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


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

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


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. Male age > 18 years

2. Histologically or cytologically confirmed adenocarcinoma of the prostate (excluding
neuroendocrine differentiation or small cell histology)

3. Ongoing androgen blockade (therapy with gonadotropin-releasing hormone (GnRH)
analogues, or orchiectomy) demonstrated by serum testosterone concentration of less
than 50 ng/dL.

4. Demonstration of progression while on androgen blockade (based upon PCWG2
guidelines).

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

Exclusion Criteria:

1. Prior treatment with androgen directed hormonal therapies (prior abiraterone
treatment allowed for some study arms)

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® (radium-223 chloride)

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

8. Treatment with Coumadin® (warfarin sodium) 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Part 1 will confirm dose to be used in Part B of the study by assessing safety and efficacy by means PSA response.

Outcome Description:

This study will monitor frequency and severity of adverse events and changes in laboratory values. This study will also assess changes in levels of prostate specific antigen as a measure of treatment response

Outcome Time Frame:

3 months

Safety Issue:

Yes

Principal Investigator

Bruce Montgomery, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Washington/Seattle Cancer Care Alliance

Authority:

United States: Food and Drug Administration

Study ID:

TOK-200-10

NCT ID:

NCT01709734

Start Date:

December 2012

Completion Date:

September 2014

Related Keywords:

  • Prostate Cancer
  • prostate cancer CRPC
  • Prostatic Neoplasms

Name

Location

Dana Farber Cancer InstituteBoston, Massachusetts  02115
San Bernardino Urological AssociatesSan Bernardino, California  
University of Washington/Seattle Cancer Care AllianceSeattle, Washington  98109
Greenville Hospital System University Medical CenterGreenville, South Carolina  29605
Urology Cancer Center and GU Research NetworkOmaha, Nebraska  
Texas UrologyCarollton, Texas  75010