None listed
Conditions
Brief summary
Oradoxel is a combination of an oral tablet, HM30181 methanesulfonate, and capsules that contain docetaxel. HM30181 is a drug that helps the body absorb docetaxel, a drug used to treat cancer. The purpose of this study is to measure the levels of docetaxel in your blood at different times when given by intravenous (IV) drip (through a vein in your arm) compared with the levels of docetaxel at different times in your blood when given by mouth (as Oradoxel).
Interventions
Participants will be enrolled in the study before or during their prescribed course of IV Docetaxel treatment. The study period consists of 2 treatment periods.
For patients who receive oral docetaxel prior to their first course of IV docetaxel: Oradoxel will be administered orally and 3 weeks later IV Docetaxel will be administered.
For patients who shall receive Oradoxel during their prescribed course of IV docetaxel treatment: the patients receive their scheduled dose of IV docetaxel and 3 we
Participants will be enrolled in the study before or during their prescribed course of IV Docetaxel treatment. The study period consists of 2 treatment periods. For patients who receive oral docetaxel prior to their first course of IV docetaxel: Oradoxel will be administered orally and 3 weeks later IV Docetaxel will be administered. For patients who shall receive Oradoxel during their prescribed course of IV docetaxel treatment: the patients receive their scheduled dose of IV docetaxel and 3 weeks later Oradoxel is to be administered. Both study treatments will be administered by study staff in an oncology unit. Participants will receive one dose of Oradoxel; Oradoxel comprises an HM30181AK-US tablet followed by oral docetaxel capsules. The oral docetaxel (at a dose of 75 mg/m2, 150 mg/m2, 300 mg/m2, 360 mg/m2 or 410 mg/m2, depending on the study cohort) is administered one hour after 15 mg HM30181AK-US tablet. Premedication for Oradoxel can be given as clinically indicated, in the judgement of the investigator. The details of premedication given is entirely at the investigator's discretion, but should be in accordance with usual practice at the study site. Participants must abstain from alcohol consumption for 3 days before Study Period 1 until the Final Visit. Participants must refrain from caffeine consumption for 12 hours prior to dosing with study drug through day 4 in study periods 1 and 2, and must fast at least 8 hours prior to and 4 hours after dosing with Oradoxel.
Sponsors
Kinex Pharmaceuticals Inc
Study design
Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed