Solid TumorsPhase 1LE-DTNCT01151384
Liposome Encapsulated Docetaxel (LE-DT) in Patients With Solid Tumors
A Phase 1 study testing LE-DT in people with Solid Tumors, run by INSYS Therapeutics Inc at 2 sites in United States.
Trial summary
Liposome Encapsulated Docetaxel (LE-DT) is a novel proprietary delivery system of docetaxel developed by NeoPharm, Inc. In this Phase I study, the LE-DT was evaluated for the maximum tolerated dose and dose limiting toxicity (DLT) in patients with advance solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- LE-DT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2008to May 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
- To be included in this study, patients must meet the following criteria:
- Be ≥18 years of age.
- Have advanced (local and/or metastatic) histologically documented cancer considered unresponsive to available conventional modalities or treatments.
- Have an ECOG Performance Status of 0-2.
- Have recovered from acute toxicities of prior treatment:
- 4 weeks must have elapsed since receiving any investigational agent.
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- 4 weeks must have elapsed since receiving any radiotherapy, or treatment with cytotoxic or biologic agents (≥6 weeks for mitomycin or nitrosoureas). Chronic treatment with non-investigational gonadotropin-releasing hormone analogs or other hormonal or supportive care is permitted.
- >6 months must have elapsed since receiving a high-dose chemotherapy regimen with stem cell support.
- 2 weeks must have elapsed since any prior surgery or granulocyte-stimulating growth factor therapy.
- 12 months must have elapsed since any prior treatment with docetaxel. 5. Be in adequate condition as evidenced by the following clinical laboratory values:
- Absolute neutrophil count (ANC) ≥1,500/mm3.
- Platelets ≥100,000/mm3.
- Hemoglobin ≥9.0 g/dL.
- Albumin ≥3.0 g/dL.
- Serum creatinine ≤2.0 mg/dL.
- Total bilirubin ≤1.5 x institutional upper limit normal (ULN).
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase ≤2.5 x ULN.
- 6. Patients (male and female) must be willing to practice an effective method of birth control during the study.
- 7. Patient or legal representative must understand the investigational nature of this study and sign an Institutional Review Board (IRB)/Independent Ethics Committee approved written informed consent form prior to treatment.
Who cannot join
- Patients are excluded from this study for the following:
- Active uncontrolled bleeding or bleeding diathesis (e.g., active peptic ulcer disease).
- Any active infection requiring parenteral or oral antibiotic treatment.
- Known infection with human immunodeficiency virus 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.)
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- Impending or symptomatic spinal cord compression or carcinomatous meningitis.
- Having pre-existing clinically significant neuropathy (NCI CTCAE Grade ≥ 2 neuromotor or Grade ≥ 2 neurosensory) except for abnormalities due to cancer.
- Having failed a docetaxel-containing regimen.
- Having known non-controllable hypersensitivity to docetaxel or liposomes.
- Currently receiving any other standard or investigational treatment for cancer or any other investigational agent for any indication.
- 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
2 sites in 1 country.
United States2 sites
TGEN/Scottsdale Clinical Research Institute
Scottsdale, Arizona, 85258
Lombardi Comprehensive Cancer Center, Georgetown University
Washington D.C., District of Columbia, 20057
About this study
Official title: A Phase 1 Study of Liposome Encapsulated Docetaxel (LE-DT) in Patients With Advanced Solid Tumors
Liposome Encapsulated Docetaxel (LE-DT) is a novel proprietary delivery system of docetaxel developed by NeoPharm, Inc. In this Phase I study, the LE-DT was evaluated for the maximum tolerated dose and dose limiting toxicity (DLT) in patients with advance solid tumors. It was also evaluated for pharmacokinetic and anti-tumor effects.
Read the detailed description
Liposome Entrapped Doxetaxel (LE-DT) is a novel, proprietary delivery system of docetaxel developed by NeoPharm, Inc. Docetaxel (currently marketed as Taxotere®) is an anti-microtubule agent that prevents cell division by promoting the assembly and stabilization of microtubules and is used for the treatment of malignancies from breast, prostate, lung, gastric, head and neck. By removing toxic detergent used in Taxotere®, LE-DT showed reduced toxicity and comparable therapeutic efficacy in preclinical studies. In clinic, it is believed that LE-DT will offer advantages to the patient of fewer side effects at similar doses, and possibly greater effectiveness when used at higher doses. In addition, routine premedication to prevent hypersensitivity may not be required.
This study is designed to determine the following:
- The maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of LE-DT.
- The pharmacokinetics of docetaxel following intravenous administration of LE-DT.
- Any anti-tumor effects of LE-DT.
Up to 5 dose levels have been studied.
- Conditions
- Solid Tumors
- Being tested
- LE-DT
- Keywords
- Cancer Patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LE-DTDrug
Also called Liposome Entrapped Docetaxel
Intravenous infusion, Upto 5 dose levels have been studied i.e. 50, 65, 85, 110 and 132 mg/m2, Every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| LE-DT | Experimental | Not described Receives: Drug: LE-DT |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the tolerability and safety
This Phase I, open-label, dose-escalation study was designed to determine the maximum tolerated dose (MTD) of LE-DT in patients with advanced cancer. LE-DT was administered by intravenous infusion, over 1 hour, once every 21 days until occurrence of disease progression or toxicity requiring early treatment discontinuation. Dose escalation was not done until the safety and tolerability at a given dose level has been confirmed.
