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

GlaxoSmithKline64 enrolled

Overview

This Phase II study is designed to evaluate the anti-tumor activity of three dose groups of SB-485232 (0.01, 0.1, and 1.0 mg/kg/day) administered intravenously as a single agent in subjects with previously untreated metastatic melanoma.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Melanoma

Interventions

SB-485232DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 corticosteroids. * Patients with the primary site being occular melanoma or patients with melanoma of the brain.

Locations (20)

GSK Investigational Site

Los Angeles, California, United States

GSK Investigational Site

Outcomes

Primary Outcomes

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

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

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

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.

Data from ClinicalTrials.gov

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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

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