Health Condition 1: null- cancer Health Condition 2: C801- Malignant (primary) neoplasm, unspecified
Conditions
Interventions
Intervention1: Paclitaxel: Paclitaxel injection concentrate for nano-dispersion
Intervention2: Paclitaxel nano-dispersion concentrate for injection (PICN) of Sun Pharma Advanced Research Company Limit
Sponsors
Sun Pharma Advanced Research Company Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine maximum tolerated dose and Pharmacokinetic profile of Paclitaxel injection concentrate for nano dispersion (PICN)Timepoint: 9 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactDr Mudgal Kothekar MD
Sun Pharma Advanced Research Company Limited
Outcome results
None listed