N/A
N=224
Caelyx in Ovarian Cancer: Prevention and Treatment of Infusion Reactions and Palmar-plantar Erythrodysesthesia (Study P04085)(COMPLETED)
Ovarian Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT00743431 ↗Enrolled (actual)
224
Serious AEs
6.5%
Results posted
Jun 2010
Primary outcome: Primary: Occurrences of Infusion Reactions and Palmar-Plantar Erythrodysesthesia (PPE) — 2; 5; 2; 1 Events
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Caelyx (Pegylated Lyposomal Doxorubicin) (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Occurrences of Infusion Reactions and Palmar-Plantar Erythrodysesthesia (PPE) |
2; 5; 2; 1; 37; 23 | — |
Summary
The purpose of this study is to evaluate the safety and tolerability of Caelyx in women with advanced ovarian cancer, focusing on infusion reactions and palmar-plantar erythrodysesthesia.
Eligibility Criteria
Inclusion Criteria
- Women with advanced ovarian cancer with:
- previous platin/taxane therapy and documented measureable and/or evaluable advanced or metastatic cancer by radiological imaging or increase of serum cancer antigen 125 (CA 125) according to Rustin et al.
Exclusion Criteria
- Patients that are not treated according to the Austrian Summary of Product Characteristics (SPC)
Data sourced from ClinicalTrials.gov (NCT00743431). 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.