Safety Study of IHL-305 (Irinotecan Liposome Injection) to Treat Advanced Solid Tumors

Launched by YAKULT HONSHA CO., LTD · Aug 11, 2006

Keywords

ClinConnect Summary

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 1 followed by a 27-day observation period for a total of 28 days (4 weeks) per cycle. Two patient populations will be evaluated separately; patients with UGT1A1\*28 genotype homozygous wild-type (wt/wt) and heterozygous (wt/\*28) variants as one group, and patients with UGT1A1\*28 homozygous variant (\*28/\*28) as another group.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Histologically confirmed malignant solid tumor and not a candidate for known regimens or protocol treatments of higher efficacy or priority
• • 2. Failed conventional therapy for their cancer or have a malignancy for which a conventional therapy does not exist
• • 3. Recovered from all acute adverse effects of prior therapies, excluding alopecia (hair loss)
• • 4. ECOG performance status of 0, 1, or 2
• • 5. 18 years of age or older
• 6. 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
• • 7. Ability to understand and the willingness to sign a written informed consent document
• Exclusion Criteria:
• • 1. 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
• • 2. Receiving any other investigational agent
• • 3. Known brain metastases
• • 4. History of allergic reactions attributed to compounds of similar chemical composition to IHL-305
• • 5. Concurrent serious infections (i.e., requiring an intravenous antibiotic)
• • 6. 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.
• • 7. 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
• • 8. 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.
• • 9. 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).