An open-label, multicentre, randomised phase II study of pazopanib in combination with pemetrexed in first-line treatment of subjects with predominantly non-squamous cell stage IIIBwet/IV non-small cell lung cancer - ND

• Conditions: subjects with predominantly non-squamous cell stage IIIBwet/IV non-small cell lung cancer; MedDRA version: 9.1Level: HLGTClassification code 10029107Term: Respiratory tract neoplasms

• Registration Number: EUCTR2008-002144-42-IT
• Lead Sponsor: GLAXOSMITHKLINE R&D LIMITED

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-04
• Last Update Posted: 24 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

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 assessments. Procedures conducted as part of the subject?s routine clinical management (e.g., blood count, imaging study) and obtained prior to signing of informed consent may be used for screening or baseline purposes provided these procedures were conducted as specified in the protocol. 2. Age ≥18 years old (or legal age of consent if greater than 18 years) 3. Histologically- or cytologically-confirmed diagnosis of predominantly nonsquamous cell Stage IIIBwet (with confirmed malignant pleural effusion) or Stage IV NSCLC. 4. ECOG performance status of 0 or 1 (Appendix 3). 5. Life expectancy of at least 12 weeks. 6. Measurable disease as defined by RECIST criteria (Section 6.2.3) [Therasse, 2000] 7. No prior systemic first-line therapy for Stage IIIBwet/IV NSCLC either by chemotherapy or any other systemic treatment. Prior surgery and/or localised irradiation for NSCLC are permitted as long as it was a minimum of 4 weeks before entering the study. Subjects with recurrence after previous NSCLC that has been treated with surgery and adjuvant chemotherapy or a radio-chemotherapy regimen with curative intent are eligible, provided 1 year has passed since this treatment ended. 8. Able to swallow and retain oral medication. 9. Adequate organ system function 10. A female is eligible to enter and participate in this study in based on some criterias
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

Active malignancy or any malignancy in the 3 years prior to first dose of study drug other than NSCLC. Subjects with a history of completely resected nonmelanomatous skin carcinoma or successfully treated in situ carcinoma are eligible. 2. History or clinical evidence of CNS metastases or leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medication for 1 week prior to first dose of study drug. Screening with CNS imaging (computerised tomography [CT] or magnetic resonance imaging [MRI]) is required only if clinically indicated or if the subject has a history of CNS metastases. 3. Clinically significant gastrointestinal abnormalities

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified