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A phase II study on the efficacy and safety of topotecan in the treatment of patients with brain metastases - ND

A phase II study on the efficacy and safety of topotecan in the treatment of patients with brain metastases - ND

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-004084-66-IT
Enrollment
Unknown
Registered
2007-06-18
Start date
2002-07-09
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

Brain metastases MedDRA version: 6.1 Level: PT Classification code 10061287

Interventions

Trade Name: HYCAMTIN*INFUS IV 5F 5ML 4MG Product Name: TOPOTECAN Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Topotecan CAS Number: 119413-54-4 Concentration unit:

Sponsors

OSPEDALE ONCOLOGICO DI BARI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Unresectable brain metastases 2. Patients with chemosensitive neoplasms must have received chemoterapic for advanced desease 3. Asymptomatic brain metastases 4. Age>18 and =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Histologically proved brain glioma 2. Contemporary radiotherapy 3. Immunotherapy 4. Pregnancy or breast-feeding

Design outcomes

Primary

MeasureTime frame
Main Objective: To assess the clinical efficacy in terms of objective response and time of response;Secondary Objective: To assess the time to progression and toxicity and safety to the therapy;Primary end point(s): Assessment of the efficacy of topotecan in patients with brain metastases—

Countries

Italy

Outcome results

None listed

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