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A phase I study of the combination of daily oral pazopanib with intravenous docetaxel in patients with advanced solid malignancies.


- candidate number8036
- NTR NumberNTR2309
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-apr-2010
- Secondary IDsEMC 2009-462 METC Erasmus MC
- Public TitleA phase I study of the combination of daily oral pazopanib with intravenous docetaxel in patients with advanced solid malignancies.
- Scientific TitleA phase I study of the combination of daily oral pazopanib with intravenous docetaxel in patients with advanced solid malignancies.
- ACRONYMPado
- hypothesisTo determine the MTD of pazopanib in combination with docetaxel dosed according to two regimens (3-weekly infusion[Arm A]; weekly infusion [Arm B]), in subjects with solid malignancies.
- Healt Condition(s) or Problem(s) studiedCancer, Advanced solid malignancies
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 18-mei-2010
- planned closingdate1-jan-2012
- Target number of participants72
- InterventionsCombination 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.
- Primary outcomeTo 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 outcome1. 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.
- TimepointsAdverse event observation during first or first 2 cycles.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. M.J.A. Jonge, de
- CONTACT for SCIENTIFIC QUERIESDr. M.J.A. Jonge, de
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
GlaxoSmithKline
- PublicationsN/A
- Brief summaryThis is a dose-finding (phase I) study on the combination of pazopanib and docetaxel. Escalating doses of docetaxel will be combined with escalating doses of pazopanib. No intrapatient escalation will take place. The highest dosing combination with dose-limiting toxicity occurring in less then 1/3 of patients in the first treatment cycle will be the maximally tolerated dose. Potential drug-drug interaction will be studied bij pharmacokinetic analysis. Efficacy will be routinely assessed by CT-scan.
- Main changes (audit trail)
- RECORD29-apr-2010 - 16-mei-2010


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