Carcinoma, Renal CellPhase 1NCT00516672
Phase I Study of Pazopanib Alone and In Combination With Lapatinib in Japanese Patients With Solid Tumors
A Phase 1 study testing pazopanib and Lapatinib in people with Carcinoma, Renal Cell, run by GlaxoSmithKline at 2 sites in Japan.
Trial summary
This is a two part phase I study in Japanese patients that will determine the safety, tolerability and pharmacokinetics of pazopanib monotherapy and of pazopanib in combination with lapatinib. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Carcinoma, Renal Cell
- What is being tested?
- pazopanib and Lapatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesJapan
- Study dates
- 10 Sep 2007to 14 Oct 2015
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent.
- Histologically or cytologically confirmed diagnosis of advanced solid tumor.
- Women and men with potential to have children must be willing to practice acceptable methods of birth control during the study.
- ECOG performance status of 0 or 1.
- Adequate bone marrow reserve and hepato-renal function.
- Able to swallow and retain oral medication.
- For combo part, left ventricular ejection fraction within normal range or above 50%.
Who cannot join
- Prior treatment with pazopanib, and with lapatinib for combo part.
- Clinically significant gastrointestinal abnormalities.
- Sevier diseases or conditions other than cancer.
- Poorly controlled hypertension.
- Use of warfarin for therapeutic anticoagulation.
- Use of other anti-angiogenesis agents, and other ErbB inhibitors for combo part.
- Unresolved and/or unstable toxicities
- Pregnant or lactating females
Trial locations and contacts
2 sites in 1 country.
Japan2 sites
GSK Investigational Site
Aichi, 466-8560
GSK Investigational Site
Saitama, 350-1298
About this study
Official title: A Phase I, Open-Label, Multiple Dose of Pazopanib Alone and In Combination With Lapatinib in Japanese Patients With Solid Tumors
This is a two part phase I study in Japanese patients that will determine the safety, tolerability and pharmacokinetics of pazopanib monotherapy and of pazopanib in combination with lapatinib.
- Conditions
- Carcinoma, Renal Cell
- Being tested
- pazopanib, Lapatinib
- Keywords
- lapatinib,, cancer, pharmacokinetics,, safety,, pazopanib,, Japanese patients,
- 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 oral tablet
LapatinibDrug
Lapatinib oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Pazopanib monotherapy or in combination with lapatinib Receives: Drug: pazopanib; Drug: Lapatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
The safety and tolerability endpoints will consist of the evaluation of adverse events (AEs), and changes in vital signs and laboratory values.
Measured: before and after taking the study medications
Secondary outcomes (2)
Pharmacokinetics
The pharmacokinetic parameters AUC0-24, AUC0-inf (Day 1 only), Cmax, tmax, and t1/2 of pazopanib and its four metabolites. To determine if target trough plasma concentration of pazopanib of 20,000 ng/ml is achieved.
Measured: over a 24 hour period
Tumor response
Assessments of tumor response will be obtained every 9 weeks and will be recorded as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD).
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2007 (estimated)
- Study start10 Sep 2007
- Primary completion30 Aug 2010
- Study completion14 Oct 2015
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 Carcinoma, Renal 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
- 30 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
- NCT00516672
- Sponsor's protocol ID
- 109693
- Status last verified
- Nov 2017
- First submitted
- 13 Aug 2007
- Last updated
- 13 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Inada-Inoue M, Ando Y, Kawada K, Mitsuma A, Sawaki M, Yokoyama T, Sunakawa Y, Ishida H, Araki K, Yamashita K, Mizuno K, Nagashima F, Takekura A, Nagamatsu K, Sasaki Y. Phase 1 study of pazopanib alone or combined with lapatinib in Japanese patients with solid tumors. Cancer Chemother Pharmacol. 2014 Apr;73(4):673-83. doi: 10.1007/s00280-014-2374-3. Epub 2014 Jan 24.
PubMed 24464355
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, Multiple Dose of Pazopanib Alone and In Combination With Lapatinib in Japanese Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT00516672
- Acronym / sponsor ID
- 109693
- Conditions
- Carcinoma, Renal Cell
- Keywords
- lapatinib,, cancer, pharmacokinetics,, safety,, pazopanib,, Japanese patients,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 10 Sep 2007 (actual)
- Primary completion
- 30 Aug 2010 (actual)
- Study completion
- 14 Oct 2015 (actual)
- First posted
- 15 Aug 2007 (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 a two part phase I study in Japanese patients that will determine the safety, tolerability and pharmacokinetics of pazopanib monotherapy and of pazopanib in combination with lapatinib.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: pazopanib, Drug: LapatinibPazopanib monotherapy or in combination with lapatinib |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed informed consent.
- Histologically or cytologically confirmed diagnosis of advanced solid tumor.
- Women and men with potential to have children must be willing to practice acceptable methods of birth control during the study.
- ECOG performance status of 0 or 1.
- Adequate bone marrow reserve and hepato-renal function.
Key exclusion criteria (8 listed)
- Prior treatment with pazopanib, and with lapatinib for combo part.
- Clinically significant gastrointestinal abnormalities.
- Sevier diseases or conditions other than cancer.
- Poorly controlled hypertension.
- Use of warfarin for therapeutic anticoagulation.
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 oral tablet | Drug | Arm 1 |
| LapatinibLapatinib oral tablet | Drug | Arm 1 |
Primary outcome
Safety and tolerability
Time frame: before and after taking the study medications
The safety and tolerability endpoints will consist of the evaluation of adverse events (AEs), and changes in vital signs and laboratory values.
2 secondary outcomes
Pharmacokinetics
Time frame: over a 24 hour period
Tumor response
Time frame: 9 weeks
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.
- Derived from this study: PubMed 24464355Inada-Inoue M, Ando Y, Kawada K, Mitsuma A, Sawaki M, Yokoyama T, Sunakawa Y, Ishida H, Araki K, Yamashita K, Mizuno K, Nagashima F, Takekura A, Nagamatsu K, Sasaki Y. Phase 1 study of pazopanib alone or combined with lapatinib in Japanese patients with solid tumors. Cancer Chemother Pharmacol. 2014 Apr;73(4):673-83. doi: 10.1007/s00280-014-2374-3. Epub 2014 Jan 24.
- Results for study 109693 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 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 Lapatinib in people with Carcinoma, Renal Cell, run by GlaxoSmithKline at 2 sites in Japan.
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 8 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 2 sites in Japan. 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?
Safety and tolerability (time frame: before and after taking the study medications). 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 NCT00516672, 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 13 Nov 2017.