Lung Cancer, Non-Small CellPhase 1NCT00678977
A Phase I, Open-label, Study of Pazopanib in Combination With Gemcitabine and Gemcitabine Plus Cisplatin for Advanced Solid Tumors
A Phase 1 study testing Pazopanib (GW786034), Gemcitabine and Cisplatin in people with Lung Cancer, Non-Small Cell, run by GlaxoSmithKline at 2 sites in 2 countries.
Trial summary
This is an open-label, two-arm, Phase I, dose escalation study to evaluate the safety and tolerability and to determine the optimal tolerated regimen(OTR) of pazopanib in combination with gemcitabine (Arm A) or pazopanib, gemcitabine, and cisplatin (Arm B) in patients with advanced solid tumors. 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), Gemcitabine and Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 3 Apr 2008to 30 Jun 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients should have a histologically or cytologically confirmed advanced solid tumor, having failed standard therapy or for whom there is no standard therapy. Patients should have unresectable or metastatic disease.
- Age greater than or equal to 18 years
- Performance status must be ECOG 0-1.
- Prior therapies allowed: unlimited.
- Adequate organ function
- Patients must have measurable or evaluable disease:
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- No unstable or serious concurrent condition.
- A female subject is eligible to enter and participate in the study if she is: Of non-childbearing potential
- Subjects must discontinue HRT prior to study enrolment due to the inhibition of CYP enzymes that metabolize estrogens and progestins.
- Childbearing potential, includes any female who has had a negative serum pregnancy test at screening and within 2 weeks prior to the first dose of study treatment, preferably as close to the first dose as possible, and agrees to use adequate contraception.
- A male with a female partner of childbearing potential is eligible to enter and participate in the study if he uses a barrier method of contraception or abstinence during the study.
- Patients must provide written informed consent prior to performance of study specific procedures or assessments, and must be willing to comply with treatment and follow up
- At least 4 weeks must have elapsed since last administration of chemotherapy and subjects must have recovered from any toxicity attributed to the agent prior to enrolment in this study.
- Prior radiotherapy is permissible, provided at least 4 weeks have elapsed since the last treatment to allow for full bone marrow recovery.
- Patients with metastatic disease to the brain should have definitive therapy for their brain metastases, should be asymptomatic. (Patients with previously treated brain metastases who are asymptomatic, off steroids and anti-seizure medications for greater than 3 months are eligible for study.)
Who cannot join
- History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti seizure medication for one week prior to first dose of study drug. Screening with CNS imaging studies (computed tomography [CT] or magnetic resonance imaging [MRI]) is required.
- Clinically significant gastrointestinal abnormalities which might interfere with oral dosing
- Presence of uncontrolled infection
- Prolongation of corrected QT interval (QTc) > 480 msecs.
- History of any one of more of the following cardiovascular conditions within the past 6 months:
- Cardiac angioplasty or stenting; myocardial infarction; unstable angina; symptomatic peripheral vascular disease; Class III or IV congestive heart failure as defined by the New York Heart Association
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- Has had any major surgery, chemotherapy, investigational agent, biological therapy or hormonal therapy within the last 28 days and/or not recovered from a prior therapy.
- Any unstable or serious concurrent condition (e.g., active infection requiring systemic therapy)
- Poorly controlled hypertension [defined as systolic blood pressure (SBP) of greater than or equal to 140mmHg or diastolic blood pressure (DBP) of greater than or equal to 90mmHg].
- History of cerebrovascular accident (CVA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
- Prior 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.
- Evidence of active bleeding or bleeding diathesis.
- Hemoptysis within 6 weeks prior to first dose of study drug.
- Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with patient's safety, provision of informed consent, or compliance to study procedures.
- Is unable or unwilling to discontinue prohibited medications, as listed in Section 8.2 for 14 days or five half-lives of a drug prior to Visit 1 and for the duration of the study.
- Use of an investigational agent, including an investigational anti-cancer agent, within 28 days or 5 half-lives, whichever is longer, prior to the first dose of study drug.
- Prior use of an investigational or licensed tyrosine kinase inhibitor that targets VEGF receptors.
- Note: Prior use of bevacizumab is allowed.
- Is now undergoing and/or has undergone in the 14 days immediately prior to first dose of study drug, any cancer therapy (surgery, tumor embolization, chemotherapy, radiation therapy, immunotherapy, biological therapy, or hormonal therapy).
