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

Primary Purpose

Carcinoma, Renal Cell

Status

Completed

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

pazopanib

Lapatinib

About this trial

This is an interventional treatment trial for Carcinoma, Renal Cell focused on measuring lapatinib,, cancer, pharmacokinetics,, safety,, pazopanib,, Japanese patients,

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

GSK Investigational Site
GSK Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

Pazopanib monotherapy or in combination with lapatinib

Outcomes

Primary Outcome Measures

Safety and tolerability

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

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

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).

Full Information

NCT ID

NCT00516672

First Posted

August 13, 2007

Last Updated

November 8, 2017

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00516672

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

September 10, 2007 (Actual)

Primary Completion Date

August 30, 2010 (Actual)

Study Completion Date

October 14, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma, Renal Cell

Keywords

lapatinib,, cancer, pharmacokinetics,, safety,, pazopanib,, Japanese patients,

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Description

Pazopanib monotherapy or in combination with lapatinib

Intervention Type

Drug

Intervention Name(s)

pazopanib

Intervention Description

Pazopanib oral tablet

Intervention Type

Drug

Intervention Name(s)

Lapatinib

Intervention Description

Lapatinib oral tablet

Primary Outcome Measure Information:

Title

Safety and tolerability

Description

The safety and tolerability endpoints will consist of the evaluation of adverse events (AEs), and changes in vital signs and laboratory values.

Time Frame

before and after taking the study medications

Secondary Outcome Measure Information:

Title

Pharmacokinetics

Description

Time Frame

over a 24 hour period

Title

Tumor response

Description

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).

Time Frame

9 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Aichi

ZIP/Postal Code

466-8560

Country

Japan

Facility Name

GSK Investigational Site

City

Saitama

ZIP/Postal Code

350-1298

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

24464355

Citation

Inada-Inoue M, Ando Y, Kawada K, Mitsuma A, Sawaki M, Yokoyama T, Sunakawa Y, Ishida H, Araki K, Yamashita K, Mizuno K, Nagashima F, Takekura A, Nagamatsu K, Sasaki Y. Phase 1 study of pazopanib alone or combined with lapatinib in Japanese patients with solid tumors. Cancer Chemother Pharmacol. 2014 Apr;73(4):673-83. doi: 10.1007/s00280-014-2374-3. Epub 2014 Jan 24.

Results Reference

derived

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

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