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

NCT ID: NCT00364143

Last Updated: 2019-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2011-06-30

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 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.

Conditions

Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

IHL-305 (irinotecan liposome injection)

Intervention Type: DRUG

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yakult Honsha Co., LTD

INDUSTRY

Sponsor Role: lead

Principal Investigators

Mace L Rothenberg, M.D.

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Locations

Sarah Cannon Cancer Center

Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

IHL-PRT001

Identifier Type: -

Identifier Source: org_study_id