- Note: For prior bevacizumab therapy at least 40 days should have elapsed since last dose.
- Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in severity.
- Has a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib, gemcitabine, or cisplatin. (To date there are no known FDA approved drugs chemically related to pazopanib).
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United Kingdom1 site
GSK Investigational Site
Newcastle upon Tyne, Northumberland, NE4 6BE
About this study
Official title: A Phase I, Open-label, Study of the Safety, Tolerability and Pharmacokinetics of Pazopanib in Combination With Gemcitabine and Gemcitabine Plus Cisplatin for Advanced Solid Tumors
This is an open-label, two-arm, Phase I, dose escalation study to evaluate the safety and tolerability and to determine the optimal tolerated regimen(OTR) of pazopanib in combination with gemcitabine (Arm A) or pazopanib, gemcitabine, and cisplatin (Arm B) in patients with advanced solid tumors. Patients will be enrolled in cohorts of 3 to receive escalating doses of pazopanib and gemcitabine or pazopanib, gemcitabine and cisplatin. Dose escalation schemas for each study arm are described in the protocol. For each arm, the OTR will be defined as the highest dose combination of the agents where no more than one out of six patients experiences a dose-limiting toxicity. Six to twelve additional patients in each arm will be studied with the OTR to evaluate toxicity and pharmacokinetics. This will allow an assessment of potential drug-drug interactions. Antitumor activity will be assessed using RECIST criteria.
- Conditions
- Lung Cancer, Non-Small Cell
- Being tested
- Pazopanib (GW786034), Gemcitabine, Cisplatin
- Keywords
- pharmacokinetics, cisplatin, pazopanib (GW786034), Solid tumors, anti-angiogenesis, gemcitabine
- 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
initial dose 400mg daily in 21-day cycles; increase in dose up to 800mg daily following evaluation of safety and tolerability
GemcitabineDrug
Gemcitabine on Days 1 and 8 of each cycle; initial dose 600 mg/m2 increase to 1,000mg/m2 after evaluation of safety and tolerability; increase to 1250mg/m2 after evaluation of safety and tolerability
CisplatinDrug
Cisplatin on Day 1 of each 21-day cycle initial dose 60mg/m2; increase to 80mg/m2 after evaluation of safety and tolerability
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Dose Escalation - Patients will be entered into dose cohorts of three patients. Each cohort will be assigned to a dose level for the duration of the study. There will be no intra-patient dose-escalation. The starting dose will be 400 mg daily of pazopanib, and 1000 mg/m2 gemcitabine. Intermediate dose levels may also be explored. Intravenous gemcitabine will be given on Day 1 and 8 of Cycle 1 and each subsequent cycle.
Cohort expansion phase - patients will receive gemcitabine alone, at the OTR dose starting on Day 1 of Cycle 1. Pazopanib will be administered at the OTR beginning on Day 2 Cycle 1 after the last blood sample for gemcitabine analysis is collected, and pazopanib administration will continue for the duration of the study. Patients will return to the clinic on Day 8 of Cycle 1 for simultaneous administration of gemcitabine and pazopanib. On Day 1 of Cycle 2 patients will receive the simultaneous administration of gemcitabine and pazopanib Receives: Drug: Pazopanib (GW786034); Drug: Gemcitabine |
| Arm B | Experimental | Dose Escalation - Patients will be entered into dose cohorts of three patients. Each cohort will be assigned to a dose level for the duration of the study. There will be no intra-patient dose-escalation. The starting dose will be 400 mg daily of pazopanib, 1000 mg/m2 gemcitabine and 60 mg/m2 cisplatin. Doses of gemcitabine may range from 600 to 1250 mg/m2. Doses of cisplatin may range from 60 to 80 mg/m2. Intermediate dose levels may also be explored. Pazopanib administered starting on Day 1 of Cycle 1, gemcitabine co-administration on Day 1 and 8, and cisplatin on Day 1 in each 21-day cycle.
