Lung CancerPhase 1/2NCT00354562
A Phase 2 Study Evaluating ABT-751 in Combination With Taxotere in Advanced Non-Small Cell Lung Cancer
A Phase 1/2 study testing ABT-751 and Docetaxel in people with Lung Cancer and Non-Small Cell Lung Cancer, run by Abbott at 32 sites in 4 countries.
Trial summary
To determine the efficacy of ABT-751 when administered in combination with standard docetaxel in subjects with advanced or metastatic NSCLC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Non-Small Cell Lung Cancer
- What is being tested?
- ABT-751 and Docetaxel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 32 sitesin 4 countries
- Study dates
- Feb 2007to Feb 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
- Pathologically documented NSCLC
- Locally advanced (Stage III) or metastatic (Stage IV) NSCLC
- Only one prior anti-tumor treatment regimen in the non-curative setting (i.e., 2nd-line therapy)
- Only one prior anti-tumor treatment regimen in the curative setting
- Progressive disease following the previous anti-tumor treatment regimen
- Measurable disease by RECIST criteria
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- Brain metastasis must be stable and well-controlled
- ECOG performance score 0-2All anti-tumor therapy discontinued at least 3 weeks prior to study entryAll adverse events from prior treatment are resolved or stableAdequate hematologic, renal, and hepatic functionFemales must not be pregnantWilling to take adequate measures to prevent pregnancyLife expectancy of at least 3 monthsAble to complete the Quality of Life questionnaireVoluntarily signed informed consent
- Only one prior anti-tumor treatment regimen in the curative setting
- Progressive disease following the previous anti-tumor treatment regimen
- Measurable disease by RECIST criteria
- Brain metastasis must be stable and well-controlled
- ECOG performance score 0-2
- All anti-tumor therapy discontinued at least 3 weeks prior to study entry
- All adverse events from prior treatment are resolved or stable
- Adequate hematologic, renal, and hepatic function
- Females must not be pregnant
- Willing to take adequate measures to prevent pregnancy
- Life expectancy of at least 3 months
- Able to complete the Quality of Life questionnaire
- Voluntarily signed informed consent
Who cannot join
- Greater that Grade 1 neurological findings
- Allergy to sulfa medications
- Previous treatment with ABT-751 or docetaxel
- Receipt of more than one investigational agent for NSCLC
- Significant weight loss (>10%) within 6 weeks of study entry
- Glucose-6-phosphate dehydrogenase deficiency or porphyria
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- Significant systemic disease that would adversely affect participation
- Class 3-4 New York Heart Association classification status
- Other cancers except in situ carcinoma of the cervix, basal or squamous cell skin cancer, or any other cancer considered adequately treated and cured by the investigator
Trial locations and contacts
32 sites in 4 countries.
32 sites in 4 countries
United States13 sites
Site Ref # / Investigator 3572
Birmingham, Alabama, 35294-3300
Site Ref # / Investigator 3569
Buffalo, New York, 14215
Site Ref # / Investigator 4771
Burbank, California, 91505
Site Ref # / Investigator 3511
Cleveland, Ohio, 44195
Site Ref # / Investigator 3551
Crossville, Tennessee, 38555
Site Ref # / Investigator 3512
Gurnee, Illinois, 60031
Site Ref # / Investigator 3565
Hackensack, New Jersey, 07601
Site Ref # / Investigator 3549
Knoxville, Tennessee, 37920
Site Ref # / Investigator 3571
Nashville, Tennessee, 37232-6307
Site Ref # / Investigator 3574
Orange, California, 92868-3298
Site Ref # / Investigator 3567
Rancho Mirage, California, 92270
Site Ref # / Investigator 5237
Ravenna, Ohio, 44266
Site Ref # / Investigator 3510
Weston, Wisconsin, 54476
Canada7 sites
Site Ref # / Investigator 3559
Barrie, Ontario, L4M 6M2
Site Ref # / Investigator 3561
Greater Sudbury, Ontario, P3E 5J1
Site Ref # / Investigator 3560
Greenfield Park, Quebec, J4V 2H1
Site Ref # / Investigator 3562
Montreal, Quebec, H2W 1S6
Site Ref # / Investigator 2222
Montreal, Quebec, H3T 1E2
Site Ref # / Investigator 3558
Regina, Saskatchewan, S4T 7T1
Site Ref # / Investigator 3563
Sydney, Nova Scotia, B1P 1P3
United Kingdom7 sites
Site Ref # / Investigator 5259
Belfast, BT9 7AB
Site Ref # / Investigator 5270
East Barming, ME16 9QQ
Site Ref # / Investigator 5271
Edinburgh, EH42XU
Site Ref # / Investigator 5017
Glasgow, G12 0YN
Site Ref # / Investigator 5274
Hull, HU8 9HE
Site Ref # / Investigator 5273
Surrey, GU2 7XX
Site Ref # / Investigator 5268
Surrey, SM2 5NG
Ireland5 sites
Site Ref # / Investigator 5097
Cork
Site Ref # / Investigator 4971
Dublin
Site Ref # / Investigator 4986
Dublin
Site Ref # / Investigator 4999
Dublin
Site Ref # / Investigator 5158
Dublin
About this study
Official title: A Phase 1/2 Study Evaluating the Safety and Efficacy of ABT-751 in Combination With Docetaxel Versus Docetaxel Alone in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer
To determine the efficacy of ABT-751 when administered in combination with standard docetaxel in subjects with advanced or metastatic NSCLC.
