The Effect of Food on the Pharmacokinetics of Paclitaxel Administered Orally as Oraxol
- Registration Number
- NCT03892018
- Lead Sponsor
- Athenex, Inc.
- Brief Summary
This is multicenter, open-label, 2-part crossover study. Eligible subjects will have metastatic or unresectable solid tumors. This study includes a pretreatment and treatment phase. The pretreatment phase consists of screening and baseline. The treatment phase consists of Periods 1 and 2 (Part A), Treatment (Part B), and Follow-up.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 29
- Signed written informed consent
- Histologically or cytologically confirmed solid tumor that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
- Measurable disease as per RECIST v1.1 criteria
- Adequate hematologic status
- Adequate liver function.
- Adequate renal function
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Life expectancy of at least 3 months.
- Women must be postmenopausal or surgically sterile.
- Sexually active male subjects must use a barrier method of contraception during the study.
- Able to consume the prescribed meals
-
Have not recovered to ≤ Grade 1 toxicity from previous anticancer treatments or previous investigational products (IPs).
-
Received IPs within 21 days or 5 half-lives of the first dosing day, whichever is shorter
-
Are currently receiving other medications or radiation intended for the treatment of their malignancy. Hormonal therapy is allowed.
-
Women of childbearing potential who are pregnant or breastfeeding.
-
Currently taking a concomitant medication, other than a premedication, that is:
- A strong P-glycoprotein (P-gp) inhibitor or inducer.
- An oral medication with a narrow therapeutic index known to be a P-gp substrate.
- Medications known to be strong inhibitors or inducers of cytochrome P450 (CYP) 2C8 or medications known to be strong CYP3A4 inhibitors or inducers.
-
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, or any concomitant illness that would limit compliance with study requirements.
-
Major surgery to the upper gastrointestinal (GI) tract, or have a history of GI disease that may interfere with oral drug absorption.
-
Cirrhosis of the liver or known active hepatitis B, hepatitis C, or HIV
-
History of hypersensitivity to paclitaxel, not attributed to a hypersensitivity-type reaction to Cremophor
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Fed/ Fasted Treatment Sequence Oraxol Subjects will be assigned a fed/fasted sequence. Fed sequence- subjects will fast overnight and continue fasting until they consume a standardized test meal at a predetermined time after paclitaxel administration. Fasted Sequence- subjects will fast overnight and continue fasting until 4 hours post paclitaxel dose. Fasted/ Fed Treatment Sequence Oraxol Subjects will be assigned a fasted/fed sequence. Fasted Sequence- subjects will fast overnight and continue fasting until 4 hours post paclitaxel dose. Fed sequence- subjects will fast overnight and continue fasting until they consume a standardized test meal at a predetermined time after paclitaxel administration.
- Primary Outcome Measures
Name Time Method Comparison of the concentration-time profile of Oral Paclitaxel in plasma for 168 hours when taken with or without food. 24 months
- Secondary Outcome Measures
Name Time Method Incidence of Adverse Events (Safety and Tolerability) 24 months Evaluate the safety of Oraxol. Number of participants with treatment-related adverse events.
Comparison of the concentration-time profile of HM30181 in plasma for 168 hours when taken with or without food. 24 months The proportion of patients with tumor responses after the initiation of treatment. At baseline and every 8 weeks through study completion, approximately 24 months RECIST v1.1 criteria defined as complete response, partial response, stable disease or progressive disease
Trial Locations
- Locations (3)
The Beatson West of Scotland Cancer Care Centre
🇬🇧Glasgow, United Kingdom
The Northern Institute for Cancer Care
🇬🇧Newcastle Upon Tyne, United Kingdom
The Christie NHS Foundation Trust
🇬🇧Manchester, United Kingdom