Status:
COMPLETED
Safety Study Of Cetuximab Plus Dasatinib (BMS-354825) in Treating Advanced Solid Malignancies
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Malignant Solid Tumour
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is an open-label, safety study of cetuximab and differing dose levels of dasatinib in adult patients with advanced solid malignancies. Cetuximab will be administered as an intravenous infusion we...
Detailed Description
This is an open-label, phase I study of cetuximab and differing dose levels of dasatinib in adult patients with advanced solid malignancies. Cetuximab will be administered as an intravenous infusion o...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed solid malignancy which is recurrent or metastatic or resistant to therapy. Patients w/plan of surgery for recurrent disease post cetuximab/dasatinib are eligible providing that they receive at least 2 cycles of therapy and provide baseline and post-treatment tumor tissue for correlatives.
- Any number of prior regimens but no prior EGFR or src inhibitors.
- Age greater or equal to 18 years.
- ECOG performance status less than or equal to 2 (Karnofsky greater than or equal to 60%).
- Life expectancy greater than 12 weeks.
- Patients must have normal organ and marrow function:
- leukocytes greater than or equal to 3,000/mcL
- absolute neutrophil count greater than or equal to 1,500/mcL
- platelets greater than or equal to 100,000/mcL
- total bilirubin within normal institutional limits
- AST(SGOT)/ALT(SGPT) less than or equal to 2.5 X institutional upper limit of normal
- creatinine up to 1.5 x normal institutional limits
- Ability to understand and the willingness to sign a written informed Consent document.
- No concomitant medication that are CYP3A4 inducers or potent inhibitors and should not take proton pump inhibitors and H2 antagonists in the first cycle of therapy and should try to avoid taking proton pump inhibitors and H2 antagonists during rest of treatment period.
- Sexually active women of childbearing potential must use an effective method of birth control during the course of the study, in a manner such that risk of failure is minimized. All WOCBP must have a negative pregnancy test prior to first receiving investigational product.
Exclusion
- Chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- Any other concurrent investigational agents.
- Patients w/ untreated brain metastases. However, patients who have stable brain disease (should be off corticosteroids) at least 4 weeks after completion of appropriate therapy are eligible.
- History of allergic reaction to monoclonal antibodies.
- Inability to swallow oral medications unless patients use a feeding tube.
- Uncontrolled angina or hypertension or any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes).
- Prolonged QTc interval on pre-entry electrocardiogram (greater than 450 msec) on both the Fridericia and Bazett's correction.
- Diagnosed or suspected congenital long QT syndrome.
- Patients currently taking drugs that are generally accepted to have a risk of causing Torsades de Pointes including: quinidine, procainamide, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, erythromycins, clarithromycin, chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide, cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine.
- Any other uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, or psychiatric illness/social situations that would limit compliance with study requirements.
- History of significant bleeding disorder unrelated to cancer, including: diagnosed congenital bleeding disorders (e.g., von Willebrand's disease), diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies).
- HIV-positive patients receiving combination antiretroviral therapy.
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00388427
Start Date
June 1 2007
End Date
February 1 2013
Last Update
May 28 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Pittsburgh Cancer Institute - Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232