Non-small Cell Lung CancerPhase 2NCT00544960
A Randomized Phase 2 Study of AT-101 in Combination With Docetaxel in Relapsed/Refractory Non-Small Cell Lung Cancer
A Phase 2 study testing AT-101 and docetaxel in people with Non-small Cell Lung Cancer, run by Ascenta Therapeutics at 18 sites in 3 countries.
Trial summary
This is a double- blind, multicenter, randomized Phase II study to evaluate the efficacy and safety of AT-101 in combination with docetaxel in relapsed/refractory non-small cell lung cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- AT-101 and docetaxel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 18 sitesin 3 countries
- Study dates
- Sep 2007to Apr 2009
- 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
- Histologically or cytologically confirmed Stage IIIb with pleural/pericardial effusion or Stage IV non-small cell lung cancer (NSCLC).
- Progression of disease after one prior systemic chemotherapeutic regimen for locally advanced or metastatic NSCLC. (Systemic therapies given in the adjuvant setting are counted only if the patient relapses within 6 months of the last cycle of therapy.) In addition to the one prior chemotherapeutic regimen, patients may have received erlotinib in any setting.
- All patients must have measurable disease.
- No unstable or progressive brain metastases.
- Patients may have received prior radiation therapy but they must have recovered from all treatment-related toxicities.
- ECOG performance status 0-1
Show all 9Show fewer
- Adequate hematologic function
- Adequate liver and renal function
- Ability to swallow oral medication
Who cannot join
- Prior chemotherapy regimen containing docetaxel.
- Active secondary malignancy.
- 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
18 sites in 3 countries.
18 sites in 3 countries
Russia10 sites
Research Site
Arkhangelsk
Research Site
Chelyabinsk
Research Site
Kaliningrad
Research Site
Kazan'
Research Site
Moscow
Research Sites (4)
Saint Petersburg
Research Site
Samara
Research Site
Stavropol
Research Site
Voronezh
Research Site
Yekaterinburg
Ukraine7 sites
Research Site
Dnipropetrovsk
Research Site
Donetsk
Research Site
Kharkiv
Research Site
Kyiv
Research Site
Luhansk
Research Site
Uzhhorod
Research Site
Zaporizhzhya
About this study
Official title: A Phase 2, Randomized, 2-Arm, Double-Blind Study of AT-101 in Combination With Docetaxel Versus Docetaxel Plus Placebo in Patients With Relapsed or Refractory Non-Small Cell Lung Cancer (NSCLC)
This is a double- blind, multicenter, randomized Phase II study to evaluate the efficacy and safety of AT-101 in combination with docetaxel in relapsed/refractory non-small cell lung cancer
Read the detailed description
Further Study Details provided by Ascenta.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- AT-101 and docetaxel, placebo and docetaxel
- Keywords
- AT101, AT-101, cancer, lung, non-small cell, docetaxel, bcl
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AT-101 and docetaxelDrug
AT-101 30 mg bid on days 1, 2, and 3 of each 21 day cycle, docetaxel, 75 mg/m2 on day 1 of each 21 day cycle; until progression or unacceptable toxicity develops
placebo and docetaxelDrug
placebo 3 tabs bid on days 1, 2, and 3 of each 21 day cycle, docetaxel, 75 mg/m2 on day 1 of each 21 day cycle; until progression or unacceptable toxicity develops
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | AT-101 and docetaxel Receives: Drug: AT-101 and docetaxel |
| 2 | Placebo comparator | placebo and docetaxel Receives: Drug: placebo and docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of disease remission
Measured: 12 months
Secondary outcomes (1)
number of participants with adverse events
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2007 (estimated)
- Study startSep 2007
- Primary completionNov 2008
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 106 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
- NCT00544960
- Sponsor's protocol ID
- AT-101-CS-204
- Status last verified
- Aug 2010
- First submitted
- 12 Oct 2007
- Last updated
- 27 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, 2-Arm, Double-Blind Study of AT-101 in Combination With Docetaxel Versus Docetaxel Plus Placebo in Patients With Relapsed or Refractory Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT00544960
- Acronym / sponsor ID
- AT-101-CS-204
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- AT101, AT-101, cancer, lung, non-small cell, docetaxel, bcl
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Ascenta TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 16 Oct 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.
This is a double- blind, multicenter, randomized Phase II study to evaluate the efficacy and safety of AT-101 in combination with docetaxel in relapsed/refractory non-small cell lung cancer
Detailed description
Further Study Details provided by Ascenta.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AT-101 and docetaxelAT-101 and docetaxel |
| 2 | Placebo comparator | Drug: placebo and docetaxelplacebo and docetaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically or cytologically confirmed Stage IIIb with pleural/pericardial effusion or Stage IV non-small cell lung cancer (NSCLC).
- Progression of disease after one prior systemic chemotherapeutic regimen for locally advanced or metastatic NSCLC. (Systemic therapies given in the adjuvant setting are counted only if the patient relapses within 6 months of the last cycle of therapy.) In addition to the one prior chemotherapeutic regimen, patients may have received erlotinib in any setting.
- All patients must have measurable disease.
- No unstable or progressive brain metastases.
- Patients may have received prior radiation therapy but they must have recovered from all treatment-related toxicities.
Key exclusion criteria (4 listed)
- Prior chemotherapy regimen containing docetaxel.
- Active secondary malignancy.
- 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).
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-101 and docetaxelAT-101 30 mg bid on days 1, 2, and 3 of each 21 day cycle, docetaxel, 75 mg/m2 on day 1 of each 21 day cycle; until progression or unacceptable toxicity develops | Drug | 1 |
| placebo and docetaxelplacebo 3 tabs bid on days 1, 2, and 3 of each 21 day cycle, docetaxel, 75 mg/m2 on day 1 of each 21 day cycle; until progression or unacceptable toxicity develops | Drug | 2 |
Primary outcome
duration of disease remission
Time frame: 12 months
1 secondary outcome
number of participants with adverse events
Time frame: 12 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 27 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.
18 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AT-101 and docetaxel in people with Non-small Cell Lung Cancer, run by Ascenta Therapeutics at 18 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 9 inclusion and 4 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 27 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 18 sites in Russia, Ukraine, 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. Some participants in this study may receive a placebo. 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?
duration of disease remission (time frame: 12 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 27 Aug 2010; AzTrials last refreshed its copy on 27 Oct 2026.