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

Prostate Cancer Clinical Trial

— ARMOR2  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01709734
• Other study ID #: TOK-200-10
• Status: Terminated
• Phase: Phase 2
• Start date: December 2012
• Est. completion date: September 2016

Study information

• Verified date: August 2018
• Source: LTN PHARMACEUTICALS, INC.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 126
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• galeterone

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	BC Cancer Agency	Vancouver	British Columbia
United States	AAHS Research Institute	Annapolis	Maryland
United States	Sidney Kimmel Johns Hopkins	Baltimore	Maryland
United States	University of Maryland	Baltimore	Maryland
United States	Raton Regional Hospital, Lynn Cancer Institute	Boca Raton	Florida
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Coastal Urology Associates	Brick	New Jersey
United States	Roswell Park Center Institute	Buffalo	New York
United States	Carolina Clinical Trials	Concord	North Carolina
United States	Urology Clinics of North Texas	Dallas	Texas
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	Greenville Hospital System University Medical Center	Greenville	South Carolina
United States	Premier Urology Associates, LLC	Lawrenceville	New Jersey
United States	UCLA David Geffen School of Medicine	Los Angeles	California
United States	Carolina Urologic Research Center	Myrtle Beach	South Carolina
United States	Tulane Cancer Center	New Orleans	Louisiana
United States	Mount Sinai	New York	New York
United States	Urology Cancer Center and GU Research Network	Omaha	Nebraska
United States	San Bernardino Urological Associates	San Bernardino	California
United States	University of Washington/Seattle Cancer Care Alliance	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
LTN PHARMACEUTICALS, INC.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Confirmation of recommended dose and patient population for Part 2 of the study.	Confirmation of recommended dose and patient population for Part 2 of the study.	3 months
Primary	Assessment of efficacy by means of PSA response.	Assessment of efficacy by means of PSA response.	3 months