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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
Not Enrolling
Male
Prostate Cancer, Bone Metastases

Thank you

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

CTRCSan Antonio, Texas  78229
NV Cancer InstituteLas Vegas, Nevada  89135