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Liposome Entrapped Paclitaxel Easy to Use

The purpose of this study is to determine the highest dose of Liposome Entrapped Paclitaxel Easy to Use formulation (LEP-ETU) that can be safely administered by an intravenous infusion to patients with advanced cancer.

LEP-ETU is a new formulation of the anti-cancer agent paclitaxel for injection or Taxol (paclitaxel and Cremophor EL). Paclitaxel is a drug currently used for treating a broad range of cancers. Paclitaxel is thought to prevent cells from dividing and growing, resulting in cell death. This new formulation consists of paclitaxel associated with liposomes, which are microscopic membrane-like structures created from lipids (fats). It is believed that LEP-ETU will maintain or enhance the anti-tumor properties of paclitaxel, while offering advantages to the patient of a shorter infusion time, routine premedication not required, fewer side effects at similar doses, and possibly greater effectiveness, especially if higher doses can be delivered without an increase in side effects.

This study is designed to determine the following:

* The highest dose of LEP-ETU that can be given safely to patients.
* The pharmacokinetics of paclitaxel following intravenous infusion with LEP-ETU.
* Any anti-tumor effects of LEP-ETU.

Up to 8 dose levels will be studied. LEP-ETU will be given to patients by intravenous infusion over 90 minutes, once every 21 days, until their disease progresses or side effects occur requiring the treatments to end. Patients will be evaluated for safety and how well they tolerate the treatments.

Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) in Patients With Advanced Cancer

Phase I Study of Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) Formulation in Patients With Advanced Cancer

INSYS Therapeutics Inc

Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU)

Paclitaxel for injection (Taxol)

In this study, Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) is being compared to Taxol® to examine whether the paclitaxel in these 2 formulations undergoes similar processing by the body. Safety and tolerability of LEP-ETU and Taxol will also be assessed. In this study, each patient will receive one intravenous infusion of LEP-ETU or Taxol, followed 3 weeks later by an infusion of the other drug, at the same dose and infusion duration. Multiple blood samples will be taken for analysis before, during, and after both drug infusions. Upon completing these 2 Cycles of treatment, eligible patients may enroll in an extension study (LEP-ETU-102B) to continue treatment with LEP-ETU.

LEP-ETU is a liposomal formulation of paclitaxel, a widely used anti-cancer drug. This LEP-ETU formulation of paclitaxel is being developed to potentially reduce toxicities associated with Taxol, by eliminating the drug formulation component polyoxyethylated castor oil (Cremophor® EL). In LEP-ETU, paclitaxel is associated with liposomes, which are microscopic membrane-like structures created from lipids (fats). Thus, the LEP-ETU formulation could potentially have reduced toxicity, while maintaining or enhancing efficacy.

This Phase 1B, open-label, two-period crossover bioequivalence study is designed to compare the pharmacokinetics (PK) of LEP-ETU and Taxol in patients with advanced cancer. Patients are randomized to determine which drug is administered first. A single dose of LEP-ETU or Taxol (Cycle A) will be administered, followed 3 weeks later by a single dose of the other drug (Cycle B). Blood samples for PK analysis will be taken before, during, and after the infusion of each drug. Following successful completion of both Cycles in this study, patients may be eligible for additional cycles of treatment with LEP-ETU in the LEP-ETU-102B extension study.

Comparison of Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) and Taxol® Pharmacokinetics in Patients With Advanced Cancer

A Randomized Two-Period Crossover, Clinical Bioequivalence Study Comparing the Pharmacokinetics of Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) Formulation Versus Taxol® in Patients With Advanced Cancer

LErafAON-ETU

The primary purpose of this study is to identify a dose of Liposome Entrapped c-raf Antisense Oligonucleotide Easy-to-Use (LErafAON-ETU) which maximizes potential benefits of the compound to patients with advanced cancer, without compromising their safety. This study will also assess the processing of LErafAON-ETU by the body over time. Patients will receive an intravenous infusion of LErafAON-ETU each week. Multiple blood samples will be taken for pharmacokinetic analysis during the first treatment; two samples will be taken during both the second and third treatments. Patients will be eligible to continue treatment until the occurrence of unacceptable toxicity or disease progression.

In LErafAON-ETU, antisense oligonucleotides specific to c-raf, are associated with liposomes, which are microscopic membrane-like structures created from lipids (fats). Raf-1 is a protein which plays a critical role in many aspects of cellular activation and growth. Therefore, it is thought to be an important factor that may support tumor development. LErafAON-ETU potentially limits the ability of a cell to produce the Raf-1 protein.

This Phase I, open-label, dose-escalation study is designed to determine the maximum tolerated dose of LErafAON-ETU in patients who have advanced cancer considered unresponsive to available, conventional modalities or treatments. LErafAON-ETU will be administered as an IV infusion once weekly for 3 consecutive weeks (a Treatment Cycle). A complete pharmacokinetic profile of raf-1 antisense oligonucleotide will be assessed in week 1 only; limited pharmacokinetic sampling will be done prior to and at the end of infusion in weeks 2 and 3 only. Tumor/disease evaluation will be performed upon completion of 6 infusions (2 Cycles). Dose escalation will not occur until the safety and tolerability at a given dose level has been confirmed for 1 Cycle.

Study to Determine the Maximum Tolerated Dose of LErafAON in Patients With Advanced Cancer

Phase I Study of an Easy-to-Use Intravenous Formulation of Liposome Entrapped C-raf Antisense Oligonucleotide (LErafAON-ETU) Administered on a Weekly Schedule in Patients With Advanced Cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) in Patients With Advanced Cancer	NCT00080418	Neoplasm	Liposome Entrap...	18 Years -	INSYS Therapeutics Inc
Comparison of Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) and Taxol® Pharmacokinetics in Patients With Advanced Cancer	NCT00100139	Neoplasm	Liposome Entrap... Paclitaxel for ...	18 Years -	INSYS Therapeutics Inc
Comparison of Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) and Taxol® Pharmacokinetics in Patients With Advanced Cancer	NCT00100139	Neoplasm	Liposome Entrap... Paclitaxel for ...	18 Years -	INSYS Therapeutics Inc
Study to Determine the Maximum Tolerated Dose of LErafAON in Patients With Advanced Cancer	NCT00100672	Neoplasms	LErafAON-ETU	18 Years -	INSYS Therapeutics Inc
Study to Determine the Maximum Tolerated Dose of LErafAON in Patients With Advanced Cancer	NCT00100672	Neoplasms	LErafAON-ETU	18 Years -	INSYS Therapeutics Inc
Comparison of Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) and Taxol® Pharmacokinetics in Patients With Advanced Cancer	NCT00100139	Neoplasm	Liposome Entrap... Paclitaxel for ...	18 Years -	INSYS Therapeutics Inc

Spots Global Cancer Trial Database for neopharm

Every month we try and update this database with for neopharm cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for neopharm

Every month we try and update this database with for neopharm cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for neopharm cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.