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

Advanced Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00608803
• Other study ID #: IPM1002
• Status: Completed
• Phase: Phase 1
• First received: January 22, 2008
• Last updated: September 16, 2009
• Start date: January 2008
• Est. completion date: January 2009

Study information

• Verified date: September 2009
• Source: Ziopharm
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Cancer

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ziopharm

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicities		5 months	Yes
Secondary	Pharmacokinetics		5 months	No