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


Phase 2
18 Years
N/A
Not Enrolling
Both
Melanoma, Unresectable Metatstatic Cutaneous Melanoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

1527-852A

NCT ID:

NCT00189332

Start Date:

February 2005

Completion Date:

August 2006

Related Keywords:

  • Melanoma
  • Unresectable Metatstatic Cutaneous Melanoma
  • Oncology
  • Melanoma
  • Melanoma
  • Skin Neoplasms

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