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STUDY PHASE I / II DETERMINATION OF THE DOSAGE, PHARMACOKINETICS AND SECURITY OF EPIRUBUBIN (ELLENCE TM / PHARMORRUBICINA TM FARMORRUBICINA TM) IN PEDIATRIC ONCOLOGICAL PATIENTS WITH REFRACTORY OR RECURRENT DISEASE, WITH EVALUATION OF EFFECTIVENESS IN PATIENTS WITH NEUROBLASTOMA, STS AND BONE SARCOMA, REFRACTORY.

STUDY PHASE I / II DETERMINATION OF THE DOSAGE, PHARMACOKINETICS AND SECURITY OF EPIRUBUBIN (ELLENCE TM / PHARMORRUBICINA TM FARMORRUBICINA TM) IN PEDIATRIC ONCOLOGICAL PATIENTS WITH REFRACTORY OR RECURRENT DISEASE, WITH EVALUATION OF EFFECTIVENESS IN PATIENTS WITH NEUROBLASTOMA, STS AND BONE SARCOMA, REFRACTORY.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-106-03
Enrollment
Unknown
Registered
2004-01-27
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Epirubicin Type of group
The calculated dose of epirubicin will be administered as a 2-hour intravenous infusion on an IV line in which 0.9% sodium chloride or 5% glucose solution will flow freely on Day 1 of repeated 21 day treatment cycles

Sponsors

PHARMACIA & UPJOHN INTERAMERICAN CORPORATION SUCURSAL DEL PERU,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Be 1 year old or older, but less than 18 years old. Have a histologically or ecologically documented diagnosis of solid tumor or lymphoma that progressed during one or more previous standard therapies or recurred afterwards, and for which there is no additional standard therapy.

Exclusion criteria

Exclusion criteria: over 18 years pregnant women

Design outcomes

Primary

MeasureTime frame
Outcome name:RECIST system Measure:Objective tumor evaluation performed according to the RECIST system for various tumor types. Timepoints:30 days

Secondary

MeasureTime frame
Outcome name:Adverse events that will be realized in each visit to the center. All adverse events will be classified according to the Common Toxicity Criteria of the National Cancer Institute (NCICTC), Version 2 Measure:Safety evaluation Timepoints:30 days

Outcome results

None listed

Source: REPEC (via WHO ICTRP)