Non-Small Cell Lung CancerPhase 1NCT01225302

A Study of Linifanib (ABT-869) in Combination With Carboplatin/Paclitaxel in Japanese Subjects With Non-Small Cell Lung Cancer (NSCLC)

A Phase 1 study testing Linifanib, Carboplatin and Paclitaxel in people with Non-Small Cell Lung Cancer, run by AbbVie.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The primary objective of this study is to assess the safety and pharmacokinetics of linifanib, and identify tolerable dose of linifanib (ABT-869) in combination with carboplatin and paclitaxel in Japanese subjects with advanced or metastatic non-small cell lung cancer (NSCLC). Read more about this study

Who is it for?: Ages 20 to 99 years
Conditions the study is for: Non-Small Cell Lung Cancer
What is being tested?: Linifanib, Carboplatin and Paclitaxel
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: No sites listed yet
Study dates: Sep 2010to Jun 2012
Phase: Phase 1
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 20 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

The subject must be 20 and older years of age.
The subject must have cytologically or histologically confirmed non-squamous NSCLC. Subjects may have a mixed histology but must be predominantly non-squamous to be eligible.
The subject must have advanced or metastatic (Stage IV [According to American Joint Committee on Cancer (AJCC) staging manual, 7th edition]) disease that is not amenable to surgical resection or radiation with curative intent.
The subject must have not received prior chemotherapy for NSCLC.
The subject has measurable disease, defined as at least 1 unidimensionally measurable lesion on a CT scan as defined by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
The subject has an Easter Cooperative Oncology Group (ECOG) Performance Score of 0-1.
The subject must have adequate bone marrow, renal and hepatic function.

Who cannot join

The subject has hypersensitivity to paclitaxel or to other drugs formulated with polyethoxylated castor oil (Cremophor).
The subject has received any anti-cancer therapy for treatment of NSCLC including investigational agents, immunotherapy, traditional Chinese medicine/herbal remedies, hormonal, "targeted" agents (i.e., erlotinib, imatinib), biologic therapy or cytotoxic chemotherapy (i.e., alkylating agents, microtubule inhibitors, antimetabolites).
The subject has a history of another active cancer within the past 5 years except cervical cancer in situ, in situ carcinoma of the bladder, squamous cell or basal cell carcinoma of the skin.
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.
The subject has NSCLC with a predominant squamous cell histology.

About this study

Official title: A Phase 1 Study of Linifanib (ABT-869) in Combination With Carboplatin/Paclitaxel in Japanese Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) as First-Line Treatment

Conditions: Non-Small Cell Lung Cancer
Being tested: Linifanib, 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.

LinifanibDrug
Also called ABT-869
Low dose linifanib (once a day)
LinifanibDrug
Also called ABT-869
High dose linifanib (once a day)
CarboplatinDrug
Also called Paraplatin
Given on Day 1 of every 21-day cycle
PaclitaxelDrug
Also called Taxol
Given on Day 1 of every 21-day cycle

Study groups in NCT01225302
Study group	Role	What they receive
Arm A	Experimental	Not described Receives: Drug: Linifanib; Drug: Carboplatin; Drug: Paclitaxel
Arm B	Experimental	Not described Receives: Drug: Linifanib; Drug: Carboplatin; Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety (Number of patients with adverse events and/or dose-limiting toxicities)
Evaluation of vital signs, physical exams, clinical lab testing and adverse event monitoring.
Measured: At each treatment visit (weekly for 6 weeks, then every 3 weeks)

Secondary outcomes (9)

Preliminary tumor response
Computed Tomography (CT) scan
Measured: Week 6
Preliminary tumor response
Computed Tomography (CT) scan
Measured: Week 12
Preliminary tumor response
Computed Tomography (CT) scan
Measured: Week 18
Preliminary tumor response
Computed Tomography (CT) scan
Measured: Week 24
Preliminary tumor response
Computed Tomography (CT) scan
Measured: Week 30
Preliminary tumor response
Computed Tomography (CT) scan
Measured: Week 36
Preliminary tumor response
Computed Tomography (CT) scan
Measured: Week 42
Preliminary tumor response
Computed Tomography (CT) scan
Measured: Week 48
Preliminary tumor response
Computed Tomography (CT) scan
Measured: Week 54

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2010Jun 2012

First posted21 Oct 2010 (estimated)
Study startSep 2010
Primary completionJun 2012
Study completionJun 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 Non-Small Cell Lung CancerStudies of the same condition, open and under way.
More trials run by AbbVieThe sponsor's other registered studies.
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
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01225302
Sponsor's protocol ID: W12-076
Status last verified: Jul 2012
First submitted: 28 Sep 2010
Last updated: 21 Nov 2017
Results posted: No
Data monitoring committee: Yes

