Study of Pazopanib and Pemetrexed in Advanced Non-small Cell Lung Cancer

GlaxoSmithKline (GSK) logo

GlaxoSmithKline (GSK)

Status and phase

Completed
Phase 2

Conditions

Lung Cancer, Non-Small Cell

Treatments

Drug: pemetrexed and cisplatin
Drug: pazopanib and pemetrexed

Study type

Interventional

Funder types

Industry

Identifiers

NCT00871403
111128

Details and patient eligibility

About

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).

Enrollment

107 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

107 participants in 2 patient groups

Arm 1
Experimental group
Description:
Investigational treatment (pazopanib and pemetrexed)
Treatment:
Drug: pazopanib and pemetrexed
Arm 2
Active Comparator group
Description:
Standard treatment (pemetrexed and cisplatin)
Treatment:
Drug: pemetrexed and cisplatin

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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