NCT02524951

Safety and Tolerability of MSI-1436C in Metastatic Breast Cancer

A Phase I Study of the Safety and Tolerability of Single Agent MSI-1436C in Metastatic Breast Cancer Patients

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Northwell Health · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I, open-label, dose escalation study. MSI-1436 will be administered as a single intravenous infusion twice a week for 3 weeks on a 4-week cycle.

Detailed description

This is a Phase I, open-label, dose escalation study. MSI-1436 will be administered as a single intravenous infusion twice a week for 3 weeks on a 4-week cycle. Subjects will be enrolled according to a standard Phase I Fibonacci design to receive MSI-1436. Drug infusions will last approximately 2 hours. If a subject has a dose-limiting toxicity (DLT) at any time during the study, MSI-1436 will be held and either re-started or discontinued in that subject as per the Dose Adjustments and Toxicities Guidelines.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	MSI-1436C	Dose escalation, single intravenous infusion twice a week for 3 weeks on a 4-week cycle.

Timeline

• Start date: 2016-04-01
• Primary completion: 2017-07-01
• Completion: 2018-05-14
• First posted: 2015-08-17
• Last updated: 2018-05-18

Locations

1 site across 1 country: United States