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Study of Oral Palifosfamide Tris in Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00607711
Recruitment Status : Suspended (IND was withdrawn)
First Posted : February 6, 2008
Last Update Posted : May 5, 2008
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Brief Summary:
The study of maximum tolerated dose and safety of oral palifosfamide tris capsules in advanced, refractory, solid tumors

Condition or disease Intervention/treatment Phase
Advanced Cancer Drug: oral palifosfamide tris Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Oral Palifosfamide Tris in Advanced, Refractory, Solid Tumors
Study Start Date : March 2008
Estimated Primary Completion Date : November 2009
Estimated Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Ifosfamide

Arm Intervention/treatment
Experimental: Single arm Drug: oral palifosfamide tris
Capsule(s) given daily for 15 days followed by a 6 day rest. This is a dose escalation arm.

Primary Outcome Measures :
  1. Toxicities [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. Safety [ Time Frame: 9 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Subjects with histological or cytological confirmation of advanced cancer that is refractory to standard therapies for their condition.
  2. Men and women of ≥18 years of age.
  3. Life expectancy of at least 12 weeks.
  4. Eastern Cooperative Oncology Group (ECOG) performance score ≤2 (see Appendix 4).
  5. Eligible subjects MUST have at least one measurable lesion as defined by RECIST guidelines. If the measurable disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology/histology. Measurable lesions must NOT have been in a previously irradiated field or injected with biological agents.
  6. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements, to be conducted ≤2 weeks prior to Baseline:

    • Creatinine < 1.5× upper limit of normal (ULN) OR a calculated creatinine clearance ≥70 cc/min
    • Total bilirubin ≤2×ULN
    • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3×ULN
    • Granulocytes in peripheral blood ≥2.0×109/L, hemoglobin ≥8.5 g/dL, and platelets ≥50,000/µL
  7. Written informed consent in compliance with ZIOPHARM policies and the Human Investigation Review Committee (IEC/IRB) having jurisdiction over the site.
  8. Men and women of childbearing potential must use effective contraception from Screening through his/her duration of study participation.
  9. Women of childbearing potential must have a negative serum pregnancy test prior to entering the study.

Exclusion Criteria:

  1. New York Heart Association (NYHA) functional Class ≥III myocardial infarction (see Appendix 5) within 6 months.
  2. Uncontrolled cardiac arrhythmia other than asymptomatic atrial fibrillation; a QTc ≥450 msec; or a ≥Grade 2 atrioventricular (AV) block or left bundle branch block (LBBB); or documented history of prolonged QTc.
  3. Pregnancy and/or lactation.
  4. Uncontrolled systemic infection (documented with microbiological studies).
  5. Inadequate renal function as defined by the presence of one or more of the following:

    • Creatinine clearance (CrCl) <70 cc/min
    • Serum creatinine >1.5×ULN
    • Prior nephrectomy
    • Urinary tract obstruction
  6. Anticancer chemotherapy or immunotherapy during the study or within 4 weeks of study entry (mitomycin C or nitrosureas should not be given within 6 weeks of study entry).
  7. Radiotherapy during study or within 3 weeks of study entry.
  8. Surgery within 4 weeks of start of study drug.
  9. Other investigational drug therapy outside of this trial during or within 4 weeks of study entry.
  10. History of invasive second primary malignancy diagnosed within the previous 3 years except for Stage I endometrial/cervical carcinoma or prostate carcinoma treated surgically, and non-melanoma skin cancer.
  11. Substance abuse, medical, psychological, or social conditions that may interfere with the subject's participation in the study or evaluation of study results.
  12. Any condition that is unstable or could jeopardize the safety of the subject and his/her compliance in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00607711

Sponsors and Collaborators
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Study Director: Sachin Shah, MD ZIOPHARM Oncology, Inc.
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Responsible Party: Brian Schwartz, MD Chief Medical Officer, ZIOPHARM Oncology, Inc. Identifier: NCT00607711    
Other Study ID Numbers: IPC1001
First Posted: February 6, 2008    Key Record Dates
Last Update Posted: May 5, 2008
Last Verified: January 2008
Additional relevant MeSH terms:
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Isophosphamide mustard
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents