Last updated: 11/07/2018 03:13:04
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study. The most up to date information is available on clinicaltrials.gov.
Study of pazopanib and pemetrexed in advanced non-small cell lung cancer
EudraCT ID
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Trial overview
Official title: 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
Trial description: 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).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Progression-free Survival (PFS)
Timeframe: Randomization until progression or death (up to 85 weeks)
Secondary outcomes:
Overall Survival (OS)
Timeframe: Randomization until death (up to 85 weeks)
Best Overall Response, Assessed as the Number of Participants with the Indicated Tumor Response: Investigator assessed only
Timeframe: Randomization until response or progressive disease (up to 85 weeks)
Percentage of participants with a complete response or a partial response
Timeframe: Randomization until response or progressive disease (up to 85 weeks)
Interventions:
Drug: pazopanib and pemetrexed
Drug: pemetrexed and cisplatin
Enrollment:
107
Observational study model:
Not applicable
Primary completion date:
2011-01-03
Time perspective:
Not applicable
Clinical publications:
Scagliotti G, Felip E, Besse B, et al. An Open-Label, Multicenter, Randomized, Phase II Study of Pazopanib in Combination with Pemetrexed in First-Line Treatment of Patients with Advanced-Stage Non-Small-Cell Lung Cancer. J Thorac Oncol. 2013;8(12):1529-1537.
Medical condition
Lung Cancer, Non-Small Cell
Product
pazopanib
Collaborators
Not applicable
Study date(s)
July 2009 to March 2011
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Written informed consent
- At least 18 years old
- 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
Inclusion and exclusion criteria
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
Trial location(s)
Location
GSK Investigational Site
Sutton, Surrey, United Kingdom, SM2 5PT
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
No longer a GSK study
Actual primary completion date
2011-01-03
Actual study completion date
2011-01-03
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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