Lung Cancer, Non-Small CellPhase 2NCT00549328
Monotherapy Pazopanib in Subjects With Advanced Non-Small Cell Lung Cancer
A Phase 2 study testing Pazopanib (GW786034) in people with Lung Cancer, Non-Small Cell, run by GlaxoSmithKline at 13 sites in United States.
Trial summary
This study is designed to evaluate the efficacy and safety of monotherapy pazopanib (a small molecule tyrosine kinase inhibitor of VEGFR-1, VEGFR-2, VEGFR-3, PDGF, and c-kit) in subjects with advanced (Stage IIIB or IV) non-small cell lung cancer. 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 (GW786034)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 13 sitesUnited States
- Study dates
- Feb 2008to Apr 2009
- 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
- Signed consent
- Histologically- or cytologically confirmed diagnosis of Stage IIIB or IV non-small cell lung cancer.
- Failed no more than two prior chemotherapy regimens for Stage IIIB or IV non-small cell lung cancer, including a platinum-containing regimen.
- Brain metastases permitted if subject has been treated with surgery and/or radiation therapy more than 4 weeks prior to date of first dose and is stable for at least one week off steroids.
- 18 years of age or older.
- Eastern Cooperative Oncology Group performance status of at least 2.
Show all 9Show fewer
- Measurable disease according to RECIST.
- Adequate organ system function.
- Females may be eligible to enroll if they are of non-childbearing potential (surgically sterile or post-menopausal)or are using appropriate contraception methods.
Who cannot join
- Prior malignancy - unless disease-free for at least 3 years, or have had completely resected non-melanomatous skin cancer or successfully treated in situ carcinoma.
- History or clinical evidence of central nervous system metastases or leptomeningeal carcinomatosis, except for subjects with previously-treated CNS metastases, who are asymptomatic, and have had no requirement for steroids or anti-seizure medication for one week prior to first dose of study drug.
- Clinically significant gastrointestinal abnormalities.
- Presence of uncontrolled infection.
- Corrected QT interval greater than 480 msec.
- History of significant cardiovascular condition(s).
Show all 15Show fewer
- Poorly controlled hypertension (systolic blood pressure of 140mmHG or greater or diastolic blood pressure of 90mmHg or greater).
- History of cerebrovascular accident, pulmonary embolism, or insufficiently treated deep venous thrombosis within the past 6 months prior to first dose of study drug.
- Major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer.
- Active bleeding or diathesis.
- Hemoptysis in excess of 2.5mL within 8 weeks of first dose of study drug.
- Serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance with study procedures.
- Use of prohibited medications as defined in protocol.
- Use of an investigational agent, including an investigational anti-cancer agent within 28 days, or 5 half-lives, whichever is longer, prior to first dose of study drug.
- Prior use of any investigational or licensed anti-angiogenic agent, including thalidomide and agents that target platelet-derived growth factor. Prior treatment with bevacizumab or epidermal growth factor receptor tyrosine kinase inhibitors
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
GSK Investigational Site
Baton Rouge, Louisiana, 70809
GSK Investigational Site
Buffalo, New York, 14263
GSK Investigational Site
Columbus, Ohio, 43219
GSK Investigational Site
Corpus Christi, Texas, 78463-3069
GSK Investigational Site
Duluth, Minnesota, 55805
GSK Investigational Site
Fort Myers, Florida, 33916
GSK Investigational Site
Newport News, Virginia, 23601
GSK Investigational Site
Orlando, Florida, 32806
GSK Investigational Site
Philadelphia, Pennsylvania, 19106
GSK Investigational Site
Sayre, Pennsylvania, 18840
GSK Investigational Site
Scottsdale, Arizona, 85258
GSK Investigational Site
Seattle, Washington, 98109
GSK Investigational Site
Tulsa, Oklahoma, 74136
About this study
Official title: A Phase II, Non-randomized, Multi-center Study to Evaluate the Efficacy and Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer
This study is designed to evaluate the efficacy and safety of monotherapy pazopanib (a small molecule tyrosine kinase inhibitor of VEGFR-1, VEGFR-2, VEGFR-3, PDGF, and c-kit) in subjects with advanced (Stage IIIB or IV) non-small cell lung cancer.
