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
Phase 1/Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Male
Prostate Cancer, Bone Metastases
Male
Prostate Cancer, Bone Metastases
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Frequency and characteristics of treatment related dose-limiting-toxicities in dose escalation phase
Outcome Time Frame:
every cycle - (cycle = 28 days)
Safety Issue:
Yes
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
CMCS110A2101
NCT ID:
NCT00757757
Start Date:
September 2008
Completion Date:
August 2009
Related Keywords:
- Prostate Cancer
- Bone Metastases
- Prostate cancer
- bone metastases
- anti-M-CSF
- M-CSF antibody
- M-CSF
- Prostate Cancer with bone metastases
- Neoplasm Metastasis
- Neoplasms, Second Primary
- Prostatic Neoplasms
- Bone Neoplasms
- Bone Marrow Diseases
Name | Location |
|---|---|
| CTRC | San Antonio, Texas 78229 |
| NV Cancer Institute | Las Vegas, Nevada 89135 |
