Prostate CancerPhase 1ARMOR1NCT00959959
ARMOR1: Study of TOK-001 to Treat Castration Resistant Prostate Cancer
A Phase 1 study testing TOK-001 in people with Prostate Cancer, run by LTN PHARMACEUTICALS, INC. at 8 sites in United States.
Trial summary
The purpose of this study is to determine whether TOK-001 is safe and shows biological effect in the treatment of castration resistant prostate cancer (CRPC). 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?
- TOK-001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 8 sitesUnited States
- Study dates
- Oct 2009to Aug 2012
- Phase
- Phase 1
- 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
- Signed informed consent form
- Confirmed cancer of the prostate
- Progressing disease in spite of androgen ablation therapy
- Able to swallow multiple capsules
Who cannot join
- Participation in another clinical trial < 4 weeks prior to enrollment
- Metastatic disease with one or more of the following:
- Liver involvement
- Bone pain associated with confirmed evidence of metastases
- Non-hepatic visceral involvement
- The following medications:
Show all 16Show fewer
- Prior treatment with MDV3100, abiraterone, Provenge or TAK700
- Prior treatment with ketoconazole
- Prior treatment with chemotherapy
- Prior radiation therapy completed ≤ 4 weeks prior to enrollment
- The following medical conditions:
- Active angina pectoris
- History of Hepatitis B or Hepatitis C
- Known HIV infection
- Ongoing hypertension
- Note: There are additional inclusion and exclusion criteria. The clinical site center will determine if you are eligible. If you are not eligible for the trial, site staff will detail the reasons to you.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21231
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Roswell Park Cancer Institute
Buffalo, New York, 14263
Greenville Hospital System University Medical Center
Greenville, South Carolina, 29605
Comprehensive Cancer Centers of Nevada & US Oncology Research
Las Vegas, Nevada, 89169
UCLA
Los Angeles, California, 90095
San Bernardino Urological Associates
San Bernardino, California, 92404
University of Washington/Seattle Cancer Care Alliance
Seattle, Washington, 98136
About this study
Official title: ARMOR1: Phase 1, Open Label, Dose Escalation Trial of TOK-001 for the Treatment of Chemotherapy Naive Castration Resistant Prostate Cancer
The purpose of this study is to determine whether TOK-001 is safe and shows biological effect in the treatment of castration resistant prostate cancer (CRPC).
- Conditions
- Prostate Cancer
- Being tested
- TOK-001
- Keywords
- CRPC, HRPC, TOK-001, ARMOR, ARMOR1, ESL, Galeterone
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOK-001Drug
Also called Dose Group 1
2 capsules (325 mg each), once per day
TOK-001Drug
Also called Dose Group 3
4 capsules (325 mg each), once per day
TOK-001Drug
Also called Dose Group 4
6 capsules (325 mg each), once per day
TOK-001Drug
Also called Dose Group 2
3 capsules (325 mg each), once per day
TOK-001Drug
Also called Dose Group 5
3 capsules (325 mg each), once per day with supplement
TOK-001Drug
Also called Dose Group 6
6 capsules (325 mg each), split dose (3 capsules with breakfast, 3 capsules with dinner)
TOK-001Drug
Also called Dose Group 7
8 capsules (325 mg each), once per day
TOK-001Drug
Also called Dose Group 8
8 capsules (325 mg each), split dose (4 capsules with breakfast, 4 capsules with dinner)
| Study group | Role | What they receive |
|---|---|---|
| 650 mg TOK-001 | Experimental | Not described Receives: Drug: TOK-001 |
| 1300 mg TOK-001 | Experimental | Not described Receives: Drug: TOK-001 |
| 1950 mg TOK-001 | Experimental | Not described Receives: Drug: TOK-001 |
| 975 mg TOK-001 | Experimental | Not described Receives: Drug: TOK-001 |
| 975 mg TOK-001, supplement | Experimental | Not described Receives: Drug: TOK-001 |
| 1950 mg TOK-001, split dose | Experimental | Not described Receives: Drug: TOK-001 |
| 2600 mg TOK-001 | Experimental | Not described Receives: Drug: TOK-001 |
| 2600 mg TOK-001, split dose | Experimental | Not described Receives: Drug: TOK-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Incidence of adverse events
Safety will be assessed by incidence of AEs and change from baseline in the following additional safety parameters: clinical laboratory assessments, physical examination, vital signs, and 12 lead electrocardiograms (ECGs)
Measured: 3 months
Secondary outcomes (1)
Efficacy Measures
Efficacy will be assessed by evaluation of change in PSA level, changes from baseline in CT/MRI and bone scans, response rate RECIST criteria and additional special laboratories
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 posted17 Aug 2009 (estimated)
- Study startOct 2009
- Primary completionAug 2011
- Study completionAug 2012
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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- LTN PHARMACEUTICALS, INC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- R. B. Montgomery, MD, Principal investigator, University of WashingtonM. E. Taplin, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00959959
- Sponsor's protocol ID
- TOK-200-05
- Acronym
- ARMOR1
- Status last verified
- Sep 2020
- First submitted
- 14 Aug 2009
- Last updated
- 4 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ARMOR1: Phase 1, Open Label, Dose Escalation Trial of TOK-001 for the Treatment of Chemotherapy Naive Castration Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT00959959
- Acronym / sponsor ID
- ARMOR1 / TOK-200-05
- Conditions
- Prostate Cancer
- Keywords
- CRPC, HRPC, TOK-001, ARMOR, ARMOR1, ESL, Galeterone
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- LTN PHARMACEUTICALS, INC.Industry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 17 Aug 2009 (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.
