An Open-label, Randomized Cross-over, Pharmacokinetic Study to Determine the Bioavailability, Safety, and Tolerability of Two Consecutive Daily Doses of Oraxol in Cancer Patients Treated With Intravenous Paclitaxel Amendment 1

Phase 1

Recruiting

• Conditions: Cancer - Any cancer; Cancer

• Registration Number: ACTRN12614000365662
• Lead Sponsor: Kinex Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-04-07
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

1.Signed written informed consent
2.18 years of age and older
3.Cancer patients for which treatment with paclitaxel at 80 mg/m2 has been recommended by their oncologist, either as monotherapy or in combination with other agents.
4.Adequate bone marrow reserve as demonstrated by:
Absolute neutrophil count (ANC) 1.0 109/L
Platelet count 100 109/L
Haemoglobin (Hgb) 9 g/L
5.Adequate liver function as demonstrated by:
Total bilirubin of 20 micro mol/L or 30 micro mol/L for subjects with liver metastasis
Alanine aminotransferase (ALT) 3 times upper limit of normal (ULN) or 5 times ULN if liver metastasis is present
Alkaline phosphatase (ALP) 3 times ULN or 5 times ULN if bone metastasis is present
6.Adequate renal function as demonstrated by serum creatinine 177 micro mol/L or creatinine clearance greater than 50 mL/min as calculated by the Cockroft and Gault formula
7.Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
8.Life expectancy of at least 3 months
9.Willing to fast for 8 hours before and 4 hours after Oraxol administration.
10.Willing to abstain from alcohol consumption for 3 days prior to the first dose of study drug through the completion of protocol-specified PK sampling on Day 12
11.Willing to refrain from caffeine consumption for 12 hours prior to each dose of study drug through the completion of protocol-specified PK sampling for that dose on Day 5 or Day 12.Women must be postmenopausal (greater than 12 months without menses) or surgically sterile (ie, by hysterectomy and/or bilateral oophorectomy) or, if sexually active, must be using effective contraception (ie, oral contraceptives, intrauterine device, double barrier method of condom and spermicide) and agree to continue use of contraception for the duration of their participation in the study. Women of childbearing potential must agree to use contraception for 30 days after their last dose of study drug.
13.Sexually active male subjects must use a barrier method of contraception during the study and agree to continue the use of male contraception for at least 30 days after the last dose of study drug.

Exclusion Criteria

Eligible subjects must not have/be:
1.Currently taking a prohibited concomitant medication:
Strong inhibitors or inducers of CYP3A4.
Clinically significant inhibitors (gemfibrozil) or inducers (rifampin) of CYP2C8
Known P-gp inhibitors or inducers
2.Unresolved toxicity from prior chemotherapy (participants must have recovered all significant toxicity to Grade 1 CTCAE toxicity from previous anticancer treatments or previous investigational agents). This does not extend to symptoms or findings that are attributable to the underlying disease
3.Received investigational agents within 14 days or 5 half-lives of the first study dosing day, whichever is longer.
4.Women of childbearing potential who are pregnant or breast feeding.
5.Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, myocardial infarction within the last 6 months, unstable angina pectoris, clinically significant cardiac arrhythmia, chronic pulmonary disease requiring oxygen, known bleeding disorders, or psychiatric illness/social situations that would limit compliance with study requirements
6.Significant or uncontrolled cardiovascular disease or bleeding disorder
7.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
8.A known history of allergy to paclitaxel. Subjects whose allergy was due to the IV solvent (such as Cremophorregister trademark) and not paclitaxel will be eligible for this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified