Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
GlaxoSmithKline |
---|---|
Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00430781 |
This study is being conducted to compare the efficacy and safety of pazopanib in combination with lapatinib with that of lapatinib alone or pazopanib alone in subjects with metastatic cervical cancer
Condition | Intervention | Phase |
---|---|---|
Metastatic Cervical Cancer |
Drug: pazopanib (GW786034), lapatinib (GW572016) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | See Detailed Description |
Estimated Enrollment: | 180 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
A Phase II, Open-Label, Randomized, Multicenter Trial of Pazopanib (GW786034) in Combination with Lapatinib (GW572016) Compared to Pazopanib Monotherapy and Lapatinib Monotherapy in Subjects with FIGO Stage IVB or Recurrent or Persistent Cervical Cancer with Zero or One Prior Chemotherapy Regimen for Advanced/Recurrent Disease
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Each lesion must be ≥ 20 mm when measured by conventional techniques, including palpitation, plain x-ray, CT and MRI, or ≥10 mm when measured by spiral CT.
Table 1:(Definitions for Adequate Organ Function) System:(Laboratory Values)
Hematologic: Absolute neutrophil count (ANC)(≥ 1.5 X 109/L)Hemoglobin1(≥9 g/dL)Platelets(≥100 X 109/L) Hepatic: Total bilirubin (≤1.5 X ULN)AST and ALT (≤2.5 X ULN) Renal: Calculated creatinine clearance2 (≥50 mL/min) Urine protein3 (Negative, trace or +1 by dipstick urinalysis or <1.0 gram determined by 24 hour urine protein analysis.)
Subjects must provide written informed consent prior to performance of study specific procedures or assessments, and must be willing to comply with treatment and follow-up as outlined in the protocol. Procedures conducted as apart of routine clinical management of the patient (e.g., blood count, imaging study) and obtained prior to signed informed consent may be utilized for screening purposes provided these tests are obtained as specified in the protocol
Exclusion Criteria:
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | VEG105281 |
Study First Received: | January 31, 2007 |
Last Updated: | April 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00430781 History of Changes |
Health Authority: | United States: Food and Drug Administration; Spain: Ministry of Health |
FIGO Stage IVB recurrent persistent VEGF ErB1/ErB2 |
pazopanib lapatinib metastatic cervical cancer advanced |
Lapatinib Protein Kinase Inhibitors Recurrence |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors |
Lapatinib Protein Kinase Inhibitors Pharmacologic Actions |