A Phase 1 Open-Label, Sequential Dose Escalation Study Investigating the Safety, Tolerability, and Pharmacokinetics of Intravenous Lipotecan® (TLC388 HCl for Injection) When Administered to Patients With Advanced Solid Tumors
Lipotecan® is a drug product of TLC388 HCl, which is a potent camptothecin analog with
cytotoxic activities against a variety of human tumor cell lines in vitro and anti-tumor
activities in several xenograft models with human tumor cell lines. Structurally, TLC388
HCl is related to other camptothecins, but it has been chemically modified to improve
stability and potency, and to minimize toxicities.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose (MTD) of Lipotecan
MTD is the highest dose of drug that did not cause an unacceptable side effect (= Dose Limiting Toxicity (DLT)). A 3+3 study design was used to determine MTD. The MTD was the highest dose level at which 0 of 3 or 1 of 6 patients experience a DLT, with the next higher dose having at least 2 of 3 or 2 of 6 patients experiencing a DLT.
First treatment to toxicity up to 42 days
Taiwan Liposome Company, Ltd.
United States: Food and Drug Administration
|Montefiore Medical Center||Bronx, New York 10467-2490|
|Medical College of Georgia||Augusta, Georgia 30912|
|Bidmc, Dfci, Mgh||Boston, Massachusetts 02215|