Liposome Encapsulated SN38 (LE-SN38) in Patients With Advanced Cancer

Phase 1

Completed

• Conditions: Neoplasms

• Registration Number: NCT00046540
• Lead Sponsor: INSYS Therapeutics Inc

Brief Summary

Liposome Encapsulated SN38 (LE-SN38) is an oncology drug product consisting of the active metabolite of irinotecan (CPT-11), a known anticancer drug, encapsulated in a liposome. Formulation of a relatively insoluble compound (SN38) and improvement in drug delivery (pharmacodynamic profile) may be obtained with liposomal formulations. An improved safety and efficacy profile, compared with the pro-drug CPT-11, may be possible. This rationale is supported by the results from animal toxicity studies in both the mouse and dog.

LE-SN38 will be infused intravenously every 3 weeks to assess safety and tolerability of study drug until there is disease progression or toxicity requiring early treatment discontinuation. Disease status will be assessed after every second cycle of treatment. In the event of disease progression, study treatment will be discontinued, all end-of-treatment study evaluations will be performed and further treatment options will be reviewed.

Detailed Description

OBJECTIVES:

I. Determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of LE-SN38.

II. Determine the plasma pharmacokinetics of SN38 following IV administration of LE-SN38.

III. Observe any anti-tumor effects of LE-SN38.

PROTOCOL OUTLINE:

This is an open-label study in patients with advanced solid tumors who have failed conventional therapy.

LE-SN38 will be administered IV over 90 minutes. At least three patients will be studied at each dose level and at least three patients will complete one 21-day course before any patient is enrolled at the next dose level. Study drug administration will continue on an every 21-day schedule in the absence of progressive disease or unacceptable toxicity. A subsequent course of treatment may be administered at least 21 days after receiving a prior dose of LE-SN38 when study criteria are met.

Cohorts of 3 patients per dose level will be studied. This will be expanded to 6 if a DLT occurs, followed by a total of 6 patients at a possible MTD.

Disease status will be assessed after every second cycle. In the event of disease progression, study treatment will be discontinued and all end of treatment study evaluations will be performed.

PROJECTED ACCRUAL: Up to 40 patients will be enrolled.

Study Timeline

• Study First Submitted: 2002-09-30
• Study Start: 2002-10
• Study First Submitted QC: 2002-10-01
• Study First Posted: 2002-10-02
• Primary Completion: 2007-08
• Study Completion: 2010-11
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-30
• Last Update Posted: 2011-07-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (3)

H. Lee Moffitt Cancer Center and Research Institute; 🇺🇸 Tampa, Florida, United States

Barbara Ann Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States

The Ohio State University; 🇺🇸 Columbus, Ohio, United States