Back to resultsA 2 Part, Phase 2 Trial of Galeterone in the Treatment of Castration Resistant Prostate Cancer (ARMOR2)
Primary Purpose
Prostate Cancer
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
galeterone
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring prostate cancer CRPC
Eligibility Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed adenocarcinoma of the prostate
- Ongoing androgen blockade demonstrated by serum testosterone concentration of less than 50 ng/dL
- Demonstration of progression while on androgen blockade
- Eastern Cooperative Oncology Group (ECOG) Performance Status <2
Exclusion Criteria:
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
- Prior chemotherapy (unless allowed for some study arms)
- Treatment with non-steroidal oral antiandrogens within 4 weeks of enrollment
- Prior use of any chronic systemic glucocorticoids .
- Prior radiation therapy within 3 weeks and radionuclide therapy within 8 weeks of enrollment
- Prior treatment with Alpharadin® (Xofigo®)
- Treatment with anti arrhythmia therapy for ventricular arrhythmia < 4 weeks prior to enrollment
- Treatment with Coumadin® or other anti-coagulant therapy (except aspirin) < 4 weeks prior to enrollment
- Severe systemic diseases or active uncontrolled illnesses.
- Abnormal heart function
- Liver metastases
- Brain metastases (unless stable disease >3 mos. by scan without additional CNS-directed therapy)
- The patient has known allergy to any of the treatment components
- 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
- History of excessive alcohol consumption
- Use of any substance known to cause AME
Sites / Locations
- UCLA David Geffen School of Medicine
- San Bernardino Urological Associates
- Raton Regional Hospital, Lynn Cancer Institute
- Tulane Cancer Center
- AAHS Research Institute
- University of Maryland
- Sidney Kimmel Johns Hopkins
- Massachusetts General Hospital
- Dana Farber Cancer Institute
- Beth Israel Deaconess Medical Center
- Karmanos Cancer Institute
- Urology Cancer Center and GU Research Network
- Coastal Urology Associates
- Premier Urology Associates, LLC
- Roswell Park Center Institute
- Mount Sinai
- Carolina Clinical Trials
- Greenville Hospital System University Medical Center
- Carolina Urologic Research Center
- Urology Clinics of North Texas
- University of Washington/Seattle Cancer Care Alliance
- BC Cancer Agency
- Sunnybrook Health Sciences Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Dose Confirmation
Dose Expansion
Arm Description
Dose A - galeterone tablets once daily PO for three months + extension Dose B - galeterone tablets once daily PO for three months + extension Dose C - galeterone tablets once daily PO for three months + extension
Single dose expansion (from part 1) of galeterone tablets once daily PO for three months + extension
Outcomes
Primary Outcome Measures
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.
Assessment of efficacy by means of PSA response.
Assessment of efficacy by means of PSA response.
Secondary Outcome Measures
Full Information
NCT ID
NCT01709734
First Posted
October 16, 2012
Last Updated
March 13, 2023
Sponsor
LTN PHARMACEUTICALS, INC.
1. Study Identification
Unique Protocol Identification Number
NCT01709734
Brief Title
A 2 Part, Phase 2 Trial of Galeterone in the Treatment of Castration Resistant Prostate Cancer
Acronym
ARMOR2
Official Title
ARMOR2: A 2 Part, Phase 2 Trial of Galeterone in the Treatment of Castration Resistant Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Why Stopped
Study was terminated prematurely in all investigational study centers upon recommendation from the study's Data Monitoring Committee (DMC).
Study was stopped due to lack of efficacy.
Study Start Date
December 2012 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LTN PHARMACEUTICALS, INC.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A Phase 2, 2 part trial to evaluate the safety and efficacy of galeterone in castration resistant prostate cancer (CRPC) patients.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate cancer CRPC
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
126 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dose Confirmation
Arm Type
Experimental
Arm Description
Dose A - galeterone tablets once daily PO for three months + extension
Dose B - galeterone tablets once daily PO for three months + extension
Dose C - galeterone tablets once daily PO for three months + extension
Arm Title
Dose Expansion
Arm Type
Experimental
Arm Description
Single dose expansion (from part 1) of galeterone tablets once daily PO for three months + extension
Intervention Type
Drug
Intervention Name(s)
galeterone
Other Intervention Name(s)
TOK-001
Primary Outcome Measure Information:
Title
Confirmation of recommended dose and patient population for Part 2 of the study.
Description
Confirmation of recommended dose and patient population for Part 2 of the study.
Time Frame
3 months
Title
Assessment of efficacy by means of PSA response.
Description
Assessment of efficacy by means of PSA response.
Time Frame
3 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed adenocarcinoma of the prostate
Ongoing androgen blockade demonstrated by serum testosterone concentration of less than 50 ng/dL
Demonstration of progression while on androgen blockade
Eastern Cooperative Oncology Group (ECOG) Performance Status <2
Exclusion Criteria:
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
Prior chemotherapy (unless allowed for some study arms)
Treatment with non-steroidal oral antiandrogens within 4 weeks of enrollment
Prior use of any chronic systemic glucocorticoids .
Prior radiation therapy within 3 weeks and radionuclide therapy within 8 weeks of enrollment
Prior treatment with Alpharadin® (Xofigo®)
Treatment with anti arrhythmia therapy for ventricular arrhythmia < 4 weeks prior to enrollment
Treatment with Coumadin® or other anti-coagulant therapy (except aspirin) < 4 weeks prior to enrollment
Severe systemic diseases or active uncontrolled illnesses.
Abnormal heart function
Liver metastases
Brain metastases (unless stable disease >3 mos. by scan without additional CNS-directed therapy)
The patient has known allergy to any of the treatment components
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
History of excessive alcohol consumption
Use of any substance known to cause AME
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Montgomery, M.D.
Organizational Affiliation
University of Washington Seattle Cancer Care Alliance
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mary Ellen Taplin, M.D.
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA David Geffen School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-7384
Country
United States
Facility Name
San Bernardino Urological Associates
City
San Bernardino
State/Province
California
ZIP/Postal Code
92404
Country
United States
Facility Name
Raton Regional Hospital, Lynn Cancer Institute
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Tulane Cancer Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
AAHS Research Institute
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Sidney Kimmel Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Urology Cancer Center and GU Research Network
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
Coastal Urology Associates
City
Brick
State/Province
New Jersey
ZIP/Postal Code
08724
Country
United States
Facility Name
Premier Urology Associates, LLC
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
Roswell Park Center Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Carolina Clinical Trials
City
Concord
State/Province
North Carolina
ZIP/Postal Code
28025
Country
United States
Facility Name
Greenville Hospital System University Medical Center
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Carolina Urologic Research Center
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Urology Clinics of North Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
University of Washington/Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98136
Country
United States
Facility Name
BC Cancer Agency
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A 2 Part, Phase 2 Trial of Galeterone in the Treatment of Castration Resistant Prostate Cancer
We'll reach out to this number within 24 hrs