Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SB-485232 · 5 trials · 5 indications
Tumor response rate (RR) is defined as the percentage of participants achieving either a complete or partial response. Response was at least one measurable lesion as defined by response evaluation criteria for solid tumors (RECIST) criteria or a cutaneous or subcutaneous lesion of at least 1 centimeter (cm) in diameter in one dimension. A distinction was drawn between responses that are confirmed at a repeat assessment and those that are not. If there were unconfirmed responses, then a sensitivity analysis was performed excluding participants with unconfirmed responses. Analysis was performed by both Investigator and independent review committee (IRC). The results were compared and a confirmatory analysis has been presented.
| Arm | Type | Description |
|---|---|---|
| SB-485232 plus pegylated liposomal doxorubicin | EXPERIMENTAL | Subjects will receive one dose of pegylated liposomal doxorubicin on Day 1 plus two doses of SB-485232 on Day 3 and Day 9 in each cycle. |
| SB-485232+Rituximab | EXPERIMENTAL | Rituximab 375 milligrams per square meter (mg/m\^2) will be administered to subjects with CD20+ B cell lymphoma by intravenous (IV) infusion once a week for four consecutive weeks on Day 1 of Weeks 1 to 4. SB-485232 will be administered by IV infusion over a 2 hour period, at doses ranging from 1 microgram (μg)/kilogram (kg) to 100 μg/kg. SB-485232 will be given once a week for 12 consecutive weeks on Day 2 of Weeks 1 to 4 and Day 2 (± 1 day) of Weeks 5 to 12. SB-485232 will be infused at least 24 hours after the Rituximab infusion was started. |
| Name | Type | Description |
|---|---|---|
| SB-485232 | DRUG | - |
| SB-485232 (interleukin 18), pegylated liposomal doxorubicin | DRUG | SB-485232 (interleukin 18), pegylated liposomal doxorubicin |
| Rituximab | DRUG | Rituximab 375 mg/m\^2 will be administered by IV infusion. |
Inclusion criteria: * Patients must have melanoma that has spread beyond the original location and has not yet been treated. * Tissue from the spreading melanoma should have been tested to confirm it is melanoma. Exclusion criteria: * Patients having hepatitis or HIV infection. * Taking corticost...
Top 20 of 52 competitors
SB-485232 is an investigational oncology drug developed by GSK plc (ticker GSK). It has been studied in Phase 1 and Phase 2 clinical trials in patients with solid tumors, lymphoma, non-Hodgkin lymphoma, melanoma, and ovarian cancer. It is a small molecule and has also been referred to as interleukin 18.
SB-485232 has been studied in clinical trials for several cancer types, including non-Hodgkin lymphoma, melanoma, ovarian neoplasms, solid tumors, and lymphoma. It was evaluated both as a single agent and in combination with pegylated liposomal doxorubicin (Doxil) in advanced stage epithelial ovarian cancer.
SB-485232 is developed by GSK plc, which trades under the ticker GSK. GSK sponsored the clinical trials evaluating the drug in oncology indications including non-Hodgkin lymphoma, melanoma, ovarian cancer, and solid tumors.
SB-485232 is an investigational drug that has been studied in Phase 1 and Phase 2 clinical trials. The trials listed are completed, and no active trials are currently recorded. It has not been approved by the FDA for any indication based on the available development information.
SB-485232 has been evaluated in completed trials including NCT00659178, a Phase 1 study combining SB-485232 with Doxil in advanced stage epithelial ovarian cancer; NCT00500058, a Phase 1 dose-escalation study in non-Hodgkin lymphoma; NCT00107718, a Phase 2 study in metastatic melanoma; and NCT00085904, a Phase 1 dose-escalating study in solid tumors or lymphomas.
SB-485232 is also known as interleukin 18, or recombinant human interleukin-18. It has additionally been studied in combination with pegylated liposomal doxorubicin, also known as Doxil, in a Phase 1 ovarian cancer trial. These names refer to the same investigational agent and its combination partner.