Study Evaluating the Biologic Activity of Guanabenz in Bone Metastasis

Stopped early · Not applicable

Conditions studied: Bone Cancer, Metastasis

In brief

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.

Key facts

Study ID

NCT02443103

Run by

Kathy Miller

People needed

4

Starts

2015-05-07

Expected to finish

2016-06-08

Last updated by the study team

2018-02-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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).

Where it is running

• Indiana University Health Hospital — Indianapolis, Indiana, United States
• Indiana University Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States
• Sidney & Lois Eskenazi Hospital — Indianapolis, Indiana, United States
• Spring Mill Medical Center — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.