A Phase 1 interventional study of bortezomib and pharmacological study in Hepatic Complications and Malignant Neoplasm, sponsored by National Cancer Institute (NCI). Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-12-16.
Sponsored by National Cancer Institute (NCI) · Phase 1, Interventional, and Treatment
Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth. This phase I trial is studying the side effects and best dose of bortezomib in treating patients with advanced cancer and liver dysfunction.
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose of bortezomib in patients with advanced malignancies and varying degrees of liver dysfunction.
II. Determine the safety and tolerability of this drug in these patients. III. Determine the pharmacokinetics and pharmacodynamics of this drug in these patients with mild, moderate, or severe liver insufficiency.
IV. Examine the dietary influences on bortezomib disposition and efficacy. V. Examine the influences of proteasome inhibition on CYP 450 activity.
OUTLINE: This is a multicenter, dose-escalation study. Patients are stratified according to hepatic function (normal vs mild dysfunction vs moderate dysfunction vs severe dysfunction).
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients per stratum receive escalating doses of bortezomib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
[Note: Patients with normal hepatic function do not receive escalating doses of bortezomib.]
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 80 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.
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Inclusion Criteria:
Tumor types may include any of the following: solid tumors:
Brain metastasis allowed if the following criteria are met:
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Drug: bortezomib · Other: pharmacological study
Given IV
Also known as: LDP 341, MLN341, VELCADE
Correlative studies
Also known as: pharmacological studies
DLT
Time frame: 21 days
MTD
Time frame: 21 days
This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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National Cancer Institute (NCI)