalutamide refractory only

2. Prior chemotherapy (unless allowed for some study arms)

3. Treatment with non-steroidal oral antiandrogens within 4 weeks of enrollment

4. Prior use of any chronic systemic glucocorticoids .

5. Prior radiation therapy within 3 weeks and radionuclide therapy within 8 weeks of
enrollment

6. Prior treatment with Alpharadin® (Xofigo®)

7. Treatment with anti arrhythmia therapy for ventricular arrhythmia < 4 weeks prior to
enrollment

8. Treatment with Coumadin® or other anti-coagulant therapy (except aspirin) < 4 weeks
prior to enrollment

9. Severe systemic diseases or active uncontrolled illnesses.

10. Abnormal heart function

11. Liver metastases

12. Brain metastases (unless stable disease >3 mos. by scan without additional
CNS-directed therapy)

13. The patient has known allergy to any of the treatment components

14. Any physical or mental condition or social situation that in the opinion of the
Investigator may interfere with the patient's ability to comply with the trial
procedures

15. History of excessive alcohol consumption

16. Use of any substance known to cause AME
We found this trial at
22
sites
Brick, New Jersey 08723
2428
mi
from 91732
Brick, NJ
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
2578
mi
from 91732
Boston, MA
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: Glenn Bubley, M.D.
Phone: 617-632-9279
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
2578
mi
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Boston, MA
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Annapolis, Maryland 21401
2309
mi
from 91732
Annapolis, MD
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Baltimore, Maryland 20742
(301) 405-1000
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
2301
mi
from 91732
Baltimore, MD
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Baltimore, Maryland 21205
2304
mi
from 91732
Baltimore, MD
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2311
mi
from 91732
Boca Raton, FL
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Mary-Ellen Taplin, MD
Phone: 617-632-5068
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
2578
mi
from 91732
Boston, MA
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Buffalo, New York 14263
2181
mi
from 91732
Buffalo, NY
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Concord, North Carolina 28025
2114
mi
from 91732
Concord, NC
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Dallas, Texas 75231
1226
mi
from 91732
Dallas, TX
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Detroit, Michigan 48201
Principal Investigator: Elisabeth Heath, M.D.
Phone: 313-576-9389
1966
mi
from 91732
Detroit, MI
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Greenville, South Carolina 29605
2020
mi
from 91732
Greenville, SC
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Lawrenceville, New Jersey
2396
mi
from 91732
Lawrenceville, NJ
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Los Angeles, California 90095
13
mi
from 91732
Los Angeles, CA
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823 82nd Parkway, Suite B
Myrtle Beach, South Carolina 29572
(843) 449-1010 ext.268
Carolina Urologic Research Center Carolina Urologic Research Center (CURC) has been recognized both nationally and...
2234
mi
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Myrtle Beach, SC
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New Orleans, Louisiana 70112
1655
mi
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New Orleans, LA
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New York, New York
2432
mi
from 91732
New York, NY
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Omaha, Nebraska 68130
Principal Investigator: Luke Nordquist, M.D.
1288
mi
from 91732
Omaha, NE
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San Bernardino, California
Principal Investigator: Franklin Chu, MD
Phone: 909-881-0555
41
mi
from 91732
San Bernardino, CA
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963
mi
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Seattle, WA
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Vancouver, British Columbia
Principal Investigator: Kim Chi, M.D.
Phone: 604-877-6000 XT2370
1082
mi
from 91732
Vancouver,
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