VX-853 in Treating Patients With Solid Tumors Who Are Receiving Liposomal Doxorubicin
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|ClinicalTrials.gov Identifier: NCT00004030|
Recruitment Status : Completed
First Posted : May 25, 2004
Last Update Posted : March 24, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: VX-853 Drug: pegylated liposomal doxorubicin hydrochloride||Phase 1 Phase 2|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Official Title:||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|
|Study Start Date :||March 1996|
|Actual Primary Completion Date :||January 2001|
|Actual Study Completion Date :||January 2001|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004030
|United States, District of Columbia|
|Vincent T. Lombardi Cancer Research Center, Georgetown University|
|Washington, District of Columbia, United States, 20007|
|Study Chair:||Michael J. Hawkins, MD||Lombardi Comprehensive Cancer Center|