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STUDY HALTED DUE TO FINANCIAL CONTRAINTS
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fed/ Fasted Treatment Sequence | Active Comparator | 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. |
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| Fasted/ Fed Treatment Sequence | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oraxol | Drug | Oraxol will be supplied as paclitaxel capsules and HM30181AK-US tablets. |
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| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the concentration-time profile of Oral Paclitaxel in plasma for 168 hours when taken with or without food. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | RECIST v1.1 criteria defined as complete response, partial response, stable disease or progressive disease |
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Inclusion Criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| David Cutler, MD | Athenex, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Beatson West of Scotland Cancer Care Centre | Glasgow | G12 0YN | United Kingdom | |||
| The Christie NHS Foundation Trust |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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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.
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| At baseline and every 8 weeks through study completion, approximately 24 months |
| Incidence of Adverse Events (Safety and Tolerability) | Evaluate the safety of Oraxol. Number of participants with treatment-related adverse events. | 24 months |
| Manchester |
| M20 4BX |
| United Kingdom |
| The Northern Institute for Cancer Care | Newcastle upon Tyne | NE2 4HH | United Kingdom |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |