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A Dose Escalation Study of E7080 Administered to Patients With Solid Tumors or Lymphomas - NCT00121680-(Clinical Trial 126210)



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City:  Houston
State:  
TX
Zip Code:
Conditions: Lymphoma - Neoplasms - Solid Tumors
Purpose: The purpose of this study is to study the safety of E7080 administered to patients with solid tumors or lymphomas. Please note: this study is now recruiting patients with advanced and/or metastatic melanoma only. In the current phase of this study, To determine the MTD and the pharmacokinetic profile of E7080 when given as continuous daily (qd) dosing in combination with temozolomide.
Study summary:
Criteria: Please note: this study is now recruiting patients with advanced and/or metastatic melanoma only. Inclusion Criteria: Patients must meet all of the inclusion criteria outlined below in order to be eligible to participate in the study. - Patients with a histologically and/or cytologically confirmed solid tumor or lymphoma who are resistant/refractory to approved therapies or for whom no curative therapies are available - All previous treatment (including surgery and radiotherapy) must have been completed at least four weeks prior to study entry and any acute toxicities must have resolved - Age >= 18 years - ECOG performance status score of 0 or 1 - Written informed consent prior to any study specific screening procedures with the understanding that the patient may withdraw consent at any time without prejudice - Willing and able to comply with the protocol guidelines for the duration of the study - For patients in the Schedule 2 Expanded Melanoma Cohort only: histologically and/or cytologically confirmed advanced and/or metastatic melanoma who are resistant/refractory to approved therapies or for whom no curative therapies are available. In addition, patients must have melanoma lesions amenable to tissue biopsy and must agree to undergo biopsies of malignant and adjacent non-malignant tissue pretreatment and at the end of Cycle 1 of treatment (added per Amendment 8) - For patients in the Melanoma Combination Cohort only: histologically and/or cytologically confirmed melanoma that is advanced and/or metastatic (added per Amendment 11) Exclusion Criteria: Patients with the following characteristics will not be eligible for the study: - Brain tumors or brain or leptomeningeal (CNS) metastases - Any of the following laboratory parameters: - hemoglobin < 9 g/dL (5.6 mmol/L); - neutrophils <1.5 x 10^9/L; - platelets <100 x 10^9/L; - serum bilirubin >25 µmol/L (1.5 mg/dL); - liver function tests with values >3 x ULN; - serum creatinine >1.5 x ULN or creatinine clearance < 60 mL/minute - Positive history of HIV, active hepatitis B or active hepatitis C, or severe/uncontrolled intercurrent illness or infection - Centrally located non-small cell lung cancers and squamous cell lung cancers - Clinically significant cardiac impairment or unstable ischemic heart disease including a myocardial infarction within six months of study start - Patients with marked Baseline prolongation of QT/QTc interval (QTc interval > 450 msec for males or > 470 msec for females) using the Fridericia method for QTc analysis - Bleeding or thrombotic disorders, or using therapeutic dosages of anticoagulants - Requirement for chronic use of full dose aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) - Poorly controlled hypertension (defined as requiring changes in any hypertensive regimen within three months of study entry) or patients diagnosed with hypertension based on repeat blood pressure measurements of >160/90 mmHg at Screening - Proteinuria > 1+ on urine dipstick testing - A history of gastrointestinal malabsorption or having undergone surgery requiring gastrointestinal anastomoses within four weeks of starting therapy or who have not recovered from major surgery within three weeks of starting therapy - History of alcoholism, drug addiction, or any psychiatric or psychological condition which, in the opinion of the Investigator, would impair study compliance - Any treatment with investigational drugs within 30 days before the start of the study - Women who are pregnant or breast-feeding; women of childbearing potential with a positive pregnancy test at Screening or no pregnancy test. Women of childbearing potential unless 1. surgically sterile or 2. using adequate measures of contraception in the opinion of the Investigator. Perimenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential - Previous treatment with E7080 (added per Amendment 11) - Known intolerance to temozolomide (or any of the excipients) (added per Amendment 11) - Fertile males with female partners who are not willing to use contraception or whose female partners are not using adequate contraceptive protection - Legal incapacity
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: February 17, 2011
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