Dasatinib and Lapatinib Ditolsylate in Treating Patients With Advanced Solid Tumors That Cannot Be Removed By Surgery
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|ClinicalTrials.gov Identifier: NCT00662636|
Recruitment Status : Completed
First Posted : April 21, 2008
Last Update Posted : March 23, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: dasatinib Drug: lapatinib ditosylate Other: pharmacological study Other: laboratory biomarker analysis||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Trial of the Combination of Dasatinib and Lapatinib|
|Actual Study Start Date :||August 2008|
|Actual Primary Completion Date :||December 18, 2014|
|Actual Study Completion Date :||December 18, 2014|
Experimental: Arm I
Patients receive oral dasatinib and lapatinib ditosylate once daily on days 1-28.
Drug: lapatinib ditosylate
Other: pharmacological study
Correlative study (cohort II only)
Other Name: pharmacological studies
Other: laboratory biomarker analysis
Correlative study (cohort II only)
- Adverse events profile
- Toxicity profile per NCI CTCAE v3.0
- Response profile [ Time Frame: Every 4 weeks ]
- Time until any treatment-related toxicity, time until treatment-related grade 3+ toxicity, and time until hematologic nadirs (WBC, ANC, platelets)
- Time to progression and time to treatment failure
- Laboratory correlates
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): NCT00662636
|United States, Arizona|
|Mayo Clinic in Arizona|
|Scottsdale, Arizona, United States, 85259|
|United States, Florida|
|Mayo Clinic in Florida|
|Jacksonville, Florida, United States, 32224-9980|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Charles Erlichman||Mayo Clinic|