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Clinical Trials/EUCTR2005-002338-36-GB
EUCTR2005-002338-36-GBActive, not recruitingPhase 1

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 enrollmentStarted: July 14, 2005Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
65
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Inclusion Criteria

  • •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
  • •e.Hemoglobin > 9.0 g/dL or > 5.6 mmol/l
  • •7.Acceptable coagulation status: PT-INR/PTT = 1.5 x ULN or in the therapeutic range if on anticoagulation therapy
  • •8.A negative pregnancy test for women of childbearing potential. For men and women of child-producing potential, the use of effective contraceptive methods during the study is required.
  • •9. Serum potassium within normal range
  • •Additional eligibility criteria at the MTD expansion only
  • •10.Patients with epithelial ovarian, primary peritoneal, fallopian tube or mixed mullerian tumours of ovarian origin in need of relapse treatment
  • •11. At least one uni-dimensional measurable lesion. Lesions must be measured by CT-scan or MRI according to RECIST
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range

Exclusion Criteria

  • •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
  • •Additional exclusion criteria at the MTD expansion only
  • •11.Mixed mullerian tumours of intra-uterine origin

Investigators

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