Study Stopped
Slow accrual
Study Evaluating the Biologic Activity of Guanabenz in Bone Metastasis
Exploratory Pilot Study Evaluating the Biologic Activity of Guanabenz in Bone Metastasis
1 other identifier
interventional
4
1 country
4
Brief Summary
This study will explore the biologic activity of guanabenz in reducing bone turn over in solid tumor patients with bone metastasis. If successful, this repurposing of an already, generic drug could benefit patients faster than manufacturing a novel expensive compound.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2015
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 7, 2015
CompletedFirst Submitted
Initial submission to the registry
May 11, 2015
CompletedFirst Posted
Study publicly available on registry
May 13, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 8, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 8, 2016
CompletedResults Posted
Study results publicly available
February 13, 2018
CompletedFebruary 13, 2018
February 1, 2018
1.1 years
May 11, 2015
August 17, 2017
February 8, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bone Turnover Markers-bone Formation and Bone Resorption
Number of patients who had blood specimens taken to collect and evaluate markers of bone formation and bone resorption. Note - due to poor accrual and early closure, bone marker data was not collected.
Day 0, Week 8, Week 12
Secondary Outcomes (1)
Treatment Related Adverse Events
Up to 1 year
Study Arms (1)
Guanabenz
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- ≥ 18 years old at the time of informed consent
- Ability to provide written informed consent and HIPAA authorization
- Solid organ malignancy with documented bone metastasis by imaging
- Adequate liver function (serum total bilirubin \<= 3 and AST/ALT \<= 3 times the upper normal limit)
- Adequate renal function (serum creatinine \<= 2mg/dL)
- Ability to swallow oral tablets
- Females of childbearing potential must have a negative pregnancy test \<= 28 days prior to registration. All females of childbearing potential who are sexually active, must agree to use a highly reliable method of contraception to prevent pregnancy. These include abstinence, partner with previous vasectomy, placement of an intrauterine device (IUD), condom with spermicidal foam/gel/film/cream/suppository, diaphragm or cervical vault cap, or hormonal birth control (pills or injections).
- NOTE: Females are considered of childbearing potential unless they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal (\> 12 months since last menses).
- Patients are permitted to participate in other clinical trials while participating in this trial.
- Patients will receive standard of care systemic treatment for underlying solid malignancy as deemed necessary by treating physician.
You may not qualify if:
- No prior history of bisphosphonate ordenosumab use in the past 12 months
- No history of SRE within past 3 months
- Excruciating bone pain requiring RT
- Cord compression
- Hypercalcemia \[serum calcium \>10.5\]
- Pathologic fracture
- No history of Paget's disease
- No history of epilepsy/seizures
- No history of hypotension (defined as resting systolic blood pressure of \< 110 mm Hg or diastolic blood pressure of \< 70 mm Hg) or orthostasis (defined as drop in systolic blood pressure of \>20 mm Hg or increase in HR of \> 20 from supine to standing position).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kathy Millerlead
Study Sites (4)
Indiana University Health Hospital
Indianapolis, Indiana, 46202, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Sidney & Lois Eskenazi Hospital
Indianapolis, Indiana, 46202, United States
Spring Mill Medical Center
Indianapolis, Indiana, 46290, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Due to poor accrual and the early closure, results were not obtained for the bone marker and pharmacokinetics analysis.
Results Point of Contact
- Title
- Dr. Kathy Miller
- Organization
- IndianaU
Study Officials
- PRINCIPAL INVESTIGATOR
Kathy Miller, MD
Indiana University (IU) School of Medicine, Department of Medicine; IU Health
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Full Professor of Medicine and Sheila D. Ward Scholar
Study Record Dates
First Submitted
May 11, 2015
First Posted
May 13, 2015
Study Start
May 7, 2015
Primary Completion
June 8, 2016
Study Completion
June 8, 2016
Last Updated
February 13, 2018
Results First Posted
February 13, 2018
Record last verified: 2018-02