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.

Phase 1

Completed

• 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

• Registration Number: CTRI/2010/091/001122
• Lead Sponsor: Sun Pharma Advanced Research Company Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2011-04-06
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified