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A Phase II Study of GSK1363089 (Formerly XL880) for Papillary Renal-Cell Carcinoma (PRC)

NCT ID: NCT00726323

Last Updated: 2017-12-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2010-08-18

Brief Summary

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This clinical study is being conducted at multiple sites to determine the best confirmed response rate, safety, and tolerability of GSK1363089 treatment in papillary renal cell carcinoma. Papillary renal cell carcinoma may be classified into hereditary and sporadic forms; subjects with either classification will be accepted into this study.

Detailed Description

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Conditions

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Carcinoma, Renal Cell

Keywords

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c-Met Papillary Renal Cell Carcinoma(PRC) Sporadic papillary renal cell carcinoma, Clear cell renal carcinoma Hereditary papillary renal cell carcinoma,

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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5/9 dosing

240 mg of foretinib on a 5 day on / 9 day off regimen every 14 days.

Group Type EXPERIMENTAL

foretinib (formerly GSK1363089 or XL880)

Intervention Type DRUG

treatment with oral foretinib on one of 2 dosing regimens: 240 mg on a 5 day on / 9 day off schedule every 14 days, or 80 mg on a daily dosing schedule

daily dosing

80 mg foretinib on a daily dosing regimen

Group Type EXPERIMENTAL

foretinib (formerly GSK1363089 or XL880)

Intervention Type DRUG

treatment with oral foretinib on one of 2 dosing regimens: 240 mg on a 5 day on / 9 day off schedule every 14 days, or 80 mg on a daily dosing schedule

Interventions

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foretinib (formerly GSK1363089 or XL880)

treatment with oral foretinib on one of 2 dosing regimens: 240 mg on a 5 day on / 9 day off schedule every 14 days, or 80 mg on a daily dosing schedule

Intervention Type DRUG

Other Intervention Names

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GSK1363089 (formerly XL880)

Eligibility Criteria

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Inclusion Criteria

* Histologically confirmed diagnosis of PRC with metastatic disease or bilateral multifocal renal tumors localized to kidneys. Measurable disease, ECOG performance status of \</= 2.
* Adequate bone marrow reserve, hepatic, renal, and cardiovascular function.

Exclusion Criteria

* Radiation to \>/=25% of bone marrow within 14 days of GSK1363089, more than 1 prior anti-cancer therapy, received prior treatment with a c-met inhibitor, brain metastases,
* Any uncontrolled intercurrent illness,
* Pregnant or breastfeeding,
* HIV positive
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Greenbrae, California, United States

Site Status

GSK Investigational Site

San Francisco, California, United States

Site Status

GSK Investigational Site

Stanford, California, United States

Site Status

GSK Investigational Site

Indianapolis, Indiana, United States

Site Status

GSK Investigational Site

Bethesda, Maryland, United States

Site Status

GSK Investigational Site

Boston, Massachusetts, United States

Site Status

GSK Investigational Site

Detroit, Michigan, United States

Site Status

GSK Investigational Site

New Brunswick, New Jersey, United States

Site Status

GSK Investigational Site

Cleveland, Ohio, United States

Site Status

GSK Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

GSK Investigational Site

Nashville, Tennessee, United States

Site Status

GSK Investigational Site

San Antonio, Texas, United States

Site Status

Countries

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United States

References

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Choueiri TK, Vaishampayan U, Rosenberg JE, Logan TF, Harzstark AL, Bukowski RM, Rini BI, Srinivas S, Stein MN, Adams LM, Ottesen LH, Laubscher KH, Sherman L, McDermott DF, Haas NB, Flaherty KT, Ross R, Eisenberg P, Meltzer PS, Merino MJ, Bottaro DP, Linehan WM, Srinivasan R. Phase II and biomarker study of the dual MET/VEGFR2 inhibitor foretinib in patients with papillary renal cell carcinoma. J Clin Oncol. 2013 Jan 10;31(2):181-6. doi: 10.1200/JCO.2012.43.3383. Epub 2012 Dec 3.

Reference Type BACKGROUND
PMID: 23213094 (View on PubMed)

Study Documents

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Document Type: Informed Consent Form

View Document

Document Type: Clinical Study Report

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Document Type: Dataset Specification

View Document

Document Type: Individual Participant Data Set

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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MET111644

Identifier Type: -

Identifier Source: org_study_id

NCT00345423

Identifier Type: -

Identifier Source: nct_alias