Anti-Tumor Activity Of SB-485232 In Patients With Previously Untreated Metastatic Melanoma

Browse trials for

• Melanoma 3,005

Keywords

• IL-18
• treatment naive
• Phase 2
• melanoma

Melanoma

3,005 studies on the registry are indexed under Melanoma; 519 are open to participants now.

This study's enrollment of 64 is above the median of 38 across 2,350 interventional studies indexed under Melanoma.

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,561 studies on the registry; 116 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Interventions

• DrugSB-485232

Primary outcomes

1. Overall response rate of tumor

   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.

   Time frame: Up to 12 months

Secondary outcomes

1. Number of participants with progression free survival

   Progression Free Survival is defined as the time from the start of treatment until the first documented sign of disease progression or death due to any cause, whichever occurred first. For participants who did not progress or die, progression free survival was censored at the time of initiation of alternative anti-cancer therapy or time of last contact, whichever occurred first. The times to progression were summarized using the Kaplan-Meier survival curve.

   Time frame: Up to 12 months

2. Response duration of SB-485232 for tumor treatment

   Response duration defined as the date criteria for Complete Response (CR) or Partial Response (PR) (whichever occured first) was first met until the date criteria for recurrent or progressive disease was first met or death due to any cause was reported, whichever occured first. Time to response was defined as the date study drug was first dosed until the date criteria for CR or PR (whichever occured first) was first met.

   Time frame: Up to 12 months

3. Time to response

   Response duration defined as the date criteria for CR or PR (whichever occured first) was first met until the date criteria for recurrent or progressive disease was first met or death due to any cause was reported, whichever occured first. Time to response was defined as the date study drug was first dosed until the date criteria for CR or PR (whichever occured first) was first met.

   Time frame: Up to 12 months

4. Number of participants with adverse events (AEs), serious adverse events (SAEs), and death.

   An AE is any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect.

   Time frame: Up to 12 months

5. Change from Baseline In vital signs [systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), and body temperature(BT)]

   Vital signs including SBP, DBP, HR and BT were taken at Day 1 to Day 15 and follow up visits of each cycle. Baseline assessment was performed pre-dose on Cycle 1 Day 1.

   Time frame: Baseline (Day 1) to Day 15 and Day 28 of each cycle

6. Number of participants with toxicity grade shift of clinical laboratory parameters over period.

   Haematology and Clinical Chemistry together are termed as Clinical Laboratory Parameters.Blood samples were collected at Day 1, Day 2, Day 15 and Follow up of each cycle for assessment of clinical chemistry and haematology parameters. Sodium, Potassium, Chloride, Bicarbonate, Calcium, Glucose, Total protein, Albumin, Lactate dehydrogenase, Uric acid, Phosphorus, Creatinine, Blood urea nitrogen, Total bilirubin, Alkaline phosphatase, Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) and Magnesium were analyzed in clinical chemistry. Similarly, Hemoglobin, Hematocrit, Platelet count, Total white blood cell count, Neutrophil count, Lymphocyte count, Monocyte count, Eosinophil count and Basophil count wee analyzed in haematology. Number of participants with shift of grades from Baseline in hematology and clinical chemistry parameters toxicities have been summarized here.

   Time frame: Baselie (Cycle1,Day 1), Day 2, Day 15 and Follow up (28 days after last dose of Cycle 13) of each cycle

7. Number of participants with immune response to SB485232 over period.

   Immunotherapy for melanoma is based on the premise that the immune system can recognize and attack host tumor cells. This may be achieved by either triggering an immune response or by potentiating an otherwise weak immune response that is capable of recognizing the participant's own tumor. Various dosing schedules and combinations involving IFN-α and interleukin (IL)-2 have been tested. The response rate reported with single agent IL-2, as well as for combinations with Interferon-α, range from a low of 3% (as single agent) to a high of 41% (for the combination), with a small percentage of long term responders. The immune response to SB-485232 was assessed by measuring the anti-SB-485232 levels (total immunoglobulin and immunoglobulin E \[IgE\]) before starting therapy and at specified time points, throughout the study period.

   Time frame: Day 15 of each cycle