Lung Cancer, Non-Small CellPhase 2NCT00871403

Study of Pazopanib and Pemetrexed in Advanced Non-small Cell Lung Cancer

A Phase 2 study testing pazopanib and pemetrexed and pemetrexed and cisplatin in people with Lung Cancer, Non-Small Cell, run by GlaxoSmithKline at 2 sites in 2 countries.

Completed

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

Official record

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Trial summary

The main purpose of this study is to determine whether the combination of pazopanib and pemetrexed is safe and effective in the treatment of advanced non-small cell lung cancer (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
What is being tested?: pazopanib and pemetrexed and pemetrexed and cisplatin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 107 participants
Where: 2 sitesin 2 countries
Study dates: Jul 2009to Mar 2011
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Written informed consent
At least 18 years old
Histologically- or cytologically-confirmed diagnosis of predominantly nonsquamous cell Stage IIIBwet (with confirmed malignant pleural effusion) or Stage IV NSCLC
No prior systemic first-line therapy for advanced NSCLC
Measurable disease
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

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Life expectancy of at least 12 weeks
Able to swallow and retain oral medication
Adequate organ system function (hematological, hepatic, and renal)
Non-childbearing potential (i.e., physiologically incapable of becoming pregnant) OR childbearing potential, and agrees to use adequate contraception. A male with a female partner of childbearing potential is eligible if he uses a barrier method of contraception or abstinence during the study

Who cannot join

Active malignancy or any malignancy in the 3 years prior to first dose of study drug other than NSCLC
Central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for asymptomatic, previously treated CNS metastases
Clinically significant gastrointestinal abnormalities
Prolongation of corrected QT interval (QTc) > 480 msecs
History of any one or more cardiovascular conditions within the past 6 months prior to randomization
Poorly controlled hypertension

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History of cerebrovascular accident (including transient ischemic attacks), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months
Major surgery or trauma within 28 days or any non-healing wound, fracture, or ulcer
Evidence of active bleeding or bleeding diathesis
Recent hemoptysis
Endobronchial lesions and/or lesions infiltrating major pulmonary vessels
Serious and/or unstable pre-existing medical (e.g., uncontrolled infection), psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures
Use of any prohibited medication
Use of an investigational agent within 28 days or 5 half-lives, whichever is longer, prior to the first dose of study drug
Ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in severity except alopecia
Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib, pemetrexed, and/or cisplatin
Inability to interrupt aspirin or other non-steroidal anti-inflammatory drugs during the study
Inability or unwillingness to take folic acid, vitamin B12 supplementation, or dexamethasone
Clinically significant third-space fluid collections (e.g., ascites or pleural effusions) that cannot be controlled by drainage or other procedures prior to study start
Recent or concurrent yellow fever vaccination

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

Denmark1 site

GSK Investigational Site
Herlev, 2730

Other trials in Denmark

United Kingdom1 site

GSK Investigational Site
Sutton, Surrey, SM2 5PT

Other trials in United Kingdom

About this study

Official title: An Open-label, Multicentre, Randomised Phase II Study of Pazopanib in Combination With Pemetrexed in First-line Treatment of Subjects With Predominantly Non-squamous Cell Stage IIIBwet/IV Non-small Cell Lung Cancer

The main purpose of this study is to determine whether the combination of pazopanib and pemetrexed is safe and effective in the treatment of advanced non-small cell lung cancer (NSCLC).

