Study of Oral Palifosfamide Tris in Solid Tumors

NCT00607711 | Suspended Phase 1

• 1 other identifier: IPC1001
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Advanced Cancer

Outcome Measures

Primary Outcomes (1)

• Toxicities

  9 months

Secondary Outcomes (1)

• Safety

  9 months

Study Arms (1)

Single arm

EXPERIMENTAL

Drug: oral palifosfamide tris

Interventions

oral palifosfamide tris DRUG

Capsule(s) given daily for 15 days followed by a 6 day rest. This is a dose escalation arm.

Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with histological or cytological confirmation of advanced cancer that is refractory to standard therapies for their condition.
• Men and women of ≥18 years of age.
• Life expectancy of at least 12 weeks.
• Eastern Cooperative Oncology Group (ECOG) performance score ≤2 (see Appendix 4).
• 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.
• 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
• Written informed consent in compliance with ZIOPHARM policies and the Human Investigation Review Committee (IEC/IRB) having jurisdiction over the site.
• Men and women of childbearing potential must use effective contraception from Screening through his/her duration of study participation.
• Women of childbearing potential must have a negative serum pregnancy test prior to entering the study.

You may not qualify if:

• New York Heart Association (NYHA) functional Class ≥III myocardial infarction (see Appendix 5) within 6 months.
• 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.
• Pregnancy and/or lactation.
• Uncontrolled systemic infection (documented with microbiological studies).
• 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
• 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).
• Radiotherapy during study or within 3 weeks of study entry.
• Surgery within 4 weeks of start of study drug.
• Other investigational drug therapy outside of this trial during or within 4 weeks of study entry.
• 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.
• Substance abuse, medical, psychological, or social conditions that may interfere with the subject's participation in the study or evaluation of study results.

Sponsors & Collaborators

• Alaunos Therapeutics: lead

MeSH Terms

Interventions

Ifosfamide

Intervention Hierarchy (Ancestors)

Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Sachin Shah, MD

  ZIOPHARM Oncology, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 24, 2008
• First Posted: February 6, 2008
• Study Start: March 1, 2008
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: May 5, 2008

Record last verified: 2008-01