NCT00871403CompletedPhase 2
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 107
- Locations
- 1
- Primary Endpoint
- Progression-free Survival (PFS)
Study Overview
Brief Summary
The main purpose of this study is to determine whether the combination of pazopanib and pemetrexed is safe and effective in the treatment of advanced non-small cell lung cancer (NSCLC).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Written informed consent
- •At least 18 years old
- •Histologically- or cytologically-confirmed diagnosis of predominantly nonsquamous cell Stage IIIBwet (with confirmed malignant pleural effusion) or Stage IV NSCLC
- •No prior systemic first-line therapy for advanced NSCLC
- •Measurable disease
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Life expectancy of at least 12 weeks
- •Able to swallow and retain oral medication
- •Adequate organ system function (hematological, hepatic, and renal)
- •Non-childbearing potential (i.e., physiologically incapable of becoming pregnant) OR childbearing potential, and agrees to use adequate contraception. A male with a female partner of childbearing potential is eligible if he uses a barrier method of contraception or abstinence during the study
Exclusion Criteria
- •Active malignancy or any malignancy in the 3 years prior to first dose of study drug other than NSCLC
- •Central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for asymptomatic, previously treated CNS metastases
- •Clinically significant gastrointestinal abnormalities
- •Prolongation of corrected QT interval (QTc) > 480 msecs
- •History of any one or more cardiovascular conditions within the past 6 months prior to randomization
- •Poorly controlled hypertension
- •History of cerebrovascular accident (including transient ischemic attacks), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months
- •Major surgery or trauma within 28 days or any non-healing wound, fracture, or ulcer
- •Evidence of active bleeding or bleeding diathesis
- •Recent hemoptysis
- •Endobronchial lesions and/or lesions infiltrating major pulmonary vessels
- •Serious and/or unstable pre-existing medical (e.g., uncontrolled infection), psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures
- •Use of any prohibited medication
- •Use of an investigational agent within 28 days or 5 half-lives, whichever is longer, prior to the first dose of study drug
- •Ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in severity except alopecia
- •Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib, pemetrexed, and/or cisplatin
- •Inability to interrupt aspirin or other non-steroidal anti-inflammatory drugs during the study
- •Inability or unwillingness to take folic acid, vitamin B12 supplementation, or dexamethasone
- •Clinically significant third-space fluid collections (e.g., ascites or pleural effusions) that cannot be controlled by drainage or other procedures prior to study start
- •Recent or concurrent yellow fever vaccination
Arms & Interventions
Arm 1
Experimental
Investigational treatment (pazopanib and pemetrexed)
Intervention: pazopanib and pemetrexed (Drug)
Arm 2
Active Comparator
Standard treatment (pemetrexed and cisplatin)
Intervention: pemetrexed and cisplatin (Drug)
Outcomes
Primary Outcomes
Progression-free Survival (PFS)
Time Frame: Randomization until progression or death (up to 85 weeks)
PFS is defined as the interval between the date of randomization (date on which the investigator evaluated the participant and first determined he/she had disease progression) and the first occurrence of progressive disease (PD) or death from any cause. Per Response Evaluation Criteria in Solid Tumors (RECIST), version 1, PD is defined as a \>=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of \>=1 new lesion).
Secondary Outcomes
- Percentage of Participants With a Complete Response or a Partial Response(Randomization until response or progressive disease (up to 85 weeks))
- Overall Survival (OS)(Randomization until death (up to 85 weeks))
- Best Overall Response, Assessed as the Number of Participants With the Indicated Tumor Response: Investigator Assessed Only(Randomization until response or progressive disease (up to 85 weeks))
Investigators
Study Sites (1)
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