Read the detailed description
Study 109609 is a single-arm, non-randomized, single-stage Phase II study of pazopanib in subjects with Stage IIIB or IV non-small cell lung cancer who have progressed after one or two prior regimens of systemic therapy. The study will be conducted at a limited number of institutions in the US. A total of 40 evaluable subjects will be enrolled and treated. Pazopanib will be given at a dose of 800mg (as determined by previous Phase I studies) orally once per day. Subjects may continue to receive study drug for up to two years unless they experience disease progression or withdraw from treatment for other reasons, or unless the Sponsor terminates the study. A rollover study may be available to those subjects who are exhibiting clinical benefit (stable disease or better). Evaluable subjects will be assessed for response as the primary endpoint.
- Conditions
- Lung Cancer, Non-Small Cell
- Being tested
- Pazopanib (GW786034)
- Keywords
- anti-angiogenesis, Non-small cell lung cancer,, pazopanib (GW786034)
- 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 (GW786034)Drug
Pazopanib monotherapy
| Study group | Role | What they receive |
|---|---|---|
| Pazopanib Open-label | Experimental | Single-arm, non-randomised, single-stage pazopanib monotherapy. Receives: Drug: Pazopanib (GW786034) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Achieved Either a Confirmed Complete Response or Partial Response Per RECIST Criteria
The best overall response using Response Evaluation Criteria In Solid Tumors (RESIST) was measured. Complete response is defined as the disappearance of all known lesion(s), confirmed at 4 weeks, and partial response is defined as at least a 30% decrease in the sum of the longest diameters of target lesions taken as a reference to baseline sum of the longest diameters, confirmed at 4 weeks. No formal efficacy analyses were performed due to early termination of the study.
Measured: Baseline through End of Study (up to 2 years)
Secondary outcomes (5)
Number of Participants Who Had a Complete or Partial Response, or Stable Disease
Disease control was measured. Stable disease (SD) is defined as neither partial response (at least a 30% decrease in the sum of the longest diameters of target lesions taken as a reference to baseline sum of the longest diameters, confirmed at 4 weeks) nor progressive disease (PD; a 20% increase in the sum of the longest diameters of target lesions, taken as a reference the smallest sum of the longest diameter recorded since the treatment started or the appearance of one or more new lesions. No formal efficacy analyses were performed due to early termination of the study.
Measured: Baseline through End of Study (up to 2 years)
Progression-Free Survival
Progression-free survival is defined as the interval between the start of treatment and the earliest date of disease progression or death due to any cause, whichever occurs first. No formal efficacy analyses were performed due to early termination of the study.
Measured: Baseline through End of Study (up to 2 years)
Overall Survival
Overall survival is defined as the time from the start of treatment until death due to any cause. No formal efficacy analyses were performed due to early termination of the study.
Measured: Baseline through End of Study (up to 2 years)
Levels of Circulating Biomarkers in Plasma
Biomarkers are proteins that respond in a unique way to treatment with the study drug; however, levels of proteins were not collected for this measurement. No formal efficacy analyses were performed due to early termination of the study.
Measured: Baseline through End of Study (up to 2 years)
Characterization of Participant Populations by Identification of Intra-tumoral Biomarkers
Biomarkers are proteins that respond in a unique way to treatment with the study drug; however, levels of proteins were not collected for this measurement. No formal efficacy analyses were performed due to early termination of the study.
Measured: Baseline through End of Study (up to 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2007 (estimated)
- Study startFeb 2008
- Primary completionApr 2009
- Study completionApr 2009
Why it stopped: Study enrolment was delayed in starting and too slow to support further development in this setting
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 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
- NCT00549328
- Sponsor's protocol ID
- 109609
- Status last verified
- Nov 2014
- First submitted
- 23 Oct 2007
- Last updated
- 19 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Non-randomized, Multi-center Study to Evaluate the Efficacy and Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00549328
- Acronym / sponsor ID
- 109609
- Conditions
- Lung Cancer, Non-Small Cell
- Keywords
- anti-angiogenesis, Non-small cell lung cancer,, pazopanib (GW786034)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study enrolment was delayed in starting and too slow to support further development in this setting
- Enrolment
- 14 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 25 Oct 2007 (estimated)
- Results
- Posted 27 Jan 2010
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 evaluate the efficacy and safety of monotherapy pazopanib (a small molecule tyrosine kinase inhibitor of VEGFR-1, VEGFR-2, VEGFR-3, PDGF, and c-kit) in subjects with advanced (Stage IIIB or IV) non-small cell lung cancer.
