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SB-485232

Phase 2

Melanoma | Small molecule | Oncology |GSK plc|Last Updated: Jul 27, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment64

FDA Designations

No designations recorded

Clinical trial landscape

SB-485232 · 4 trials · 4 indications

Phase 2 1Phase 1 3
NCT00107718Anti-Tumor Activity Of SB-485232 In Patients With Previously Untreated Metastatic MelanomaMelanoma
COMPLETED64 Analytics
PHASE2COMPLETED
Anti-Tumor Activity Of SB-485232 In Patients With Previously Untreated Metastatic Melanoma
MelanomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Overall response rate of tumor
Up to 12 months

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.

safety/tolerability of combination treatment for 4 weeks safety/tolerability of SB-485232 for additional 8 weeks
12 weeks
Evaluation of adverse events and changes in laboratory values. The potential dose is a dose regimen with no more than 2 out of 6 patients experiencing a dose-limiting toxicity.
6 Months
- Safety and tolerability endpoints will include evaluation of adverse events and changes in laboratory values and clinical variables from pre-dose values.
11 Weeks

Secondary Endpoints

Number of participants with progression free survival
Up to 12 months
Response duration of SB-485232 for tumor treatment
Up to 12 months
Time to response
Up to 12 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SB-485232+RituximabEXPERIMENTALRituximab 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.

Interventions

NameTypeDescription
SB-485232DRUG -
RituximabDRUGRituximab 375 mg/m\^2 will be administered by IV infusion.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites20

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...

Countries:United StatesAustralia
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Frequently asked questions about SB-485232

What is SB-485232 used for?

SB-485232 is an investigational oncology drug being studied for solid tumor cancer, melanoma, lymphoma, and non-Hodgkin lymphoma. It is a small molecule developed by GSK plc. Clinical trials have evaluated it in adults with these conditions, though it remains in clinical development and is not approved.

Who makes SB-485232?

SB-485232 is developed by GSK plc, a pharmaceutical company traded on the New York Stock Exchange under the ticker GSK. The company has sponsored clinical trials of this investigational drug in oncology indications.

What phase is SB-485232 in?

SB-485232 is in Phase 1 clinical development. Multiple Phase 1 trials have been completed, along with one Phase 2 trial in metastatic melanoma. All trials are completed, and the drug remains investigational, not approved for any use.

What clinical trials is SB-485232 in?

SB-485232 has completed several clinical trials. NCT00085878 studied daily subcutaneous injections in adults with solid tumors. NCT00085904 evaluated intravenous dosing every 28 days in solid tumors or lymphomas. NCT00107718 assessed anti-tumor activity in previously untreated metastatic melanoma. NCT00500058 examined safety and biological activity in lymphoma and non-Hodgkin lymphoma.

Is SB-485232 the same as recombinant human interleukin-18?

Yes, SB-485232 is also known as recombinant human interleukin-18. One clinical trial, NCT00500058, explicitly describes SB-485232 as recombinant human interleukin-18, indicating these names refer to the same investigational drug.