Status:
COMPLETED
Safety Study of IHL-305 (Irinotecan Liposome Injection) to Treat Advanced Solid Tumors
Lead Sponsor:
Yakult Honsha Co., LTD
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine whether IHL-305 (irinotecan liposome injection) is safe and effective in the treatment of advanced solid tumors.
Detailed Description
This is a Phase I dose-escalation study of intravenous administration of IHL-305 in patients with advanced solid tumors. Patients will receive IHL-305 as an intravenous infusion over 60 minutes on Day...
Eligibility Criteria
Inclusion
- Histologically confirmed malignant solid tumor and not a candidate for known regimens or protocol treatments of higher efficacy or priority
- Failed conventional therapy for their cancer or have a malignancy for which a conventional therapy does not exist
- Recovered from all acute adverse effects of prior therapies, excluding alopecia (hair loss)
- ECOG performance status of 0, 1, or 2
- 18 years of age or older
- Normal organ and bone marrow function as defined by:
- absolute neutrophil count greater than or equal to 1,500 cells/microliter
- platelets greater than or equal to 100,000 cells/microliter
- total bilirubin within normal institutional limits
- AST (SGOT)/ALT (SGPT) less than or equal to 2.5 x institutional upper limit of normal (ULN) or less than or equal to 5.0 x ULN in patients with liver metastases
- plasma creatinine less than or equal to 1.5 x institutional ULN OR
- creatinine clearance greater than or equal to 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
- Ability to understand and the willingness to sign a written informed consent document
Exclusion
- Previously treated with irinotecan, or had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study, or not recovered from adverse effects due to agents administered more than 4 weeks earlier
- Receiving any other investigational agent
- Known brain metastases
- History of allergic reactions attributed to compounds of similar chemical composition to IHL-305
- Concurrent serious infections (i.e., requiring an intravenous antibiotic)
- Pregnant women or women of childbearing potential and not using methods to avoid pregnancy; a negative pregnancy test (urine or serum) must be documented at baseline for women of childbearing potential; no breast-feeding while on study.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements
- Significant cardiac disease including heart failure that meets New York Heart Association (NYHA) class III and IV definitions; history of myocardial infarction within one year of study entry; uncontrolled dysrhythmias; or poorly controlled angina.
- History of serious ventricular arrhythmia (ventricular tachycardia \[VT\] or ventricular fibrillation \[VF\], greater than or equal to 3 beats in a row); QTc greater than or equal to 450 msec for men and 470 msec for women; or left ventricular ejection fraction (LVEF) less than or equal to 40% by multi-gated acquisition scan (MUGA).
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00364143
Start Date
September 1 2006
End Date
June 1 2011
Last Update
July 5 2019
Active Locations (2)
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1
Sarah Cannon Cancer Center
Nashville, Tennessee, United States, 37203
2
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6307