Conditions: Lung Cancer, Non-Small Cell
Being tested: pazopanib and pemetrexed, pemetrexed and cisplatin
Keywords: GW786034, pazopanib, pemetrexed, cisplatin, non-small cell lung cancer, NSCLC
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.

pazopanib and pemetrexedDrug
oral pazopanib 600 mg once daily and pemetrexed intravenous (IV) 500mg/m^2 once every 3 weeks, then pazopanib 800 mg once daily
pemetrexed and cisplatinDrug
pemetrexed IV 500 mg/m^2 and cisplatin IV 75 mg/m^2 once every 3 weeks

Study groups in NCT00871403
Study group	Role	What they receive
Arm 1	Experimental	Investigational treatment (pazopanib and pemetrexed) Receives: Drug: pazopanib and pemetrexed
Arm 2	Active comparator	Standard treatment (pemetrexed and cisplatin) Receives: Drug: pemetrexed and cisplatin

What is being measured

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

Progression-free Survival (PFS)
PFS is defined as the interval between the date of randomization (date on which the investigator evaluated the participant and first determined he/she had disease progression) and the first occurrence of progressive disease (PD) or death from any cause. Per Response Evaluation Criteria in Solid Tumors (RECIST), version 1, PD is defined as a >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of >=1 new lesion).
Measured: Randomization until progression or death (up to 85 weeks)

Secondary outcomes (3)

Overall Survival (OS)
OS was determined from the date of randomization to the date of death from any cause. Participants who had not died at the time of the cut-off for the final analysis were censored at the date the participants were last known to be alive. Because enrollment in the study was halted prematurely, the ability to achieve an estimate of OS was compromised. Consequently, OS was not estimated.
Measured: Randomization until death (up to 85 weeks)
Best Overall Response, Assessed as the Number of Participants With the Indicated Tumor Response: Investigator Assessed Only
Tumor response was assessed by the Investigator according to the RECIST, version 1.0. A participant was defined as a responder if he/she sustained a complete response (CR; the disappearance of all target lesions) or partial response (PR; >=30% decrease in the sum of the longest diameter of target lesions) for at least 4 weeks at any time during randomized treatment. Stable disease is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started.
Measured: Randomization until response or progressive disease (up to 85 weeks)
Percentage of Participants With a Complete Response or a Partial Response
The percentage of participants with a complete response or a partial response was evaluated.
Measured: Randomization until response or progressive disease (up to 85 weeks)

Timeline

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

Jul 2009Mar 2011

First posted30 Mar 2009 (estimated)
Study startJul 2009
Primary completionMar 2011
Study completionMar 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Lung Cancer, Non-Small CellStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 107 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00871403
Sponsor's protocol ID: 111128
Status last verified: Mar 2012
First submitted: 26 Mar 2009
Last updated: 20 Jun 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Multicentre, Randomised Phase II Study of Pazopanib in Combination With Pemetrexed in First-line Treatment of Subjects With Predominantly Non-squamous Cell Stage IIIBwet/IV Non-small Cell Lung Cancer
ClinicalTrials.gov ID: NCT00871403
Acronym / sponsor ID: 111128
Conditions: Lung Cancer, Non-Small Cell
Keywords: GW786034, pazopanib, pemetrexed, cisplatin, non-small cell lung cancer, NSCLC
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 107 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Jul 2009
Primary completion: Mar 2011 (actual)
Study completion: Mar 2011 (actual)
First posted: 30 Mar 2009 (estimated)
Results: Posted 16 Feb 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The main purpose of this study is to determine whether the combination of pazopanib and pemetrexed is safe and effective in the treatment of advanced non-small cell lung cancer (NSCLC).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arm 1	Experimental	Drug: pazopanib and pemetrexedInvestigational treatment (pazopanib and pemetrexed)
Arm 2	Active comparator	Drug: pemetrexed and cisplatinStandard treatment (pemetrexed and cisplatin)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Written informed consent
At least 18 years old
Histologically- or cytologically-confirmed diagnosis of predominantly nonsquamous cell Stage IIIBwet (with confirmed malignant pleural effusion) or Stage IV NSCLC
No prior systemic first-line therapy for advanced NSCLC
Measurable disease

Key exclusion criteria (20 listed)

Active malignancy or any malignancy in the 3 years prior to first dose of study drug other than NSCLC
Central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for asymptomatic, previously treated CNS metastases
Clinically significant gastrointestinal abnormalities
Prolongation of corrected QT interval (QTc) > 480 msecs
History of any one or more cardiovascular conditions within the past 6 months prior to randomization

