Advanced or Metastatic Non-Small Cell Lung CancerPhase 2NCT00716534
Study of Carboplatin/Paclitaxel in Combination With ABT-869 in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
A Phase 2 study testing ABT-869, Carboplatin and Paclitaxel in people with Advanced or Metastatic Non-Small Cell Lung Cancer, run by AbbVie (prior sponsor, Abbott) at 37 sites in 6 countries.
Trial summary
This study is designed to determine the clinical efficacy and toxicity of ABT-869 in combination with carboplatin and paclitaxel in the treatment of 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
- Advanced or Metastatic Non-Small Cell Lung Cancer
- What is being tested?
- ABT-869, Carboplatin and Paclitaxel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 145 participants
- Where
- 37 sitesin 6 countries
- Study dates
- Jun 2008to Apr 2012
- 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
- Subject must be at least 18 years of age.
- Subject must have cytologically or histologically confirmed non-squamous NSCLC
- Subject must have recurrent or advanced (Stage IIIb with pleural or pericardial effusion) or metastatic (Stage IV) disease that is not amenable to surgical resection or radiation with curative intent.
- Subject has measurable disease, defined as at least 1 unidimensional measurable lesion on a computed tomography (CT) scan as defined by RECIST (for subjects in the randomized portion only).
- Subject has an ECOG Performance Score of 0-1.
- Willing to take adequate measures to prevent pregnancy.
Who cannot join
- The subject has NSCLC with a predominant squamous cell histology
- Subject has hypersensitivity to paclitaxel.
- Subject has received any anti-cancer therapy for treatment of NSCLC.
- Subject has received radiation therapy within 21 days of Study Day 1.
- Subject has had major surgery within 21 days.
- Subject has untreated brain or meningeal metastases.
Show all 20Show fewer
- Subject is receiving therapeutic anticoagulation therapy.
- Subject has a central thoracic tumor lesion as defined by location within the hilar structures.
- Subject has proteinuria CTC Grade > 1 at baseline.
- Subject has a history of, or currently exhibits clinically significant cancer related events of bleeding.
- The subject currently exhibits symptomatic or persistent, uncontrolled hypertension defined as diastolic blood pressure (BP) > 90 mm Hg or systolic BP > 140 mm Hg.
- The subject has a history of myocardial infarction, stroke or Transient Ischemic Attack (TIA) within 6 months of Study Day 1.
- The subject has a documented left ventricular (LV) ejection fraction < 50%.
- The subject has known autoimmune disease with renal involvement (i.e., lupus).
- The subject is receiving combination anti-retroviral therapy for HIV.
- The subject has clinically significant uncontrolled condition(s).
- The subject has a history of another active cancer within the past 5 years.
- The subject has active ulcerative colitis, Crohn's disease, celiac disease or any other conditions that interfere with absorption.
- The subject has a medical condition, which in the opinion of the study investigator places them at an unacceptably high risk for toxicities.
- The subject is pregnant or breast feeding.
Trial locations and contacts
37 sites in 6 countries.
