Safety Study of IHL-305 (Irinotecan Liposome Injection) to Treat Advanced Solid Tumors
Completed · Phase 1
Conditions studied: Cancer
In brief
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.
Key facts
- Study ID
- NCT00364143
- Run by
- Yakult Honsha Co., LTD
- People needed
- 40
- Starts
- 2006-09-01
- Expected to finish
- 2011-06-01
- Last updated by the study team
- 2019-07-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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).
Where it is running
- Sarah Cannon Cancer Center — Nashville, Tennessee, United States
- Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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