Status:
COMPLETED
A Phase I/II Clinical Trial of PXD101 in Combination With Doxorubicin in Patients With Soft Tissue Sarcomas
Lead Sponsor:
Valerio Therapeutics
Collaborating Sponsors:
Spectrum Pharmaceuticals, Inc
Conditions:
Dose Escalation: Solid Tumors
MTD: Soft Tissue Sarcomas
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Open-label, multicentre, dose-escalation Phase I/II study to evaluate safety, efficacy, pharmacodynamics, and pharmacokinetics of the combination of PXD101 with doxorubicin administered q 3 weeks in p...
Eligibility Criteria
Inclusion
- Signed consent of an IEC (Independent Ethics Committee)-approved Information consent form
- A. For the dose escalation phase: Patients with histological or cytological confirmed solid tumours (including sarcomas), for which there is no known curative therapy B. For the MTD expansion phase: Patients with an established diagnosis of soft tissue sarcoma in need of first line chemotherapy and with measurable disease
- Performance status (ECOG) ≤ 2
- Life expectancy of at least 3 months
- Age ≥ 18 years
- Acceptable liver, renal and bone marrow function including the following:
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST (\[Aspartate Amino Transferase\]\](SGOT), ALT (SGPT) and Alkaline Phosphatase ≤ 3 times upper limit of normal (if liver metastases are present, then ≤ 5 x ULN is allowed)
- Serum creatinine ≤ 1.5 times upper limit of normal (ULN)
- Leucocytes \> 2.5 x 109/ L, neutrophils \> 1.0 x 109/L, platelets \> 100 x 109/L
- Haemoglobin \> 9.0 g/dL or \> 5.6 mmol/l
- Acceptable coagulation status: PT and APTT (\[activated partial thromboplastin time \]) within ≤ 1.5 times upper limit of normal or in the therapeutic range if on anticoagulation.
- 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
- Serum potassium within normal range
Exclusion
- Treatment with investigational agents within the last 4 weeks
- Prior anticancer therapy, within the last 3 weeks of trial dosing including chemotherapy, radiotherapy, endocrine therapy or immunotherapy
- 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 (\[corrected QT interval \]) 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.
- Altered mental status precluding understanding of the informed consent process and/or completion of the necessary studies
- Concurrent second malignancy
- History of hypersensitivity to doxorubicin
- A. For dose escalation phase: More than two prior doses of anthracycline, more than three prior lines of chemotherapy given for metastatic disease B. For MTD expansion phase: Prior chemotherapy
- Bowel obstruction or impending bowel obstruction
- Known HIV positivity
- LVEF (\[left ventricular ejection fraction\]) below normal range (45% by MUGA)
- Presence of metastatic disease that, in the opinion of the investigator, would require palliative treatment within 4 weeks of enrolment
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00878800
Start Date
December 1 2006
End Date
October 1 2012
Last Update
July 28 2015
Active Locations (3)
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1
Århus Hospital, Department of Oncology
Aarhus, Denmark, DK-8000 C
2
Herlev Hospital, Department of Oncology
Herlev, Denmark, DK-2730
3
The Royal Marsden NHS Trust, Cancer Research
Surrey, United Kingdom, SM2 5PT Surrey