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NON PEGILATED LIPOSOMIAL DOXORUBICIN (TLC D-99) IN ASSOCIATION WITH IFOSFAMIDE IN PATIENTS WITH METASTATIC SOFT TISSUE SARCOMA - ND

NON PEGILATED LIPOSOMIAL DOXORUBICIN (TLC D-99) IN ASSOCIATION WITH IFOSFAMIDE IN PATIENTS WITH METASTATIC SOFT TISSUE SARCOMA - ND

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-003316-36-IT
Enrollment
Unknown
Registered
2008-08-01
Start date
2008-07-28
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

METASTATIC SOFT TISSUE SARCOMAS MedDRA version: 9.1 Level: HLGT Classification code 10041299 Term: Soft tissue sarcomas

Interventions

Trade Name: MYOCET Pharmaceutical Form: Emulsion for infusion INN or Proposed INN: Doxorubicin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Trade Name: HOLO

Sponsors

CENTRO DI RIFERIMENTO ONCOLOGICO DI AVIANO
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - CONFIRMED DIAGNOSIS OF METASTATIC SOFT TISSUE SARCOMA OR RELAPSED AFTER 6 MONTHS OF ADJUVANT OR NEOADJUVANT CHEMOTEHRAPY - AGE > 18 YEARS - PS 3 MONTHS Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - PREVIOUS CHEMOTHERAPY WITH CUMULATIVE DOSE OF ADRIAMYCINE >/= 300 MG/M² OR EPIRUBICINE > 600 MG/M² - PREGNANCY OR LACTANCY - UNCONTROLLED CONCOMITANT DISEASES OR INFECTIONS - CLINICAL SIGNS OF BRAIN METASTASES

Design outcomes

Primary

MeasureTime frame
Main Objective: DETERMINING GLOBAL RESPONSE RATE AND CLINICAL BENEFIT IN PATIENTS WITH METASTATIC SOFT TISSUE SARCOMAS.;Secondary Objective: DETERMINING TIME TO PROGRESSION, DURATION OF RESPONSE, INDUCED TOXICITY AND OVERALL SURVIVAL;Primary end point(s): RESPONSE TO TREATMENT—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026