Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Capecitabine
Ispinesib · 4 trials · 4 indications
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 | - |
| Capecitabine | DRUG | - |
Inclusion criteria: * Must have a screening CA-125 of greater than or equal to 40 U/ml. * Must have received only one prior platinum/taxane-based chemotherapy regimen. * Blood tests will be done to check if blood counts are adequate for taking part in the study. Exclusion criteria: * Received mor...
Ispinesib is an investigational small molecule studied in oncology for the treatment of solid tumors, including breast cancer, non-small-cell lung cancer, and ovarian cancer. It has been evaluated in Phase 2 clinical trials in these indications. It is not approved for any use and remains in clinical development.
Ispinesib targets KIF11, a kinesin motor protein, and acts as an inhibitor of this target. By inhibiting KIF11, ispinesib interferes with mitotic spindle function during cell division, which is the proposed mechanism for its anticancer activity in solid tumors.
Ispinesib is being developed by GSK plc, which trades under the ticker GSK. The company has sponsored the clinical trials evaluating ispinesib in solid tumors, including breast cancer, non-small-cell lung cancer, and ovarian cancer.
Ispinesib is in Phase 2 clinical development. It is an investigational agent and has not been approved by the FDA or any other regulatory authority. The Phase 2 trials in breast cancer, non-small-cell lung cancer, and ovarian cancer have been completed.
Ispinesib has been studied in completed trials including NCT00119171 in solid tumors with capecitabine, NCT00097409 in platinum-taxane-refractory or resistant relapsed ovarian cancer, NCT00089973 in breast cancer, and NCT00085813 in advanced or metastatic non-small-cell lung cancer. All four trials are completed.