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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00516672
Recruitment Status : Completed
First Posted : August 15, 2007
Last Update Posted : November 13, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Carcinoma, Renal Cell Drug: pazopanib Drug: Lapatinib Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
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
Actual Study Start Date : September 10, 2007
Primary Completion Date : August 30, 2010
Study Completion Date : October 14, 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Arm 1
Pazopanib monotherapy or in combination with lapatinib
Drug: pazopanib
Pazopanib oral tablet
Drug: Lapatinib
Lapatinib oral tablet


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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).


Eligibility Criteria

Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00516672


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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00516672     History of Changes
Other Study ID Numbers: 109693
First Posted: August 15, 2007    Key Record Dates
Last Update Posted: November 13, 2017
Last Verified: November 2017

Keywords provided by GlaxoSmithKline:
lapatinib,
cancer
pharmacokinetics,
safety,
pazopanib,
Japanese patients,

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Lapatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action