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

NCT00364143 | Completed Phase 1

• 1 other identifier: IHL-PRT001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Cancer

Keywords

Cancer; Advanced Solid Tumor; Oncology

Outcome Measures

Primary Outcomes (2)

• Incidence of dose-limiting toxicity within 28 days of treatment administration for patients with UGT1A1*28 genotype (wt/wt and wt/*28)

• determination of maximum tolerated dose (MTD) and recommended Phase 2 dose for patients with UGT1A1*28 genotype (wt/wt and wt/*28)

Secondary Outcomes (3)

• Tumor shrinkage per Response Evaluation Criteria in Solid Tumors (RECIST) every 8 weeks/2 cycles while receiving study drug for patients with UGT1A1*28 genotype (wt/wt and wt/*28)

• limited pharmacokinetics (PK) for patients with UGT1A1*28 genotype (wt/wt and wt/*28)

• limited incidence and severity of adverse events (AEs) and PK for UGT1A1 homozygous (*28/*28) patients

Interventions

IHL-305 (irinotecan liposome injection) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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).

Sponsors & Collaborators

• Yakult Honsha Co., LTD: lead

Study Sites (2)

Sarah Cannon Cancer Center

Nashville, Tennessee, 37203, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6307, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

irinotecan sucrosofate

Study Officials

• Mace L Rothenberg, M.D.

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Expanded Access: Yes

Study Record Dates

• First Submitted: August 11, 2006
• First Posted: August 15, 2006
• Study Start: September 1, 2006
• Study Completion: June 1, 2011
• Last Updated: July 5, 2019

Record last verified: 2019-07

Locations

US (2)