Use of 852A in Metastatic Cutaneous Melanoma.

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00189332
• Date of registration: 13/09/2005
• Prospective Registration: No
• Primary sponsor: Pfizer
• Public title: Use of 852A in Metastatic Cutaneous Melanoma.
• Scientific title: Pilot Phase II, Open Label, Multicenter, Efficacy and Safety Study of 852A Administered Intravenously to Subjects With Unresectable Metastatic Cutaneous Melanoma.
• Date of first enrolment: February 2005
• Target sample size: 28
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00189332
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

France, Germany, Switzerland

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Unresectable Metatstatic Cutaneous Melanoma

Melanoma

Intervention(s)

Drug: 852A

Primary Outcome(s)

assessing antitumor activity of 852A intravenous bolus injection administered 3 times a week for 12 weeks

Secondary Outcome(s)

to assess the safety of the dosage regiment over 12 weeks

to obtain preliminary data regarding the safety and long term efficacy of 852A in subjects treated with the drug for more than 12 weeks

Secondary ID(s)

1527-852A

Source(s) of Monetary Support

Please refer to primary and secondary sponsors