Lung CancerPhase 1/2NCT00297089
A Phase 1/2 Study Evaluating ABT-751 in Combination With Alimta in Advanced Non-Small Cell Lung Cancer
A Phase 1/2 study testing ABT-751 and pemetrexed in people with Lung Cancer and NSCLC, run by AbbVie (prior sponsor, Abbott) at 48 sites in 6 countries.
Trial summary
To determine the efficacy of ABT-751 when administered in combination with standard pemetrexed in subjects with advanced or metastatic NSCLC. The Phase 1 portion of the study is complete and the study is currently enrolling subjects in Phase 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, NSCLC, Non-Small-Cell Lung Cancer
- What is being tested?
- ABT-751 and pemetrexed
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- 48 sitesin 6 countries
- Study dates
- Nov 2006to Jan 2009
- 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 0-2
- 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 than Grade 1 neurological findings
- Allergy to sulfa medications
- Previous treatment with ABT-751 or pemetrexed
- 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
48 sites in 6 countries.
48 sites in 6 countries
United States27 sites
Site Reference ID/Investigator# 3807
Atlanta, Georgia, 30309
Site Reference ID/Investigator# 2416
Baltimore, Maryland, 21229
Site Reference ID/Investigator# 2244
Baltimore, Maryland, 21231-1000
Site Reference ID/Investigator# 3354
Bethelem, Pennsylvania, 18015
Site Reference ID/Investigator# 2401
Bethesda, Maryland, 20817
Site Reference ID/Investigator# 2414
Bristol, Tennessee, 37620
Site Reference ID/Investigator# 3353
Chicago, Illinois, 60637
Site Reference ID/Investigator# 2413
Columbus, Ohio, 43235
Site Reference ID/Investigator# 3358
Fayetteville, Arkansas, 72703
Site Reference ID/Investigator# 2417
Fort Collins, Colorado, 80524
Site Reference ID/Investigator# 2411
Fort Lauderdale, Florida, 33316
Site Reference ID/Investigator# 2127
Greenbrae, California, 94904
Site Reference ID/Investigator# 4102
Hot Springs, Arkansas, 71913
Site Reference ID/Investigator# 2242
Huntersville, North Carolina, 28078
Site Reference ID/Investigator# 3359
Indianapolis, Indiana, 46256
Site Reference ID/Investigator# 2418
Jefferson City, Missouri, 65109
Site Reference ID/Investigator# 2075
Kalamazoo, Michigan, 49048
Site Reference ID/Investigator# 5098
Lake Success, New York, 11042
Site Reference ID/Investigator# 3363
Lakeland, Florida, 33805
Site Reference ID/Investigator# 3357
Lebanon, New Hampshire, 03756
Site Reference ID/Investigator# 3793
Peabody, Massachusetts, 01960
Site Reference ID/Investigator# 6006
Philadelphia, Pennsylvania, 19141
Site Reference ID/Investigator# 3352
Port Saint Lucie, Florida, 34952
Site Reference ID/Investigator# 4170
St Louis, Missouri, 63110-0250
Site Reference ID/Investigator# 2070
Tacoma, Washington, 98405
Site Reference ID/Investigator# 5690
Torrington, Connecticut, 06790
Site Reference ID/Investigator# 3362
Worcester, Massachusetts, 01608
Czechia9 sites
Site Reference ID/Investigator# 4687
Brno, 62500
Site Reference ID/Investigator# 3337
Brno, 656 53
Site Reference ID/Investigator# 4278
Kyjov, 69733
Site Reference ID/Investigator# 3328
Nový Jičín, 741 01
Site Reference ID/Investigator# 3327
Olomouc, 775 20
Site Reference ID/Investigator# 3343
Ostrava-Poruba, 708 52
Site Reference ID/Investigator# 3344
Prague, 128 08
Site Reference ID/Investigator# 3342
Prague, 140 59
Site Reference ID/Investigator# 3411
Příbram, 262 04
Netherlands4 sites
Site Reference ID/Investigator# 3409
Amsterdam, 1081 HV
Site Reference ID/Investigator# 3319
Eindhoven, 5623 EJ
Site Reference ID/Investigator# 3341
Haraderwijk, 3844 DG
Site Reference ID/Investigator# 3528
Hoorn, 1624 NP
Greece3 sites
Site Reference ID/Investigator# 3405
Heraklion, 71110
Site Reference ID/Investigator# 3403
Thessaloniki, 54007
Site Reference ID/Investigator# 3406
Thessaloniki, 56403
Hungary3 sites
Site Reference ID/Investigator# 3331
Budapest, H-1529
Site Reference ID/Investigator# 3333
Miskolc, 3529
Site Reference ID/Investigator# 3332
Székesfehérvár, 8000
Slovakia2 sites
Site Reference ID/Investigator# 3400
Bratislava, 826 06
Site Reference ID/Investigator# 3410
Martin, 036 59
About this study
Official title: A Phase 1/2 Study Evaluating the Safety and Efficacy of ABT 751 in Combination With Pemetrexed Versus Pemetrexed 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 pemetrexed in subjects with advanced or metastatic NSCLC. The Phase 1 portion of the study is complete and the study is currently enrolling subjects in Phase 2.
