Efficacy and Safety Study of Toremifene Citrate for the Reduction in the Risk of New Bone Fracture Occurrences in Men With Prostate Cancer (TREAT2)
This study has been terminated.
(cost of conducting the study and increased burden on the clinical trial professionals make it impossible for us to proceed with the development of the drug.)
Sponsor:
GTx
Collaborator:
Ipsen
Information provided by:
GTx
ClinicalTrials.gov Identifier:
NCT01214291
First received: October 1, 2010
Last updated: May 13, 2011
Last verified: May 2011
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Purpose
The purpose of this study is to determine whether Toremifene Citrate is effective in reducing the risk of bone fractures in men with prostate cancer who are on Androgen Deprivation Therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Risk of Bone Fracture Occurrences |
Drug: Toremifene |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention |
| Official Title: | Phase III Randomized, Double-Blind, Placebo Controlled, Multicenter Efficacy and Safety Study of Toremifene Citrate 80 mg for the Reduction in the Risk of New Bone Fracture Occurrences in Men With Prostate Cancer on Androgen Deprivation Therapy |
Resource links provided by NLM:
Further study details as provided by GTx:
Primary Outcome Measures:
- To confirm the efficacy of toremifene 80mg compared with placebo in the reduction in the risk of new bone fracture occurrences in men with prostate cancer on androgen deprivation therapy as measured by semiquantitative assessment of vertebral fractures [ Time Frame: 36 months ] [ Designated as safety issue: No ]
| Enrollment: | 0 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | September 2015 |
| Estimated Primary Completion Date: | September 2015 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: Toremifene
Toremifene 80mg daily
Eligibility| Ages Eligible for Study: | 50 Years to 80 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- give voluntary signed informed consent
- have histologically documented prostate cancer
- have been on ADT treatment for 6 months prior to randomization or intermittent LHRHa for preceeding 12 months
- expected to continue LHRHa therapy uninterrupted for the next 12 months
- have total testosterone levels less than 50 ng/dL
- Have BMD of lumbar spine or femoral neck at or below the BMD thresholds
- have a Zubrod performance status <or equal to 1
- subject weight <300 lbs(<136 kg)
- agree to complete a daily diary of medication intake
- agree not to take excluded medications throughout the trial
- agree to use an effective method of contraception
- have adequate bone marrow, liver and renal functions
Exclusion Criteria:
- Currently or previously exposed
- within the past 5 years to intravenous bisphosphonates, strontium ranelate or Denosumab
- for more than 3 years to oral bisphosphonates
- within the last 45 days to PTH or PTH derivative, anabolic steroids or testosterone, SERMs, calcitonin, calcitriol or oral gluccorticoids
- have any disease or condition that would preclude an accurate evaluation of radiographs of the thoracic or lumbar spine
- have <8 evaluable vertebrae
- have a BMD T score <-4 at the lumbar spine or total hip or femoral neck
- have any history of other carcinomas within the last 5 years
- Serum PSA > 5ng/mL at baseline under ADT
- have Paget's disease, Cushing's disease, chronic hepatitis or cirrhosis or rheumatoid arthritis
- have active uncontrolled systemic viral, bacterial or fungal infections
- have a clinically significant concurrent illness or psychological, familial, sociological, geograhical or other condition that would not permit adequate follow-up and compliance
- received treatment with other investigational agents within 30 days
- taking finasteride, dutasteride, danazol or testosterone like substances
- taking herbal medicines or dietary supplements
- have a history of thromboembolic disease including DVT or pulmonary embolus
- have a QTcF of > or equal to 450 msec or congenital or acquired QTc prolongation
- have HIV
- calcicum urolithiasis prohibiting the use of vitamin D
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01214291
Locations
| United States, Washington | |
| VA Puget Sound | |
| Seattle, Washington, United States, 98108 | |
Sponsors and Collaborators
GTx
Ipsen
Investigators
| Study Director: | Michael Brawer, MD | GTx |
| Principal Investigator: | Daniel W Lin, MD | VA Puget Sound |
More Information
No publications provided
| Responsible Party: | Ron Morton MD, CMO, GTx Inc. |
| ClinicalTrials.gov Identifier: | NCT01214291 History of Changes |
| Other Study ID Numbers: | G300213 |
| Study First Received: | October 1, 2010 |
| Last Updated: | May 13, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by GTx:
|
fractures prostate cancer androgen deprivation therapy |
Additional relevant MeSH terms:
|
Fractures, Bone Prostatic Neoplasms Wounds and Injuries Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Androgens Toremifene |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Hormone Antagonists Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on May 19, 2013