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Sponsored by: |
Yakult Honsha Co., LTD |
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Information provided by: | Yakult Honsha Co., LTD |
ClinicalTrials.gov Identifier: | NCT00364143 |
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 |
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Cancer |
Drug: IHL-305 (irinotecan liposome injection) |
Phase I |
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 |
Estimated Enrollment: | 40 |
Study Start Date: | September 2006 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Normal organ and bone marrow function as defined by:
Exclusion Criteria:
Contact: Christina A Weaver, BS | 609-799-7580 ext 406 | cweaver@theradex.com |
Contact: Brad Davis | 609-799-7580 ext 394 | bdavis@theradex.com |
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 |
Principal Investigator: | Mace L Rothenberg, M.D. | Vanderbilt University |
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 |
Cancer Advanced Solid Tumor Oncology |
Irinotecan Antineoplastic Agents, Phytogenic |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Irinotecan |
Enzyme Inhibitors Antineoplastic Agents, Phytogenic Pharmacologic Actions |