Phase 3
N=80
Extension Study to VEG105192 to Assess Pazopanib in Patients With Advanced/Metastatic Renal Cell Cancer
Carcinoma, Renal Cell
Bottom Line
View on ClinicalTrials.gov: NCT00387764 ↗Enrolled (actual)
80
Serious AEs
33.8%
Results posted
Dec 2013
Primary outcome: Primary: Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) — 78; 27 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- pazopanib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) |
78; 27 | — |
| PRIMARY Number of Participants With Any Adverse Event (Serious and Non-serious) of the Indicated Severity, Per National Cancer Institute (NCI) Common Terminology Criteria in Adverse Events (CTCAE) |
12; 33; 22; 7; 4 | — |
| PRIMARY Number of Participants With Adverse Events Related to Investigational Product |
70 | — |
| PRIMARY Median Time on Investigational Product |
9.7 | — |
| PRIMARY Number of Participants With the Indicated Worst-case Toxicity Grade Increase From Baseline for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline |
26; 2; 0; 39; 5; 1 | — |
| PRIMARY Number of Participants With the Indicated Worst-case Grade Increase From Baseline for the Indicated Hematology Parameters at Any Time Post-Baseline |
29; 2; 0; 10; 2; 0 | — |
| PRIMARY Number of Participants With the Indicated Shift From Baseline in Blood Pressure at Any Time Post-Baseline |
1; 29; 44; 6; 1; 32 | — |
| PRIMARY Number of Participants With the Indicated Shift in Heart Rate From Baseline at Any Time Post-Baseline |
0; 66; 12; 1 | — |
| PRIMARY Number of Participants With a Change From Baseline to the Indicated Worst-case Post-Baseline Bazett's Heart Rate-corrected QT Interval (QTc) Value |
63; 2; 8; 3; 1 | — |
| SECONDARY Number of Participants With a Complete Response (CR) or Partial Response (PR) |
0; 30; 30 | — |
| SECONDARY Number of Participants With a Response of Confirmed CR+PR+6-month Stable Disease (SD) |
35 | — |
| SECONDARY Number of Participants With the Indicated Best Overall Response |
0; 30; 31; 10; 9 | — |
| SECONDARY Progression-free Survival (PFS) |
9.2 | — |
| SECONDARY Overall Survival (OS) |
23.5 | — |
| SECONDARY Percentage of Participants Who Survived Until Month 12 |
72 | — |
Summary
This is an open-label, international, multi-center study designed to provide access to pazopanib for subjects who have been enrolled in the Phase III renal cell carcinoma study (VEG105192) and have progressed on placebo. Subjects will receive 800 mg pazopanib once daily. The study treatment will continue until subjects experience disease progression, unacceptable toxicity, withdrawal of consent, or death. The primary objective of the study is to evaluate the safety and tolerability of pazopanib for the treatment of renal cell carcinoma. The secondary objectives of the study are to assess response rate (defined as complete response or partial response), progression-free survival, and overall survival. Response rates will be collected per investigator assessment (no central review). Subjects will have a CT/MRI scan every 6 weeks until week 24 and every 12 weeks thereafter.
Eligibility Criteria
Inclusion criteria
- Progressed from VEG105192 study treatment
- Patient's VEG105192 was placebo
- Baseline has good organ function
Exclusion criteria
- No brain metastasis
Data sourced from ClinicalTrials.gov (NCT00387764). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.