Ignite Creation Date:
2025-12-24 @ 12:19 PM
Ignite Modification Date:
2025-12-27 @ 4:09 PM
Study NCT ID:
NCT01611961
Status:
UNKNOWN
Last Update Posted:
2014-09-30
First Post:
2012-05-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Docetaxel Lipid Microsphere (DT-LM) for Injection in Chemotherapy Patients
Sponsor:
Shenyang Pharmaceutical University
Organization:
Study Overview
Official Title:
A Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics of Docetaxel Lipid Microsphere for Injection in Cancer Patients Receiving Chemotherapy
Status:
UNKNOWN
Status Verified Date:
2014-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Docetaxel Lipid Microsphere (DT-LM) is a novel proprietary delivery system of docetaxel developed by Shenyang Pharmaceutical University. In this Phase I study, the DT-LM was evaluated for the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) in patients with advance solid tumors. It was also evaluated for pharmacokinetic and anti-tumor effects of DT-LM compared to commerical docetaxel.
Detailed Description:
Docetaxel (currently marketed as Taxotere®), given by intravenous or intraperitoneal injection, has contributed significantly to the treatment of a variety of malignancies, such as ovarian, breast, gastric, and non-small-cell lung cancer (NSCLC), as well as head and neck cancer and some other cancers. In the preclinical, DT-LM showed reduced toxicity (especially myelosuppression）and comparable therapeutic efficacy. In clinic, it is believed that DT-LM will offer fewer side effects to the patient at similar doses, and possibly greater effectiveness when used at higher doses. DT-LM could not only avoid the serious hypersensitivity reactions caused by Tween 80, but also be stable, safe and convenient for clinical administration.
This study is designed to determine the following:
* The maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of DT-LM.
* The pharmacokinetics of docetaxel following intravenous administration of DT-LM.
* Any anti-tumor effects of DT-LM.
Controlled trial is also carrying out to reveal the differences in safety, pharmacokinetics and pharmacodynamics between DT-LM and Taxotere.
This study is designed to determine the following:
* The maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of DT-LM.
* The pharmacokinetics of docetaxel following intravenous administration of DT-LM.
* Any anti-tumor effects of DT-LM.
Controlled trial is also carrying out to reveal the differences in safety, pharmacokinetics and pharmacodynamics between DT-LM and Taxotere.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: