N/A
Completed N=294
Effect of Proactive Management of Side Effects on Treatment Compliance in Malignant Melanoma Patients on High-dose Intron A Therapy (Study P04600)
Source: ClinicalTrials.gov NCT00723710 ↗Enrolled (actual)
294
Serious AEs
7.0%
Results posted
Oct 2013
Primary outcomePrimary: Number of Participants Who Completed Treatment — 120 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Completed Treatment |
120 | — |
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. Informational only — not medical advice.