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
pazopanib and pemetrexedoral pazopanib 600 mg once daily and pemetrexed intravenous (IV) 500mg/m^2 once every 3 weeks, then pazopanib 800 mg once daily	Drug	Arm 1
pemetrexed and cisplatinpemetrexed IV 500 mg/m^2 and cisplatin IV 75 mg/m^2 once every 3 weeks	Drug	Arm 2

Primary outcome

Progression-free Survival (PFS)
Time frame: Randomization until progression or death (up to 85 weeks)
PFS is defined as the interval between the date of randomization (date on which the investigator evaluated the participant and first determined he/she had disease progression) and the first occurrence of progressive disease (PD) or death from any cause. Per Response Evaluation Criteria in Solid Tumors (RECIST), version 1, PD is defined as a >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of >=1 new lesion).

3 secondary outcomes

Overall Survival (OS)
Time frame: Randomization until death (up to 85 weeks)
Best Overall Response, Assessed as the Number of Participants With the Indicated Tumor Response: Investigator Assessed Only
Time frame: Randomization until response or progressive disease (up to 85 weeks)
Percentage of Participants With a Complete Response or a Partial Response
Time frame: Randomization until response or progressive disease (up to 85 weeks)

Results and safety

Results posted to the registry on 16 Feb 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pazopanib 600 mg Plus Pemetrexed 500 mg/m^2	9	0
Pazopanib 800 mg Plus Pemetrexed 500 mg/m^2	62	13
Cisplatin 75 mg/m^2 Plus Pemetrexed 500 mg/m^2	35	23

Primary outcome: Progression-free Survival (PFS)

Time frame: Randomization until progression or death (up to 85 weeks). Median (95% Confidence Interval). Unit: weeks

Measure	Pazopanib 800 mg Plus Pemetrexed 500 mg/m^2 n = 62	Cisplatin 75 mg/m^2 Plus Pemetrexed 500 mg/m^2 n = 35
Value	25.0 (17.3 to 34.1)	22.9 (18.4 to 27.7)

Pazopanib 800 mg Plus Pemetrexed 500 mg/m^2 vs Cisplatin 75 mg/m^2 Plus Pemetrexed 500 mg/m^2: Hazard Ratio (HR): 0.75 (95% CI 0.43 to 1.28), p = 0.2647, Log Rank

Population analysed: Intent-to-Treat (ITT) Population: all participants randomized to receive treatment and who were analyzed based on the assigned randomized treatment and not based on actual treatment received/not received. Participants who had neither progressed nor died were censored at the date of the last adequate tumor assessment at the time of the cut-off.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pazopanib 600 mg Plus Pemetrexed 500 mg/m^2	3 of 8 (37.5%)	7 of 8 (87.5%)	Not reported
Pazopanib 800 mg Plus Pemetrexed 500 mg/m^2	34 of 61 (55.7%)	59 of 61 (96.7%)	Not reported
Cisplatin 75 mg/m^2 Plus Pemetrexed 500 mg/m^2	12 of 34 (35.3%)	32 of 34 (94.1%)	Not reported

Limitations and caveats (from the sponsor): Efficacy data were only summarized for the pazopanib (pazo.) 800 mg + pemetrexed (peme.) 500 mg/m\^2 and the cisplatin 75 mg/m\^2 + peme. 500 mg/m\^2 arms due to the small sample size/short treatment duration in the pazo. 600 mg + peme. 500 mg/m\^2 arm.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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
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RecruitingPhase 3
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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.

GSK Clinical Trials study director

GlaxoSmithKline

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing pazopanib and pemetrexed and pemetrexed and cisplatin in people with Lung Cancer, Non-Small Cell, run by GlaxoSmithKline at 2 sites in 2 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 10 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 20 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Denmark, United Kingdom. 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. 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?

Yes. Results are posted in the registry (first posted 16 Feb 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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: Randomization until progression or death (up to 85 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 NCT00871403.

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 20 Jun 2013.