37 sites in 6 countries
United States13 sites
Site Reference ID/Investigator# 7179
Atlanta, Georgia, 30322
Site Reference ID/Investigator# 22444
Canton, Ohio, 44718
Site Reference ID/Investigator# 15850
Chandler, Arizona, 85224
Site Reference ID/Investigator# 15847
Cleveland, Ohio, 44195
Site Reference ID/Investigator# 15848
Greensboro, North Carolina, 27403
Site Reference ID/Investigator# 22443
Hackensack, New Jersey, 07601
Site Reference ID/Investigator# 26842
Hershey, Pennsylvania, 17033-0850
Site Reference ID/Investigator# 15851
Lansing, Michigan, 48912
Site Reference ID/Investigator# 15844
Lebanon, New Hampshire, 03756
Site Reference ID/Investigator# 15841
Miami, Florida, 33136
Site Reference ID/Investigator# 15846
Peoria, Arizona, 85381
Site Reference ID/Investigator# 13101
Philadelphia, Pennsylvania, 19106
Site Reference ID/Investigator# 24122
Philadelphia, Pennsylvania, 19107
Brazil7 sites
Site Reference ID/Investigator# 17703
Jaú, 17210-120
Site Reference ID/Investigator# 23522
Porto Alegre, 90050-170
Site Reference ID/Investigator# 15601
Porto Alegre, 90610-000
Site Reference ID/Investigator# 17704
Rio de Janeiro, 20231-050
Site Reference ID/Investigator# 22684
Santo André, 09060-650
Site Reference ID/Investigator# 17702
São Paulo, 01224-010
Site Reference ID/Investigator# 23582
São Paulo, 04024-002
Russia7 sites
Site Reference ID/Investigator# 38003
Kazan', 420029
Site Reference ID/Investigator# 38260
Kirov, 610021
Site Reference ID/Investigator# 18064
Moscow, 115478
Site Reference ID/Investigator# 18065
Moscow, 115478
Site Reference ID/Investigator# 23312
Moscow, 115478
Site Reference ID/Investigator# 18066
Moscow, 143423
Site Reference ID/Investigator# 23562
Saint Petersburg, 198255
Czechia5 sites
Site Reference ID/Investigator# 18964
Kyjov, 69733
Site Reference ID/Investigator# 22504
Náchod, 54769
Site Reference ID/Investigator# 18963
Olomouc, 77520
Site Reference ID/Investigator# 18962
Prague, 12808
Site Reference ID/Investigator# 19022
Pribram V, 26995
Australia4 sites
Site Reference ID/Investigator# 19042
Bedford Park, 5042
Site Reference ID/Investigator# 23682
Cairns, 4870
Site Reference ID/Investigator# 21862
Lismore, 2480
Site Reference ID/Investigator# 19043
Woodville South, 5011
About this study
Official title: A Phase 2 Randomized, Placebo-Controlled, Double-Blind Study of Carboplatin/Paclitaxel in Combination With ABT-869 Versus Carboplatin/Paclitaxel Alone in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) as First-Line Treatment
This study is designed to determine the clinical efficacy and toxicity of ABT-869 in combination with carboplatin and paclitaxel in the treatment of subjects with advanced or metastatic NSCLC.
- Being tested
- ABT-869, Placebo for ABT-869, Carboplatin, Paclitaxel
- Medical subject headings
- 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-869Drug
12.5 mg ABT-869
Placebo for ABT-869Drug
Also called Placebo
Placebo Comparator (12.5 mg or 7.5 mg)
ABT-869Drug
7.5 mg ABT-869
CarboplatinDrug
Carboplatin (AUC 6 mg/mL/min)
PaclitaxelDrug
Paclitaxel (200 mg/m2)
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | 12.5 mg ABT-869 + Carboplatin/Paclitaxel Receives: Drug: ABT-869; Drug: Carboplatin; Drug: Paclitaxel |
| B | Experimental | 7.5 mg ABT-869 + Carboplatin/Paclitaxel Receives: Drug: ABT-869; Drug: Carboplatin; Drug: Paclitaxel |
| C | Placebo comparator | Placebo (7.5 mg or 12.5 mg) + Carboplatin/Paclitaxel Receives: Drug: Placebo for ABT-869; Drug: Carboplatin; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
Measured: Disease Progression
Secondary outcomes (2)
Overall survival, best response rate, time to tumor progression, objective response rate, best percent change in tumor size, duration of response
Measured: Disease Progression
Survival Rate
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 Jul 2008 (estimated)
- Study startJun 2008
- Primary completionApr 2012
- Study completionApr 2012
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 Advanced or Metastatic 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Justin L. Ricker, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00716534
- Sponsor's protocol ID
- M10-301
- Other IDs
- 2007-007107-32
- Status last verified
- Apr 2013
- First submitted
- 14 Jul 2008
- Last updated
- 29 Apr 2013
- Results posted
- No
Publications
Ramalingam SS, Shtivelband M, Soo RA, Barrios CH, Makhson A, Segalla JG, Pittman KB, Kolman P, Pereira JR, Srkalovic G, Belani CP, Axelrod R, Owonikoko TK, Qin Q, Qian J, McKeegan EM, Devanarayan V, McKee MD, Ricker JL, Carlson DM, Gorbunova VA. Randomized phase II study of carboplatin and paclitaxel with either linifanib or placebo for advanced nonsquamous non-small-cell lung cancer. J Clin Oncol. 2015 Feb 10;33(5):433-41. doi: 10.1200/JCO.2014.55.7173. Epub 2015 Jan 5.
