Breast CancerPhase 2NCT01190982
Efficacy and Safety Study of LEP-ETU to Treat Metastatic Breast Cancer
A Phase 2 study testing LEP-ETU in people with Breast Cancer, run by INSYS Therapeutics Inc at 3 sites in India.
Trial summary
LEP-ETU is a novel, proprietary delivery system of paclitaxel developed by NeoPharm, Inc. Paclitaxel (currently marketed as Taxol) is an anti-microtubular network agent and is active in a broad spectrum of malignancies. Paclitaxel has poor solubility. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- LEP-ETU
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 3 sitesIndia
- Study dates
- Mar 2008to Dec 2011
- Phase
- Phase 2
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be 18 years or older and female.
- Have histologically or cytologically confirmed diagnosis of invasive adenocarcinoma originating in the breast.
- Have at least one target lesion per RECIST criteria
- If the patient has received adjuvant or neoadjuvant taxane therapy, the patient must not have relapsed with breast cancer within one year of completing this therapy.
- Have received prior chemotherapy in the adjuvant or metastatic setting with an anthracycline unless contraindicated.
- Have no other malignancy within the past five years, except non-melanoma skin cancer, cervical intraepithelial neoplasia (CIN), or in-situ cervical cancer (CIS).
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- Have the following hematology levels at Baseline:
- ANC greater than or equal to 1,500 x 106 cells/L;
- Platelets greater than or equal to 100 x 109 cells/L;
- Hgb greater than or equal to 90 g/L.
- Have the following chemistry levels at Baseline:
- AST (SGOT), ALT (SGPT) less than or equal to 2.5 x ULN if no evidence of liver metastases;
- AST (SGOT), ALT (SGPT) less than or equal to 5 x ULN if liver metastases are present;
- Total bilirubin less than or equal to 26 micromol/L (1.5 mg/dL);
- Creatinine less than or equal to 177 micromol/L (2 mg/dL); or 24-hour
- Alkaline phosphatase less than or equal to 5 x ULN (unless bone metastasis is present in the absence of liver metastasis).
- Have a life expectancy of greater than or equal to 12 weeks.
- Have an ECOG Performance status of 0-2.
- Patients of child-bearing potential must agree to use acceptable contraceptive methods (e.g., double barrier) during treatment.
- Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee -approved written informed consent form prior to receiving any study related procedure.
Who cannot join
- Patient has radiographic evidence of active (symptomatic, untreated) intraparenchymal brain metastases; any leptomeningeal metastases; or asymptomatic untreated intraparenchymal brain metastases requiring treatment.
- Patient has received more than 1 prior treatment with a non-taxane agent in the metastatic setting.
- The only evidence of metastasis is lytic or blastic bone metastases or pleural effusion or ascites.
- Patient has a known infection with human immunodeficiency virus or active viral hepatitis.
- Patient has active heart disease including myocardial infarction or congestive heart failure within the previous 6 months, symptomatic coronary artery disease, or uncontrolled arrhythmias.
- Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive study drug (e.g., uncontrolled bleeding or bleeding diathesis).
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- Any active infection requiring parenteral or oral antibiotics.
- The patient receives treatment with any:
- Hormonal or other non-investigational agent therapy within 2 weeks prior to first dose of study drug;
- Herceptin, mitomycin, or nitrosoureas therapy within 6 weeks prior to first dose;
- Chemotherapy (except for palliative bisphosphonate therapy for bone pain which can be administered as clinically indicated) within 4 weeks prior to first dose study drug;
- Investigational drug or immunotherapy within 4 weeks prior to first dose study drug;
- Concurrent radiation therapy (except for palliative radiotherapy for
- Radiation therapy within 4 weeks prior to first dose of study drug.
- Patient has pre-existing peripheral neuropathy of NCI-CTCAE Grade >1.
- Patient has received paclitaxel, docetaxel, or Abraxane because of metastatic carcinoma.
- Known hypersensitivity to paclitaxel, Cremophor EL, or liposomes.
- Pregnant or nursing female patients.
- Unwilling or unable to follow protocol requirements.
Trial locations and contacts
3 sites in 1 country.
India3 sites
Indo-American Cancer Institute and Research Center
Banjara Hills, Hyderabad
P.D. Hinduja Antional Hospital & Medical Research Center
Mahīm, Mumbia
Jaslok Hospital and Research Center
Mumbai
About this study
Official title: A Multicenter, Open-Label, Phase II Study of LEP-ETU for Efficacy and Safety in Patients With Metastatic Breast Cancer
LEP-ETU is a novel, proprietary delivery system of paclitaxel developed by NeoPharm, Inc. Paclitaxel (currently marketed as Taxol) is an anti-microtubular network agent and is active in a broad spectrum of malignancies. Paclitaxel has poor solubility. In order to enhance the solubility, this drug is formulated with polyoxyethylated castor oil, which leading to infusion-related hypersensitivity reactions. The NeoPharm LEP-ETU is formulated with a mixture of well characterized, synthetic phospholipids and cholesterol. This design eliminates the need for the oil. The LEP-ETU formulation has improved safety profile that is necessary for administering higher doses than would commonly be used with Taxol. The clinical evidence obtained from the NeoPharm Phase I study shows LEP-ETU is better tolerated than Taxol, as indicated by a higher maximum-tolerated dose (MTD). The current Phase II study is designed to accomplish the following objectives:
- Assess the Overall Response Rate (ORR) of patients with metastatic breast cancer after administered over 90 minutes at the dose of 275 mg/m2 LEP-ETU
- To evaluate the Progression-Free Survival (PFS)
- To evaluate the safety of LEP-ETU at 275 mg/m2 level, in particular peripheral neuropathy
- To evaluate the Overall Survival (OS)
- Conditions
- Breast Cancer
- Being tested
- LEP-ETU
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEP-ETUDrug
Also called Liposome Entrapped Paclitaxel Easy to Use
275 mg/m2, IV (in the vein) on day 1 of each 21 day cycle, 6 Cycles or until progression or unacceptable toxicity develops.
