Phase I Study of Pazopanib Alone and In Combination With Lapatinib in Japanese Patients With Solid Tumors
A Phase I, Open-Label, Multiple Dose of Pazopanib Alone and In Combination With Lapatinib in Japanese Patients With Solid Tumors
1 other identifier
interventional
30
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Sep 2007
Longer than P75 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 13, 2007
CompletedFirst Posted
Study publicly available on registry
August 15, 2007
CompletedStudy Start
First participant enrolled
September 10, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 14, 2015
CompletedNovember 13, 2017
November 1, 2017
3 years
August 13, 2007
November 8, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
before and after taking the study medications
Secondary Outcomes (2)
Pharmacokinetics
over a 24 hour period
Tumor response
9 weeks
Study Arms (1)
Arm 1
EXPERIMENTALPazopanib monotherapy or in combination with lapatinib
Interventions
Eligibility Criteria
You may qualify if:
- 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%.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (2)
GSK Investigational Site
Aichi, 466-8560, Japan
GSK Investigational Site
Saitama, 350-1298, Japan
Related Publications (1)
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.
PMID: 24464355DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2007
First Posted
August 15, 2007
Study Start
September 10, 2007
Primary Completion
August 30, 2010
Study Completion
October 14, 2015
Last Updated
November 13, 2017
Record last verified: 2017-11