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An Open Label Study to Determine the Effect of Avastin in Combination With Dacarbazine on Overall Response Rate in Patients With Unresectable/Metastatic Melanoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Malignant Melanoma

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Trial Information

An Open Label Study to Determine the Effect of Avastin in Combination With Dacarbazine on Overall Response Rate in Patients With Unresectable/Metastatic Melanoma


Inclusion Criteria:



- adult patients, >=18 years of age;

- cutaneous malignant melanoma;

- clinical evidence of metastatic disease and/or unresectable regional lymphatic
disease and/or extensive in transit recurrent disease;

- measurable lesions.

Exclusion Criteria:

- prior interferon alfa and/or cytokine therapy for metastatic disease;

- prior chemotherapy for metastatic disease;

- brain metastases;

- chronic daily treatment with high dose aspirin (>325mg/day);

- other coexisting malignancies, or malignancies diagnosed within the past 5 years,
other then basal cell cancer or cervical cancer in situ.

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:

Overall response rate (complete and partial responses), tumor assessments by computer tomography (CT) or magnetic resonance imaging (MRI)

Outcome Time Frame:

4 years

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Chair

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Italy: Ministry of Health

Study ID:

ML18727

NCT ID:

NCT01164007

Start Date:

June 2006

Completion Date:

December 2012

Related Keywords:

  • Malignant Melanoma
  • Melanoma

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