Study Evaluating the Biologic Activity of Guanabenz in Bone Metastasis
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02443103
Recruitment Status :
First Posted : May 13, 2015
Results First Posted : February 13, 2018
Last Update Posted : February 13, 2018
Information provided by (Responsible Party):
Kathy Miller, Indiana University School of Medicine
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.
Bone Turnover Markers-bone Formation and Bone Resorption [ Time Frame: Day 0, Week 8, Week 12 ]
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.
Secondary Outcome Measures :
Treatment Related Adverse Events [ Time Frame: Up to 1 year ]
Number of unique patients who had a treatment related (possible, probable or definite) adverse events.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
≥ 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.
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
Hypercalcemia [serum calcium >10.5]
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).
Keywords provided by Kathy Miller, Indiana University School of Medicine:
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasm Metastasis Bone Neoplasms Neoplasms Neoplasms by Site Bone Diseases Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type