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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00364143
Recruitment Status : Unknown
Verified January 2012 by Yakult Honsha Co., LTD.
Recruitment status was:  Recruiting
First Posted : August 15, 2006
Last Update Posted : January 26, 2012
Information provided by:
Yakult Honsha Co., LTD

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.

Condition or disease Intervention/treatment Phase
Cancer Drug: IHL-305 (irinotecan liposome injection) Phase 1

Yakult Honsha Co., LTD has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of IHL-305 (Irinotecan Liposome Injection) in Patients With Advanced Solid Tumors
Study Start Date : September 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Incidence of dose-limiting toxicity within 28 days of treatment administration for patients with UGT1A1*28 genotype (wt/wt and wt/*28)
  2. determination of maximum tolerated dose (MTD) and recommended Phase 2 dose for patients with UGT1A1*28 genotype (wt/wt and wt/*28)

Secondary Outcome Measures :
  1. 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)
  2. limited pharmacokinetics (PK) for patients with UGT1A1*28 genotype (wt/wt and wt/*28)
  3. limited incidence and severity of adverse events (AEs) and PK for UGT1A1 homozygous (*28/*28) patients

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00364143

Contact: Christina A Weaver, BS 609-799-7580 ext 406
Contact: Brad Davis 609-799-7580 ext 394

United States, Tennessee
Sarah Cannon Cancer Center Recruiting
Nashville, Tennessee, United States, 37203
Principal Investigator: Howard Burris, MD         
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232-6307
Contact: Wendy L. VerMeulen, RN, BSN    615-343-0798   
Contact: Wendy Cooper, RN, BSN, OCN    615-936-5869   
Principal Investigator: Mace Rothenberg, MD         
Sponsors and Collaborators
Yakult Honsha Co., LTD
Principal Investigator: Mace L Rothenberg, M.D. Vanderbilt University Identifier: NCT00364143     History of Changes
Other Study ID Numbers: IHL-PRT001
First Posted: August 15, 2006    Key Record Dates
Last Update Posted: January 26, 2012
Last Verified: January 2012

Keywords provided by Yakult Honsha Co., LTD:
Advanced Solid Tumor

Additional relevant MeSH terms:
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action