We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00516672
First Posted: August 15, 2007
Last Update Posted: November 10, 2017
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.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
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: 30
Actual Study Start Date: September 10, 2007
Study Completion Date: October 14, 2015
Primary Completion Date: August 30, 2010 (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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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 Submitted: August 13, 2007
First Posted: August 15, 2007
Last Update Posted: November 10, 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