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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00516672
First received: August 13, 2007
Last updated: April 11, 2013
Last verified: February 2013
History of Changes
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Safety and tolerability [ Time Frame: before and after taking the study medications ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 36
Study Start Date: September 2007
Estimated Study Completion Date: November 2013
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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00516672     History of Changes
Other Study ID Numbers: 109693
Study First Received: August 13, 2007
Last Updated: April 11, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

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

ClinicalTrials.gov processed this record on May 19, 2013