Cohort expansion - patients will receive gemcitabine and cisplatin alone, at the OTR doses, starting on Day 1 of Cycle 1. Pazopanib will be administered at the OTR dose beginning on Day 2 of Cycle 1, and pazopanib administration will continue for the duration of the study. Patients will return to the clinic on Day 8 of Cycle 1 for simultaneous administration of gemcitabine and pazopanib Receives: Drug: Gemcitabine; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimum tolerated regimen (OTR) for each regimen in each arm of the study. OTR determined evaluation of AEs and change in lab values. OTR defined as the highest dosing regimen that results in dose limiting toxicity in no more than 1 of 6 subjects
Measured: Until disease progression
Secondary outcomes (4)
Anti-tumor activity evaluated using RECIST criteria (if subjects have measurable disease). Assessments of disease every 6 to 12 weeks, recorded as complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD).
Measured: Until Disease progression
Pharmacokinetic parameters AUC(0-24), Cmax, and tmax of pazopanib, gemcitabine, and ultrafilterable platinum.
Measured: Dose Expansion - Cycle; Dose-Expansion Cycle 2
Levels of circulating cytokine and angiogenic factors (CAF) biomarkers (such as IL 2, IL-10, VEGF, sVEGFR2) in plasma will be determined
Measured: Day 1 of each cycle until disease progression
Genetic variants in select candidate genes in the host DNA will be evaluated
Measured: Day 1 of first cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2008 (estimated)
- Study start3 Apr 2008
- Primary completion30 Mar 2010
- Study completion30 Jun 2011
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 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 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
- NCT00678977
- Sponsor's protocol ID
- VEG109599
- Status last verified
- Nov 2017
- First submitted
- 14 May 2008
- Last updated
- 14 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Plummer R, Madi A, Jeffels M, Richly H, Nokay B, Rubin S, Ball HA, Weller S, Botbyl J, Gibson DM, Scheulen ME. A Phase I study of pazopanib in combination with gemcitabine in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2013 Jan;71(1):93-101. doi: 10.1007/s00280-012-1982-z. Epub 2012 Oct 11.
PubMed 23064954
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Study of the Safety, Tolerability and Pharmacokinetics of Pazopanib in Combination With Gemcitabine and Gemcitabine Plus Cisplatin for Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00678977
- Acronym / sponsor ID
- VEG109599
- Conditions
- Lung Cancer, Non-Small Cell
- Keywords
- pharmacokinetics, cisplatin, pazopanib (GW786034), Solid tumors, anti-angiogenesis, gemcitabine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 3 Apr 2008 (actual)
- Primary completion
- 30 Mar 2010 (actual)
- Study completion
- 30 Jun 2011 (actual)
- First posted
- 16 May 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 is an open-label, two-arm, Phase I, dose escalation study to evaluate the safety and tolerability and to determine the optimal tolerated regimen(OTR) of pazopanib in combination with gemcitabine (Arm A) or pazopanib, gemcitabine, and cisplatin (Arm B) in patients with advanced solid tumors. Patients will be enrolled in cohorts of 3 to receive escalating doses of pazopanib and gemcitabine or pazopanib, gemcitabine and cisplatin. Dose escalation schemas for each study arm are described in the protocol. For each arm, the OTR will be defined as the highest dose combination of the agents where no more than one out of six patients experiences a dose-limiting toxicity. Six to twelve additional patients in each arm will be studied with the OTR to evaluate toxicity and pharmacokinetics. This will allow an assessment of potential drug-drug interactions. Antitumor activity will be assessed using RECIST criteria.
