Status:
COMPLETED
Effect of Proactive Management of Side Effects on Treatment Compliance in Malignant Melanoma Patients on High-dose Intron A Therapy (Study P04600)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Brief Summary
Patients with malignant melanoma who had undergone surgery will receive adjuvant treatment with high-dose Intron A for one year. The objective of this study is to maximize treatment compliance by proa...
Eligibility Criteria
Inclusion
- Signed informed consent
- Age \> 18 years
- Confirmed melanoma
- Patient has been prescribed Intron A therapy for High-Risk Stage II \& III Melanoma
- Intron A therapy started within 70 days of surgery (additional 15 days may be granted by the sponsor upon written approval)
- Proper contraception in both male and female subjects and the female partner(s) of male study subjects
Exclusion
- Metastatic disease at the time of diagnosis
- Other malignancies
- History of non compliance to other therapies
- Pregnancy or breast feeding
- Previous Intron A therapy
Key Trial Info
Start Date :
April 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
299 Patients enrolled
Trial Details
Trial ID
NCT00723710
Start Date
April 1 2006
End Date
September 1 2012
Last Update
August 26 2015
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