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| Sponsor: | ZIOPHARM |
|---|---|
| Information provided by: | ZIOPHARM |
| ClinicalTrials.gov Identifier: | NCT00718484 |
Purpose
This is a randomized, controlled trial to evaluate the clinical benefit of palifosfamide tris administered with doxorubicin in combination, compared with single-agent doxorubicin administered in subjects diagnosed with unresectable or metastatic soft-tissue sarcoma (STS). Subjects who meet the entry criteria will be randomized into 1 of 2 arms: either to receive palifosfamide tris plus doxorubicin or treatment with single-agent doxorubicin. Subjects will be anthracyclin naïve.
| Condition | Intervention | Phase |
|---|---|---|
|
Soft Tissue Sarcoma |
Drug: Palifosfamide Tris and Doxorubicin Drug: Doxorubicin |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Multicenter, Parallel Group, Randomized Study of Palifosfamide Tris Plus Doxorubicin Versus Doxorubicin in Subjects With Unresectable or Metastatic Soft-tissue Sarcoma |
| Estimated Enrollment: | 100 |
| Study Start Date: | August 2008 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
On Day 1 of each cycle (21 days), 150 mg/m2 IV (intravenous) palifosfamide tris and 75 mg/m2 IV doxorubicin are administered on the same day. Doxorubicin administration will be initiated approximately 60 minutes after the completion of palifosfamide tris dosing. Palifosfamide tris alone is administered on Days 2 and 3, every 3 weeks (one 21-day cycle).
|
Drug: Palifosfamide Tris and Doxorubicin
On Day 1 of each cycle (21 days), 150 mg/m2 IV (intravenous) palifosfamide tris and 75 mg/m2 IV doxorubicin are administered on the same day. Doxorubicin administration will be initiated approximately 60 minutes after the completion of palifosfamide tris dosing. Palifosfamide tris alone is administered on Days 2 and 3, every 3 weeks (one 21-day cycle).
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Active Comparator: B
On Day 1 of each cycle, 75 mg/m2 doxorubicin is administered IV.
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Drug: Doxorubicin
On Day 1 of each cycle, 75 mg/m2 doxorubicin is administered IV.
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Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate bone marrow, liver, and renal function, as assessed by the following laboratory requirements conducted within 14 days prior to dosing:
Exclusion Criteria:
Any condition that is unstable or could jeopardize the safety of a subject and his/her compliance with the protocol requirements
In addition, use of the following therapies and medications—prior or concomitant—would exclude a subject from this study:
Contacts and Locations
Show 23 Study Locations| Study Director: | Jonathan J Lewis, MD, PhD | ZIOPHARM Oncology, Inc |
More Information
| Responsible Party: | Jonathan Lewis, MD PhD CEO and CMO, ZIOPHARM Oncology, Inc |
| ClinicalTrials.gov Identifier: | NCT00718484 History of Changes |
| Other Study ID Numbers: | IPM2002 |
| Study First Received: | July 16, 2008 |
| Last Updated: | October 15, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
Sarcoma Soft Tissue Sarcoma Doxorubicin |
anthracyclin Palifosfamide IFOS |
|
Sarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Doxorubicin Isophosphamide mustard Ifosfamide |
Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action |