Metastatic Non Small Cell Lung CancerPhase 1NCT01060514
Pazopanib + Vinorelbine in Non Small Cell Lung Cancer (NSCLC) and Breast Cancer
A Phase 1 study testing Pazopanib and Vinorelbine in people with Metastatic Non Small Cell Lung Cancer and Metastatic Breast Cancer, run by Northwestern University at 1 site in United States.
Trial summary
The purpose of this study is to determine the highest dose of Vinorelbine and Pazopanib that can be given together without causing severe side effects. Also, this study will evaluate what effects (good and bad) that the treatment has on patients and their cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Non Small Cell Lung Cancer, Metastatic Breast Cancer
- What is being tested?
- Pazopanib and Vinorelbine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Sep 2013
- 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
- Age > 18 years
- Patients must have diagnosis of breast cancer or non small cell lung cancer
- Patients must have evaluable disease
- Women of childbearing potential and sexually active males must commit to the use of effective contraception while on study.
- Patients must have given signed, informed consent prior to registration on study.
Who cannot join
- Patients must not be pregnant and/or lactating.
- Patients must not be receiving any other investigational agents.
- No prior exposure to vinorelbine or other VEGF inhibitors as treatment for metastatic disease
- Patients must not have received prior therapy (including radiation, surgery, and/or chemotherapy) within 30 days
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to pazopanib or vinorelbine.
- Patients cannot have received more than 2 prior chemotherapy regimens for lung cancer or 3 prior chemotherapy regimens for breast cancer. This criterion can be discussed further with the study doctor.
- Must not have uncontrolled illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmic, psychiatric illness/social situations that would limit compliance with study requirements.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University, Northwestern Medical Faculty Foundation
Chicago, Illinois, 60611
About this study
Official title: Phase I Study of Pazopanib in Combination With Vinorelbine in Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC) and Breast Cancer
The purpose of this study is to determine the highest dose of Vinorelbine and Pazopanib that can be given together without causing severe side effects. Also, this study will evaluate what effects (good and bad) that the treatment has on patients and their cancer.
Read the detailed description
This study involves an investigational drug called pazopanib in combination with the chemotherapy drug vinorelbine. An investigational drug is a drug that has not been approved by the U.S. Food and Drug Administration (FDA) for use in the United States. Vinorelbine has been FDA approved to treat patients with NSCLC and breast cancer. Pazopanib is a vascular endothelial growth factor inhibitor, which means it may prevent the tumor from growing its own blood vessels thereby interfering with the growth of the tumor. Participants in this study will be assigned to one of three groups with each group receiving a higher dose of vinorelbine and pazopanib than the previous group. Vinorelbine will be given through a needle in the vein on days 1 and 8 of each 21 day study treatment cycle. Pazopanib is a pill which will be taken by mouth every day during the 21 day study treatment cycle.
- Being tested
- Pazopanib, Vinorelbine
- Keywords
- Lung cancer, Breast cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Breast Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PazopanibDrug
dose escalation, administered orally, daily
VinorelbineDrug
Also called Navelbine
dose escalation, IV days 1 and 8 of every cycle (cycles begin every 3 weeks)
| Study group | Role | What they receive |
|---|---|---|
| Pazopanib + Vinorelbine | Experimental | Not described Receives: Drug: Pazopanib; Drug: Vinorelbine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the maximum tolerated dose (MTD), and the recommended Phase II dose to be used in patients with metastatic NSCLC and breast cancer.
Measured: at study completion (estimated at 2 years)
Secondary outcomes (3)
To determine the response rate, progression free survival and overall survival in patients with metastatic NSCLC and metastatic breast cancer treated with pazopanib in combination with vinorelbine.
Measured: imaging done every 6 weeks
To characterize dose limiting toxicities (DLT).
Measured: labs drawn weekly
To determine the pharmacokinetic effect of pazopanib on vinorelbine.
