Study of PXD101 and Doxorubicin to Treat Soft Tissue Sarcomas

This study has been completed.
Sponsor:
Collaborator:
Spectrum Pharmaceuticals, Inc
Information provided by (Responsible Party):
TopoTarget A/S
ClinicalTrials.gov Identifier:
NCT00878800
First received: April 7, 2009
Last updated: November 29, 2013
Last verified: November 2013
  Purpose

The present PXD101-CLN-14 study is an open-label non-randomized, multicenter, phase I/II trial to assess the efficacy and safety of PXD101 in combination with doxorubicin in patients with soft tissue sarcomas (and in the dose escalation phase all solid tumours) in need of chemotherapy.


Condition Intervention Phase
Soft Tissue Sarcomas
Drug: PXD101 + doxorubicin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Clinical Trial of PXD101 in Combination With Doxorubicin in Patients With Soft Tissue Sarcomas

Resource links provided by NLM:


Further study details as provided by TopoTarget A/S:

Primary Outcome Measures:
  • 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. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The time to response, duration of response, and survival following PXD101 combination therapy disease control rate (CR+PR+SD) PK of PXD101 and doxorubicin in the combination PD aspects of the treatment [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 47
Study Start Date: December 2006
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BelDox IV Drug: PXD101 + doxorubicin
5-day PXD101 schedule with dose escalation combined with doxorubicin
Other Names:
  • PXD101 (Belinostat)
  • Doxorubicin (Adriamycin)

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: (abbreviated)

  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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00878800

Locations
Denmark
Herlev Hospital, Department of Oncology
Herlev, Denmark, DK-2730
Århus Hospital, Department of Oncology
Århus, Denmark, DK-8000 C
United Kingdom
The Royal MarsdenNHS Trust, Cancer Research
Surrey, United Kingdom, SM2 5PT Surrey
Sponsors and Collaborators
TopoTarget A/S
Spectrum Pharmaceuticals, Inc
Investigators
Principal Investigator: Ole Steen Nielsen, MD Århus Hospital, Department of Oncology
Principal Investigator: Ian Judson, MD Royal Marsden NHS Foundation Trust
Principal Investigator: Anders K Hansen, MD Herlev Hospital, Deparment of Oncology
  More Information

No publications provided

Responsible Party: TopoTarget A/S
ClinicalTrials.gov Identifier: NCT00878800     History of Changes
Other Study ID Numbers: PXD101-CLN-14
Study First Received: April 7, 2009
Last Updated: November 29, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by TopoTarget A/S:
Phase I/II trial
Soft tissue sarcoma
PXD101
Doxorubicin

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 21, 2014