Know Cancer

forgot password

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

Phase 2
18 Years
Not Enrolling
Lung Cancer, Non-Small Cell

Thank you

Trial Information

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

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

- Clinically significant third-space fluid collections (e.g., ascites or pleural
effusions) that cannot be controlled by drainage or other procedures prior to study

- Recent or concurrent yellow fever vaccination

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free Survival (PFS)

Outcome Description:

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).

Outcome Time Frame:

Randomization until progression or death (up to 85 weeks)

Safety Issue:


Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:



Spain: Agencia EspaƱola del Medicamento y Productos Sanitarios

Study ID:




Start Date:

July 2009

Completion Date:

March 2011

Related Keywords:

  • Lung Cancer, Non-Small Cell
  • GW786034
  • pazopanib
  • pemetrexed
  • cisplatin
  • non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms