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A Phase I/II Clinical Trial of PXD101 in Combination With Doxorubicin in Patients With Soft Tissue Sarcomas

Phase 1/Phase 2
18 Years
Not Enrolling
Soft Tissue Sarcomas

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Trial Information

A Phase I/II Clinical Trial of PXD101 in Combination With Doxorubicin in Patients With Soft Tissue Sarcomas

This trial is an 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 patients with advanced solid tumours. Once the MTD has
been established, up to a total of 20-40 patients with STS may be enrolled at the MTD dose
level to examine efficacy and safety in this specific patient population. The trial is
stopped if no more than 2 responses are seen among the first 20 of these patients.

Inclusion Criteria:


1. Signed consent

2. For the dose escalation phase: patients with histological or cytological confirmed
solid tumours.

3. For the MTD expansion phase: patients with an established diagnosis of soft tissue
sarcoma in need of first line chemotherapy and with measurable disease

4. Performance status (ECOG) ≤ 2

5. Life expectancy of at least 3 months

6. Age ≥ 18 years

7. Acceptable liver, renal and bone marrow function as defined

8. Acceptable coagulation status as defined

Exclusion Criteria:

1. Treatment with investigational agents within the last 4 weeks

2. Prior anticancer therapy, within the last 3 weeks of trial

3. Co-existing active infection or any co-existing medical condition likely to interfere
with trial procedures, including significant cardiovascular disease

4. Altered mental status precluding understanding of the informed consent process and/or
completion of the necessary studies

5. Concurrent second malignancy

6. History of hypersensitivity to doxorubicin

7. 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

8. Bowel obstruction or impending bowel obstruction

9. Known HIV positivity

10. LVEF below normal range (45% by MUGA)

11. Presence of metastatic disease that, in the opinion of the investigator, would
require palliative treatment within 4 weeks of enrolment

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose (MTD) and Dose Limiting Toxicity (DLT)) and efficacy of PXD101 and doxorubicin combination treatment measured by response rate using the RECIST response criteria.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Ole Steen Nielsen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Århus Hospital, Department of Oncology


United States: Food and Drug Administration

Study ID:




Start Date:

December 2006

Completion Date:

October 2012

Related Keywords:

  • Soft Tissue Sarcomas
  • Phase I/II trial
  • Soft tissue sarcoma
  • PXD101
  • Doxorubicin
  • Sarcoma