Phase 1 Study of ZIO-201-T in Combination With Doxorubicin 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: NCT00608803
Recruitment Status : Completed
First Posted : February 6, 2008
Last Update Posted : September 17, 2009
Information provided by:

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

Condition or disease Intervention/treatment Phase
Advanced Cancer Drug: ZIO-201-T and doxorubicin Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of ZIO-201-T in Combination With Doxorubicin in Subjects With Advanced, Refractory Solid Tumors for Which no Standard Therapy Exists and for Whom Treatment With Doxorubicin is Considered Medically Acceptable
Study Start Date : January 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Single arm
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
ZIO-201-T given for 3 consecutive days every 3 weeks. Doxorubicin is given once every 3 weeks. This is a dose escalation arm.

Primary Outcome Measures :
  1. Toxicities [ Time Frame: 5 months ]

Secondary Outcome Measures :
  1. Pharmacokinetics [ Time Frame: 5 months ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • Serious myocardial dysfunction defined as scintigraphically (MUGA, myocardial scintigram) determined absolute left ventricular ejection fraction (LVEF) below 45% or an LVEF below the normal limit (one or both criteria is sufficient for exclusion)
  • 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).
  • History of seizure disorder (a subject with seizures related to brain metastasis will be allowed provided he/she has been seizure-free for at least 2 months and meets the criteria defined above for inclusion of subjects with brain metastasis)
  • 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

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): NCT00608803

United States, California
Santa Monica, California, United States, 90403
United States, Texas
Houston, Texas, United States, 77024
Sponsors and Collaborators
Study Director: Jonathan Lewis, MD, PhD ZIOPHARM Oncology, Inc.

Responsible Party: Jon Lewis, Chief Medical Officer, ZIOPHARM Oncology, Inc. Identifier: NCT00608803     History of Changes
Other Study ID Numbers: IPM1002
First Posted: February 6, 2008    Key Record Dates
Last Update Posted: September 17, 2009
Last Verified: September 2009

Additional relevant MeSH terms:
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents