Solid Tumor, Adult
Conditions
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.
Interventions
DRUGOraxol
Oraxol will be supplied as paclitaxel capsules and HM30181AK-US tablets.
Sponsors
Athenex, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This will be an open-label, 2-part, crossover study to assess the effect of food on Oraxol exposure. The study will consist of the following periods: Screening, Baseline, Periods 1 and 2 (Part A), Treatment (Part B), and Follow-up. Part A will assess the effect of food on Oraxol pharmacokinetics. In Part A, subjects will be randomized to the sequence (fed/fasted or fasted/fed conditions) under which they will be administered single-dose treatment after an overnight fast. There will be a minimum of 7 days after Period 1 treatment before subjects cross over to Period 2 treatment. Subjects who have participated in the PK assessments in Part A of the study may continue into Part B, during which Oraxol will be dosed for 3 consecutive days per week under fasting conditions.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of the concentration-time profile of Oral Paclitaxel in plasma for 168 hours when taken with or without food. | 24 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Incidence of Adverse Events (Safety and Tolerability) | 24 months | Evaluate the safety of Oraxol. Number of participants with treatment-related adverse events. |
Countries
United Kingdom
Outcome results
None listed