NeoplasmsPhase 1NCT00046540
Liposome Encapsulated SN38 (LE-SN38) in Patients With Advanced Cancer
A Phase 1 study testing Liposome-encapsulated SN38 in people with Neoplasms, run by INSYS Therapeutics Inc at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- Liposome-encapsulated SN38
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2002to Nov 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
Disease Characteristics:
- Advanced (local and/or metastatic) histologically documented solid tumors
- Disease not considered responsive to available conventional modalities or treatments
- No life prolonging therapy or therapy with a greater potential for patient benefit is available
Prior/Concurrent Therapy:
- No treatment with cytotoxic or biologic agents within 3 weeks prior to study entry (6 weeks for radiotherapy, mitomycin and nitrosoureas)
- At least 2 weeks since any prior surgery or hematopoietic growth factor therapy
- Chronic Grade 1 toxicities due to prior treatment or other causes are permitted
Patient Characteristics:
- Must have ECOG Performance status of 0-2
- Must be at least 18 years of age
- Must have the following clinical laboratory values: ANC at least 1,500/mm3, platelets at least 100,000/mm3, hemoglobin at least 9 g/dL, albumin at least 3.0 g/dL, serum creatinine not more than 2.0 mg/dL, total bilirubin not more than the institutional upper limit of normal, alanine aminotransferase, aspartate aminotransferase, and alkaline phosphatase not more than 1.5 x the institutional upper limit of normal
- Must sign informed consent
- No active uncontrolled bleeding or bleeding diathesis (e.g., active peptic ulcer disease)
- No infection requiring parenteral antibiotics
- No known HIV infection or viral hepatitis
- No active heart disease including myocardial infarction or congestive heart failure within the previous 6 months, symptomatic coronary artery disease, arrhythmias requiring medication
- No known or suspected active CNS metastasis
- No pregnant or nursing female patients. Women of child-bearing potential must have negative serum or urine pregnancy test within 1 week prior to study entry. Sexually active patients (both men and women) must agree to use acceptable contraceptive methods, e.g., double barrier, during the conduct of the study
- No agent which could interfere with SN38 metabolism, including phenobarbital, valproic acid, cyclosporine or phenytoin
- No concurrent treatment for cancer or any other investigational agent for any indication within 30 days prior to receiving the first dose of study drug
- No immediate palliative treatment of any kind including surgery
- No high-dose chemotherapy regimen with stem cell support in the previous 6 months
- No abdominal or pelvic radiation therapy
- Not willing or unable to follow protocol requirements
- No known hypersensitivity to irinotecan, SN38, or liposomes
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The Ohio State University
Columbus, Ohio, 43210
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
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.
Read the detailed description
OBJECTIVES:
- 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.
- Conditions
- Neoplasms
- Being tested
- Liposome-encapsulated SN38
- Keywords
- Liposome-Encapsulated SN38, Irinotecan, CPT-11, Malignant Tumors
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposome-encapsulated SN38Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2002 (estimated)
- Study startOct 2002
- Primary completionAug 2007
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- INSYS Therapeutics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mayer Fishman, MD, PhD, Principal investigator, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FloridaPatricia LoRusso, DO, Principal investigator, Barbara Ann Karmanos Cancer Institute, Detroit, MichiganEric Kraut, MD, Principal investigator, The Ohio State University, Columbus, Ohio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00046540
- Sponsor's protocol ID
- LE-SN38-101
- Status last verified
- Jun 2011
- First submitted
- 30 Sep 2002
- 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
- Liposome Encapsulated SN38 (LE-SN38) in Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT00046540
- Acronym / sponsor ID
- LE-SN38-101
- Conditions
- Neoplasms
- Keywords
- Liposome-Encapsulated SN38, Irinotecan, CPT-11, Malignant Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- INSYS Therapeutics IncIndustry (pharma, biotech, devices)
- Study start
- Oct 2002
- Primary completion
- Aug 2007 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 2 Oct 2002 (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.
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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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-encapsulated SN38 | Drug | – |
Primary outcome
Not reported in the source record.
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.
Mayer Fishman, MD, PhD principal investigator
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida
Patricia LoRusso, DO principal investigator
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan
Eric Kraut, MD principal investigator
The Ohio State University, Columbus, Ohio
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Liposome-encapsulated SN38 in people with Neoplasms, run by INSYS Therapeutics Inc at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 3 sites in 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.
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.