Use of 852A in Metastatic Cutaneous Melanoma.

Pilot Phase II, Open Label, Multicenter, Efficacy and Safety Study of 852A Administered Intravenously to Subjects With Unresectable Metastatic Cutaneous Melanoma.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00189332

Enrollment

Registered

2005-09-19

Start date

2005-02-28

Completion date

2006-08-31

Last updated

2008-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma, Unresectable Metatstatic Cutaneous Melanoma

Keywords

Oncology, Melanoma

Brief summary

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.

Interventions

DRUG852A

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Countries

France, Germany, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026