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.
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
Show all 10Show fewer
- 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
Show all 20Show fewer
- 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.
2 sites in 2 countries
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
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
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
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.
Related trials for Lung Cancer, Non-Small Cell
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)
Non-Small Cell Lung Cancer (NSCLC)
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
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?
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.