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OpenTrials
Completed

NCT Number: NCT00516672

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

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.

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Key information

Conditions

Carcinoma, Renal Cell Adenocarcinoma Carcinoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site, Aichi, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pazopanib

Drug

Pazopanib oral tablet

Lapatinib

Drug

Lapatinib oral tablet

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Phase I, Open-Label, Multiple Dose of Pazopanib Alone and In Combination With Lapatinib in Japanese Patients With Solid Tumors

Important dates

Study start
2007
Primary completion
2010
Study completion
2015
First posted
Aug 15, 2007
Registry last updated
Nov 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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