Neoplasms, BreastPhase 1NCT00722293
A Phase I, Open-label, Study of Pazopanib in Combination With Epirubicin or Doxorubicin for Advanced Solid Tumors
A Phase 1 study testing Doxorubicin, Pazopanib (GW786034) and Epirubicin in people with Neoplasms, Breast, run by GlaxoSmithKline at 4 sites in 2 countries.
Trial summary
This is an open-label, four-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 epirubicin or doxorubicin 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
- Neoplasms, Breast
- What is being tested?
- Doxorubicin, Pazopanib (GW786034) and Epirubicin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 8 Jul 2008to 25 Feb 2014
- 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 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
- Histologically or cytologically confirmed diagnosis of advanced solid tumor that has failed standard therapy or for which there is no standard therapy and is indicated for treatment with anthracyclines.
- Age greater than or equal to 18 years.
- Adequate organ system function as defined by the protocol.
- ECOG performance value of 0 or 1.
- Less than or equal to one prior line of chemotherapy for advanced disease. 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 the study).
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- There must be measurable disease or evaluable disease for subjects to be included in the cohort expansion phase. Measurable disease is not a criterion for subjects enrolling in the dose escalation phase.
- Has a left ventricular ejection fraction (LVEF) greater than or equal to 50% or greater than or equal to the institution's LLN.
- Women of childbearing potential must have a negative pregnancy test within 2 weeks of starting study drug and use acceptable birth control methods as outlined in the protocol.
- Women may participate if they are of non childbearing potential (bilateral tubal ligation, hysterectomy, post menopausal or bilateral ovariectomy.
- Males with female partners of childbearing potential may participate if they practice acceptable methods of birth control as outlined in the study protocol.
- Able to swallow and retain oral medications.
- Less than or equal to one prior line of chemotherapy for advanced disease.
- Life expectancy of at least 12 weeks.
Who cannot join
- Prior use of pazopanib or prior treatment with anthracyclines. Prior therapy with other angiogenesis inhibitors is permitted.
- Clinically significant gastrointestinal abnormalities which might interfere with oral dosing.
- Any unstable or serious concurrent condition (e.g., active infection requiring systemic therapy).
- QTc > 480 msecs.
- History of any one or more of the following cardiovascular conditions within the past 6 months:
- Cardiac angioplasty or stenting
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- Myocardial infarction
- Unstable angina
- Symptomatic peripheral vascular disease
- Class III or IV congestive heart failure
- Any major surgery or trauma within the last 28 days and or presence of non-healing wound, fracture, or ulcer.
- Any unstable or serious concurrent condition.
- Poorly controlled hypertension [defined as systolic blood pressure (SBP) of =140mmHg or diastolic blood pressure (DBP) of = 90mmHg].
- History of cerebrovascular accident (CVA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months. Subjects with a recent DVT who have been treated with therapeutic agents (excluding therapeutic warfarin) for at least 6 weeks are eligible.
- 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.
- 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 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.
- Is now undergoing and/or has undergone within 28 days immediately prior to first dose of study drug, any cancer therapy (major surgery, investigational agent, tumor embolization, chemotherapy, radiation therapy, immunotherapy, biological therapy, or hormonal therapy).
- Clinically assessed as having inadequate venous access for PK sampling.
