- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00472771
INNO-206 in Patients With Small Cell Lung Cancer (SCLC)
February 8, 2012 updated by: CytRx
A Phase II, Open-label Study of INNO-206 in Patients With Recurrent Extensive Small Cell Lung Cancer After First-line Platinum-based Therapy
The purpose of this study is to determine whether INNO-206 is effective in the treatment of small cell lung cancer.
Study Overview
Detailed Description
This is a phase II, open-label, prospective, multicenter, single-arm study of INNO 206 in adult patients with recurrent extensive small cell lung cancer sensitive to first-line platinum-based therapy.
The primary objective of the study is to determine the objective overall response rate.
Secondary objectives include evaluating the treatment-related toxicities in this patient population and determining the pharmacokinetic (PK) profile of INNO-206 in a minimum of 12 patients.
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Illinois
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Chicago, Illinois, United States, 60637
- University of Chicago
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Montana
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Billings, Montana, United States, 59107
- Billings Clinic
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New York
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Albany, New York, United States, 12206
- New York Oncology Hematology, P.C.
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Ohio
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Kettering, Ohio, United States, 45409
- Dayton Oncology And Hematology
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Middletown, Ohio, United States, 45042
- Signal Point Hematology/Oncology, Inc.
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South Carolina
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Greenville, South Carolina, United States, 29605
- Cancer Centers of the Carolinas
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Texas
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Dallas, Texas, United States, 75246
- Mary Crowley Medical Research Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Be ≥18 years old.
- Have a histologically or cytologically confirmed diagnosis of recurrent extensive small cell lung cancer (SCLC) at the time of enrollment into the study.
- Have responded to first-line platinum-based chemotherapy, but progressed or relapsed ≥60 days after completion of first-line therapy.
- Have measurable disease defined by RECIST.
- Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤2.
- Have an estimated life expectancy of ≥4 weeks.
- Be male or non-pregnant, non-lactating female patients. Patients who are fertile must agree to use an effective barrier method of birth control to avoid pregnancy while on therapy and for 90 days following the discontinuation of the study medication.
- Have a negative serum or urine pregnancy test within 7 days prior to the first dose of study medication (if patient is a female of childbearing potential).
- Have adequate organ function.
Exclusion Criteria:
- Are pregnant or lactating.
- Have received prior anthracycline therapy.
- Have participated in any investigational drug study within 30 days prior to study entry.
- Have received radiotherapy within 2 weeks of treatment in this study.
- Have not recovered from acute toxicity of all previous therapy prior to enrollment.
- Have a history of a malignancy other than SCLC. Exceptions to this include: curatively treated nonmelanomatous carcinoma of the skin or in situ carcinoma of the cervix, or prior low-grade, localized prostate cancer (Gleason score ≤6); or a history of another malignancy that was curatively treated and no evidence of recurrence for a minimum of 5 years.
- Have symptomatic central nervous system (CNS) metastases.
- Have any concurrent severe or uncontrolled medical disease (such as active systemic infection, hypertension, congestive heart failure ≥NYHA Grade II, myocardial infarction within 6 months before study start, severe rhythm disturbances, etc.) that, in the opinion of the Investigator, would compromise the safety of the patient or compromise the ability of the patient to complete the study.
- Have a psychiatric disorder(s) that would interfere with consent, study participation, or follow-up.
- Have received radiotherapy with >25% involvement of the bone marrow within 6 weeks prior to study start.
- Have a known hypersensitivity to doxorubicin, 5% D-(+)-sucrose, 10 mM sodium phosphate, and/or 0.3% N-acetyltryptophane.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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To determine the objective overall response rate (OR; complete [CR] and partial [PR] responses).
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Secondary Outcome Measures
Outcome Measure |
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To determine the rates of stable disease and progressive disease.
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To determine time to progression.
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To determine progression-free survival.
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To determine overall survival.
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To evaluate the treatment-related toxicities in this patient population.
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To determine the pharmacokinetic profile of INNO-206 in a minimum of 12 patients.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michael Maitland, MD, University of Chicago
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2008
Primary Completion
December 7, 2022
Study Completion (Actual)
November 1, 2008
Study Registration Dates
First Submitted
May 11, 2007
First Submitted That Met QC Criteria
May 11, 2007
First Posted (Estimate)
May 14, 2007
Study Record Updates
Last Update Posted (Estimate)
February 9, 2012
Last Update Submitted That Met QC Criteria
February 8, 2012
Last Verified
February 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- INNO-206-P2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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