Phase 1 Study of ZIO-201-T in Combination With Doxorubicin in Solid Tumors

NCT00608803 | Completed Phase 1

• 1 other identifier: IPM1002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

The study of safety of ZIO-201-T in combination with doxorubicin in the treatment of advanced cancer.

Conditions

Advanced Cancer

Outcome Measures

Primary Outcomes (1)

• Toxicities

  5 months

Secondary Outcomes (1)

• Pharmacokinetics

  5 months

Study Arms (1)

Single arm

EXPERIMENTAL

Once the maximum tolerated dose (MTD) is determined, an expanded cohort of 20 subjects with advanced, ifosfamide and doxorubicin naive soft-tissue sarcoma subjects will be dosed at the MTD and evaluated for efficacy.

Drug: ZIO-201-T and doxorubicin

Interventions

ZIO-201-T and doxorubicin DRUG

ZIO-201-T given for 3 consecutive days every 3 weeks. Doxorubicin is given once every 3 weeks. 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:

• Age ≥18 years
• Histological or cytological documentation of cancer
• Measurable disease
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
• Ifosfamide and doxorubicin naïve
• Life expectancy of at least 12 weeks
• Adequate bone marrow, liver, and renal function, as assessed by the following laboratory requirements conducted within 7 days prior to dosing:Hemoglobin \>9.0 g/dL, Absolute neutrophil count (ANC) \>1,500/mm3,Platelet count ≥100,000/mm3,Total bilirubin \<1.5×ULN,ALT and AST ≤2.5×ULN,Partial thromboplastin \[PT\]-INR/activated partial thromboplastin time \[PTT\] \<1.5×ULN. Subjects who are being therapeutically anticoagulated with an agent such as Coumadin (warfarin sodium) or heparin are allowed provided there is no prior evidence of underlying abnormality in coagulation parameters. If an interaction between study drug and anticoagulant is suspected, anticoagulation monitoring should be increased as appropriate. Serum creatinine ≤ULN
• Written, informed consent must be obtained from a potential subject prior to the conduct of any study-specific procedures
• Male and female subjects must agree to use adequate birth control measures/barrier control during the course of the trial.
• Women of childbearing potential must have a pregnancy test performed within 7 days of the start of treatment.

You may not qualify if:

• Clinically evident congestive heart failure \>Class II of the New York Heart Association (NYHA) guidelines
• Serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia, or ventricular arrhythmias classified as Lown III, IV, or V
• History and/or signs of active coronary artery disease/ischemia with or without angina pectoris
• History of HIV infection
• Prior nephrectomy of history of urinary tract obstruction
• Active, clinically serious infection requiring systemic antibacterial, antifungal, or antiviral therapy
• Any major surgery within 3 weeks prior to start of treatment
• Metastatic brain or meningeal tumors, unless the subject is \>6 months from definitive therapy and has a negative imaging study within 4 weeks of study entry. In addition, the subject must not be undergoing acute steroid therapy or taper (chronic steroid therapy is acceptable, provided the dose is stable for 1 month prior to study start, and following screening radiographic studies).
• Previous malignancy (except cervical carcinoma in situ, adequately treated basal cell carcinoma, or superficial bladder tumors \[Ta, Tis, \& T1\] or other malignancies curatively treated \>3 years prior to entry)
• Pregnancy or lactation
• Substance abuse or medical, psychological, or social conditions that may interfere with the subject's participation in the study or evaluation of the study results
• Any condition that is unstable or could jeopardize the safety of a subject and his/her compliance with the protocol requirements

Sponsors & Collaborators

• Alaunos Therapeutics: lead

Study Sites (2)

Unknown Facility

Santa Monica, California, 90403, United States

Location

Unknown Facility

Houston, Texas, 77024, United States

Location

MeSH Terms

Interventions

Doxorubicin

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Jonathan Lewis, MD, PhD

  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 22, 2008
• First Posted: February 6, 2008
• Study Start: January 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: September 17, 2009

Record last verified: 2009-09

Locations

US (2)