Castration Resistant Prostate CancerPhase 2NCT01540071
Trial of NRX 194204 in Castration- and Taxane-Resistant Prostate Cancer
A Phase 2 study testing NRX 194204 in people with Castration Resistant Prostate Cancer, run by Io Therapeutics at 1 site in United States.
Trial summary
This study is to evaluate the benefits of investigational drug, NRX 194204 in slowing down/stopping/reversing progression of the castration resistant and taxane resistant prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Castration Resistant Prostate Cancer
- What is being tested?
- NRX 194204
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Dec 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 prostate cancer
- Documented progression on at least one prior hormone treatment, AND at least one taxane based chemotherapy regimen, or patient's refusal of chemotherapy treatment
- Male, Age > 18 years
- ECOG (Eastern Cooperative Oncology Group) performance score of 0-2
- Adequate bone marrow, renal and hepatic function
- Men of childbearing potential must consent to use barrier contraception while on treatment and for 90 days thereafter
Who cannot join
- Prior treatment with NRX 194204 or bexarotene (Targretin)
- Presence of parenchymal brain metastases
- History of prior malignancy within the past 5 years with the exception of curatively treated basal cell or squamous cell carcinoma of the skin or superficial bladder or other stage I or stage II cancer in complete remission for at least 12 months
- Patients with a history of unstable or newly diagnosed angina pectoris, documented history of current serious arrhythmia or congestive heart failure or myocardial infarction within 6 months of enrollment
- Known HIV or hepatitis B or C infection
- Life expectancy < 3 months
- Patients with any history of thyroid disease, pituitary disease or treatment with thyroid replacement hormone
- Patients with a history of pancreatitis or at significant risk of developing pancreatitis
Trial locations and contacts
1 site in 1 country.
United States1 site
Lalita Pandit, MD
Fountain Valley, California, 92708
About this study
Official title: A Phase II Trial of NRX 194204 in Castration- and Taxane-Resistant Prostate Cancer
This study is to evaluate the benefits of investigational drug, NRX 194204 in slowing down/stopping/reversing progression of the castration resistant and taxane resistant prostate cancer.
Read the detailed description
Numerous studies in pre-clinical models and in human clinical trials have clearly established the potential for the use of rexinoids in the treatment and prevention of cancer. NRX 194204, a second generation rexinoid, is a highly potent and specific activator of RXRs (retinoid X receptors). Because NRX 194204 is significantly more selective for the RXRs relative to the RARs (retinoic acid receptors) than a first generation approved drug, it is associated with fewer adverse events in clinical use. This study seeks to investigate NRX 194204 monotherapy in patients with castration- and taxane- resistant prostate cancer.
- Conditions
- Castration Resistant Prostate Cancer
- Being tested
- NRX 194204
- Keywords
- HRPC (Hormone refractory prostate cancer), Androgen independent prostate cancer, CRPC (Castration and Taxane Resistant Prostate Cancer)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NRX 194204Drug
Also called Rexinoid
NRX 194204 is an oblong, soft, gelatin capsule and will be taken once a day
| Study group | Role | What they receive |
|---|---|---|
| NRX 194204 | Experimental | This was a single arm open-label study. All patients enrolled received 20 mg of IRX4204 per day orally, for six months, or longer if the patient had disease stabilization and was tolerating the experimental treatment. Receives: Drug: NRX 194204 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Benefit of NRX 194204 in Men With Castration- and Taxane-resistant Metastatic Prostate Cancer
Clinical benefit will be defined as either non-progression at 8 weeks or radiologic and/or PSA response at any time point with no dose limiting toxicity (DLT) or other toxicity requiring termination of treatment.
Measured: participants will be followed for the duration of treatment and follow up, which is up to 2.5 years
Secondary outcomes (4)
Overall Survival
Overall Survival [Time Frame: participants will be followed for the duration of treatment and follow up, which is up to 2.5 years]
Measured: participants will be followed for the duration of treatment and follow up, which is up to 2.5 years
Time to Disease Progression
Time to Disease Progression was evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines, version 1.1. Progression was defined as at least a 20% relative increase and an absolute increase of at least 5mm; or appearance of new lesions.
