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

NCT00871403 | Completed Phase 2 Results

• 1 other identifier: 111128
• Study Type: interventional
• Target: 107
• Locations: 2 countries
• Sites: 2

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).

Conditions

Lung Cancer, Non-Small Cell

Keywords

GW786034; pazopanib; pemetrexed; cisplatin; non-small cell lung cancer; NSCLC

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS)

  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).

  Randomization until progression or death (up to 85 weeks)

Secondary Outcomes (3)

• 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)

• Percentage of Participants With a Complete Response or a Partial Response

  Randomization until response or progressive disease (up to 85 weeks)

Study Arms (2)

Arm 1

EXPERIMENTAL

Investigational treatment (pazopanib and pemetrexed)

Drug: pazopanib and pemetrexed

Arm 2

ACTIVE COMPARATOR

Standard treatment (pemetrexed and cisplatin)

Drug: pemetrexed and cisplatin

Interventions

pazopanib and pemetrexed DRUG

oral pazopanib 600 mg once daily and pemetrexed intravenous (IV) 500mg/m\^2 once every 3 weeks, then pazopanib 800 mg once daily

Arm 1

pemetrexed and cisplatin DRUG

pemetrexed IV 500 mg/m\^2 and cisplatin IV 75 mg/m\^2 once every 3 weeks

Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (2)

GSK Investigational Site

Herlev, 2730, Denmark

Location

GSK Investigational Site

Sutton, Surrey, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

pazopanib; Pemetrexed; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Limitations and Caveats

Efficacy data were only summarized for the pazopanib (pazo.) 800 mg + pemetrexed (peme.) 500 mg/m\^2 and the cisplatin 75 mg/m\^2 + peme. 500 mg/m\^2 arms due to the small sample size/short treatment duration in the pazo. 600 mg + peme. 500 mg/m\^2 arm.

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2009
• First Posted: March 30, 2009
• Study Start: July 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: June 20, 2013
• Results First Posted: February 16, 2012

Record last verified: 2012-03

Locations

DK (1); GB (1)