Study of Oral Palifosfamide Tris in Solid Tumors

A Phase I Study of Oral Palifosfamide Tris in Advanced, Refractory, Solid Tumors

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

Study Overview

• Status: Suspended
• Conditions: Advanced Cancer
• Intervention / Treatment: Drug: oral palifosfamide tris

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Toxicities	9 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety	9 months

Collaborators and Investigators

• Sponsor: Alaunos Therapeutics
• Investigators: Study Director: Sachin Shah, MD, ZIOPHARM Oncology, Inc.

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Anticipated): November 1, 2009
• Study Completion (Anticipated): November 1, 2009

Study Registration Dates

• First Submitted: January 24, 2008
• First Submitted That Met QC Criteria: January 24, 2008
• First Posted (Estimate): February 6, 2008

Study Record Updates

• Last Update Posted (Estimate): May 5, 2008
• Last Update Submitted That Met QC Criteria: April 30, 2008
• Last Verified: January 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Alkylating; Alkylating Agents; Ifosfamide; Isophosphamide mustard
• Other Study ID Numbers: IPC1001