EUCTR2008-002144-42-FR
Active, not recruiting
Phase 1
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
GlaxoSmithKline R&D Limited0 sites0 target enrollmentMay 29, 2009
ConditionsHistologically- or cytologically-confirmed diagnosis of non-predominantly squamous cell Stage IIIBwet (with confirmed malignant pleural effusion) or Stage IV NSCLCMedDRA version: 9.1 Level: LLT Classification code 10029521 Term: Non-small cell lung cancer stage IIIBMedDRA version: 9.1 Level: LLT Classification code 10029522 Term: Non-small cell lung cancer stage IV
DrugsALIMTA
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Histologically- or cytologically-confirmed diagnosis of non-predominantly squamous cell Stage IIIBwet (with confirmed malignant pleural effusion) or Stage IV NSCLC
- Sponsor
- GlaxoSmithKline R&D Limited
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Specific information regarding warnings, precautions, contraindications, AEs, and other pertinent information on the IP that may impact subject eligibility is provided in the IB for pazopanib. For pemetrexed and cisplatin, please refer to the approved product labels.
- •Subjects eligible for enrollment in the study must meet all of the following 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.
- •Age 18 years old (or legal age of consent if greater than 18 years)
- •Histologically\- or cytologically\-confirmed diagnosis of predominantly non\-squamous cell Stage IIIBwet (with confirmed malignant pleural effusion) or Stage IV NSCLC.
- •ECOG performance status of 0 or 1 (Appendix 3\).
- •Life expectancy of at least 12 weeks.
- •Measurable disease as defined by RECIST criteria (Section 6\.2\.3\) \[Therasse, 2000]
- •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.
- •Able to swallow and retain oral medication.
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 non\-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible.
- •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.
- •Clinically significant gastrointestinal abnormalities including, but not limited to:
- •Malabsorption syndrome .
- •Major resection of the stomach or small bowel that could affect the absorption of study drug.
- •Active peptic ulcer disease.
- •Known intraluminal metastatic lesion/s with risk of bleeding.
- •Inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease), or other gastrointestinal conditions with increased risk of perforation.
- •History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment.
- •Presence of uncontrolled infection.
Outcomes
Primary Outcomes
Not specified
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