- Lactating and pregnant women should discontinue lactation prior to first use of study drug and refrain from nursing throughout the treatment period and for 14 days after final dose.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Switzerland3 sites
GSK Investigational Site
Bellinzona
GSK Investigational Site
Lausanne, 1011
GSK Investigational Site
Sankt Gallen, 9007
About this study
Official title: A Phase I, Open-label, Study of the Safety, Pharmacokinetics, and Pharmacodynamics Dose Escalation of Pazopanib in Combination With Epirubicin or Doxorubicin for Advanced Solid Tumors
This is an open-label, four-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 epirubicin or doxorubicin in patients with advanced solid tumors. Patients will be enrolled in cohorts of 3 to receive escalating doses of pazopanib and epirubicin or doxorubicin. 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. 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
- Neoplasms, Breast
- Being tested
- Doxorubicin, Pazopanib (GW786034), Epirubicin
- Keywords
- Solid tumors, Cancer, Neoplasms, Ovarian, doxorubicin, epirubicin, anti-angiogenesis, pharmacodynamics, pazopanib (GW786034), pharmacokinetics, Soft Tissue, Sarcoma
- Medical subject headings
- Breast Neoplasms, Neoplasms, Ovarian Neoplasms, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxorubicinDrug
Arm D - doxorubicin given as a intravenous bolus injection on Day 1 or Day 3 depending on schedule selected from Arm A, B or C - starting dose 60 mg/m2 and increase to 75mg/m2
Pazopanib (GW786034)Drug
Arm A - daily administration of pazopanib on Days 1 through 21 starting at 200mg with a maximum dose of 800mg; Arm B daily administration of pazopanib on Days 1 through 8 of a 3-week cycle starting at 200mg escalating to a maximum dose of 800mg; Arm C daily dose of pazopanib on Days 14 through 21 of a 3-week cycle starting at 200mg escalating to a maximum dose of 800mg; Arm D once daily administration of pazopanib (according to schedule selected from Arm A, B, or C) starting at 400mg escalating to a maximum dose of 800mg
EpirubicinDrug
Also called Doxorubicin, Pazopanib (GW786034)
Arm A and Arm B - epirubicin given as a bolus intravenous injection on Day 3 starting dose 60mg/m2 increase to 90mg/m2 if tolerated; Arm C - epirubicin given as a bolus intravenous injection on Day 1 starting dose 60mg/m2 increase to 90mg/m2 if tolerated
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | once daily oral administration of pazopanib for Days 1-21 days in combination with epirubicin given as a bolus intravenous administration on Day 3 Receives: Drug: Pazopanib (GW786034); Drug: Epirubicin |
| Arm B | Experimental | once daily oral administration of pazopanib for Days 1-8 of a 3-week cycle in combination with epirubicin (bolus intravenous administration) on Day 3 Receives: Drug: Pazopanib (GW786034); Drug: Epirubicin |
| Arm C | Experimental | epirubicin (bolus intravenous administration) on Day 1 with once-daily oral administration of pazopanib for Days 14-21 of a 3-week cycle Receives: Drug: Epirubicin |
| Arm D | Experimental | once-daily oral administration of pazopanib (according to schedule selected from either Arm A, B, or C) (3 week cycle) in combination with doxorubicin (bolus intravenous administration) on Day 1 or 3, depending on the schedule selected from either Arm A, B, or C Receives: Drug: Doxorubicin; Drug: Pazopanib (GW786034) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimum tolerated regimen (OTR) for each combination regimen in each arm of the study.OTR determined by evaluation of AEs and change in lab values.OTR defined as highest dosing regimen that results in dose limiting toxicity in no more than 1 of 6 subject
Measured: Subjects will continue on the study until disease progression occurs or one of the discontinuation criteria is met up to approximately 48 months.
Secondary outcomes (8)
Safety assessments, including routine physical exam findings, vital signs, clinical laboratory tests (chemistry and hematology to include coagulation factors), clinical monitoring and/or observation, and adverse event reporting.
Measured: Safety assessment timing is noted on the Time and Events Table. Subjects will continue on the study until disease progression occurs or one of the discontinuation criteria is met up to approximately 48 months.
Safety and tolerability endpoints will include cardiac function (left ventricular ejection fraction) monitored by either MUGA or ECHO. A 12-lead ECG will also be monitored.
Measured: Safety assessment timing is noted on the Time and Events Table. Subjects will continue on the study until disease progression occurs or one of the discontinuation criteria is met up to approximately 48 months.
Pharmacokinetic endpoints will be AUC, Cmax, Tmax, and t1/2 of pazopanib, epirubicin, and doxorubicin, and clearance of epirubicin and doxorubicin if data are sufficient.
Measured: PK samples will only be collected in Cycle 1 and Cycle 2. Subjects will continue on the study until disease progression occurs or one of the discontinuation criteria is met up to approximately 48 months.
Assessment of anti-tumor activity using RECIST criteria will be recorded as complete response, partial response, stable disease, or progressive disease.
Measured: Subjects will continue on the study until disease progression occurs or one of the discontinuation criteria is met up to approximately 48 months.
Levels of circulating cytokine and angiogenic factors (CAF) biomarkers (such as IL 2, IL-10, VEGF, sVEGFR2) in plasma will be determined.
Measured: Biomarker samples will only be collected in Cycles 1, 2, and 3. Subjects will continue on the study until disease progression occurs or one of the discontinuation criteria is met up to approximately 48 months.