Measured: participants were to be followed for the duration of treatment and follow up; for up to 2.5 years from baseline
Number of Grade 3 and Higher Adverse Events Deemed at Least Possibly Related to NRX 194204
Number of Grade 3 and higher Adverse Events deemed at least possibly related to NRX 194204
Measured: participants will be followed for the duration of treatment and follow up, which is up to 2.5 years
PSA Response Rate
Prostate specific Antigen (PSA) response rate based on 50% reduction from baseline PSA
Measured: participants will be followed for the duration of treatment and follow up, which is up to 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2012 (estimated)
- Study startAug 2011
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Castration Resistant 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Io Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lalita Pandit, MD, Principal investigator, Lalita Pandit, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01540071
- Sponsor's protocol ID
- 4204-202-2011
- Status last verified
- Apr 2021
- First submitted
- 13 Nov 2011
- Last updated
- 14 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of NRX 194204 in Castration- and Taxane-Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT01540071
- Acronym / sponsor ID
- 4204-202-2011
- Conditions
- Castration Resistant Prostate Cancer
- Keywords
- HRPC (Hormone refractory prostate cancer), Androgen independent prostate cancer, CRPC (Castration and Taxane Resistant Prostate Cancer)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Io TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 28 Feb 2012 (estimated)
- Results
- Posted 14 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to evaluate the benefits of investigational drug, NRX 194204 in slowing down/stopping/reversing progression of the castration resistant and taxane resistant prostate cancer.
Detailed description
Numerous studies in pre-clinical models and in human clinical trials have clearly established the potential for the use of rexinoids in the treatment and prevention of cancer. NRX 194204, a second generation rexinoid, is a highly potent and specific activator of RXRs (retinoid X receptors). Because NRX 194204 is significantly more selective for the RXRs relative to the RARs (retinoic acid receptors) than a first generation approved drug, it is associated with fewer adverse events in clinical use. This study seeks to investigate NRX 194204 monotherapy in patients with castration- and taxane- resistant prostate cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NRX 194204 | Experimental | Drug: NRX 194204This was a single arm open-label study. All patients enrolled received 20 mg of IRX4204 per day orally, for six months, or longer if the patient had disease stabilization and was tolerating the experimental treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically or cytologically confirmed prostate cancer
- Documented progression on at least one prior hormone treatment, AND at least one taxane based chemotherapy regimen, or patient's refusal of chemotherapy treatment
- Male, Age > 18 years
- ECOG (Eastern Cooperative Oncology Group) performance score of 0-2
- Adequate bone marrow, renal and hepatic function
Key exclusion criteria (8 listed)
- Prior treatment with NRX 194204 or bexarotene (Targretin)
- Presence of parenchymal brain metastases
- History of prior malignancy within the past 5 years with the exception of curatively treated basal cell or squamous cell carcinoma of the skin or superficial bladder or other stage I or stage II cancer in complete remission for at least 12 months
- Patients with a history of unstable or newly diagnosed angina pectoris, documented history of current serious arrhythmia or congestive heart failure or myocardial infarction within 6 months of enrollment
- Known HIV or hepatitis B or C infection
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 |
|---|---|---|
| NRX 194204Also: RexinoidNRX 194204 is an oblong, soft, gelatin capsule and will be taken once a day | Drug | NRX 194204 |
Primary outcome
Clinical Benefit of NRX 194204 in Men With Castration- and Taxane-resistant Metastatic Prostate Cancer
Time frame: participants will be followed for the duration of treatment and follow up, which is up to 2.5 years
Clinical benefit will be defined as either non-progression at 8 weeks or radiologic and/or PSA response at any time point with no dose limiting toxicity (DLT) or other toxicity requiring termination of treatment.
4 secondary outcomes
Overall Survival
Time frame: participants will be followed for the duration of treatment and follow up, which is up to 2.5 years
Time to Disease Progression
Time frame: participants were to be followed for the duration of treatment and follow up; for up to 2.5 years from baseline
Number of Grade 3 and Higher Adverse Events Deemed at Least Possibly Related to NRX 194204
Time frame: participants will be followed for the duration of treatment and follow up, which is up to 2.5 years
PSA Response Rate
Time frame: participants will be followed for the duration of treatment and follow up, which is up to 2.5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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RecruitingPhase 2
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
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RecruitingPhase 1/2
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ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
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Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
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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.
Lalita Pandit, MD principal investigator
Lalita Pandit, MD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NRX 194204 in people with Castration Resistant Prostate Cancer, run by Io Therapeutics at 1 site 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 6 inclusion and 8 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 14 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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?
Yes. Results are posted in the registry (first posted 14 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Clinical Benefit of NRX 194204 in Men With Castration- and Taxane-resistant Metastatic Prostate Cancer (time frame: participants will be followed for the duration of treatment and follow up, which is up to 2.5 years). 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 14 May 2021.