Clinical trial · Interventional
Study Evaluating the Biologic Activity of Guanabenz in Bone Metastasis
Exploratory Pilot Study Evaluating the Biologic Activity of Guanabenz in Bone Metastasis
NCT02443103CI-TRIAL-00031663terminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Cancer | Malignant Bone Neoplasm | ALIAS | 0.90 |
| Metastasis | Bone Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Guanabenz acetate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Guanabenz
- interventionNames
- Drug: Guanabenz acetate
Primary outcomes (1)
- measure
- Bone Turnover Markers-bone Formation and Bone Resorption
- timeFrame
- Day 0, Week 8, Week 12
- description
- 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 outcomes (1)
- measure
- Treatment Related Adverse Events
- timeFrame
- Up to 1 year
- description
- Number of unique patients who had a treatment related (possible, probable or definite) adverse events.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. ≥ 18 years old at the time of informed consent 2. Ability to provide written informed consent and HIPAA authorization 3. Solid organ malignancy with documented bone metastasis by imaging 4. Adequate liver function (serum total bilirubin \<= 3 and AST/ALT \<= 3 times the upper normal limit) 5. Adequate renal function (serum creatinine \<= 2mg/dL) 6. Ability to swallow oral tablets 7. 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). 8. Patients are permitted to participate in other clinical trials while participating in this trial. 9. Patients will receive standard of care systemic treatment for underlying solid malignancy as deemed necessary by treating physician. Exclusion Criteria: 1. No prior history of bisphosphonate ordenosumab use in the past 12 months 2. No history of SRE within past 3 months 1. Excruciating bone pain requiring RT 2. Cord compression 3. Hypercalcemia \[serum calcium \>10.5\] 4. Pathologic fracture 3. No history of Paget's disease 4. No history of epilepsy/seizures 5. 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).
References
Publications (0)
Data not yet available
No reference posted for this study.