Assessment of circulating BMD angiogenic cells in cancer peripheral blood in patients before and during treatment with oral pazopanib (continuous and intermittent regimens) and epirubicin or doxorubicin.
Measured: Biomarker samples will only be collected in Cycles 1 and 2. Subjects will continue on the study until disease progression occurs or one of the discontinuation criteria is met up to approximately 48 months.
Gene expression profiling in selected subpopulations of BMD angiogenic cells in peripheral blood of cancer patients before and during treatment with pazopanib (continuous or intermittent regimens) in combination with epirubicin or doxorubicin.
Measured: Biomarker samples will only be collected in Cycles 1 and 2. Subjects will continue on the study until disease progression occurs or one of the discontinuation criteria is met up to approximately 48 months.
Genetic variants in candidate genes in the host DNA will be evaluated
Measured: One pharmacogenetic sample will be collected during the study ideally in Cycle 1. Subjects will continue on the study until disease progression occurs or one of the discontinuation criteria is met up to approximately 48 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2008 (estimated)
- Study start8 Jul 2008
- Primary completion11 Jun 2012
- Study completion25 Feb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasms, BreastStudies 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
- 111 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
- NCT00722293
- Sponsor's protocol ID
- VEG109603
- Status last verified
- Nov 2017
- First submitted
- 23 Jul 2008
- Last updated
- 13 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 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, Pharmacokinetics, and Pharmacodynamics Dose Escalation of Pazopanib in Combination With Epirubicin or Doxorubicin for Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00722293
- Acronym / sponsor ID
- VEG109603
- Conditions
- Neoplasms, Breast
- Keywords
- Solid tumors, Cancer, Neoplasms, Ovarian, doxorubicin, epirubicin, anti-angiogenesis, pharmacodynamics, pazopanib (GW786034)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 8 Jul 2008 (actual)
- Primary completion
- 11 Jun 2012 (actual)
- Study completion
- 25 Feb 2014 (actual)
- First posted
- 25 Jul 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, four-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 epirubicin or doxorubicin in patients with advanced solid tumors. Patients will be enrolled in cohorts of 3 to receive escalating doses of pazopanib and epirubicin or doxorubicin. 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. 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
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Pazopanib (GW786034), Drug: Epirubicinonce daily oral administration of pazopanib for Days 1-21 days in combination with epirubicin given as a bolus intravenous administration on Day 3 |
| Arm B | Experimental | Drug: Pazopanib (GW786034), Drug: Epirubicinonce daily oral administration of pazopanib for Days 1-8 of a 3-week cycle in combination with epirubicin (bolus intravenous administration) on Day 3 |
| Arm C | Experimental | Drug: Epirubicinepirubicin (bolus intravenous administration) on Day 1 with once-daily oral administration of pazopanib for Days 14-21 of a 3-week cycle |
| Arm D | Experimental | Drug: Doxorubicin, Drug: Pazopanib (GW786034)once-daily oral administration of pazopanib (according to schedule selected from either Arm A, B, or C) (3 week cycle) in combination with doxorubicin (bolus intravenous administration) on Day 1 or 3, depending on the schedule selected from either Arm A, B, or C |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
- Histologically or cytologically confirmed diagnosis of advanced solid tumor that has failed standard therapy or for which there is no standard therapy and is indicated for treatment with anthracyclines.
- Age greater than or equal to 18 years.
- Adequate organ system function as defined by the protocol.
- ECOG performance value of 0 or 1.
Key exclusion criteria (22 listed)
- Prior use of pazopanib or prior treatment with anthracyclines. Prior therapy with other angiogenesis inhibitors is permitted.
- Clinically significant gastrointestinal abnormalities which might interfere with oral dosing.
- Any unstable or serious concurrent condition (e.g., active infection requiring systemic therapy).
- QTc > 480 msecs.