The purpose of this study is to determine whether TOK-001 is safe and shows biological effect in the treatment of castration resistant prostate cancer (CRPC).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 650 mg TOK-001 | Experimental | Drug: TOK-001 |
| 1300 mg TOK-001 | Experimental | Drug: TOK-001 |
| 1950 mg TOK-001 | Experimental | Drug: TOK-001 |
| 975 mg TOK-001 | Experimental | Drug: TOK-001 |
| 975 mg TOK-001, supplement | Experimental | Drug: TOK-001 |
| 1950 mg TOK-001, split dose | Experimental | Drug: TOK-001 |
| 2600 mg TOK-001 | Experimental | Drug: TOK-001 |
| 2600 mg TOK-001, split dose | Experimental | Drug: TOK-001 |
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)
- Signed informed consent form
- Confirmed cancer of the prostate
- Progressing disease in spite of androgen ablation therapy
- Able to swallow multiple capsules
Key exclusion criteria (16 listed)
- Participation in another clinical trial < 4 weeks prior to enrollment
- Metastatic disease with one or more of the following:
- The following medications:
- The following medical conditions:
- Note: There are additional inclusion and exclusion criteria. The clinical site center will determine if you are eligible. If you are not eligible for the trial, site staff will detail the reasons to you.
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 |
|---|---|---|
| TOK-001Also: Dose Group 12 capsules (325 mg each), once per day | Drug | 650 mg TOK-001 |
| TOK-001Also: Dose Group 34 capsules (325 mg each), once per day | Drug | 1300 mg TOK-001 |
| TOK-001Also: Dose Group 46 capsules (325 mg each), once per day | Drug | 1950 mg TOK-001 |
| TOK-001Also: Dose Group 23 capsules (325 mg each), once per day | Drug | 975 mg TOK-001 |
| TOK-001Also: Dose Group 53 capsules (325 mg each), once per day with supplement | Drug | 975 mg TOK-001, supplement |
| TOK-001Also: Dose Group 66 capsules (325 mg each), split dose (3 capsules with breakfast, 3 capsules with dinner) | Drug | 1950 mg TOK-001, split dose |
| TOK-001Also: Dose Group 78 capsules (325 mg each), once per day | Drug | 2600 mg TOK-001 |
| TOK-001Also: Dose Group 88 capsules (325 mg each), split dose (4 capsules with breakfast, 4 capsules with dinner) | Drug | 2600 mg TOK-001, split dose |
Primary outcome
Phase 1: Incidence of adverse events
Time frame: 3 months
Safety will be assessed by incidence of AEs and change from baseline in the following additional safety parameters: clinical laboratory assessments, physical examination, vital signs, and 12 lead electrocardiograms (ECGs)
1 secondary outcome
Efficacy Measures
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2020.
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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.
R. B. Montgomery, MD principal investigator
University of Washington
M. E. Taplin, MD principal investigator
Dana-Farber Cancer Institute
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TOK-001 in people with Prostate Cancer, run by LTN PHARMACEUTICALS, INC. at 8 sites in United States.
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 16 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: finished, as of the sponsor's last update on 4 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Phase 1: Incidence of adverse events (time frame: 3 months). 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 4 Sep 2020.