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Safety Study of IHL-305 (Irinotecan Liposome Injection) to Treat Advanced Solid Tumors
This study is currently recruiting participants.
Verified by Yakult Honsha Co., LTD, January 2007
First Received: August 11, 2006   Last Updated: April 6, 2007   History of Changes
Sponsored by: Yakult Honsha Co., LTD
Information provided by: Yakult Honsha Co., LTD
ClinicalTrials.gov Identifier: NCT00364143
  Purpose

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 Intervention Phase
Cancer
Drug: IHL-305 (irinotecan liposome injection)
Phase I

MedlinePlus related topics: Cancer
Drug Information available for: Irinotecan U 101440E Irinotecan hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase I Study of IHL-305 (Irinotecan Liposome Injection) in Patients With Advanced Solid Tumors

Further study details as provided by Yakult Honsha Co., LTD:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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

Estimated Enrollment: 40
Study Start Date: September 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00364143

Contacts
Contact: Christina A Weaver, BS 609-799-7580 ext 406 cweaver@theradex.com
Contact: Brad Davis 609-799-7580 ext 394 bdavis@theradex.com

Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232-6307
Contact: Wendy L. VerMeulen, RN, BSN     615-343-0798     wendy.vermeulen@vanderbilt.edu    
Contact: Wendy Cooper, RN, BSN, OCN     615-936-5869     wendy.cooper@vanderbilt.edu    
Principal Investigator: Mace Rothenberg, MD            
Sarah Cannon Cancer Center Not yet recruiting
Nashville, Tennessee, United States, 37203
Principal Investigator: Howard Burris, MD            
Sponsors and Collaborators
Yakult Honsha Co., LTD
Investigators
Principal Investigator: Mace L Rothenberg, M.D. Vanderbilt University
  More Information

No publications provided

Study ID Numbers: IHL-PRT001
Study First Received: August 11, 2006
Last Updated: April 6, 2007
ClinicalTrials.gov Identifier: NCT00364143     History of Changes
Health Authority: United States: Food and Drug Administration

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

Study placed in the following topic categories:
Irinotecan
Antineoplastic Agents, Phytogenic

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Irinotecan
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 06, 2009