PubMed 25559798
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized, Placebo-Controlled, Double-Blind Study of Carboplatin/Paclitaxel in Combination With ABT-869 Versus Carboplatin/Paclitaxel Alone in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) as First-Line Treatment
- ClinicalTrials.gov ID
- NCT00716534
- Acronym / sponsor ID
- M10-301
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Collaborators
- Genentech, Inc.
- Study start
- Jun 2008
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 16 Jul 2008 (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 study is designed to determine the clinical efficacy and toxicity of ABT-869 in combination with carboplatin and paclitaxel in the treatment of subjects with advanced or metastatic NSCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: ABT-869, Drug: Carboplatin, Drug: Paclitaxel12.5 mg ABT-869 + Carboplatin/Paclitaxel |
| B | Experimental | Drug: ABT-869, Drug: Carboplatin, Drug: Paclitaxel7.5 mg ABT-869 + Carboplatin/Paclitaxel |
| C | Placebo comparator | Drug: Placebo for ABT-869, Drug: Carboplatin, Drug: PaclitaxelPlacebo (7.5 mg or 12.5 mg) + Carboplatin/Paclitaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject must be at least 18 years of age.
- Subject must have cytologically or histologically confirmed non-squamous NSCLC
- Subject must have recurrent or advanced (Stage IIIb with pleural or pericardial effusion) or metastatic (Stage IV) disease that is not amenable to surgical resection or radiation with curative intent.
- Subject has measurable disease, defined as at least 1 unidimensional measurable lesion on a computed tomography (CT) scan as defined by RECIST (for subjects in the randomized portion only).
- Subject has an ECOG Performance Score of 0-1.
Key exclusion criteria (20 listed)
- The subject has NSCLC with a predominant squamous cell histology
- Subject has hypersensitivity to paclitaxel.
- Subject has received any anti-cancer therapy for treatment of NSCLC.
- Subject has received radiation therapy within 21 days of Study Day 1.
- Subject has had major surgery within 21 days.
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-86912.5 mg ABT-869 | Drug | A |
| Placebo for ABT-869Also: PlaceboPlacebo Comparator (12.5 mg or 7.5 mg) | Drug | C |
| ABT-8697.5 mg ABT-869 | Drug | B |
| CarboplatinCarboplatin (AUC 6 mg/mL/min) | Drug | A, B, C |
| PaclitaxelPaclitaxel (200 mg/m2) | Drug | A, B, C |
Primary outcome
Progression Free Survival (PFS)
Time frame: Disease Progression
2 secondary outcomes
Overall survival, best response rate, time to tumor progression, objective response rate, best percent change in tumor size, duration of response
Time frame: Disease Progression
Survival Rate
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 29 Apr 2013.
- Derived from this study: PubMed 25559798Ramalingam SS, Shtivelband M, Soo RA, Barrios CH, Makhson A, Segalla JG, Pittman KB, Kolman P, Pereira JR, Srkalovic G, Belani CP, Axelrod R, Owonikoko TK, Qin Q, Qian J, McKeegan EM, Devanarayan V, McKee MD, Ricker JL, Carlson DM, Gorbunova VA. Randomized phase II study of carboplatin and paclitaxel with either linifanib or placebo for advanced nonsquamous non-small-cell lung cancer. J Clin Oncol. 2015 Feb 10;33(5):433-41. doi: 10.1200/JCO.2014.55.7173. Epub 2015 Jan 5.
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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.
Justin L. Ricker, MD study director
AbbVie
37 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ABT-869, Carboplatin and Paclitaxel in people with Advanced or Metastatic Non-Small Cell Lung Cancer, run by AbbVie (prior sponsor, Abbott) at 37 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 6 inclusion and 20 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 29 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States, Brazil, Russia, Czechia, Australia 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 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?
Progression Free Survival (PFS) (time frame: 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 NCT00716534, 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 29 Apr 2013.