A Study to Evaluate Pazopanib in Comparison to Pemetrexed in Maintenance Setting in Non-progressing Subjects With Metastatic Stage IVA and IVB Non-squamous Non-small Cell Lung Cancer (NSCLC) Population

Stopped early · Phase 2

Conditions studied: Lung Cancer, Small Cell

In brief

This is a Phase II, randomized, open-label, multi-center study in advanced (Stage IVA and IVB subjects per the International Association for the Study of Lung Cancer (IASLC) 2009 Lung cancer staging schema) non-squamous NSCLC subjects comparing pazopanib relative to pemetrexed in the maintenance setting. Subjects should have completed 4-6 cycles of induction therapy with carboplatin + pemetrexed or cisplatin + pemetrexed and have had Stable Disease (SD), Partial Response (PR) or Complete Response (CR) as the best response to be enrolled into the study. The primary objective is to estimate the hazard ratio of progression free survival (PFS) in advanced NSCLC subjects given maintenance therapy of pazopanib (Arm A) relative to pemetrexed (Arm B). The secondary objectives are: overall survival, response rates, safety and tolerability. A total of approximately 200 subjects will be enrolled and randomized in a 1:1 ratio. Safety and efficacy assessments will be regularly performed on all subjects.

Key facts

Study ID

NCT01313663

Run by

GlaxoSmithKline

People needed

20

Starts

2011-02-01

Expected to finish

2012-07-01

Last updated by the study team

2014-10-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed written Informed Consent.
• Subjects must complete 4 to 6 cycles of chemotherapy with carboplatin + pemetrexed or cisplatin + pemetrexed and have had SD, PR or CR at the time of screening/enrolment as the best response.
• Prior surgery and/or localized irradiation for NSCLC is 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.
• Histologically or cytologically confirmed diagnosis of predominantly non-squamous cell Stage IVA Wet (with cytology positive Malignant Pleural Effusion (MPE)) or Stage IVB (metastatic) NSCLC.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy of at least 12 weeks.
• Must have measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST). A measurable lesion is defined as a lesion that can be accurately measured in at least one dimension with the longest diameter ≥ 20 mm using conventional techniques, or ≥ 10 mm with spiral computed tomography (CT) scan.
• Able to swallow and retain oral medication.
• Adequate organ system function.
• Women of childbearing potential must have a negative pregnancy test within <= 7 days prior to administration or dispensing of study treatment and agree to use effective contraception.
• Age ≥ 18 years of legal age of consent if different from 18 years.

You may not qualify if…

• History of active or any other malignancy other than lung cancer in the 2 yrs prior to the first dose of study drug other than NSCLC. Exception: Subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible.
• History or clinical evidence of central nervous system (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 medications for 4 months prior to first dose of study drug. Screening with CNS imaging studies (computed 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 that may increase the risk for gastrointestinal bleeding including, but not limited to:
• 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
• Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but not limited to:
• Malabsorption syndrome Major resection of the stomach or small bowel
• Presence of uncontrolled infection.
• Corrected QT interval (QTc) > 480 msecs using Bazett's formula
• History of any one or more of the following cardiovascular conditions within the past 6 months:
• Cardiac angioplasty or stenting Myocardial infarction Unstable angina Coronary artery bypass graft surgery Symptomatic peripheral vascular disease Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA).
• Poorly controlled hypertension, defined as systolic blood pressure (SBP) of ≥140 mmHg or diastolic blood pressure (DBP) of
• 90mmHg.
• Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. Blood pressure (BP) must be re-assessed on two occasions that are separated by a minimum of 1 hour; on each of these occasions, the mean (of 3 readings) SBP / DBP values from each BP assessment must be <140/90 mmHg in order for a subject to be eligible for the study.
• History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months. Note: Subjects with recent DVT who have been treated with therapeutic anti- coagulating agents for at least 6 weeks are eligible.
• Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement not considered to be major).
• Evidence of active bleeding or bleeding diathesis.
• Recent hemoptysis (>=½ teaspoon of red blood within 8 weeks before first dose of study drug).
• Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels (Note: tumor abutting the vessel is acceptable, but contiguous tumor and vessel is not; CT with contrast is strongly recommended to evaluate such lesions).
• Any serious and/or unstable pre-existing medical, psychiatric, or other condition that would make the subject inappropriate for study participation including any serious condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures.
• Use of any prohibited medication within the timeframes listed in the protocol.
• Prior use of an investigational agent within 28 days or 5 half-lives, whichever is longer, prior the first dose of study drug.
• Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 (except the value for hemoglobin; see Table 1) and/or that is progressing in severity, except alopecia.

Where it is running

• GSK Investigational Site — Tucson, Arizona, United States
• GSK Investigational Site — Skokie, Illinois, United States
• GSK Investigational Site — Skokie, Illinois, United States
• GSK Investigational Site — Indianapolis, Indiana, United States
• GSK Investigational Site — Ames, Iowa, United States
• GSK Investigational Site — Overland Park, Kansas, United States
• GSK Investigational Site — Pikeville, Kentucky, United States
• GSK Investigational Site — Columbia, Missouri, United States
• GSK Investigational Site — Las Vegas, Nevada, United States
• GSK Investigational Site — Latham, New York, United States
• GSK Investigational Site — Raleigh, North Carolina, United States
• GSK Investigational Site — Fargo, North Dakota, United States
• GSK Investigational Site — Charleston, South Carolina, United States
• GSK Investigational Site — Chattanooga, Tennessee, United States
• GSK Investigational Site — Bedford, Texas, United States
• GSK Investigational Site — Dallas, Texas, United States
• GSK Investigational Site — Dallas, Texas, United States
• GSK Investigational Site — Dallas, Texas, United States
• GSK Investigational Site — Garland, Texas, United States
• GSK Investigational Site — Houston, Texas, United States
• GSK Investigational Site — Mesquite, Texas, United States
• GSK Investigational Site — San Marcos, Texas, United States
• GSK Investigational Site — Tyler, Texas, United States
• GSK Investigational Site — Everett, Washington, United States
• GSK Investigational Site — Vancouver, Washington, United States

Full record on ClinicalTrials.gov

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