NCT01190982

Efficacy and Safety Study of LEP-ETU to Treat Metastatic Breast Cancer

A Multicenter, Open-Label, Phase II Study of LEP-ETU for Efficacy and Safety in Patients With Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: INSYS Therapeutics Inc · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

LEP-ETU is a novel, proprietary delivery system of paclitaxel developed by NeoPharm, Inc. Paclitaxel (currently marketed as Taxol) is an anti-microtubular network agent and is active in a broad spectrum of malignancies. Paclitaxel has poor solubility. In order to enhance the solubility, this drug is formulated with polyoxyethylated castor oil, which leading to infusion-related hypersensitivity reactions. The NeoPharm LEP-ETU is formulated with a mixture of well characterized, synthetic phospholipids and cholesterol. This design eliminates the need for the oil. The LEP-ETU formulation has improved safety profile that is necessary for administering higher doses than would commonly be used with Taxol. The clinical evidence obtained from the NeoPharm Phase I study shows LEP-ETU is better tolerated than Taxol, as indicated by a higher maximum-tolerated dose (MTD). The current Phase II study is designed to accomplish the following objectives: 1. Assess the Overall Response Rate (ORR) of patients with metastatic breast cancer after administered over 90 minutes at the dose of 275 mg/m2 LEP-ETU 2. To evaluate the Progression-Free Survival (PFS) 3. To evaluate the safety of LEP-ETU at 275 mg/m2 level, in particular peripheral neuropathy 4. To evaluate the Overall Survival (OS)

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	LEP-ETU	275 mg/m2, IV (in the vein) on day 1 of each 21 day cycle, 6 Cycles or until progression or unacceptable toxicity develops.

Timeline

• Start date: 2008-03-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2010-08-30
• Last updated: 2012-08-24

Locations

3 sites across 1 country: India