Publications

Horinouchi H, Yamamoto N, Nokihara H, Horai T, Nishio M, Ohyanagi F, Horiike A, Nakagawa K, Terashima M, Okabe T, Kaneda H, McKee MD, Carlson DM, Xiong H, Tamura T. A phase 1 study of linifanib in combination with carboplatin/paclitaxel as first-line treatment of Japanese patients with advanced or metastatic non-small cell lung cancer (NSCLC). Cancer Chemother Pharmacol. 2014 Jul;74(1):37-43. doi: 10.1007/s00280-014-2478-9. Epub 2014 May 8.
PubMed 24807459

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
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RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
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Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer

All Non-Small Cell Lung Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Study of Linifanib (ABT-869) in Combination With Carboplatin/Paclitaxel in Japanese Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) as First-Line Treatment
ClinicalTrials.gov ID: NCT01225302
Acronym / sponsor ID: W12-076
Conditions: Non-Small Cell Lung Cancer
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: AbbVieIndustry (pharma, biotech, devices)
Study start: Sep 2010
Primary completion: Jun 2012 (actual)
Study completion: Jun 2012 (actual)
First posted: 21 Oct 2010 (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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arm A	Experimental	Drug: Linifanib, Drug: Carboplatin, Drug: Paclitaxel
Arm B	Experimental	Drug: Linifanib, Drug: Carboplatin, Drug: Paclitaxel

Who may qualify

Ages: 20 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

The subject must be 20 and older years of age.
The subject must have cytologically or histologically confirmed non-squamous NSCLC. Subjects may have a mixed histology but must be predominantly non-squamous to be eligible.
The subject must have advanced or metastatic (Stage IV [According to American Joint Committee on Cancer (AJCC) staging manual, 7th edition]) disease that is not amenable to surgical resection or radiation with curative intent.
The subject must have not received prior chemotherapy for NSCLC.
The subject has measurable disease, defined as at least 1 unidimensionally measurable lesion on a CT scan as defined by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.

Key exclusion criteria (7 listed)

The subject has hypersensitivity to paclitaxel or to other drugs formulated with polyethoxylated castor oil (Cremophor).
The subject has received any anti-cancer therapy for treatment of NSCLC including investigational agents, immunotherapy, traditional Chinese medicine/herbal remedies, hormonal, "targeted" agents (i.e., erlotinib, imatinib), biologic therapy or cytotoxic chemotherapy (i.e., alkylating agents, microtubule inhibitors, antimetabolites).
The subject has a history of another active cancer within the past 5 years except cervical cancer in situ, in situ carcinoma of the bladder, squamous cell or basal cell carcinoma of the skin.
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.

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
LinifanibAlso: ABT-869Low dose linifanib (once a day)	Drug	Arm A
LinifanibAlso: ABT-869High dose linifanib (once a day)	Drug	Arm B
CarboplatinAlso: ParaplatinGiven on Day 1 of every 21-day cycle	Drug	Arm A, Arm B
PaclitaxelAlso: TaxolGiven on Day 1 of every 21-day cycle	Drug	Arm A, Arm B

Primary outcome

Safety (Number of patients with adverse events and/or dose-limiting toxicities)
Time frame: At each treatment visit (weekly for 6 weeks, then every 3 weeks)
Evaluation of vital signs, physical exams, clinical lab testing and adverse event monitoring.

9 secondary outcomes

Preliminary tumor response
Time frame: Week 6
Preliminary tumor response
Time frame: Week 12
Preliminary tumor response
Time frame: Week 18
Preliminary tumor response
Time frame: Week 24
Preliminary tumor response
Time frame: Week 30
Preliminary tumor response
Time frame: Week 36
Preliminary tumor response
Time frame: Week 42
Preliminary tumor response
Time frame: Week 48
Preliminary tumor response
Time frame: Week 54

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 21 Nov 2017.
Results publication: PubMed 24807459Horinouchi H, Yamamoto N, Nokihara H, Horai T, Nishio M, Ohyanagi F, Horiike A, Nakagawa K, Terashima M, Okabe T, Kaneda H, McKee MD, Carlson DM, Xiong H, Tamura T. A phase 1 study of linifanib in combination with carboplatin/paclitaxel as first-line treatment of Japanese patients with advanced or metastatic non-small cell lung cancer (NSCLC). Cancer Chemother Pharmacol. 2014 Jul;74(1):37-43. doi: 10.1007/s00280-014-2478-9. Epub 2014 May 8.

Related trials for Non-Small Cell Lung Cancer

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
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Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
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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.

Susumu Matsuki, BS study director

Abbott Japan Co.,Ltd

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Linifanib, Carboplatin and Paclitaxel in people with Non-Small Cell Lung Cancer, run by AbbVie.

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 7 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 21 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

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 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.

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?

Safety (Number of patients with adverse events and/or dose-limiting toxicities) (time frame: At each treatment visit (weekly for 6 weeks, then every 3 weeks)). 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 NCT01225302, 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 21 Nov 2017.