Study of Oral Palifosfamide Tris in Solid Tumors

This study has suspended participant recruitment.
(IND was withdrawn)
Sponsor:
Information provided by:
Ziopharm
ClinicalTrials.gov Identifier:
NCT00607711
First received: January 24, 2008
Last updated: April 30, 2008
Last verified: January 2008
  Purpose

The study of maximum tolerated dose and safety of oral palifosfamide tris capsules in advanced, refractory, solid tumors


Condition Intervention Phase
Advanced Cancer
Drug: oral palifosfamide tris
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of Oral Palifosfamide Tris in Advanced, Refractory, Solid Tumors

Resource links provided by NLM:


Further study details as provided by Ziopharm:

Primary Outcome Measures:
  • Toxicities [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: March 2008
Estimated Study Completion Date: November 2009
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00607711

Sponsors and Collaborators
Ziopharm
Investigators
Study Director: Sachin Shah, MD ZIOPHARM Oncology, Inc.
  More Information

No publications provided

Responsible Party: Brian Schwartz, MD Chief Medical Officer, ZIOPHARM Oncology, Inc.
ClinicalTrials.gov Identifier: NCT00607711     History of Changes
Other Study ID Numbers: IPC1001
Study First Received: January 24, 2008
Last Updated: April 30, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Ifosfamide
Isophosphamide mustard
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014