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: Pazopanib (GW786034), Drug: GemcitabineDose Escalation - Patients will be entered into dose cohorts of three patients. Each cohort will be assigned to a dose level for the duration of the study. There will be no intra-patient dose-escalation. The starting dose will be 400 mg daily of pazopanib, and 1000 mg/m2 gemcitabine. Intermediate dose levels may also be explored. Intravenous gemcitabine will be given on Day 1 and 8 of Cycle 1 and each subsequent cycle. Cohort expansion phase - patients will receive gemcitabine alone, at the OTR dose starting on Day 1 of Cycle 1. Pazopanib will be administered at the OTR beginning on Day 2 Cycle 1 after the last blood sample for gemcitabine analysis is collected, and pazopanib administration will continue for the duration of the study. Patients will return to the clinic on Day 8 of Cycle 1 for simultaneous administration of gemcitabine and pazopanib. On Day 1 of Cycle 2 patients will receive the simultaneous administration of gemcitabine and pazopanib |
| Arm B | Experimental | Drug: Gemcitabine, Drug: CisplatinDose Escalation - Patients will be entered into dose cohorts of three patients. Each cohort will be assigned to a dose level for the duration of the study. There will be no intra-patient dose-escalation. The starting dose will be 400 mg daily of pazopanib, 1000 mg/m2 gemcitabine and 60 mg/m2 cisplatin. Doses of gemcitabine may range from 600 to 1250 mg/m2. Doses of cisplatin may range from 60 to 80 mg/m2. Intermediate dose levels may also be explored. Pazopanib administered starting on Day 1 of Cycle 1, gemcitabine co-administration on Day 1 and 8, and cisplatin on Day 1 in each 21-day cycle. Cohort expansion - patients will receive gemcitabine and cisplatin alone, at the OTR doses, starting on Day 1 of Cycle 1. Pazopanib will be administered at the OTR dose beginning on Day 2 of Cycle 1, and pazopanib administration will continue for the duration of the study. Patients will return to the clinic on Day 8 of Cycle 1 for simultaneous administration of gemcitabine and pazopanib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients should have a histologically or cytologically confirmed advanced solid tumor, having failed standard therapy or for whom there is no standard therapy. Patients should have unresectable or metastatic disease.
- Age greater than or equal to 18 years
- Performance status must be ECOG 0-1.
- Prior therapies allowed: unlimited.
- Adequate organ function
Key exclusion criteria (22 listed)
- History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti seizure medication for one week prior to first dose of study drug. Screening with CNS imaging studies (computed tomography [CT] or magnetic resonance imaging [MRI]) is required.
- Clinically significant gastrointestinal abnormalities which might interfere with oral dosing
- Presence of uncontrolled infection
- Prolongation of corrected QT interval (QTc) > 480 msecs.
- History of any one of more of the following cardiovascular conditions within the past 6 months:
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)initial dose 400mg daily in 21-day cycles; increase in dose up to 800mg daily following evaluation of safety and tolerability | Drug | Arm A |
| GemcitabineGemcitabine on Days 1 and 8 of each cycle; initial dose 600 mg/m2 increase to 1,000mg/m2 after evaluation of safety and tolerability; increase to 1250mg/m2 after evaluation of safety and tolerability | Drug | Arm A, Arm B |
| CisplatinCisplatin on Day 1 of each 21-day cycle initial dose 60mg/m2; increase to 80mg/m2 after evaluation of safety and tolerability | Drug | Arm B |
Primary outcome
Optimum tolerated regimen (OTR) for each regimen in each arm of the study. OTR determined evaluation of AEs and change in lab values. OTR defined as the highest dosing regimen that results in dose limiting toxicity in no more than 1 of 6 subjects
Time frame: Until disease progression
4 secondary outcomes
Anti-tumor activity evaluated using RECIST criteria (if subjects have measurable disease). Assessments of disease every 6 to 12 weeks, recorded as complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD).
Time frame: Until Disease progression
Pharmacokinetic parameters AUC(0-24), Cmax, and tmax of pazopanib, gemcitabine, and ultrafilterable platinum.
Time frame: Dose Expansion - Cycle; Dose-Expansion Cycle 2
Levels of circulating cytokine and angiogenic factors (CAF) biomarkers (such as IL 2, IL-10, VEGF, sVEGFR2) in plasma will be determined
Time frame: Day 1 of each cycle until disease progression
Genetic variants in select candidate genes in the host DNA will be evaluated
Time frame: Day 1 of first cycle
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 14 Nov 2017.
- Background: PubMed 23064954Plummer R, Madi A, Jeffels M, Richly H, Nokay B, Rubin S, Ball HA, Weller S, Botbyl J, Gibson DM, Scheulen ME. A Phase I study of pazopanib in combination with gemcitabine in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2013 Jan;71(1):93-101. doi: 10.1007/s00280-012-1982-z. Epub 2012 Oct 11.
- Results for study VEG109599 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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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 1 study testing Pazopanib (GW786034), Gemcitabine 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 15 inclusion and 22 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 14 Nov 2017. 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 Germany, 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 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?
Optimum tolerated regimen (OTR) for each regimen in each arm of the study. OTR determined evaluation of AEs and change in lab values. OTR defined as the highest dosing regimen that results in dose limiting toxicity in no more than 1 of 6 subjects (time frame: Until 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 NCT00678977, 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 14 Nov 2017.