Measured: 1 year
Secondary outcomes (1)
To evaluate the pharmacokinetic and anti-tumor effect
The patients were evaluated for pharmacokinetic profile upto 48 hours post treatment after cycle 1. The anti-tumor effects were evaluated after every two cycles of treatment.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2010 (estimated)
- Study startFeb 2008
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumorsStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- INSYS Therapeutics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- John L Marshall, MD, Principal investigator, Georgetowm University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01151384
- Sponsor's protocol ID
- LE-DT-101
- Acronym
- LE-DT
- Status last verified
- Jun 2011
- First submitted
- 23 Jun 2010
- Last updated
- 4 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Deeken JF, Slack R, Weiss GJ, Ramanathan RK, Pishvaian MJ, Hwang J, Lewandowski K, Subramaniam D, He AR, Cotarla I, Rahman A, Marshall JL. A phase I study of liposomal-encapsulated docetaxel (LE-DT) in patients with advanced solid tumor malignancies. Cancer Chemother Pharmacol. 2013 Mar;71(3):627-33. doi: 10.1007/s00280-012-2048-y. Epub 2012 Dec 30.
PubMed 23274395
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 Phase 1 Study of Liposome Encapsulated Docetaxel (LE-DT) in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT01151384
- Acronym / sponsor ID
- LE-DT / LE-DT-101
- Conditions
- Solid Tumors
- Keywords
- Cancer Patients
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- INSYS Therapeutics IncIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 28 Jun 2010 (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 Docetaxel (LE-DT) is a novel proprietary delivery system of docetaxel developed by NeoPharm, Inc. In this Phase I study, the LE-DT was evaluated for the maximum tolerated dose and dose limiting toxicity (DLT) in patients with advance solid tumors. It was also evaluated for pharmacokinetic and anti-tumor effects.
Detailed description
Liposome Entrapped Doxetaxel (LE-DT) is a novel, proprietary delivery system of docetaxel developed by NeoPharm, Inc. Docetaxel (currently marketed as Taxotere®) is an anti-microtubule agent that prevents cell division by promoting the assembly and stabilization of microtubules and is used for the treatment of malignancies from breast, prostate, lung, gastric, head and neck. By removing toxic detergent used in Taxotere®, LE-DT showed reduced toxicity and comparable therapeutic efficacy in preclinical studies. In clinic, it is believed that LE-DT will offer advantages to the patient of fewer side effects at similar doses, and possibly greater effectiveness when used at higher doses. In addition, routine premedication to prevent hypersensitivity may not be required.
This study is designed to determine the following:
- The maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of LE-DT.
- The pharmacokinetics of docetaxel following intravenous administration of LE-DT.
- Any anti-tumor effects of LE-DT.
Up to 5 dose levels have been studied.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LE-DT | Experimental | Drug: LE-DT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- To be included in this study, patients must meet the following criteria:
- Be ≥18 years of age.
- Have advanced (local and/or metastatic) histologically documented cancer considered unresponsive to available conventional modalities or treatments.
- Have an ECOG Performance Status of 0-2.
- Have recovered from acute toxicities of prior treatment:
Key exclusion criteria (15 listed)
- Patients are excluded from this study for the following:
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 |
|---|---|---|
| LE-DTAlso: Liposome Entrapped DocetaxelIntravenous infusion, Upto 5 dose levels have been studied i.e. 50, 65, 85, 110 and 132 mg/m2, Every 3 weeks | Drug | LE-DT |
Primary outcome
To evaluate the tolerability and safety
Time frame: 1 year
This Phase I, open-label, dose-escalation study was designed to determine the maximum tolerated dose (MTD) of LE-DT in patients with advanced cancer. LE-DT was administered by intravenous infusion, over 1 hour, once every 21 days until occurrence of disease progression or toxicity requiring early treatment discontinuation. Dose escalation was not done until the safety and tolerability at a given dose level has been confirmed.
1 secondary outcome
To evaluate the pharmacokinetic and anti-tumor effect
Time frame: 1 year
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.
- Derived from this study: PubMed 23274395Deeken JF, Slack R, Weiss GJ, Ramanathan RK, Pishvaian MJ, Hwang J, Lewandowski K, Subramaniam D, He AR, Cotarla I, Rahman A, Marshall JL. A phase I study of liposomal-encapsulated docetaxel (LE-DT) in patients with advanced solid tumor malignancies. Cancer Chemother Pharmacol. 2013 Mar;71(3):627-33. doi: 10.1007/s00280-012-2048-y. Epub 2012 Dec 30.
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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.
John L Marshall, MD principal investigator
Georgetowm University Medical Center
2 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 LE-DT in people with Solid Tumors, run by INSYS Therapeutics Inc at 2 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?
The sponsor lists 19 inclusion and 15 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 2 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.
What does the primary outcome measure?
To evaluate the tolerability and safety (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01151384, which also lists 1 linked publication.
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.