Trial of NRX 194204 in Castration- and Taxane-Resistant Prostate Cancer
This study is currently recruiting participants.
Verified February 2012 by Io Therapeutics
Sponsor:
Io Therapeutics
Information provided by (Responsible Party):
Io Therapeutics
ClinicalTrials.gov Identifier:
NCT01540071
First received: November 13, 2011
Last updated: February 22, 2012
Last verified: February 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Castration Resistant Prostate Cancer |
Drug: NRX 194204 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of NRX 194204 in Castration- and Taxane-Resistant Prostate Cancer |
Resource links provided by NLM:
Further study details as provided by Io Therapeutics:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]Clinical benefit will be defined as either non-progression at 8 weeks or radiologic and/or PSA response at any time point with no DLT or other toxicity requiring termination of treatment.
Secondary Outcome Measures:
- overall survival [ Time Frame: participants will be followed for the duration of treatment and follow up, which is up to 2.5 years ] [ Designated as safety issue: No ]
- time to radiologic progression [ Time Frame: participants will be followed for the duration of treatment and follow up, which is up to 2.5 years ] [ Designated as safety issue: No ]
- RECIST response rate for patients with measurable disease [ Time Frame: participants will be followed for the duration of treatment and follow up, which is up to 2.5 years ] [ Designated as safety issue: No ]RECIST 1.1 will be used
- Number of Grade 3 and higher AEs 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 ] [ Designated as safety issue: Yes ]
- PSA response rate [ Time Frame: participants will be followed for the duration of treatment and follow up, which is up to 2.5 years ] [ Designated as safety issue: No ]
- pain palliation [ Time Frame: participants will be followed for the duration of treatment and follow up, which is up to 2.5 years ] [ Designated as safety issue: No ]Questionnaire based on the SWOG symptom questionnaire will be used.
| Estimated Enrollment: | 37 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: NRX 194204 |
Drug: NRX 194204
NRX 194204 is an oblong, soft, gelatin capsule and will be taken once a day
Other Name: Rexinoid
|
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. Because NRX 194204 is significantly more selective for the RXRs relative to the RARs 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- resitant prostate cancer.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01540071
Contacts
| Contact: For an updated listing of recruitment sites contact | clinicaltrials@io-therapeutics.com |
Locations
| United States, California | |
| Lalita Pandit, MD | Recruiting |
| Fountain Valley, California, United States, 92708 | |
| Contact: Kelly Nelson 714-432-9200 kelly19nelson@sbcglobal.net | |
Sponsors and Collaborators
Io Therapeutics
Investigators
| Principal Investigator: | Lalita Pandit, MD | Lalita Pandit, MD |
More Information
No publications provided
| Responsible Party: | Io Therapeutics |
| ClinicalTrials.gov Identifier: | NCT01540071 History of Changes |
| Other Study ID Numbers: | 4202-202-2011 |
| Study First Received: | November 13, 2011 |
| Last Updated: | February 22, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Io Therapeutics:
|
Hormone refractory prostate cancer HRPC Androgen independent prostate cancer CRPC Castration and Taxane Resistant Prostate Cancer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male |
Prostatic Diseases Taxane Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013