Clinical trial · Interventional
Multi-Center Phase II Study to Compare MER-101 20mg Tablets to Intravenous Zometa 4mg in Male Bisphosphonate-Naive, Hormone Refractory Prostate Cancer Patients
A Multi-Center Phase II Study to Compare MER-101 (20mg) Tablets To Intravenous Zometa 4mg in Male Bisphosphonate-Naive Hormone Refractory Prostate Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The objective of MER-101-03 is to examine the effects of two different dosing regimens of MER-101 20mg tablets versus Zometa 4mg IV infusion once-monthly therapy. The effects will be monitored on a weekly basis by measuring various markers of bone metabolism. Patients to be enrolled will be those who have not received any previous bisphosphonate therapy. The study will be carried out on prostate cancer patients who are no longer on hormone therapy. Treatment in the study will be for a 2-month period.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hormone-Refractory Prostate Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Zoledronic Acid | Drug | Zoledronic Acid | ALIAS |
| Zoledronic Acid 20mg Tablets | Drug | Zoledronic Acid | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- B
- description
- MER-101 20mg Tablets Regimen 1
- interventionNames
- Drug: Zoledronic Acid 20mg Tablets
- type
- EXPERIMENTAL
- label
- C
- description
- MER-101 20mg Tablets Regimen 2
- interventionNames
- Drug: Zoledronic Acid 20mg Tablets
- type
- ACTIVE_COMPARATOR
- label
- A
- description
- Zometa Injection
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Prostate Cancer with rising PSA levels after hormone treatment and bone metastasis based on an X-ray. Exclusion Criteria: * Already be on a bisphosphonate treatment (Zometa, Fosamax, Actonel)
References
Publications (0)
Data not yet available