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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00430781 |
Purpose
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 |
|---|---|---|
|
Neoplasms, Uterine Cervix Metastatic Cervical Cancer |
Drug: pazopanib (GW786034) Drug: lapatinib (GW572016) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
| Enrollment: | 228 |
| Study Start Date: | November 2006 |
| Study Completion Date: | July 2011 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Combination arm
Pazopanib plus lapatinib
|
Drug: pazopanib (GW786034) Drug: lapatinib (GW572016) |
|
Active Comparator: Lapatinib monotherapy
Lapatinib
|
Drug: lapatinib (GW572016) |
|
Active Comparator: Pazopanib monotherapy
Pazopanib
|
Drug: pazopanib (GW786034) |
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 International Federation of Gynecology (FIGO) Stage IVB or Recurrent or Persistent Cervical Cancer with Zero or One Prior Chemotherapy Regimen for Advanced/Recurrent Disease
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Note: Oral contraceptives are not reliable due to potential drug-drug interactions.
Exclusion Criteria:
Contacts and Locations
Show 63 Study Locations| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT00430781 History of Changes |
| Other Study ID Numbers: | VEG105281 |
| Study First Received: | January 31, 2007 |
| Results First Received: | November 19, 2009 |
| Last Updated: | February 2, 2012 |
| Health Authority: | Spain: Ministry of Health; United States: Food and Drug Administration |
|
pazopanib ErB1/ErB2 lapatinib persistent VEGF |
recurrent metastatic cervical cancer advanced FIGO Stage IVB |
|
Neoplasms Uterine Cervical Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Uterine Cervical Diseases Uterine Diseases |
Genital Diseases, Female Lapatinib Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |