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Phase I Study of Pazopanib Alone and In Combination With Lapatinib in Japanese Patients With Solid Tumors.

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: August 13, 2007
Last updated: March 21, 2016
Last verified: March 2016
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.

Condition Intervention Phase
Carcinoma, Renal Cell Drug: pazopanib Drug: Lapatinib Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open-Label, Multiple Dose of Pazopanib Alone and In Combination With Lapatinib in Japanese Patients With Solid Tumors.

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • Pharmacokinetics [ Time Frame: over a 24 hour period ]
    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.

  • Tumor response [ Time Frame: 9 weeks ]
    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).

Enrollment: 36
Study Start Date: September 2007
Study Completion Date: October 2015
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Pazopanib monotherapy or in combination with lapatinib
Drug: pazopanib
Pazopanib oral tablet
Drug: Lapatinib
Lapatinib oral tablet


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • 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%.

Exclusion criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00516672

GSK Investigational Site
Aichi, Japan, 466-8560
GSK Investigational Site
Saitama, Japan, 350-1298
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: GlaxoSmithKline Identifier: NCT00516672     History of Changes
Other Study ID Numbers: 109693
Study First Received: August 13, 2007
Last Updated: March 21, 2016

Keywords provided by GlaxoSmithKline:
Japanese patients,

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on August 22, 2017