A Phase II, Open-Label, Randomized, Multicenter Trial of Pazopanib (GW786034) in Combination with Lapatinib (GW572016) Compared to Pazopanib Montherapy 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
- Conditions
- Patients with FIGO Stage IVB or recurrent or persistent cervical cancer with zero or one prior chemotherapy regimen for advanced/recurrent diseaseMedDRA version: 8.1Level: LLTClassification code 10008229Term: Cervical cancer
- Registration Number
- EUCTR2006-000236-27-EE
- Lead Sponsor
- GlaxoSmithKline Research & Development Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate progression-free survival (PFS) of pazopanib monotherapy versus lapatinib monotherapy in subjects with FIGO Stage IVB, or recurrent or persistent cervical cancer who have had zero or one prior chemotherapy regimen for advanced disease.;Secondary Objective: To evaluate overall survival, the anti-tumor activity in terms of clinical benefit (complete or partial response or durable stable disease), response rate (defined as the percentage of patients achieving either a complete or partial tumor response per RECIST criteria), time to response and duration of response for each treatment arm.<br>Evaluate the safety and tolerability of pazopanib monotherapy versus lapatinib monotherapy in this subject population.;Primary end point(s):
- Secondary Outcome Measures
Name Time Method