Pharmacokinetics of PazopanibEarly Phase 1NCT02810756
Study With Improved Solubility Pazopanib
A Early Phase 1 study testing New Pazopanib formulation in people with Pharmacokinetics of Pazopanib, run by The Netherlands Cancer Institute at 1 site in Netherlands.
Trial summary
The pharmacokinetics of a new formulation with Pazopanib will be studied. This will be done in a patient cohort of n = 12. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pharmacokinetics of Pazopanib
- What is being tested?
- New Pazopanib formulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Sep 2016to 28 Aug 2017
- Phase
- Early 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
- Locally advanced or metastatic cancer;
- Able and willing to give written consent;
- WHO performance status of 0, 1 or 2;
- Able and willing to undergo blood sampling for PK analysis;
- Minimal acceptable safety laboratory values;
- Negative pregnancy test for female patients with childbearing potential;
- Able and willing to swallow oral medication.
Who cannot join
- Any treatment with investigational drugs within 30 days prior to receiving the investigational treatment;
- Any treatment with CYP3A4, BCRP or PGP interfering drugs;
- Patients who received treatment with Votrient(R) kess than 1 week ago;
- Woman who are pregnant or breast feeding;
- Patients suffering from any known condition that may influence the dissolution or absorption of Pazopanib.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Netherlands Cancer Institute
Amsterdam, North Holland, 1066 CX
About this study
Official title: Proof of Principle and Pharmacological Phase 0 Study With Improved Solubility Pazopanib
The pharmacokinetics of a new formulation with Pazopanib will be studied. This will be done in a patient cohort of n = 12.
- Conditions
- Pharmacokinetics of Pazopanib
- Being tested
- New Pazopanib formulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New Pazopanib formulationDrug
| Study group | Role | What they receive |
|---|---|---|
| Treated patients | Experimental | Not described Receives: Drug: New Pazopanib formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration
Concentration of pazopanib in plasma
Measured: 24 hours
Secondary outcomes (2)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 1 week
Area under the plasma concentration versus time curve (AUC)
Area under the plasma concentration versus time curve (AUC)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study start15 Sep 2016
- Primary completion28 Aug 2017
- Study completion28 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacokinetics of PazopanibStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02810756
- Sponsor's protocol ID
- N16PZN
- Status last verified
- Sep 2017
- First submitted
- 31 May 2016
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Individual participant data will remain confidential
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof of Principle and Pharmacological Phase 0 Study With Improved Solubility Pazopanib
- ClinicalTrials.gov ID
- NCT02810756
- Acronym / sponsor ID
- N16PZN
- Conditions
- Pharmacokinetics of Pazopanib
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Study start
- 15 Sep 2016 (actual)
- Primary completion
- 28 Aug 2017 (actual)
- Study completion
- 28 Aug 2017 (actual)
- First posted
- 23 Jun 2016 (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 pharmacokinetics of a new formulation with Pazopanib will be studied. This will be done in a patient cohort of n = 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treated patients | Experimental | Drug: New Pazopanib formulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Locally advanced or metastatic cancer;
- Able and willing to give written consent;
- WHO performance status of 0, 1 or 2;
- Able and willing to undergo blood sampling for PK analysis;
- Minimal acceptable safety laboratory values;
Key exclusion criteria (5 listed)
- Any treatment with investigational drugs within 30 days prior to receiving the investigational treatment;
- Any treatment with CYP3A4, BCRP or PGP interfering drugs;
- Patients who received treatment with Votrient(R) kess than 1 week ago;
- Woman who are pregnant or breast feeding;
- Patients suffering from any known condition that may influence the dissolution or absorption of Pazopanib.
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 |
|---|---|---|
| New Pazopanib formulation | Drug | Treated patients |
Primary outcome
Plasma concentration
Time frame: 24 hours
Concentration of pazopanib in plasma
2 secondary outcomes
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 1 week
Area under the plasma concentration versus time curve (AUC)
Time frame: 24 hours
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 11 Sep 2017.
- Individual participant dataSharing planned: No. Individual participant data will remain confidential
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing New Pazopanib formulation in people with Pharmacokinetics of Pazopanib, run by The Netherlands Cancer Institute at 1 site in Netherlands.
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 7 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 11 Sep 2017. 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 Netherlands. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Plasma concentration (time frame: 24 hours). 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 11 Sep 2017; AzTrials last refreshed its copy on 2 Nov 2026.