S0916, A Phase II, Window Trial of the Anti-CCR2 Antibody MLN1202 in Patients With Bone Metastases

NCT01015560 Phase 2 COMPLETED Results posted

RATIONALE: Monoclonal antibodies, such MLN1202, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. PURPOSE: This phase II trial is studying how well MLN1202 works in treating patients with bone metastases.

Details

Lead sponsor	SWOG Cancer Research Network
Phase	Phase 2
Status	COMPLETED
Enrolment	44
Start date	2010-03
Completion	2012-12

Conditions

• Metastatic Cancer
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

• anti-CCR2 monoclonal antibody MLN1202
• polymorphism analysis
• laboratory biomarker analysis

Primary outcomes

• uNTX Response Rate at 43 Days — 43 days
  Urinary n-telopeptide (uNTX) response is defined as a 25% reduction from baseline levels. Patients with missing response data were included as non-responders.

Countries

United States