- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00004030
VX-853 in Treating Patients With Solid Tumors Who Are Receiving Liposomal Doxorubicin
A Phase I/II Study of the Pharmacokinetics, Tolerability and Safety of Administration of VX-853 to Patients Receiving Single Agent Therapy With Doxorubicin HCI
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I/II trial to study the effectiveness of VX-853 in treating patients who have solid tumors who are receiving liposomal doxorubicin.
Study Overview
Status
Intervention / Treatment
Detailed Description
OBJECTIVES: I. Determine the safety and tolerability of VX-853 in combination with doxorubicin HCl liposome in patients with relapsed or incurable solid tumors. II. Obtain pharmacokinetic profiles for various dosages of VX-853 administered in combination with doxorubicin HCl liposome. III. Achieve whole blood concentrations of VX-853 in the predicted therapeutically effective range and characterize the pharmacokinetics at these doses. IV. Document antitumor effects of VX-853 in combination with doxorubicin HCl liposome in these patients.
OUTLINE: This is a dose escalation study of VX-853. Patients receive VX-853 orally every 8 hours on days 1-3 and doxorubicin HCL liposome IV over approximately 15 minutes beginning 26 hours after starting VX-853. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of VX-853 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 or more of 6 patients experience dose limiting toxicity.
PROJECTED ACCRUAL: A maximum of 45 patients will be accrued for this study within approximately 18 months.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
District of Columbia
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Washington, District of Columbia, United States, 20007
- Vincent T. Lombardi Cancer Research Center, Georgetown University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS: Histologically proven relapsed or incurable solid tumors No primary or metastatic CNS disease
PATIENT CHARACTERISTICS: See General Eligibility Criteria
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 3 weeks since prior cytotoxic chemotherapy (6 weeks since prior mitomycin or nitrosourea) Prior doxorubicin HCl allowed (no extensive therapy) Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Prior surgery allowed Other: Recovered from toxic effects of prior therapy At least 4 weeks since prior investigational or approved clinical trial agents No concurrent cimetidine, phenothiazines, phenytoin, calcium channel blockers, or cyclosporine or other P-glycoprotein inhibitors --Patients Characteristics-- Age: 18 and over Performance Status: Karnofsky 70-100% Life Expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Hemoglobin at least 9.0 g/dL Platelet count at least 100,000/mm3 Hepatic: AST and/or ALT no greater than 2 times upper limit of normal Bilirubin normal Renal: Creatinine normal Creatinine clearance at least 60 mL/min Cardiovascular: No clinically significant EKG abnormalities No atrial or ventricular arrhythmias requiring medication No ischemic event within 6 months of study Cardiac ejection fraction at least 50% by MUGA scan Other: Not pregnant or nursing Fertile patients must use effective contraception No prior or concurrent seizure disorders No prior or concurrent clinically significant medical illness No known hypersensitivity to doxorubicin HCl or other study medications No other active malignancies except curatively treated carcinoma in situ of the cervix or basal cell skin cancer
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Michael J. Hawkins, MD, Lombardi Comprehensive Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000065641
- P30CA051008 (U.S. NIH Grant/Contract)
- GUMC-96007
- VX-95-853-001
- VX-GUMC-96007
- NCI-V97-1275
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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