Phase I Study of Pazopanib Alone and In Combination With Lapatinib in Japanese Patients With Solid Tumors
NCT ID: NCT00516672
Last Updated: 2017-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2007-09-10
2015-10-14
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm 1
Pazopanib monotherapy or in combination with lapatinib
pazopanib
Pazopanib oral tablet
Lapatinib
Lapatinib oral tablet
Interventions
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pazopanib
Pazopanib oral tablet
Lapatinib
Lapatinib oral tablet
Eligibility Criteria
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Inclusion Criteria
* 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%.
Exclusion Criteria
* 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
20 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Aichi, , Japan
GSK Investigational Site
Saitama, , Japan
Countries
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References
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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.
Other Identifiers
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109693
Identifier Type: -
Identifier Source: org_study_id