- Conditions
- Lung Cancer, NSCLC, Non-Small-Cell Lung Cancer
- Being tested
- ABT-751, pemetrexed, placebo
- Keywords
- Lung Cancer, ABT-751, NSCLC, Alimta, Non-Small-Cell Lung Cancer, pemetrexed
- 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
200 mg ABT-751 daily for 14 days every 21 days
pemetrexedDrug
Also called Alimta
Standard pemetrexed every 21 days
placeboDrug
Placebo daily for 14 days every 21 days
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Pemetrexed + ABT-751 Receives: Drug: ABT-751; Drug: pemetrexed |
| B | Placebo comparator | Pemetrexed + placebo Receives: Drug: pemetrexed; Drug: placebo |
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: Subjects may remain on study until disease progression.
Response Rate
Measured: Subjects may remain on study until disease progression.
Time-to-Progression (TTP)
Measured: Subjects 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 posted28 Feb 2006 (estimated)
- Study startNov 2006
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gary Gordon, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00297089
- Sponsor's protocol ID
- M05-780
- Other IDs
- 2006-002830-38
- Status last verified
- Jan 2013
- First submitted
- 27 Feb 2006
- Last updated
- 31 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Rudin CM, Mauer A, Smakal M, Juergens R, Spelda S, Wertheim M, Coates A, McKeegan E, Ansell P, Zhou X, Qian J, Pradhan R, Dowell B, Krivoshik A, Gordon G. Phase I/II study of pemetrexed with or without ABT-751 in advanced or metastatic non-small-cell lung cancer. J Clin Oncol. 2011 Mar 10;29(8):1075-82. doi: 10.1200/JCO.2010.32.5944. Epub 2011 Feb 7.
PubMed 21300929
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2013. 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 Pemetrexed Versus Pemetrexed Alone in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00297089
- Acronym / sponsor ID
- M05-780
- Conditions
- Lung Cancer, NSCLC, Non-Small-Cell Lung Cancer
- Keywords
- Lung Cancer, ABT-751, NSCLC, Alimta, Non-Small-Cell Lung Cancer, pemetrexed
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 28 Feb 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 pemetrexed in subjects with advanced or metastatic NSCLC. The Phase 1 portion of the study is complete and the study is currently enrolling subjects in Phase 2.
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: pemetrexedPemetrexed + ABT-751 |
| B | Placebo comparator | Drug: pemetrexed, Drug: placeboPemetrexed + placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 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 than Grade 1 neurological findings
- Allergy to sulfa medications
- Previous treatment with ABT-751 or pemetrexed
- 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-751200 mg ABT-751 daily for 14 days every 21 days | Drug | A |
| pemetrexedAlso: AlimtaStandard pemetrexed every 21 days | Drug | A, B |
| placeboPlacebo daily for 14 days every 21 days | Drug | B |
Primary outcome
Progression-free Survival
Time frame: Subjects may remain on study until disease progression.
3 secondary outcomes
Overall Survival
Time frame: Subjects may remain on study until disease progression.
Response Rate
Time frame: Subjects may remain on study until disease progression.
Time-to-Progression (TTP)
Time frame: Subjects may remain on study until disease progression.
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 31 Jan 2013.
- Derived from this study: PubMed 21300929Rudin CM, Mauer A, Smakal M, Juergens R, Spelda S, Wertheim M, Coates A, McKeegan E, Ansell P, Zhou X, Qian J, Pradhan R, Dowell B, Krivoshik A, Gordon G. Phase I/II study of pemetrexed with or without ABT-751 in advanced or metastatic non-small-cell lung cancer. J Clin Oncol. 2011 Mar 10;29(8):1075-82. doi: 10.1200/JCO.2010.32.5944. Epub 2011 Feb 7.
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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.
Gary Gordon, MD study director
AbbVie
48 sites in 6 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 pemetrexed in people with Lung Cancer and NSCLC, run by AbbVie (prior sponsor, Abbott) at 48 sites in 6 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 16 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: finished, as of the sponsor's last update on 31 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in United States, Czechia, Netherlands, Greece, Hungary and 1 more country. 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 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?
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?
On the ClinicalTrials.gov record for NCT00297089, which also lists 1 linked publication.
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 31 Jan 2013.