Carcinoma, Renal CellPhase 1NCT00387205
Study To Assess Long Term Safety Of Pazopanib
A Phase 1 study testing Pazopanib in people with Carcinoma, Renal Cell, run by Novartis Pharmaceuticals at 19 sites in 4 countries.
Trial summary
This study was a rollover study to evaluate the long term safety of pazopanib and to continue to provide pazopanib to patients who participated in a GSK sponsored pazopanib study until pazopanib is available commercially. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Renal Cell
- What is being tested?
- Pazopanib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 19 sitesin 4 countries
- Study dates
- 20 Jun 2006to 8 Mar 2018
- 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
- Participated or completed a GSK sponsored pazopanib study and remains eligible for continued treatment with pazopanib and lapatinib (if on combination therapy).
- Able to understand and provide written informed consent
- Women and men agree to use protocol specific birth control measures
Who cannot join
- The subject has a treatment related serious adverse event that remains unresolved or unstable or had pazopanib permanently stopped in a previous study because of intolerate or because it was unsuccessful in treating your cancer
- If you are pregnant or breast feeding
- Your doctor does not think you would be a good candidate for the study
- Poorly controlled high blood pressure
- Subject is unwilling or unable to follow the procedures outlined in the protocol.
Trial locations and contacts
19 sites in 4 countries.
19 sites in 4 countries
United States15 sites
Novartis Investigative Site
Aurora, Colorado, 80045
Novartis Investigative Site
Buffalo, New York, 14263
Novartis Investigative Site
Cleveland, Ohio, 44106
Novartis Investigative Site
Detroit, Michigan, 48201
Novartis Investigative Site
Duarte, California, 91010
Novartis Investigative Site
Durham, North Carolina, 27710
Novartis Investigative Site
Greenville, South Carolina, 29605
Novartis Investigative Site
Houston, Texas, 77030-4009
Novartis Investigative Site
Indianapolis, Indiana, 46202
Novartis Investigative Site
Lebanon, New Hampshire, 03756
Novartis Investigative Site
Minneapolis, Minnesota, 55404
Novartis Investigative Site
Nashville, Tennessee, 37203
Novartis Investigative Site
New Brunswick, New Jersey, 08901
Novartis Investigative Site
Santa Monica, California, 90404
Novartis Investigative Site
Tacoma, Washington, 98405
United Kingdom2 sites
Novartis Investigative Site
Newcastle upon Tyne, NE7 7DN
Novartis Investigative Site
Sutton, Surrey, SM2 5PT
About this study
Official title: An Open-Label, Phase Ib Study to Assess the Long Term Safety Profile of Pazopanib in Cancer Patients
This study was a rollover study to evaluate the long term safety of pazopanib and to continue to provide pazopanib to patients who participated in a GSK sponsored pazopanib study until pazopanib is available commercially.
- Conditions
- Carcinoma, Renal Cell
- Being tested
- Pazopanib
- Keywords
- chronic administration, monotherapy and combination therapies, solid, lapatinib (TYKERB, TYVERB), malignant tumor, Pazopanib, GW786034, cancer, safety
- Medical subject headings
- Carcinoma, Renal Cell, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PazopanibDrug
Pazopanib monotherapy or in combination with lapatinib or other approved anti-cancer medications
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Pazopanib monotherapy or in combination with lapatinib or other approved anti-cancer medications Receives: Drug: Pazopanib |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the long-term safety of repeat daily doses of pazopanib in cancer subjects with solid tumors
To evaluate the safety assessments; adverse events, vital signs, physical examinations, electrocardiograms, multi-gated acquisition scans or echocardiograms (only for patients on pazopanib and lapatinib combination therapy), and clinical laboratory assessments.
Measured: Subjects will stay on the study as long as they are benefiting from treatment, have not met one of the stopping criteria, or experienced a toxicity up to 72 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2006 (estimated)
- Study start20 Jun 2006
- Primary completion13 Feb 2013
- Study completion8 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Renal CellStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Masking
- None (open label)
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00387205
- Sponsor's protocol ID
- VEG105430
- Other IDs
- 2006-005528-17
- Status last verified
- Mar 2019
- First submitted
- 10 Oct 2006
- Last updated
- 6 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Phase Ib Study to Assess the Long Term Safety Profile of Pazopanib in Cancer Patients
- ClinicalTrials.gov ID
- NCT00387205
- Acronym / sponsor ID
- VEG105430
- Conditions
- Carcinoma, Renal Cell
- Keywords
- chronic administration, monotherapy and combination therapies, solid, lapatinib (TYKERB, TYVERB), malignant tumor, Pazopanib, GW786034, cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 20 Jun 2006 (actual)
- Primary completion
- 13 Feb 2013 (actual)
- Study completion
- 8 Mar 2018 (actual)
- First posted
- 12 Oct 2006 (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 study was a rollover study to evaluate the long term safety of pazopanib and to continue to provide pazopanib to patients who participated in a GSK sponsored pazopanib study until pazopanib is available commercially.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: PazopanibPazopanib monotherapy or in combination with lapatinib or other approved anti-cancer medications |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participated or completed a GSK sponsored pazopanib study and remains eligible for continued treatment with pazopanib and lapatinib (if on combination therapy).
- Able to understand and provide written informed consent
- Women and men agree to use protocol specific birth control measures
Key exclusion criteria (5 listed)
- The subject has a treatment related serious adverse event that remains unresolved or unstable or had pazopanib permanently stopped in a previous study because of intolerate or because it was unsuccessful in treating your cancer
- If you are pregnant or breast feeding
- Your doctor does not think you would be a good candidate for the study
- Poorly controlled high blood pressure
- Subject is unwilling or unable to follow the procedures outlined in the protocol.
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 |
|---|---|---|
| PazopanibPazopanib monotherapy or in combination with lapatinib or other approved anti-cancer medications | Drug | Arm 1 |
Primary outcome
To evaluate the long-term safety of repeat daily doses of pazopanib in cancer subjects with solid tumors
Time frame: Subjects will stay on the study as long as they are benefiting from treatment, have not met one of the stopping criteria, or experienced a toxicity up to 72 months.
To evaluate the safety assessments; adverse events, vital signs, physical examinations, electrocardiograms, multi-gated acquisition scans or echocardiograms (only for patients on pazopanib and lapatinib combination therapy), and clinical laboratory assessments.
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 6 Mar 2019.
- Individual participant dataSharing planned: No
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
19 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pazopanib in people with Carcinoma, Renal Cell, run by Novartis Pharmaceuticals at 19 sites in 4 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 3 inclusion and 5 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 6 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, United Kingdom, France, Singapore. 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?
To evaluate the long-term safety of repeat daily doses of pazopanib in cancer subjects with solid tumors (time frame: Subjects will stay on the study as long as they are benefiting from treatment, have not met one of the stopping criteria, or experienced a toxicity up to 72 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 6 Mar 2019.