Status:
TERMINATED
Lapatinib and Bortezomib in Patients With Advanced Malignancies
Lead Sponsor:
Georgetown University
Collaborating Sponsors:
GlaxoSmithKline
Millennium Pharmaceuticals, Inc.
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study is for patients with an advanced type of cancer for which no curative treatment exists. The purpose of this study is to test the safety and efficacy of the combination of the study drugs, ...
Eligibility Criteria
Inclusion
- Histologically proven malignant solid tumor with measurable disease
- Progression on, or intolerance of, or ineligibility for all standard therapies
- Biopsy accessible tumor deposits
- LVEF \>/= institutional normal
- Corrected QT interval less than 500 milliseconds by EKG
- ECOG performance status 0-2
- Subjects with no brain metastases or a history of previously treated brain metastases who have been treated by surgery or stereotactic radiosurgery at least 4 weeks prior to enrollment and have a baseline MRI that shows no evidence of active intercranial disease and have not had treatment with steroids within 1 week of enrollment.
- Adequate hepatic, bone marrow, and renal function
- Partial thromboplastin time must be \</= 1.5 x upper limit of institution's normal range and INR \< 1.5. Subjects on anticoagulants will be permitted to enroll as long as the INR is in the acceptable therapeutic range.
- Life expectancy \> 12 weeks
- Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of treatment and/or postmenopausal women must be amenorrheic for at least 12 months.
- Subject is capable of understanding and complying with parameters as outlines in the protocol and able to sign and date the informed consent form.
Exclusion
- Patients with lymphomas
- CNS metastases which do not meet the criteria outlines in the inclusion criteria
- Peripheral neuropathy \>/= Grade 2 at baseline or peripheral neuropathy \>/= Grade 1 with neuropathic pain
- Active severe infection or known chronic infection with HIV or hepatitis B virus
- Cardiovascular disease problems including unstable angina, therapy for life-threatening ventricular arrhythmia, or myocardial infarction, stroke, or congestive heart failure within the last 6 months
- Life-threatening visceral disease or other severe concurrent disease
- Women who are pregnant or breastfeeding
- Anticipated patient survival under 3 months
- Concurrent use of known CYP 3A4 inhibiting or activating medications
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01497626
Start Date
September 1 2011
End Date
December 1 2015
Last Update
February 17 2016
Active Locations (1)
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1
Georgetown Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, United States, 20007