- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00364143
Safety Study of IHL-305 (Irinotecan Liposome Injection) to Treat Advanced Solid Tumors
July 2, 2019 updated by: Yakult Honsha Co., LTD
A Phase I Study of IHL-305 (Irinotecan Liposome Injection) in Patients With Advanced Solid Tumors
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
40
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37203
- Sarah Cannon Cancer Center
-
Nashville, Tennessee, United States, 37232-6307
- Vanderbilt-Ingram Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- 18 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
Exclusion Criteria:
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
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
Outcome Measure |
---|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mace L Rothenberg, M.D., Vanderbilt University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2006
Study Completion
June 1, 2011
Study Registration Dates
First Submitted
August 11, 2006
First Submitted That Met QC Criteria
August 11, 2006
First Posted (Estimate)
August 15, 2006
Study Record Updates
Last Update Posted (Actual)
July 5, 2019
Last Update Submitted That Met QC Criteria
July 2, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IHL-PRT001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cancer
-
University of Michigan Rogel Cancer CenterRecruitingCancer Liver | Cancer Brain | Cancer Head &Neck | Cancer PelvisUnited States
-
Cellworks Group Inc.RecruitingCancer | Relapsed Cancer | Refractory CancerUnited States
-
UNC Lineberger Comprehensive Cancer CenterHyundai Hope On WheelsRecruitingCancer | Pediatric Cancer | Survivorship | Cancer MetastaticUnited States
-
Vanderbilt-Ingram Cancer CenterNational Institutes of Health (NIH)Active, not recruitingAdvanced Cancer | Relapsed Cancer | Refractory CancerUnited States
-
MiRXES Pte LtdRecruitingBreast Cancer | Gastric Cancer | Colorectal Cancer | Pancreatic Cancer | Esophageal Cancer | Ovarian Cancer | Prostate Cancer | Thoracic Cancer | Liver CancerSingapore
-
Sidney Kimmel Cancer Center at Thomas Jefferson...CompletedStage I Breast Cancer | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage... and other conditionsUnited States
-
Massachusetts General HospitalNational Comprehensive Cancer NetworkCompletedGastric Cancer | Pancreatic Cancer | Esophageal Cancer | Rectal Cancer | Colon Cancer | Hepatobiliary CancerUnited States
-
Johns Hopkins UniversityNational Cancer Institute (NCI); National Institute on Minority Health and...Enrolling by invitationCancer | Advanced Cancer | End Stage Cancer | MalignancyUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedStage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IV Gastric Cancer | Stage IVA Colorectal Cancer | Stage IVA Pancreatic Cancer | Stage IVB Colorectal Cancer | Stage IVB Pancreatic Cancer | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric... and other conditionsUnited States
-
Case Comprehensive Cancer CenterCompletedStage IIA Rectal Cancer | Stage IIB Rectal Cancer | Stage IIC Rectal Cancer | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Recurrent Colon Cancer | Recurrent Rectal Cancer | Stage IVA Colon Cancer | Stage IVA Rectal Cancer and other conditionsUnited States
Clinical Trials on IHL-305 (irinotecan liposome injection)
-
Fudan UniversityNot yet recruitingSmall Cell Lung Cancer RecurrentChina
-
Luye Pharma Group Ltd.CompletedAdvanced Solid TumorChina
-
CSPC Ouyi Pharmaceutical Co., Ltd.Not yet recruitingAdvanced Breast Cancer
-
CSPC Ouyi Pharmaceutical Co., Ltd.Not yet recruitingSmall Cell Lung Cancer (SCLC)
-
Luye Pharma Group Ltd.RecruitingRelapsed Small Cell Lung CancerChina
-
Luye Pharma Group Ltd.CompletedSmall Cell Lung CancerChina
-
Baohui HanNot yet recruitingExtensive-stage Small-cell Lung CancerChina
-
Sabine Mueller, MD, PhDPacific Pediatric Neuro-Oncology Consortium; The V Foundation for Cancer ResearchCompletedDiffuse Intrinsic Pontine GliomaUnited States
-
Peking University People's HospitalPeking University Shougang Hospital; Shandong Cancer Hospital and InstituteRecruiting
-
IpsenCompletedSmall Cell Lung CancerSpain, United States, France, Taiwan, Korea, Republic of, Germany, China, Belgium, Italy, Brazil, Ukraine, Australia, Russian Federation, Serbia, Poland, Hungary, Turkey, Romania