GW786034 In Subjects With Locally Recurrent Or Metastatic Clear Cell Renal Cell Carcinoma

Phase 2

Completed

• Conditions: Carcinoma, Renal Cell
• Interventions: Drug: GW786034; Drug: Placebo

• Registration Number: NCT00244764
• Lead Sponsor: GlaxoSmithKline

Brief Summary

Phase II, multi-center, two-stage study utilising a randomised discontinuation design to evaluate the safety and efficacy of GW786034 (pazopanib) in adult subjects with locally recurrent or metastatic clear-cell Renal Cell Carcinoma (RCC). After the interim analysis, the design was changed to an open label, single arm study with all subjects receiving pazopanib.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2005-10-25
• Study First Submitted QC: 2005-10-26
• Study First Posted: 2005-10-27
• Primary Completion: 2008-03
• Results First Submitted: 2009-11-19
• Results First Submitted QC: 2011-01-06
• Results First Posted: 2011-01-25
• Study Completion: 2013-09
• Status Verified: 2015-09
• Last Update Submitted: 2017-02-23
• Last Update Posted: 2017-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 225

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pazopanib	GW786034	All patients receive GW786034. At week 12, some subjects will be randomized based on response (SD) and the others will remain on drug. After the interim analysis, the design was changed to an open label, single arm study with all subjects receiving pazopanib.
Placebo	Placebo	All patients receive GW786034. At week 12, some subjects will be randomized based on response (SD) and the others will remain on drug. After the interim analysis, the design was changed to an open label, single arm study with all subjects receiving pazopanib.

Primary Outcome Measures

Name	Time	Method
Overall Response by RECIST Criteria	Baseline to Response (up to 2.40 years). Assessments occurred at Week 12 and every 8 weeks thereafter.	The overall response is the number of participants who experience a confirmed complete (CR) or partial response (PR) of the total analysis population. Per the Response Evaluation Criteria In Solid Tumors (RECIST): CR = all detectable tumor has disappeared, PR = a \>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum, Progressive disease (PD) = a \>=20% increase in target lesions, Stable Disease = small changes that do not meet previously given criteria.
Stable Disease at 12 Weeks - Interim Analysis of First 60 Participants	Week 12	The protocol called for an interim analysis of the first 60 participants to determine their status at Week 12, and to determine the number of participants with stable disease, although all categories were reported. Stable disease is defined as a disease that has not grown enough to be called progressive disease and has not shrunk enough to be called partial/complete response.

Secondary Outcome Measures

Name	Time	Method
Duration of Response	First response until progression of disease (up to 2.40 years). Assessments occurred at Week 12 and every 8 weeks thereafter.	Using RECIST criteria: date of first confirmed tumor response (CR or PR) to date of tumor progression or to death. Participants who did not progress or die were censored at their last radiologic assessment. Only participants who had a response were analyzed.
Progression-free Survival	From the first day of treatment to the earliest date of disease progression or death due to any cause (up to 2.40 years)	Progression-free Survival is defined as the interval between the first day of treatment and the earliest date of disease progression or death due to any cause, whichever occurred first. Progressive disease is defined as a \>=20% increase in target lesions.

Trial Locations

Locations (1)

GSK Investigational Site; 🇨🇳 Taipei, Taiwan