CTRI/2010/091/001122
Completed
Phase 1
Phase 1 safety, tolerability, and pharmacokinetic study of Docetaxel nano-dispersion: A randomized, open label, dose ranging, active controlled, comparative, parallel groups, and multi-centric study.
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- locally advanced or metastatic breast cancer, locally advanced non-small cell lung cancer, hormone refractory metastatic prostate cancer, other tumor type with no standard treatment
- Sponsor
- Sun Pharma Advanced Research Company Ltd
- Enrollment
- 30
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically or cytologically confirmed advanced cancer potentially sensitive to single agent docetaxel; e.g. locally advanced or metastatic breast cancer, locally advanced non\-small cell lung cancer, hormone refractory metastatic prostate cancer, other tumor type with no standard treatment. Age 18 to 65\-years inclusive;
- •Performance status less than or equal to 2 on the ECOG performance scale;
- •Estimated life expectancy of at least 12\-weeks;
- •Adequate organ and immune system function as indicated by
- •the following laboratory values, obtained less than or equal to 2 weeks prior to dosing;
- •Any chemotherapy (except taxanes), 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;
- •Women of child bearing potential practicing an acceptable method of birth control as judged by the investigator(s) 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;Willing to participate and give written informed consent.
Exclusion Criteria
- •Hematological malignancies including leukemia, lymphoma or multiple myeloma;
- •Uncontrolled angina, subjects with a history of myocardial infarction within 2\-months of enrollment, or subjects with cardiac functional capacity Class III or IV as defined by NYHA classification;
- •Known hypersensitivity to study drugs or its excipients or analogs;
- •Treatment with any investigational agents within 30\-days of study entry; Active and uncontrolled infection;
- •Psychiatric disorders or alcohol/chemical abuse that would interfere with consent or follow\-up;
- •Presence of clinically apparent CNS metastases or carcinomatous meningitis;
- •Pre\-existing peripheral neuropathy (grade 1 or higher ? as per CTCAE);
- •Any other severe concurrent disease which in the judgment of the investigator would make the subject inappropriate for entry into this study;
- •HIV positive or who have an AIDS\-related illness;
- •Prior radiation therapy to less than or equal to 25% of the bone marrow (e.g. whole pelvic radiation is allowed). Subjects must have recovered from the acute side effects of radiotherapy; Prior bone marrow/stem cell transplantation.
Outcomes
Primary Outcomes
Not specified
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