A Study of Ispinesib in Metastatic Breast Cancer
Phase I is a dose-escalation study designed to assess safety and tolerability in patients with metastatic breast cancer. Phase II will measure response rate in patients with metastatic breast cancer.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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).|
- Safety and tolerability in patients with metastatic breast cancer. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
- Assessment of response rate based on RECIST in patients with metastatic breast cancer [ Time Frame: 28 days ] [ Designated as safety issue: No ]
|Study Start Date:||December 2007|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
Phase I dose escalation to determine maximum tolerated dose (MTD).
Phase II using fixed dose determined in Phase I portion of study.
Drug: Ispinesib (SB-715992)
Phase I: Dose escalation of I.V. injection starting at 10mg/m2 on Days 1 and 15 of a 28 day cycle.Drug: Ispinesib (SB-715992)
Phase II: Fixed dose to be determined based on Phase I findings on Days 1 and 15 of a 28 day cycle
The Phase I dose-escalation portion of the trial will determine the Dose Limiting Toxicities (DLT) and Maximum Tolerated Dose (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 will evaluate the MTD determined in Phase I in chemotherapy-naïve female patients with measurable, locally advanced or metastatic breast cancer. Phase II will 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.
|Instituto Nacional de Enfermedades Neoplásicas|
|Hospital Nacional Edgardo Rebagliati Martins|
|Hospital Nacional Alberto Sabogal Sologúren|