Measured: labs drawn on days 1 and 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionFeb 2012
- Study completionSep 2013
Why it stopped: Lack of timely accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Robert H. Lurie Cancer Center
- Responsible party
- Principal investigator, Jyoti Patel, Northwestern University
- Investigators
- Jyoti D Patel, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01060514
- Sponsor's protocol ID
- NU 09L1
- Other IDs
- STU00019948, NCI-2010-01850
- Status last verified
- Oct 2013
- First submitted
- 29 Jan 2010
- Last updated
- 30 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Pazopanib in Combination With Vinorelbine in Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC) and Breast Cancer
- ClinicalTrials.gov ID
- NCT01060514
- Acronym / sponsor ID
- NU 09L1
- Keywords
- Lung cancer, Breast cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of timely accrual.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Robert H. Lurie Cancer Center
- Study start
- Feb 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 2 Feb 2010 (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.
The purpose of this study is to determine the highest dose of Vinorelbine and Pazopanib that can be given together without causing severe side effects. Also, this study will evaluate what effects (good and bad) that the treatment has on patients and their cancer.
Detailed description
This study involves an investigational drug called pazopanib in combination with the chemotherapy drug vinorelbine. An investigational drug is a drug that has not been approved by the U.S. Food and Drug Administration (FDA) for use in the United States. Vinorelbine has been FDA approved to treat patients with NSCLC and breast cancer. Pazopanib is a vascular endothelial growth factor inhibitor, which means it may prevent the tumor from growing its own blood vessels thereby interfering with the growth of the tumor. Participants in this study will be assigned to one of three groups with each group receiving a higher dose of vinorelbine and pazopanib than the previous group. Vinorelbine will be given through a needle in the vein on days 1 and 8 of each 21 day study treatment cycle. Pazopanib is a pill which will be taken by mouth every day during the 21 day study treatment cycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pazopanib + Vinorelbine | Experimental | Drug: Pazopanib, Drug: Vinorelbine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 18 years
- Patients must have diagnosis of breast cancer or non small cell lung cancer
- Patients must have evaluable disease
- Women of childbearing potential and sexually active males must commit to the use of effective contraception while on study.
- Patients must have given signed, informed consent prior to registration on study.
Key exclusion criteria (7 listed)
- Patients must not be pregnant and/or lactating.
- Patients must not be receiving any other investigational agents.
- No prior exposure to vinorelbine or other VEGF inhibitors as treatment for metastatic disease
- Patients must not have received prior therapy (including radiation, surgery, and/or chemotherapy) within 30 days
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to pazopanib or vinorelbine.
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 |
|---|---|---|
| Pazopanibdose escalation, administered orally, daily | Drug | Pazopanib + Vinorelbine |
| VinorelbineAlso: Navelbinedose escalation, IV days 1 and 8 of every cycle (cycles begin every 3 weeks) | Drug | Pazopanib + Vinorelbine |
Primary outcome
To determine the maximum tolerated dose (MTD), and the recommended Phase II dose to be used in patients with metastatic NSCLC and breast cancer.
Time frame: at study completion (estimated at 2 years)
3 secondary outcomes
To determine the response rate, progression free survival and overall survival in patients with metastatic NSCLC and metastatic breast cancer treated with pazopanib in combination with vinorelbine.
Time frame: imaging done every 6 weeks
To characterize dose limiting toxicities (DLT).
Time frame: labs drawn weekly
To determine the pharmacokinetic effect of pazopanib on vinorelbine.
Time frame: labs drawn on days 1 and 22
Results and safety
The study was stopped early (reason given: Lack of timely accrual.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2013.
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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.
Jyoti D Patel, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pazopanib and Vinorelbine in people with Metastatic Non Small Cell Lung Cancer and Metastatic Breast Cancer, run by Northwestern University at 1 site 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 5 inclusion and 7 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 30 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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 was stopped early (reason given: Lack of timely accrual.). Results are not available in the source record.
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?
To determine the maximum tolerated dose (MTD), and the recommended Phase II dose to be used in patients with metastatic NSCLC and breast cancer. (time frame: at study completion (estimated at 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 30 Oct 2013.