NCT00662636

Dasatinib and Lapatinib Ditolsylate in Treating Patients With Advanced Solid Tumors That Cannot Be Removed By Surgery

Phase I Trial of the Combination of Dasatinib and Lapatinib

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Dasatinib and lapatinib ditoslylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I trial is studying the side effects and best dose of dasatinib and lapatinib ditoslylate when given together in treating patients with advanced solid tumors that cannot be removed by surgery.

Detailed description

PRIMARY OBJECTIVES: I. To determine the maximally tolerated dose of dasatinib combined with lapatinib. II. To describe the toxicities associated with this treatment combination. III. To assess the pharmacokinetic interaction of lapatinib and dasatinib. IV. To assess the effect of the lapatinib and dasatinib combination on circulating tumor cells and on osteoclast precursor activation. V. To study the association of clinical (toxicity and/or tumor response or activity) with the pharmacokinetic parameters, and/or biologic (pharmacodynamic) results. VI. To describe the responses of this treatment combination. OUTLINE: This is a multicenter, phase I, dose-escalation study. COHORT I: Patients receive oral dasatinib and oral lapatinib ditosylate once daily on days 1-28. COHORT II: Patients receive oral dasatinib once daily on days 1 and 9-28 and oral lapatinib ditosylate once daily on days 2-28 of course 1. In all subsequent courses patients receive oral dasatinib and oral lapatinib ditosylate once daily on days 1-28. In both cohorts courses repeat every 28 days, in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed for 3 months.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	dasatinib	Given orally
DRUG	lapatinib ditosylate	Given orally
OTHER	pharmacological study	Correlative study (cohort II only)
OTHER	laboratory biomarker analysis	Correlative study (cohort II only)

Timeline

• Start date: 2008-08-01
• Primary completion: 2014-12-18
• Completion: 2014-12-18
• First posted: 2008-04-21
• Last updated: 2017-03-23

Locations

3 sites across 1 country: United States