N/A
N=294
Effect of Proactive Management of Side Effects on Treatment Compliance in Malignant Melanoma Patients on High-dose Intron A Therapy (Study P04600)
Melanoma
Bottom Line
View on ClinicalTrials.gov: NCT00723710 ↗Enrolled (actual)
294
Serious AEs
7.0%
Results posted
Oct 2013
Primary outcome: Primary: Number of Participants Who Completed Treatment — 120 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Intron A (interferon alfa-2b; SCH 30500) (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Completed Treatment |
120 | — |
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 proactive management of side effects in a day-to-day healthcare setting.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- Metastatic disease at the time of diagnosis
- Other malignancies
- History of non compliance to other therapies
- Pregnancy or breast feeding
- Previous Intron A therapy
Data sourced from ClinicalTrials.gov (NCT00723710). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.