A Study Extension to Evaluate the Safety and Tolerability of Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) in Patients that Completed Study LEP-ETU-102A

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-001349-14-DE

Enrollment

Registered

2004-10-01

Start date

2004-11-18

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

advanced non-hematologic malignancies MedDRA version: 6.1 Level: HLGT Classification code 10027655

Interventions

Product Name: Liposome Entrapped Paclitaxel Easy to Use Product Code: LEP-ETU Pharmaceutical Form: Intravenous infusion INN or Proposed INN: paclitaxel CAS Number: 33069-62-4 Current Sponsor code: LEP

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Have completed 2 treatment cycles in study LEP-ETU-102A and in the opinion of the investigator have benefited from treatment OR patients who have been involuntarily withdrawn from study LEP-ETU-102A, due to an interrupted infusion and who are considered by the investigator to be candidates for continued treatment with LEP-ETU. -Absolute neutrophil count (ANC) is greater than or equal to 1,500 X 10^6 cells/L and platelet count is greater than or equal to 100 X 10^9 cells/L. -Have recovered from treatment-related toxicity to baseline grade or Grade 1, whichever is less restrictive. (Grade 2 neurotoxicity and alopecia are also permitted.) -Patients (male and female) must be willing to practice an effective method of birth control during the study. -Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethical Committee approved written informed consent form prior to treatment. 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: -Unwilling or unable to follow protocol requirements. -Informed Consent not signed within 30 days of the last dose in study LEP-ETU-102A. -Any condition which, in the Investigator’s opinion, deems the patient an unsuitable candidate to receive study drug.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the safety and tolerability of liposome entrapped paclitaxel easy to use (LEP-ETU). ;Secondary Objective: ;Primary end point(s): Patients may continue on treatment until disease progression or development of unacceptable toxicity.	—

Countries

Germany

Outcome results

None listed

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