| Study group | Role | What they receive |
|---|---|---|
| LEP-ETU | Experimental | All patient will have baseline to confirm disease status. The disease progression/response is assessed inaccordance to the RECIST guidelines Receives: Drug: LEP-ETU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Overall Response Rate (ORR) following treatment of LEP-ETU at 275 mg/m2 dose
The time frame is average. The patient will be treated once every 21 day cycle for 6 cycles. Disease status and tumor response/progression will be assessed based on the Response Evaluation Criteria in Solid Tumor (RECIST) after 2, 4 and 6 cycle. Patient will be followed for overall survival until death.
Measured: 2 years
Secondary outcomes (1)
LEP-ETU 275mg/m2 Induce Progression-Free Survival Assessment
The time frame is average. The patient will be treated once every 21 day cycle for 6 cycles. Disease progression will be assessed after 2, 4 and 6 cycle. Patient will be followed for overall Survival until death.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2010 (estimated)
- Study startMar 2008
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- INSYS Therapeutics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01190982
- Sponsor's protocol ID
- LEP-ETU 202
- Status last verified
- Aug 2012
- First submitted
- 26 Aug 2010
- Last updated
- 24 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Phase II Study of LEP-ETU for Efficacy and Safety in Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT01190982
- Acronym / sponsor ID
- LEP-ETU 202
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- INSYS Therapeutics IncIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 30 Aug 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.
LEP-ETU is a novel, proprietary delivery system of paclitaxel developed by NeoPharm, Inc. Paclitaxel (currently marketed as Taxol) is an anti-microtubular network agent and is active in a broad spectrum of malignancies. Paclitaxel has poor solubility. In order to enhance the solubility, this drug is formulated with polyoxyethylated castor oil, which leading to infusion-related hypersensitivity reactions. The NeoPharm LEP-ETU is formulated with a mixture of well characterized, synthetic phospholipids and cholesterol. This design eliminates the need for the oil. The LEP-ETU formulation has improved safety profile that is necessary for administering higher doses than would commonly be used with Taxol. The clinical evidence obtained from the NeoPharm Phase I study shows LEP-ETU is better tolerated than Taxol, as indicated by a higher maximum-tolerated dose (MTD). The current Phase II study is designed to accomplish the following objectives:
- Assess the Overall Response Rate (ORR) of patients with metastatic breast cancer after administered over 90 minutes at the dose of 275 mg/m2 LEP-ETU
- To evaluate the Progression-Free Survival (PFS)
- To evaluate the safety of LEP-ETU at 275 mg/m2 level, in particular peripheral neuropathy
- To evaluate the Overall Survival (OS)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LEP-ETU | Experimental | Drug: LEP-ETUAll patient will have baseline to confirm disease status. The disease progression/response is assessed inaccordance to the RECIST guidelines |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Be 18 years or older and female.
- Have histologically or cytologically confirmed diagnosis of invasive adenocarcinoma originating in the breast.
- Have at least one target lesion per RECIST criteria
- If the patient has received adjuvant or neoadjuvant taxane therapy, the patient must not have relapsed with breast cancer within one year of completing this therapy.
- Have received prior chemotherapy in the adjuvant or metastatic setting with an anthracycline unless contraindicated.
Key exclusion criteria (19 listed)
- Patient has radiographic evidence of active (symptomatic, untreated) intraparenchymal brain metastases; any leptomeningeal metastases; or asymptomatic untreated intraparenchymal brain metastases requiring treatment.
- Patient has received more than 1 prior treatment with a non-taxane agent in the metastatic setting.
- The only evidence of metastasis is lytic or blastic bone metastases or pleural effusion or ascites.
- Patient has a known infection with human immunodeficiency virus or active viral hepatitis.
- Patient has active heart disease including myocardial infarction or congestive heart failure within the previous 6 months, symptomatic coronary artery disease, or uncontrolled arrhythmias.
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 |
|---|---|---|
| LEP-ETUAlso: Liposome Entrapped Paclitaxel Easy to Use275 mg/m2, IV (in the vein) on day 1 of each 21 day cycle, 6 Cycles or until progression or unacceptable toxicity develops. | Drug | LEP-ETU |
Primary outcome
Assessment of Overall Response Rate (ORR) following treatment of LEP-ETU at 275 mg/m2 dose
Time frame: 2 years
The time frame is average. The patient will be treated once every 21 day cycle for 6 cycles. Disease status and tumor response/progression will be assessed based on the Response Evaluation Criteria in Solid Tumor (RECIST) after 2, 4 and 6 cycle. Patient will be followed for overall survival until death.
1 secondary outcome
LEP-ETU 275mg/m2 Induce Progression-Free Survival Assessment
Time frame: 2 years
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 24 Aug 2012.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LEP-ETU in people with Breast Cancer, run by INSYS Therapeutics Inc at 3 sites in India.
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 20 inclusion and 19 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 24 Aug 2012. 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 India. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Assessment of Overall Response Rate (ORR) following treatment of LEP-ETU at 275 mg/m2 dose (time frame: 2 years). 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 24 Aug 2012.