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An Open-label Study to Assess the Anti-tumor Activity of Avastin in Combination With Fotemustine as First-line Therapy in Patients With Metastatic Melanoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Malignant Melanoma

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Trial Information

An Open-label Study to Assess the Anti-tumor Activity of Avastin in Combination With Fotemustine as First-line Therapy in Patients With Metastatic Melanoma


Inclusion Criteria:



- cutaneous malignant melanoma;

- advanced, inoperable stage IV melanoma;

- measurable and/or evaluable sites of metastases.

Exclusion Criteria:

- prior chemotherapy and/or IFN/IL2 based immunotherapy for metastatic disease;

- prior malignancies within past 5 years, with the exception of cured non-melanoma skin
cancer, or in situ cancer of cervix;

- clinically significant cardiovascular disease;

- ongoing treatment with aspirin (>325mg/day) or other medications known to predispose
to gastrointestinal ulceration.

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 (ORR)

Outcome Time Frame:

From study start through study completion or early study discontinuation

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Chair

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Italy: Ministero della Salute

Study ID:

ML19309

NCT ID:

NCT01069627

Start Date:

Completion Date:

April 2010

Related Keywords:

  • Malignant Melanoma
  • Melanoma

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