Use of 852A in Metastatic Cutaneous Melanoma.

Pfizer

Status and phase: Completed; Phase 2

Conditions: Melanoma; Unresectable Metatstatic Cutaneous Melanoma

Treatments: Drug: 852A

Study type: Interventional

Funder types: Industry

Identifiers

NCT00189332

1527-852A

Details and patient eligibility

About

Pilot study to test the efficacy of 852A administered intravenously up to 3 times per week for 12 weeks in subjects with inoperable metastatic cutaneous melanoma.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Advanced melanoma not responding to 1st line chemotherapy
• Histological evidence of melanoma
• Measurable disease according to RECIST criteria
• ECOG performance status less than or equal to 2
• Life expectancy 6 months or more
• Normal organ and bone marrow function as defined by hematological and serum chemistry limits
• Adequate contraception for females of childbearing potential

Exclusion criteria

• Stage IV disease which has previously progressed during interferon treatment.
• Restriction of some therapies/medications for a certain timeframe prior to enrollment and during the study including: investigational drugs, high dose corticosteroids, immunotherapy, immunosuppressive medications, radiotherapy and drugs known to prolong QT interval and/or induce Torsades De Pointes
• History of uncontrolled seizure disorders
• Uncontrolled coagulation disorders.
• History or evidence of myocardial ischemia, congestive heart failure or arrythmias requiring treatment in the past 6 months
• History of uncontrolled intercurrent or chronic illness
• Concurrent malignancies.
• Brain metastases.
• HIV positive.
• Prolonged QTc interval
• Uncontrolled intercurrent or chronic illnesses.
• Pregnant or lactating women

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)