An Open-label, Pilot Pharmacokinetic Study to Determine the Bioavailability, Safety, and Tolerability of a Single Dose of Oradoxel in Metastatic Prostate Cancer Patients Treated With Intravenous Docetaxel

Kinex Pharmaceuticals Inc0 sites11 target enrollmentJuly 27, 2016

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Kinex Pharmaceuticals Inc
Enrollment: 11
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 27, 2016

End Date

November 16, 2020

Last Updated

4 years ago

Study Type

Interventional

Sex

Male

Investigators

Sponsor

Kinex Pharmaceuticals Inc

Eligibility Criteria

Inclusion Criteria

•Eligible participants must be males at least 18 years of age with metastatic prostate cancer who are scheduled to receive their prescribed dose of treatment with IV docetaxel. Patients may be receiving steroid treatment or ADT for prostate cancer, but other concomitant cancer chemotherapy is not permitted.
•They must have:
•\- adequate hematologic status as demonstrated by not requiring transfusion support or granulocyte\-colony stimulating factor (G\-CSF);
•\- Adequate liver function as demonstrated by: Total bilirubin of less than the upper limit of normal (ULN); Aspartate transaminase (AST) and alanine aminotransferase (ALT) less than/equal to 1\.5 times ULN; Alkaline phosphatase (ALP) less than/equal to 2\.5 times ULN or less than 5 times ULN if bone metastases are present
•\- Adequate renal function as demonstrated by serum creatinine less than/equal to 177 micromole/L or creatinine clearance greater than 60 mL/min as calculated by the Cockcroft and Gault formula
•Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy of at least 6 months; Willing to fast for 8 hours before and 4 hours after Oradoxel administration; Willing to abstain from alcohol consumption from 3 days prior Study Period 1 through to the Final Visit; Willing to refrain from caffeine consumption for 12 hours prior to each dose of study drug through the completion of protocol\-specified PK sampling time\-points; Sexually active participants must use a barrier method of contraception during the study and agree to continue the use of contraception for at least 30 days after the last dose of study drug.

Exclusion Criteria

•Eligible participants must not be
•\- currently taking a prohibited concomitant medication;
•\- have unresolved toxicity from prior chemotherapy (participants must have recovered from all significant toxicity to less than or equal to Grade 1 CTCAE toxicity from previous anticancer treatments or previous investigational agents);
•\- planning to receive other medical, surgical, or radiological treatments for prostate cancer during the course of this study;
•\- received investigational agents within 14 days or 5 half\-lives prior to the first study dosing day, whichever is longer;
•\- uncontrolled intercurrent illness; no major surgery to the upper gastrointestinal (GI) tract, or have a history of GI disease or other medical condition that, in the opinion of the Investigator may interfere with oral drug absorption;
•\- known history of allergy to docetaxel, Cremophor (Registered Trademark), or polysorbate 80 (Tween 80\);
•\- any other condition which the Investigator believes would make participation in the study not acceptable.