A pharmacokinetic, safety, and tolerability study of paclitaxel administered once a week in subjects with advanced solid malignancies in Indian population.
- Conditions
- Health Condition 1: null- cancerHealth Condition 2: C801- Malignant (primary) neoplasm, unspecified
- Registration Number
- CTRI/2011/11/002124
- Lead Sponsor
- Sun Pharma Advanced Research Company Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 21
1. Histologically or cytologically confirmed diagnosis of solid tumor in advanced stage for
which taxane-based therapy is a rational treatment option;
2. Age more than or equal to 18 years;
3. ECOG performance status less than or equal to 2;
4. Estimated life expectancy of at least 12-weeks;
5. Measurable disease as per RECIST guideline (Version 1.1);
6. Adequate organ and immune system function as indicated by the following laboratory
values, obtained less than or equal to 2 weeks prior to dosing:
7. Any chemotherapy (except palliative bisphosphate therapy for bone pain), major surgery, or irradiation must have been completed at least 4-weeks before enrollment in this study (6-weeks for Mitomycin C or nitrosurea); subjects must have recovered from all toxicities
incurred as a result of previous therapy;
8. If subject has received taxanes, he/she must not have relapsed with cancer within 48-weeks
of completing taxane therapy;
9. Women of child bearing potential practicing an acceptable method of birth control as judged
by the investigator(s) [such as condoms, foams, jellies, diaphragm, intrauterine device
(IUD), oral or log acting injected contraceptives] from atleast 2 months prior to study entry and through the duration of the study; or postmenopausal for at least 1 year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject); with a negative urine pregnancy test; if male, subject must practice adequate contraception;
10. Willing to participate and give written informed consent.
Known hypersensitivity to the study drug;
Treatment with any investigational agents within 30-days of study entry;
Presence of clinically evident active CNS metastases, including leptomeningial involvement,
requiring steroid or radiation therapy;
Pre-existing peripheral neuropathy (grade 1 or higher â?? as per CTCAE, Version 4.02);
Any other severe concurrent disease which in the judgment of the investigator would make
the subject inappropriate for entry into this study;
Presence of clinically significant pleural/ascitic fluid (Fluid should be tapped before dosing).
Tests for exclusion: Serum Pregnancy Test (If applicable), Human immunodeficiency virus
antibodies I/II (HIV-I/II Ab), Hepatitis B surface antigen (HBs-Ag), Hepatitis C virus
antibodies (HCV-Ab).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine maximum tolerated dose and Pharmacokinetic profile of Paclitaxel injection concentrate for nano dispersion (PICN)Timepoint: 9 months
- Secondary Outcome Measures
Name Time Method To evaluate safety of Paclitaxel injection concentrate for nano dispersion (PICN)as per Commen Terminology Criteria for Adverse Event(CTCAE) reporting Version 4.0Timepoint: During course of study