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MULTICENTRIC PROSPECTIVE DOSE-FINDING AND PHASE II STUDY WITH ORAL TOPOTECAN IN ADVANCED SMALL-CELL LUNG CANCER (SCLC) PATIENTS RECURRENT AFTER A FIRST LINE THERAPY - SCLC

MULTICENTRIC PROSPECTIVE DOSE-FINDING AND PHASE II STUDY WITH ORAL TOPOTECAN IN ADVANCED SMALL-CELL LUNG CANCER (SCLC) PATIENTS RECURRENT AFTER A FIRST LINE THERAPY - SCLC

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-015296-26-IT
Enrollment
Unknown
Registered
2009-12-14
Start date
2009-12-09
Completion date
Unknown
Last updated
2012-04-03

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

Conditions

patients with ADVANCED SMALL-CELL LUNG CANCER (SCLC) MedDRA version: 9.1 Level: HLT Classification code 10041059

Interventions

Trade Name: HYCAMTIN Pharmaceutical Form: Capsule, hard INN or Proposed INN: Topotecan Concentration unit: mg milligram(s) Concentration type: equal Concentration number: .25-

Sponsors

AZIENDA USL 6 LIVORNO ZONA LIVORNESE
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Histological or cytological confirmed small cell lung cancer; - Measurable disease with RECIST criteria; - Recurrent disease after a first line therapy; - Age =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patient not candidated to chemotherapic treatment; - Second malignancies; - More than one previous chemotherapeutic regimens

Design outcomes

Primary

MeasureTime frame
Main Objective: activity of oral topotecan treatment;Secondary Objective: safety profile time to progression overall survival;Primary end point(s): acttivity of treatment—

Countries

Italy

Outcome results

None listed

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