A Dose Escalation Study of E7080 Administered to Patients With Solid Tumors or Lymphomas - NCT00121680-77030 (Clinical Trial 126211)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy126211.aspx
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| City: |
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Houston |
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State:
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TX |
| Zip Code: |
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77030 |
| Conditions: |
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Lymphoma - Neoplasms - Solid Tumors |
| Purpose: |
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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.
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| Study summary: |
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| Criteria: |
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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
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
- Fertile males with female partners who are not willing to use contraception or whose
female partners are not using adequate contraceptive protection
- Legal incapacity |
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| Study is available at: |
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MD Anderson Cancer Center
Houston, TX 77030
United States
Primary Contact:
Eisai Medical Services
Phone: 1-888-422-4743 |
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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: |
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ClinicalTrials.gov |
| Date Processed: |
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November 15, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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