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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

Phase 1/Phase 2
18 Years
Not Enrolling
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

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

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

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.

Inclusion Criteria

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Michael J. Hawkins, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Lombardi Cancer Research Center


United States: Federal Government

Study ID:




Start Date:

March 1996

Completion Date:

January 2001

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific



Vincent T. Lombardi Cancer Research Center, Georgetown University Washington, District of Columbia  20007