A Trial to Determine the Maximum Tolerated Dose and Evaluate the Safety and Pharmacokinetics of Docetaxel-PNP, Polymeric Nanoparticle Formulation of Docetaxel, in Subjects With Advanced Solid Malignancies
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Samyang Biopharmaceuticals Corporation.
Recruitment status was Recruiting
Information provided by:
Samyang Biopharmaceuticals Corporation
First received: April 5, 2010
Last updated: April 25, 2010
Last verified: April 2010
This is a phase I trial to determine the maximum tolerated dose and recommended phase II dose of docetaxel-PNP (polymeric nanoparticle formulation of docetaxel) and to evaluate the safety and pharmacokinetics of docetaxel-PNP in subjects with advanced solid malignancies.
Advanced Solid Malignancies
||Primary Purpose: Treatment
||A Trial to Determine the Maximum Tolerated Dose and Evaluate the Safety and Pharmacokinetics of Docetaxel-PNP, Polymeric Nanoparticle Formulation of Docetaxel, in Subjects With Advanced Solid Malignancies
Primary Outcome Measures:
- The maximum tolerated dose (MTD) of Docetaxel-PNP
- The recommended phase II dose of Docetaxel-PNP
Secondary Outcome Measures:
- The Dose Limiting Toxicity (DLT)
- The pharmacokinetics of Docetaxel-PNP on Day 1 of 1st cycle (AUC, CL, T1/2, Tmax, Cmax, Vdss)
- Objective response rate
| Study Start Date:
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Patient has had a major surgery except tumor ablation within 2 weeks before screening visit
- Patient has a brain metastasis with neurologic symptom
- Patient has a sensory neuropathy or motor neuropathy ≥ grade 2 by NCI-CTCAE
- Patient has any serious concurrent disease such as:
Any medical or psychiatric condition that, in the opinion of the investigator, would prohibit the understanding and giving of informed consent Severe cardiovascular disease (e.g. ischemic heart disease requiring medication or myocardial infraction within the past six months, grade 3-4 congestive heart failure defined by the New York Heart Association criteria) Active un controlled infection.
- Patient has hypersensitivity to the Investigational product or their excipients
- Patient has participated in any other clinical trial within 4 weeks before screening visit
- Woman is pregnant or breast feeding
Subjects who are of childbearing potential who do not use a medically acceptable method of birth control or do not agree to continue use of this method throughout the trial (screening, treatment period, and 3 weeks from the last done). A negative pregnancy test (urine or serum) should be documented within 14 days prior to initiation of trial medication for women of childbearing potential who have not been amenorrheic for at least 12 months prior to registration into the trial or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy). Medically acceptable methods include:
- Barrier method with spermicide
- Intrauterine device
- Complete abstinence, etc.
- Patient who has a history of resistance, intolerance, or no response to Docetaxel therapy
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01103791
|Asan Medical Center
|Seoul, Korea, Republic of |
|Contact: Kyung Hae Kim, Ph. D. firstname.lastname@example.org |
Samyang Biopharmaceuticals Corporation
||Kyung Hae Jung, Ph. D.
||Asan Medical Center
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 5, 2010
||April 25, 2010
||South Korea: Korea Food and Drug Administration (KFDA)
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 24, 2014