advanced solid malignancies
Conditions
Interventions
Combination therapy will consist out of daily pazopanib and 3-weekly or 1-weekly infusion of docetaxel. Up to 6 courses of docetaxel will be administered.
Sponsors
Erasmus University Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects must provide written informed consent prior to performance of study specific procedures or assessments, and must be willing to comply with treatment and follow up assessments and procedures; 2. Histologically or cytologically confirmed diagnosis of advanced solid tumor for which docetaxel-based systemic therapy is considered appropriate or for which there is no standard therapy; 3. Age of 18 years or older; 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 5. There must be measurable disease or evaluable disease (according to RECIST v1.1 criteria) for subjects to be included in the cohort expansion phase. Measurable disease is not a criterion for subjects enrolling in the dose escalation phase; 6. Able to swallow and retain oral medication; 7. A life expectancy of at least 12 weeks.
Exclusion criteria
Exclusion criteria: 1. Unable to discontinue prohibited medications, 14 days or five half-lives (whichever is longer) of the drug prior to Visit 1 and for the duration of the study; 2. Clinically significant gastrointestinal abnormalities which might interfere with oral dosing; 3. Any unstable or serious concurrent condition (e.g., active infection requiring systemic therapy); 4. Poorly controlled hypertension (SBP of >160 mmHg, or DBP of >90 mmHg); 5. Prolongation of corrected QT interval (QTc) >480 msecs; 6. History of any one of more of the following cardiovascular conditions within the past 6 months: A. Cardiac angioplasty or stenting; B. Myocardial infarction; C. Unstable angina; D. Symptomatic peripheral vascular disease; E. Class II, III or IV congestive heart failure as defined by the New York Heart Association (NYHA); F. History of cerebrovascular accident, pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months. 7. Macroscopic hematuria; 8. Hemoptysis that is clinically relevant within 4 weeks of first dose of study drug; 9. Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer; 10. Chemotherapy or radiation therapy within 2 weeks prior to the first dose of study drug; 11. Biological therapy, hormonal therapy or treatment with an investigational agent within 28 days (for bevacizumab, 60 days) prior to the first dose of study drug; 12. Has not recovered from toxicities associated with prior anti-cancer therapy; 13. Metastatic disease to the brain or leptomeninges; 14. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol; 15. Clinically assessed as having inadequate venous access for PK sampling; 16. Is pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the MTD of pazopanib in combination with docetaxel, dosed according to two regimens (3-weekly [Arm A]; weekly [Arm B]), in subjects with solid malignancies. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess the safety and tolerability of the investigational combination of pazopanib and docetaxel; 2. To characterize the PK of pazopanib when administered alone and with docetaxel, and of docetaxel when administered alone and with pazopanib; 3. To explore the anti-tumor activity of the combination of pazopanib and docetaxel in solid tumors. | — |
Contacts
Public ContactM.J.A. Jonge, de
Postbus 5201
Outcome results
None listed