Phase I Study of Intravenous Lipotecan® (TLC388 HCl for Injection) in Patients With Advanced Solid Tumors
Completed · Phase 1
Conditions studied: Advanced Solid Tumors
In brief
The purpose of this study is to find a safe and tolerable dose of Lipotecan® when administered to patients with advanced solid tumors.
Key facts
- Study ID
- NCT00747474
- Run by
- Taiwan Liposome Company
- People needed
- 54
- Starts
- 2008-09-01
- Expected to finish
- 2011-12-01
- Last updated by the study team
- 2019-11-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adult patients defined by age ≥18 years.
- Pathologically confirmed advanced solid tumors for which standard therapy proven to provide clinical benefit does not exist or is no longer effective
- Evaluable disease, either measurable on imaging or with informative tumor marker(s), by RECIST (Response Evaluation Criteria in Solid Tumors) criteria.
You may not qualify if…
- Pregnancy or lactation. Women of childbearing potential must have a negative pregnancy test within 7 days prior to enrolment. Male and female patients of childbearing potential must agree to use appropriate birth control (barrier methods with spermicides, oral or parenteral contraceptives and/or intrauterine devices) during the entire duration of the study, or the patient must be surgically sterile (with documentation in the patient's medical records).
- Previous malignancy, except for non-basal-cell carcinoma of skin or carcinoma-in-situ of the uterine cervix, unless the tumor was treated with curative intent more than 2 years prior to study entry.
- Receipt of more than 3 prior regimens of chemotherapy.
- Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to baseline. Receipt of radiotherapy to >25 % of bone marrow. Major surgery within 4 weeks prior to baseline.
- Concomitant treatment with, or anticipated use of, pharmaceutical or herbal agents which are potent inhibitors or inducers of cytochrome P450 enzymes unless approved by the Sponsor.
- Uncontrolled intercurrent illness that would jeopardize patient safety, interfere with the objectives of the protocol, or limit patient compliance with study requirements, as determined by the Investigator.
Where it is running
- Medical College of Georgia — Augusta, Georgia, United States
- Bidmc, Dfci, Mgh — Boston, Massachusetts, United States
- Montefiore Medical Center — The Bronx, New York, United States
- National Taiwan University Hospital — Taipei, Taiwan
Full record on ClinicalTrials.gov
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