GW786034 in Patients With Non Small Cell Lung Cancer 3rd Line

NCT01049776 | Terminated Phase 2 Results

• 1 other identifier: ILCC #2 IllinoisCancerCare #2
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 13

Brief Summary

Lung Cancer is the most common cause of cancer death in the United States with an estimated mortality in excess of 160,000, more than the combined mortality seen with prostate, breast, colorectal cancers(1). Most patients with Lung Cancer have Non-Small Cell Lung Cancers( NSCLC) and only 25-30% of patients with NSCLC (Non Small Cell Lung Cancer) have resectable disease( Stage I or II) at the time of diagnosis. The vast majority of patients with advanced NSCLC (Non Small Cell Lung Cancer) are not curable and overall five year survival is 11%-14%1. Chemotherapy is beneficial for patients with locally advanced and metastatic disease. Numerous phase III studies have determined the superiority of systemic chemotherapy over best supportive care. Platinum based chemotherapy has been widely accepted as the standard of care for the initial treatment of advanced NSCLC. However first line chemotherapy is modest at best. A randomized trial comparing four of the most commonly used chemotherapy regimens in the United States not only failed to show a clearly superior arm but also confirmed the dismal prognosis of these patients. The response rate for all 1207 patients was 18.6% with a median survival of eight months and one year survival of 33.5 % and a two year survival of 12%5. Clearly a different paradigm is needed for the treatment of this disease.

Conditions

Non Small Cell Lung Cancer

Keywords

Lung Cancer Non Small Cell

Outcome Measures

Primary Outcomes (1)

• Proportion of Non Small Cell Lung Cancer Participants With Disease Control (Complete Response+Partial Response+Stable Disease) Based on RECIST 1.0 Measured by CT or MRI

  Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions: Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesion, taking as reference the baseline sum of the longest diameter: Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease, taking as reference the smallest sum Longest Diameter since the treatment started

  12 weeks

Secondary Outcomes (1)

• To Describe the Clinical Toxicity Profile of Pazopanib in This Particular Patient Population

  after the first 6 patients and quarterly

Study Arms (1)

Pazapanib (GW786034)

EXPERIMENTAL

Drug: Pazopanib (GW786034)

Interventions

Pazopanib (GW786034) DRUG

Pazopanib 800 mg daily x 12 weeks, (Cycle = 21 days) up to 24 months

Also known as: Pazopanib monohydrochloride salt GW786034

Pazapanib (GW786034)

Eligibility Criteria

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

You may qualify if:

• Required Characteristics 3.1. Subjects must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow up. Procedures conducted as part of the subject's routine clinical management (e.g., blood count, imaging study) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol.
• Note: It is not necessary that informed consent be obtained within the protocol-specified screening window.
• ≥18 years of age.
• ≥2 prior systemic therapies for Non Small Cell Lung Cancer.
• Histologic or cytologic diagnosis of stage IV Non Small Cell Lung cancer
• Measurable disease. For patients having only lesions measuring ≥1 cm to ≤2 cm per RECIST criteria must use spiral CT imaging for both pre- and post-treatment tumor assessments.
• Laboratory values obtained ≤14 days prior to registration: Hematologic Absolute neutrophil count (ANC) 1.5 X 109/L Hemoglobin1 9 g/dL (5.6 mmol/L) Platelets 100 X 109/L Prothrombin time (PT) or international normalized ratio (INR) 1.2 X upper limit of normal (ULN) Partial thromboplastin time (PTT) 1.2 X ULN Hepatic2 Total bilirubin 1.5 X ULN AST and ALT 2.5 X ULN Renal Serum creatinine 1.5 mg/dL (133 µmol/L)
• Or, if greater than 1.5 mg/dL:
• Calculated creatinine clearance 50 mL/min
• Urine Protein to Creatinine Ratio (UPC)3 \< 1
• Subjects may not have had a transfusion within 7 days of screening assessment.
• Concomitant elevations in bilirubin and AST/ALT above 1.0 x ULN are not permitted
• If UPC \>/= 1, then a 24-hour urine protein must be assessed. Subjects must have a 24-hour urine protein value \<1g to be eligible.
• ECOG Performance Score 0, or 1.
• Negative pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only.

You may not qualify if:

• Any of the following as this regimen may be harmful to a developing fetus or nursing child.
• Pregnant women
• Nursing women
• Men or women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception.
• Any abnormal serum calcium, magnesium, and potassium levels
• Clinically significant hemoptysis, cerebral hemorrhage, or gastrointestinal hemorrhage in the past 6 months
• Any patient currently on an antiarrhythmics or other medications that are know to prolong the QT interval.
• Uncontrolled infection.
• 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. 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
• Any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures, affecting absorption, or active peptic ulcer disease) that impairs their ability to swallow and retain pazopanib tablets.
• Malabsorption syndrome
• Major resection of the stomach or small bowel. 3.28 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

Sponsors & Collaborators

• Illinois CancerCare, P.C.: lead

Study Sites (13)

Illinois CancerCare, P.C.

Bloomington, Illinois, 61701, United States

Location

Illinois CancerCare, P.C.

Canton, Illinois, 61520, United States

Location

Illinois CancerCare, P.C.

Carthage, Illinois, 62321, United States

Location

Illinois CancerCare, P.C.

Eureka, Illinois, 61530, United States

Location

Illinois CancerCare, P.C.

Galesburg, Illinois, 61401, United States

Location

Illinois CancerCare, P.C.

Macomb, Illinois, 61455, United States

Location

Illinois CancerCare, P.C.

Monmouth, Illinois, 61462, United States

Location

Illinois CancerCare, P.C.

Normal, Illinois, 61761, United States

Location

Illinois CancerCare, P.C.

Ottawa, Illinois, 61350, United States

Location

Illinois CancerCare, P.C.

Pekin, Illinois, 61554, United States

Location

Illinois CancerCare, P.C.

Peoria, Illinois, 61615, United States

Location

Illinois CancerCare, P.C.

Peru, Illinois, 61354, United States

Location

Illinois CancerCare, P.C.

Princeton, Illinois, 61356, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

pazopanib

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Due to the lack of patients with squamous histology, the study was closed prior to meeting the enrollment goal of 44 subjects.

Results Point of Contact

• Title: Sachdev Thomas, M.D.
• Organization: Illinois CancerCare, P.C.

sthomas@illinoiscancercare.com

309-243-3000

Study Officials

• Sachdev P. Thomas, M.D.

  Illinois CancerCare, P.C.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 12, 2010
• First Posted: January 14, 2010
• Study Start: January 1, 2010
• Primary Completion: March 1, 2014
• Last Updated: September 19, 2014
• Results First Posted: September 19, 2014

Record last verified: 2014-09

Locations

US (13)