A Phase I/II Safety, Pharmacodynamic, and Pharmacokinetic Study of Intravenously Administered PXD101 Plus Carboplatin or Paclitaxel or Both in Patients with Advanced Solid Tumours - PXD101-040-EU Global V4

TopoTarget A/S0 sites65 target enrollmentJuly 14, 2005

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: In the MTD expansion arm only women with a history of epithelial ovarian, primary peritoneal, fallopian tube or mixed mullerian tumours of ovarian origin participate to confirm the safety and to examine efficacy in this specific patient population.
Sponsor: TopoTarget A/S
Enrollment: 65
Status: Active, not recruiting
Last Updated: 6 years ago

No summary available.

Registry

who.int

Start Date

July 14, 2005

End Date

February 27, 2009

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

•1\.Signed consent of an IRB\-approved consent form
•2\.Patients with histologically or cytologically confirmed solid carcinomas, for which there is no known curative therapy
•3\.Performance status (ECOG) \= 2
•4\.Life expectancy of at least 3 months
•5\.Age \= 18 years
•6\.Acceptable liver, renal and bone marrow function including the following:
•a.Bilirubin \= 1\.5 times upper limit of normal (ULN)
•b.AST (SGOT), ALT (SGPT) and Alkaline Phosphatase \= 3 times upper limit of normal (if liver metastases are present, then \= 5 x ULN is allowed)
•c.Measured EDTA renal clearance \= 45 mL/min (EU sites). At the US sites a calculated creatinine clearance \= 45 mL/min using the Jeliffe formula.
•d.Leucocytes \> 2\.5 x 109/L, neutrophils \> 1\.0 x 109/L, platelets \> 100 x 109/L

•1\.Treatment with investigational agents within the last 4 weeks
•2\.Prior anticancer therapy within the last 3 weeks of trial dosing including chemotherapy, radiotherapy, endocrine therapy or immunotherapy
•3\.Co\-existing active infection or any co\-existing medical condition likely to interfere with trial procedures, including significant cardiovascular disease (New York Heart Association Class III or IV cardiac disease), myocardial infarction within the past 6 months, unstable angina, congestive heart failure requiring therapy, unstable arrhythmia or a need for anti\-arrhythmic therapy, or evidence of ischemia on ECG, marked baseline prolongation of QT/QTc interval, e.g., repeated demonstration of a QTc interval \> 500 msec; Long QT Syndrome; the required use of concomitant medication on PXD101 infusion days that may cause Torsade de Pointes. (See Appendix A).
•4\.Altered mental status precluding understanding of the informed consent process and/or completion of the necessary studies
•5\.History of a concurrent second malignancy
•6\.History of hypersensitivity to either platinum or paclitaxel that is unable to be desentized
•7\.More than three prior lines of chemotherapy given for metastatic disease
•8\.Bowel obstruction or impending bowel obstruction
•9\.Known HIV positivity
•10\.Any existing grade 2 or above drug\-related neurotoxicity due to prior treatment with agents causing neurotoxicity