Prostate CancerPhase 2ARMOR2NCT01709734
A 2 Part, Phase 2 Trial of Galeterone in the Treatment of Castration Resistant Prostate Cancer
A Phase 2 study testing galeterone in people with Prostate Cancer, run by LTN PHARMACEUTICALS, INC. at 23 sites in 2 countries.
Trial summary
A Phase 2, 2 part trial to evaluate the safety and efficacy of galeterone in castration resistant prostate cancer (CRPC) patients. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- galeterone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 23 sitesin 2 countries
- Study dates
- Dec 2012to Sep 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
23 sites in 2 countries.
23 sites in 2 countries
United States21 sites
AAHS Research Institute
Annapolis, Maryland, 21401
University of Maryland
Baltimore, Maryland, 21201
Sidney Kimmel Johns Hopkins
Baltimore, Maryland, 21205
Raton Regional Hospital, Lynn Cancer Institute
Boca Raton, Florida, 33486
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Coastal Urology Associates
Brick, New Jersey, 08724
Roswell Park Center Institute
Buffalo, New York, 14263
Carolina Clinical Trials
Concord, North Carolina, 28025
Urology Clinics of North Texas
Dallas, Texas, 75230
Karmanos Cancer Institute
Detroit, Michigan, 48201
Greenville Hospital System University Medical Center
Greenville, South Carolina, 29605
Premier Urology Associates, LLC
Lawrenceville, New Jersey, 08648
UCLA David Geffen School of Medicine
Los Angeles, California, 90095-7384
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
Tulane Cancer Center
New Orleans, Louisiana, 70112
Mount Sinai
New York, New York, 10029
Urology Cancer Center and GU Research Network
Omaha, Nebraska, 68130
San Bernardino Urological Associates
San Bernardino, California, 92404
University of Washington/Seattle Cancer Care Alliance
Seattle, Washington, 98136
Canada2 sites
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
BC Cancer Agency
Vancouver, British Columbia, V5Z 4E6
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- galeterone
- Keywords
- prostate cancer CRPC
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
galeteroneDrug
Also called TOK-001
| Study group | Role | What they receive |
|---|---|---|
| Dose Confirmation | Experimental | 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 Receives: Drug: galeterone |
| Dose Expansion | Experimental | Single dose expansion (from part 1) of galeterone tablets once daily PO for three months + extension Receives: Drug: galeterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Assessment of efficacy by means of PSA response.
Assessment of efficacy by means of PSA response.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2012 (estimated)
- Study startDec 2012
- Primary completionSep 2016
- Study completionSep 2016
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- LTN PHARMACEUTICALS, INC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bruce Montgomery, M.D., Principal investigator, University of Washington Seattle Cancer Care AllianceMary Ellen Taplin, M.D., Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01709734
- Sponsor's protocol ID
- TOK-200-10
- Acronym
- ARMOR2
- Status last verified
- Aug 2018
- First submitted
- 16 Oct 2012
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ARMOR2: A 2 Part, Phase 2 Trial of Galeterone in the Treatment of Castration Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT01709734
- Acronym / sponsor ID
- ARMOR2 / TOK-200-10
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer CRPC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 126 participants (actual)
- Lead sponsor
- LTN PHARMACEUTICALS, INC.Industry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 18 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Confirmation | Experimental | Drug: galeteroneDose 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 |
| Dose Expansion | Experimental | Drug: galeteroneSingle dose expansion (from part 1) of galeterone tablets once daily PO for three months + extension |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (19 listed)
- Depending upon patient prior treatment the following apply:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| galeteroneAlso: TOK-001 | Drug | Dose Confirmation, Dose Expansion |
Primary outcome
Confirmation of recommended dose and patient population for Part 2 of the study.
Time frame: 3 months
Confirmation of recommended dose and patient population for Part 2 of the study.
Assessment of efficacy by means of PSA response.
Time frame: 3 months
Assessment of efficacy by means of PSA response.
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce Montgomery, M.D. principal investigator
University of Washington Seattle Cancer Care Alliance
Mary Ellen Taplin, M.D. principal investigator
Dana-Farber Cancer Institute
23 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing galeterone in people with Prostate Cancer, run by LTN PHARMACEUTICALS, INC. at 23 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confirmation of recommended dose and patient population for Part 2 of the study. (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023.