Clinical trial · Interventional
A Phase I/II Open-label Study of MCS110 in Patients With Prostate Cancer and Bone Metastases
A Phase I/II Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MCS110 in Patients With Prostate Cancer and Bone Metastases
NCT00757757CI-TRIAL-00048968terminatedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
This study will evaluate the safety and efficacy of MCS110 in patients with prostate cancer and bone metastases
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 Metastases | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MCS110 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MCS110
- interventionNames
- Drug: MCS110
Primary outcomes (2)
- measure
- Frequency and characteristics of treatment related dose-limiting-toxicities in dose escalation phase
- timeFrame
- every cycle - (cycle = 28 days)
- measure
- Type and frequency of adverse drug reactions and serious adverse drug reactions
- timeFrame
- every cycle - (cycle = 28 days)
Secondary outcomes (1)
- measure
- Change in markers of bone resorption and formation (pre- vs. post-treatment)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with asymptomatic castrate-resistant prostate cancer with bone metastases who have not received any bisphosphonates in the 12 months prior to enrollment * 18 years old and over Exclusion Criteria: * Plan to be on cytotoxic or biologic therapy during study * Active dental problems * Active heart complications * Active infection * Patients with moderate to severe swelling due to fluid Other protocol-defined inclusion/exclusion criteria may apply
References
Publications (0)
Data not yet available
No reference posted for this study.