Detailed description
Study 109609 is a single-arm, non-randomized, single-stage Phase II study of pazopanib in subjects with Stage IIIB or IV non-small cell lung cancer who have progressed after one or two prior regimens of systemic therapy. The study will be conducted at a limited number of institutions in the US. A total of 40 evaluable subjects will be enrolled and treated. Pazopanib will be given at a dose of 800mg (as determined by previous Phase I studies) orally once per day. Subjects may continue to receive study drug for up to two years unless they experience disease progression or withdraw from treatment for other reasons, or unless the Sponsor terminates the study. A rollover study may be available to those subjects who are exhibiting clinical benefit (stable disease or better). Evaluable subjects will be assessed for response as the primary endpoint.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pazopanib Open-label | Experimental | Drug: Pazopanib (GW786034)Single-arm, non-randomised, single-stage pazopanib monotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Signed consent
- Histologically- or cytologically confirmed diagnosis of Stage IIIB or IV non-small cell lung cancer.
- Failed no more than two prior chemotherapy regimens for Stage IIIB or IV non-small cell lung cancer, including a platinum-containing regimen.
- Brain metastases permitted if subject has been treated with surgery and/or radiation therapy more than 4 weeks prior to date of first dose and is stable for at least one week off steroids.
- 18 years of age or older.
Key exclusion criteria (15 listed)
- Prior malignancy - unless disease-free for at least 3 years, or have had completely resected non-melanomatous skin cancer or successfully treated in situ carcinoma.
- History or clinical evidence of central nervous system metastases or leptomeningeal carcinomatosis, except for subjects with previously-treated CNS metastases, who are asymptomatic, and have had no requirement for steroids or anti-seizure medication for one week prior to first dose of study drug.
- Clinically significant gastrointestinal abnormalities.
- Presence of uncontrolled infection.
- Corrected QT interval greater than 480 msec.
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 (GW786034)Pazopanib monotherapy | Drug | Pazopanib Open-label |
Primary outcome
Percentage of Participants Who Achieved Either a Confirmed Complete Response or Partial Response Per RECIST Criteria
Time frame: Baseline through End of Study (up to 2 years)
The best overall response using Response Evaluation Criteria In Solid Tumors (RESIST) was measured. Complete response is defined as the disappearance of all known lesion(s), confirmed at 4 weeks, and partial response is defined as at least a 30% decrease in the sum of the longest diameters of target lesions taken as a reference to baseline sum of the longest diameters, confirmed at 4 weeks. No formal efficacy analyses were performed due to early termination of the study.
5 secondary outcomes
Number of Participants Who Had a Complete or Partial Response, or Stable Disease
Time frame: Baseline through End of Study (up to 2 years)
Progression-Free Survival
Time frame: Baseline through End of Study (up to 2 years)
Overall Survival
Time frame: Baseline through End of Study (up to 2 years)
Levels of Circulating Biomarkers in Plasma
Time frame: Baseline through End of Study (up to 2 years)
Characterization of Participant Populations by Identification of Intra-tumoral Biomarkers
Time frame: Baseline through End of Study (up to 2 years)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2014.
- 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
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pazopanib (GW786034) in people with Lung Cancer, Non-Small Cell, run by GlaxoSmithKline at 13 sites in United States.
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 9 inclusion and 15 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: stopped early, as of the sponsor's last update on 19 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. 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 27 Jan 2010). 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?
Percentage of Participants Who Achieved Either a Confirmed Complete Response or Partial Response Per RECIST Criteria (time frame: Baseline through End of Study (up to 2 years)). 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 19 Nov 2014.