Small Cell Lung CancerPhase 2NCT00472771
INNO-206 in Patients With Small Cell Lung Cancer (SCLC)
A Phase 2 study testing INNO-206 in people with Small Cell Lung Cancer, run by CytRx at 7 sites in United States.
Trial summary
The purpose of this study is to determine whether INNO-206 is effective in the treatment of small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- INNO-206
- How many people
- 0 participants
- Where
- 7 sitesUnited States
- Study dates
- May 2008to Nov 2008
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
New York Oncology Hematology, P.C.
Albany, New York, 12206
Billings Clinic
Billings, Montana, 59107
University of Chicago
Chicago, Illinois, 60637
Mary Crowley Medical Research Center
Dallas, Texas, 75246
Cancer Centers of the Carolinas
Greenville, South Carolina, 29605
Dayton Oncology and Hematology
Kettering, Ohio, 45409
Signal Point Hematology/Oncology, Inc.
Middletown, Ohio, 45042
About this study
Official title: 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.
Read the 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.
- Conditions
- Small Cell Lung Cancer
- Being tested
- INNO-206
- Keywords
- Recurrent extensive small cell lung cancer
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INNO-206Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the objective overall response rate (OR; complete [CR] and partial [PR] responses).
Secondary outcomes (6)
To determine the rates of stable disease and progressive disease.
To determine time to progression.
To determine progression-free survival.
To determine overall survival.
To evaluate the treatment-related toxicities in this patient population.
To determine the pharmacokinetic profile of INNO-206 in a minimum of 12 patients.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2007 (estimated)
- Study startMay 2008
- Study completionNov 2008
Why it stopped: Terminated due to clinical trial material production delays
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- CytRx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Maitland, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00472771
- Sponsor's protocol ID
- INNO-206-P2
- Status last verified
- Feb 2012
- First submitted
- 11 May 2007
- Last updated
- 9 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-label Study of INNO-206 in Patients With Recurrent Extensive Small Cell Lung Cancer After First-line Platinum-based Therapy
- ClinicalTrials.gov ID
- NCT00472771
- Acronym / sponsor ID
- INNO-206-P2
- Conditions
- Small Cell Lung Cancer
- Keywords
- Recurrent extensive small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Terminated due to clinical trial material production delays
- Enrolment
- 0 participants (actual)
- Lead sponsor
- CytRxIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Study completion
- Nov 2008 (actual)
- First posted
- 14 May 2007 (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.
The purpose of this study is to determine whether INNO-206 is effective in the treatment of small cell lung cancer.
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 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
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
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 |
|---|---|---|
| INNO-206 | Drug | – |
Primary outcome
To determine the objective overall response rate (OR; complete [CR] and partial [PR] responses).
6 secondary outcomes
To determine the rates of stable disease and progressive disease.
To determine time to progression.
To determine progression-free survival.
To determine overall survival.
To evaluate the treatment-related toxicities in this patient population.
To determine the pharmacokinetic profile of INNO-206 in a minimum of 12 patients.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 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.
Michael Maitland, MD principal investigator
University of Chicago
7 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 INNO-206 in people with Small Cell Lung Cancer, run by CytRx at 7 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 9 inclusion and 11 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: withdrawn, as of the sponsor's last update on 9 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 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 was withdrawn before enrolling participants, so there are no results.
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 the objective overall response rate (OR; complete [CR] and partial [PR] responses).. 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 9 Feb 2012.