Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00089973 | Study Of Ispinesib In Subjects With Breast Cancer | PHASE2 | COMPLETED | 50 | — | — | Jun 30, 2004 | Aug 25, 2006 | Feb 26, 2018 | 13 | United States, Belgium +3 |
Overall tumor response rate, was defined as the percentage of participants achieving either a complete response (CR) or partial response (PR), stable disease (SD), or progressive disease (PD). It was assessed by Computer tomography (CT) or Magnetic Resonance Imaging (MRI) scan. Response and progression was evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST) 1.0. The target lesions (TLs): CR, Disappearance of all TLs; PR where at least a 30% decrease in the sum of the longest diameter (LD) of TLs, taking as reference the baseline sum LD; PD : At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
| Arm | Type | Description |
|---|---|---|
| SB-715992 | EXPERIMENTAL | Females with advanced or metastatic breast cancer were administered Ispinesib |
| Name | Type | Description |
|---|---|---|
| Ispinesib | DRUG | Given intravenously at a dose of 18 milligram (mg)/ meter square (m\^2). |
Inclusion Criteria: * Stage IIIB or Stage IV breast cancer * Previously received anthracycline and taxane therapy Exclusion criteria: * Actively receiving anti-cancer therapy agent(s).