Clinical trial NCT01709734: A 2 Part, Phase 2 Trial of Galeterone in the Treatment of Castration Resistant Prostate Cancer
Official title: ARMOR2: A 2 Part, Phase 2 Trial of Galeterone in the Treatment of Castration Resistant Prostate Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: prostate cancer CRPC
Lead sponsor: LTN PHARMACEUTICALS, INC.
Sponsor class: INDUSTRY
First posted: 2012-10-18
Enrollment: 126
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Confirmation of recommended dose and patient population for Part 2 of the study.
timeFrame: 3 months
measure: Assessment of efficacy by means of PSA response.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA David Geffen School of Medicine
state: California
city: San Bernardino
country: United States
facility: San Bernardino Urological Associates
state: California
city: Boca Raton
country: United States
facility: Raton Regional Hospital, Lynn Cancer Institute
state: Florida
city: New Orleans
country: United States
facility: Tulane Cancer Center
state: Louisiana
city: Annapolis
country: United States
facility: AAHS Research Institute
state: Maryland
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Baltimore
country: United States
facility: Sidney Kimmel Johns Hopkins
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Omaha
country: United States
facility: Urology Cancer Center and GU Research Network
state: Nebraska
city: Brick
country: United States
facility: Coastal Urology Associates
state: New Jersey
city: Lawrenceville
country: United States
facility: Premier Urology Associates, LLC
state: New Jersey
city: Buffalo
country: United States
facility: Roswell Park Center Institute
state: New York
city: New York
country: United States
facility: Mount Sinai
state: New York
city: Concord
country: United States
facility: Carolina Clinical Trials
state: North Carolina
city: Greenville
country: United States
facility: Greenville Hospital System University Medical Center
state: South Carolina
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: Dallas
country: United States
facility: Urology Clinics of North Texas
state: Texas
city: Seattle
country: United States
facility: University of Washington/Seattle Cancer Care Alliance
state: Washington
city: Vancouver
country: Canada
facility: BC Cancer Agency
state: British Columbia
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: University of Washington Seattle Cancer Care Alliance
name: Bruce Montgomery, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Dana-Farber Cancer Institute
name: Mary Ellen Taplin, M.D.
role: PRINCIPAL_INVESTIGATOR
References: