NeoplasmPhase 1NCT00100139
Comparison of Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) and Taxol® Pharmacokinetics in Patients With Advanced Cancer
A Phase 1 study testing Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) and Paclitaxel for injection (Taxol) in people with Neoplasm, run by INSYS Therapeutics Inc at 6 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasm
- What is being tested?
- Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) and Paclitaxel for injection (Taxol)
- Type of treatment
- Injection or infusion
- How many people
- 48 participants
- Where
- 6 sitesin 3 countries
- Study dates
- Nov 2004to Jun 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have advanced histologically diagnosed non-hematological malignancy for which there is no curative therapy and for which treatment with single agent paclitaxel is appropriate in the opinion of the investigator.
- Patients must have a life expectancy of 12 weeks or more.
- Patients must have an ECOG Performance Status of 0-2.
- Patients must have recovered from acute toxicities of prior treatment. Specifically: *4 or more weeks must have elapsed since receiving any investigational agent. *3 or more weeks must have elapsed since receiving any radiotherapy, or treatment with cytotoxic or biologic agents (6 weeks or more for mitomycin or nitrosureas). Chronic treatment with non-investigational gonadotropin-releasing hormone analogs or other hormonal or supportive care is permitted. *2 or more weeks must have elapsed since any prior surgery or granulocyte-stimulating growth factor therapy.
- Patients must be in adequate condition as evidenced by the following clinical laboratory values: *Absolute neutrophil count (ANC) ≥1,500/mm³, *Platelet count ≥100,000/mm³, *Hemoglobin ≥9.0 g/dL, *Albumin ≥3.0 g/dl, *Serum creatinine ≥2.0 mg/dL, *Total bilirubin 1.5 x the institutional upper limit of normal (ULN) or greater. *Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 x ULN. In the case of known liver metastasis, ALT and AST ≤5 x ULN. *Alkaline phosphatase (ALP) ≤2.5 x ULN. No ULN applies to alkaline phosphatase in the case of known bone metastasis.
- Patients (male and female) must be willing to practice an effective method of birth control during the study.
- Patients must be available for and able to comply with the study-specific blood sampling requirements for pharmacokinetic evaluations.
- Patients or legal representative must understand the investigational nature of this study and sign an Institutional Review Board (IRB) approved written informed consent form prior to treatment.
Who cannot join
- Active uncontrolled bleeding or bleeding diathesis (e.g., active peptic ulcer disease).
- Any active infection requiring parenteral or oral antibiotic treatment; any use of trimethoprim, including use for antimicrobial prophylaxis.
- Known infection with human immunodeficiency virus (HIV) or hepatitis virus.
- Active heart disease including myocardial infarction or congestive heart failure within the previous 6 months, symptomatic coronary artery disease, or arrhythmias currently requiring medication.
- Known or suspected active central nervous system metastasis. (Patients stable 8 weeks after completion of treatment for central nervous system metastasis are eligible.)
- Impending or symptomatic spinal cord compression or carcinomatous meningitis.
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- Having pre-existing clinically significant neuropathy (National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) greater than or equal to Grade 2 neuromotor or Grade 2 neurosensory) except for abnormalities due to cancer.
- Having known hypersensitivity to paclitaxel or liposomes.
- Receiving any agent that could interfere with LEP-ETU metabolism, including CYP3A4 inducers and inhibitors within 3 weeks prior to, or while receiving, study drug (Please refer to http://medicine.iupui.edu/flockhart/ for a list of such agents).
- Requiring immediate palliative treatment of any kind including surgery and/or radiotherapy.
- Female patients who are pregnant or breast feeding.
- Unwilling or unable to follow protocol requirements.
- Any condition which, in the Investigator's opinion, deems the patient an unsuitable candidate to receive study drug.
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Netherlands3 sites
Academisch Medisch Centrum
Amsterdam
Catharina ziekenhuis
Eindhoven
Leids Universitair Medisch Centrum
Leiden
Germany2 sites
Universitatsklinikum Essen
Essen
Allgemeines Krankenhaus St. Georg
Hamburg
United States1 site
Cancer Institute of New Jersey - University of Medicine and Dentistry of New Jersey
New Brunswick, New Jersey, 08903
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Neoplasm
- Being tested
- Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU), Paclitaxel for injection (Taxol)
- Keywords
- Neoplasm, Cancer, NeoPharm, Liposomes, Taxol, Paclitaxel, Anti-cancer, Advanced neoplasm, Advanced cancer, Chemotherapy, Refractory cancer, Metastatic cancer
- Medical subject headings
- Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU)Drug
Paclitaxel for injection (Taxol)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine whether LEP-ETU and Taxol are bioequivalent.
Secondary outcomes (2)
To evaluate the pharmacokinetics of paclitaxel and major metabolites in plasma
To assess the safety and tolerability of paclitaxel following intravenous administration of LEP-ETU and Taxol.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2004 (estimated)
- Study startNov 2004
- Primary completionNov 2006
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants
Sponsor and investigators
- Lead sponsor
- INSYS Therapeutics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00100139
- Sponsor's protocol ID
- LEP-ETU-102A
- Status last verified
- Jun 2011
- First submitted
- 23 Dec 2004
- Last updated
- 4 Jul 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00100139
- Acronym / sponsor ID
- LEP-ETU-102A
- Conditions
- Neoplasm
- Keywords
- Neoplasm, Cancer, NeoPharm, Liposomes, Taxol, Paclitaxel, Anti-cancer, Advanced neoplasm
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants
- Lead sponsor
- INSYS Therapeutics IncIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Primary completion
- Nov 2006 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 24 Dec 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients must have advanced histologically diagnosed non-hematological malignancy for which there is no curative therapy and for which treatment with single agent paclitaxel is appropriate in the opinion of the investigator.
- Patients must have a life expectancy of 12 weeks or more.
- Patients must have an ECOG Performance Status of 0-2.
- Patients must have recovered from acute toxicities of prior treatment. Specifically: *4 or more weeks must have elapsed since receiving any investigational agent. *3 or more weeks must have elapsed since receiving any radiotherapy, or treatment with cytotoxic or biologic agents (6 weeks or more for mitomycin or nitrosureas). Chronic treatment with non-investigational gonadotropin-releasing hormone analogs or other hormonal or supportive care is permitted. *2 or more weeks must have elapsed since any prior surgery or granulocyte-stimulating growth factor therapy.
Key exclusion criteria (13 listed)
- Active uncontrolled bleeding or bleeding diathesis (e.g., active peptic ulcer disease).
- Any active infection requiring parenteral or oral antibiotic treatment; any use of trimethoprim, including use for antimicrobial prophylaxis.
- Known infection with human immunodeficiency virus (HIV) or hepatitis virus.
- Active heart disease including myocardial infarction or congestive heart failure within the previous 6 months, symptomatic coronary artery disease, or arrhythmias currently requiring medication.
- Known or suspected active central nervous system metastasis. (Patients stable 8 weeks after completion of treatment for central nervous system metastasis are eligible.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) | Drug | – |
| Paclitaxel for injection (Taxol) | Drug | – |
Primary outcome
To determine whether LEP-ETU and Taxol are bioequivalent.
2 secondary outcomes
To evaluate the pharmacokinetics of paclitaxel and major metabolites in plasma
To assess the safety and tolerability of paclitaxel following intravenous administration of LEP-ETU and Taxol.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) and Paclitaxel for injection (Taxol) in people with Neoplasm, run by INSYS Therapeutics Inc at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Netherlands, Germany, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine whether LEP-ETU and Taxol are bioequivalent.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2011.