- History of any one or 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 |
|---|---|---|
| DoxorubicinArm D - doxorubicin given as a intravenous bolus injection on Day 1 or Day 3 depending on schedule selected from Arm A, B or C - starting dose 60 mg/m2 and increase to 75mg/m2 | Drug | Arm D |
| Pazopanib (GW786034)Arm A - daily administration of pazopanib on Days 1 through 21 starting at 200mg with a maximum dose of 800mg; Arm B daily administration of pazopanib on Days 1 through 8 of a 3-week cycle starting at 200mg escalating to a maximum dose of 800mg; Arm C daily dose of pazopanib on Days 14 through 21 of a 3-week cycle starting at 200mg escalating to a maximum dose of 800mg; Arm D once daily administration of pazopanib (according to schedule selected from Arm A, B, or C) starting at 400mg escalating to a maximum dose of 800mg | Drug | Arm A, Arm B, Arm D |
| EpirubicinAlso: Doxorubicin, Pazopanib (GW786034)Arm A and Arm B - epirubicin given as a bolus intravenous injection on Day 3 starting dose 60mg/m2 increase to 90mg/m2 if tolerated; Arm C - epirubicin given as a bolus intravenous injection on Day 1 starting dose 60mg/m2 increase to 90mg/m2 if tolerated | Drug | Arm A, Arm B, Arm C |
Primary outcome
Optimum tolerated regimen (OTR) for each combination regimen in each arm of the study.OTR determined by evaluation of AEs and change in lab values.OTR defined as highest dosing regimen that results in dose limiting toxicity in no more than 1 of 6 subject
Time frame: Subjects will continue on the study until disease progression occurs or one of the discontinuation criteria is met up to approximately 48 months.
8 secondary outcomes
Safety assessments, including routine physical exam findings, vital signs, clinical laboratory tests (chemistry and hematology to include coagulation factors), clinical monitoring and/or observation, and adverse event reporting.
Time frame: Safety assessment timing is noted on the Time and Events Table. Subjects will continue on the study until disease progression occurs or one of the discontinuation criteria is met up to approximately 48 months.
Safety and tolerability endpoints will include cardiac function (left ventricular ejection fraction) monitored by either MUGA or ECHO. A 12-lead ECG will also be monitored.
Time frame: Safety assessment timing is noted on the Time and Events Table. Subjects will continue on the study until disease progression occurs or one of the discontinuation criteria is met up to approximately 48 months.
Pharmacokinetic endpoints will be AUC, Cmax, Tmax, and t1/2 of pazopanib, epirubicin, and doxorubicin, and clearance of epirubicin and doxorubicin if data are sufficient.
Time frame: PK samples will only be collected in Cycle 1 and Cycle 2. Subjects will continue on the study until disease progression occurs or one of the discontinuation criteria is met up to approximately 48 months.
Assessment of anti-tumor activity using RECIST criteria will be recorded as complete response, partial response, stable disease, or progressive disease.
Time frame: Subjects will continue on the study until disease progression occurs or one of the discontinuation criteria is met up to approximately 48 months.
Levels of circulating cytokine and angiogenic factors (CAF) biomarkers (such as IL 2, IL-10, VEGF, sVEGFR2) in plasma will be determined.
Time frame: Biomarker samples will only be collected in Cycles 1, 2, and 3. Subjects will continue on the study until disease progression occurs or one of the discontinuation criteria is met up to approximately 48 months.
Assessment of circulating BMD angiogenic cells in cancer peripheral blood in patients before and during treatment with oral pazopanib (continuous and intermittent regimens) and epirubicin or doxorubicin.
Time frame: Biomarker samples will only be collected in Cycles 1 and 2. Subjects will continue on the study until disease progression occurs or one of the discontinuation criteria is met up to approximately 48 months.
Gene expression profiling in selected subpopulations of BMD angiogenic cells in peripheral blood of cancer patients before and during treatment with pazopanib (continuous or intermittent regimens) in combination with epirubicin or doxorubicin.
Time frame: Biomarker samples will only be collected in Cycles 1 and 2. Subjects will continue on the study until disease progression occurs or one of the discontinuation criteria is met up to approximately 48 months.
Genetic variants in candidate genes in the host DNA will be evaluated
Time frame: One pharmacogenetic sample will be collected during the study ideally in Cycle 1. Subjects will continue on the study until disease progression occurs or one of the discontinuation criteria is met up to approximately 48 months.
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 13 Nov 2017.
- Results for study VEG109603 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
4 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 Doxorubicin, Pazopanib (GW786034) and Epirubicin in people with Neoplasms, Breast, run by GlaxoSmithKline at 4 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 14 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 13 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 4 sites in Switzerland, Italy. 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 combination regimen in each arm of the study.OTR determined by evaluation of AEs and change in lab values.OTR defined as highest dosing regimen that results in dose limiting toxicity in no more than 1 of 6 subject (time frame: Subjects will continue on the study until disease progression occurs or one of the discontinuation criteria is met up to approximately 48 months.). 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 13 Nov 2017.