- Conditions
- Lung Cancer, Non-Small Cell Lung Cancer
- Being tested
- ABT-751, Placebo, Docetaxel
- Keywords
- Lung Cancer, Non-Small Cell Lung Cancer, NSCLC, ABT-751, docetaxel, Taxotere
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-751Drug
200mg ABT-751 daily for 14 days every 21 days
PlaceboDrug
Placebo daily for 14 days every 21 days
DocetaxelDrug
Also called Taxotere
Standard Docetaxel every 21 days
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Docetaxel + ABT-751 Receives: Drug: ABT-751; Drug: Docetaxel |
| B | Placebo comparator | Docetaxel + placebo Receives: Drug: Placebo; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival
Measured: Subjects may remain on study until disease progression
Secondary outcomes (3)
Overall Survival
Measured: Subject may remain on study until disease progression
Response Rate
Measured: Subject may remain on study until disease progression
Time-to-Progression (TTP)
Measured: Subject may remain on study until disease progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2006 (estimated)
- Study startFeb 2007
- Primary completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Helen Eliopoulos, MD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00354562
- Sponsor's protocol ID
- M05-782
- Other IDs
- 2006-002838-38
- Status last verified
- Sep 2010
- First submitted
- 18 Jul 2006
- Last updated
- 7 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study Evaluating the Safety and Efficacy of ABT-751 in Combination With Docetaxel Versus Docetaxel Alone in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00354562
- Acronym / sponsor ID
- M05-782
- Conditions
- Lung Cancer, Non-Small Cell Lung Cancer
- Keywords
- Lung Cancer, Non-Small Cell Lung Cancer, NSCLC, ABT-751, docetaxel, Taxotere
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 75 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Feb 2008 (actual)
- First posted
- 20 Jul 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.
To determine the efficacy of ABT-751 when administered in combination with standard docetaxel in subjects with advanced or metastatic NSCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: ABT-751, Drug: DocetaxelDocetaxel + ABT-751 |
| B | Placebo comparator | Drug: Placebo, Drug: DocetaxelDocetaxel + placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Pathologically documented NSCLC
- Locally advanced (Stage III) or metastatic (Stage IV) NSCLC
- Only one prior anti-tumor treatment regimen in the non-curative setting (i.e., 2nd-line therapy)
- Only one prior anti-tumor treatment regimen in the curative setting
- Progressive disease following the previous anti-tumor treatment regimen
Key exclusion criteria (9 listed)
- Greater that Grade 1 neurological findings
- Allergy to sulfa medications
- Previous treatment with ABT-751 or docetaxel
- Receipt of more than one investigational agent for NSCLC
- Significant weight loss (>10%) within 6 weeks of study entry
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 |
|---|---|---|
| ABT-751200mg ABT-751 daily for 14 days every 21 days | Drug | A |
| PlaceboPlacebo daily for 14 days every 21 days | Drug | B |
| DocetaxelAlso: TaxotereStandard Docetaxel every 21 days | Drug | A, B |
Primary outcome
Progression-free Survival
Time frame: Subjects may remain on study until disease progression
3 secondary outcomes
Overall Survival
Time frame: Subject may remain on study until disease progression
Response Rate
Time frame: Subject may remain on study until disease progression
Time-to-Progression (TTP)
Time frame: Subject may remain on study until disease progression
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2011.
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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.
Helen Eliopoulos, MD study director
Abbott
32 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ABT-751 and Docetaxel in people with Lung Cancer and Non-Small Cell Lung Cancer, run by Abbott at 32 sites in 4 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 21 inclusion and 9 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: stopped early, as of the sponsor's last update on 7 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, Canada, United Kingdom, Ireland. 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 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 was stopped early. Results are not available in the source record.
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?
Progression-free Survival (time frame: Subjects may remain on study until disease progression). 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 7 Jan 2011; AzTrials last refreshed its copy on 27 Oct 2026.