Small Cell Lung CancerPhase 1/2NCT00397293
Study of AT-101 in Combination With Topotecan in Relapsed/Refractory Small Cell Lung Cancer
A Phase 1/2 study testing AT-101 and topotecan in people with Small Cell Lung Cancer, run by Ascenta Therapeutics at 19 sites in 3 countries.
Trial summary
This is an open label, multicenter Phase I/II study to evaluate the safety and efficacy of AT-101 in combination with topotecan in relapsed/refractory 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?
- AT-101 and topotecan
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 36 participants
- Where
- 19 sitesin 3 countries
- Study dates
- Nov 2006to Dec 2008
- Phase
- Phase 1/2
- 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
- Histologically or cytologically confirmed small cell lung cancer (SCLC). Mixed histology will not be eligible.
- Progression of disease after only one prior platinum containing chemotherapy regimen. Prior Regimen must not have contained irinotecan
- All patients must have measurable disease.
- Patients may have received prior radiation therapy but they must have recovered from all treatment-related toxicities.
- ECOG performance status 0-1
- Adequate hematologic function
- Adequate liver and renal function
- Ability to swallow oral medication
Who cannot join
- Patients with more than one prior regimen of chemotherapy or prior regimen that did not contain a platinum agent. Note: Patient who stopped prior therapy due to toxicity or had less than 2 cycles of platinum based therapy would not be eligible for the phase II portion of this study.
- Prior chemotherapy regimen containing irinotecan.
- Active secondary malignancy.
- Unstable or progressive brain metastases.
- Prior history of radiation therapy to > 25% of the bone marrow.
- Uncontrolled concurrent illness including, but not limited to: serious uncontrolled infection, symptomatic congestive heart failure (CHF), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with the study requirements.
- Failure to recover from toxicities related to prior therapy (e.g., surgery, radiation, chemotherapy).
Trial locations and contacts
19 sites in 3 countries.
19 sites in 3 countries
United States17 sites
Study site
Austin, Texas, 78705
Study site
Birmingham, Alabama, 35233
Study site
Boston, Massachusetts, 02114
Study site
Burlington, Vermont, 05405
Study site
Columbia, South Carolina
Study site
Germantown, Tennessee
Study site
High Point, North Carolina
Study site
Hilton Head Island, South Carolina
Study site
Hot Springs, Arkansas
Study site
Huntington, West Virginia
Study site
Jacksonville, Florida
Study site
Lake City, Florida
Study site
Lebanon, New Hampshire
Study site
Loma Linda, California, 92354
Study site
Portland, Oregon, 97213
Study site
Rochester, Minnesota, 55905
Study site
Stamford, Connecticut
About this study
Official title: An Open-label, Multicenter, Phase I/II Study of AT-101 in Combination With Topotecan in Patients With Relapsed or Refractory Small Cell Lung Cancer After Prior Platinum Containing First Line Chemotherapy
This is an open label, multicenter Phase I/II study to evaluate the safety and efficacy of AT-101 in combination with topotecan in relapsed/refractory small cell lung cancer
Read the detailed description
Further Study Details provided by Ascenta:
- Conditions
- Small Cell Lung Cancer
- Being tested
- AT-101, topotecan
- Keywords
- AT101, AT-101, cancer, lung, small-cell, topotecan
- Medical subject headings
- Small Cell Lung Carcinoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AT-101Drug
40 mg of AT-101 (by mouth) on days 1-5 of each 21 day cycle with topotecan 1.25 mg/m2, IV (in the vein) on days 1-5 of each 21 day cycle for approx. 4 cycles or until progression or unacceptable toxicity develops.
topotecanDrug
40 mg of AT-101 (by mouth) on days 1-5 of each 21 day cycle with topotecan 1.25 mg/m2, IV (in the vein) on days 1-5 of each 21 day cycle for approx. 4 cycles or until progression or unacceptable toxicity develops.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events.
Measured: 13 months
Secondary outcomes (1)
complete or partial remission of disease
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2006 (estimated)
- Study startNov 2006
- Primary completionDec 2008
- Study completionDec 2008
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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ascenta Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Lance Leopold, MD, Study chair, Ascenta Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00397293
- Sponsor's protocol ID
- AT-101-CS-101
- Status last verified
- Aug 2010
- First submitted
- 7 Nov 2006
- Last updated
- 24 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter, Phase I/II Study of AT-101 in Combination With Topotecan in Patients With Relapsed or Refractory Small Cell Lung Cancer After Prior Platinum Containing First Line Chemotherapy
- ClinicalTrials.gov ID
- NCT00397293
- Acronym / sponsor ID
- AT-101-CS-101
- Conditions
- Small Cell Lung Cancer
- Keywords
- AT101, AT-101, cancer, lung, small-cell, topotecan
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Ascenta TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 9 Nov 2006 (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.
This is an open label, multicenter Phase I/II study to evaluate the safety and efficacy of AT-101 in combination with topotecan in relapsed/refractory small cell lung cancer
Detailed description
Further Study Details provided by Ascenta:
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 (8 listed)
- Histologically or cytologically confirmed small cell lung cancer (SCLC). Mixed histology will not be eligible.
- Progression of disease after only one prior platinum containing chemotherapy regimen. Prior Regimen must not have contained irinotecan
- All patients must have measurable disease.
- Patients may have received prior radiation therapy but they must have recovered from all treatment-related toxicities.
- ECOG performance status 0-1
Key exclusion criteria (7 listed)
- Patients with more than one prior regimen of chemotherapy or prior regimen that did not contain a platinum agent. Note: Patient who stopped prior therapy due to toxicity or had less than 2 cycles of platinum based therapy would not be eligible for the phase II portion of this study.
- Prior chemotherapy regimen containing irinotecan.
- Active secondary malignancy.
- Unstable or progressive brain metastases.
- Prior history of radiation therapy to > 25% of the bone marrow.
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 |
|---|---|---|
| AT-10140 mg of AT-101 (by mouth) on days 1-5 of each 21 day cycle with topotecan 1.25 mg/m2, IV (in the vein) on days 1-5 of each 21 day cycle for approx. 4 cycles or until progression or unacceptable toxicity develops. | Drug | – |
| topotecan40 mg of AT-101 (by mouth) on days 1-5 of each 21 day cycle with topotecan 1.25 mg/m2, IV (in the vein) on days 1-5 of each 21 day cycle for approx. 4 cycles or until progression or unacceptable toxicity develops. | Drug | – |
Primary outcome
Number of participants with adverse events.
Time frame: 13 months
1 secondary outcome
complete or partial remission of disease
Time frame: 16 months
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 2010.
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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.
Lance Leopold, MD study chair
Ascenta Therapeutics, Inc.
19 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AT-101 and topotecan in people with Small Cell Lung Cancer, run by Ascenta Therapeutics at 19 sites in 3 countries.
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 8 inclusion and 7 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 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Russia, Ukraine. 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 combined 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.
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?
Number of participants with adverse events. (time frame: 13 months). 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 2010.