NCT00607841

A Study of Ispinesib in Metastatic Breast Cancer

A Phase I/II Non-Randomized, Open-Label, Dose-Finding Study of Ispinesib (SB-715992) Followed By a Fixed-Dose Study in Chemotherapy-Naïve Patients With Metastatic Breast Cancer (MBC).

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Cytokinetics · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The Phase I portion was a dose-escalation study designed to assess safety and tolerability in patients with metastatic breast cancer. Phase II was intended to measure response rate in patients with metastatic breast cancer but did not enroll because the Phase I portion was halted prior to Maximum Tolerated Dose (MTD) determination.

Detailed description

Only the Phase I portion of the study was enrolled. The Phase I dose-escalation portion of the trial was designed to determine the Dose Limiting Toxicities (DLT) and MTD of Ispinesib (SB-715992) monotherapy when administered as a one-hour infusion on Days 1 and 15 of a 28-day cycle in female patients with locally advanced or metastatic breast cancer. The Phase II regimen was intended to evaluate the MTD determined in Phase I in chemotherapy-naïve female patients with measurable, locally advanced or metastatic breast cancer. Phase II was intended to assess the overall response rate (ORR) derived from individual patient assessments of complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) based on RECIST, as determined by independent review.

Conditions

• Breast Neoplasms

Interventions

Type	Name	Description
DRUG	Ispinesib	10 mg/m2 dose as a 1-hour intravenous infusion.
DRUG	Ispinesib	12 mg/m2 dose as a 1-hour intravenous infusion.
DRUG	Ispinesib	14 mg/m2 dose as a 1-hour intravenous infusion.

Timeline

• Start date: 2007-12-01
• Primary completion: 2009-11-01
• Completion: 2009-11-01
• First posted: 2008-02-06
• Last updated: 2019-05-06

Locations

3 sites across 1 country: Peru