Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT03892018
Status:
TERMINATED
Last Update Posted:
2023-05-22
First Post:
2019-03-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Food on the Pharmacokinetics of Paclitaxel Administered Orally as Oraxol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017239', 'term': 'Paclitaxel'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'whyStopped': 'STUDY HALTED DUE TO FINANCIAL CONTRAINTS', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-08-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2023-05-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-19', 'studyFirstSubmitDate': '2019-03-19', 'studyFirstSubmitQcDate': '2019-03-25', 'lastUpdatePostDateStruct': {'date': '2023-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of the concentration-time profile of Oral Paclitaxel in plasma for 168 hours when taken with or without food.', 'timeFrame': '24 months'}], 'secondaryOutcomes': [{'measure': 'Comparison of the concentration-time profile of HM30181 in plasma for 168 hours when taken with or without food.', 'timeFrame': '24 months'}, {'measure': 'The proportion of patients with tumor responses after the initiation of treatment.', 'timeFrame': 'At baseline and every 8 weeks through study completion, approximately 24 months', 'description': 'RECIST v1.1 criteria defined as complete response, partial response, stable disease or progressive disease'}, {'measure': 'Incidence of Adverse Events (Safety and Tolerability)', 'timeFrame': '24 months', 'description': 'Evaluate the safety of Oraxol. Number of participants with treatment-related adverse events.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Solid Tumor, Adult']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed written informed consent\n* 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.\n* Measurable disease as per RECIST v1.1 criteria\n* Adequate hematologic status\n* Adequate liver function.\n* Adequate renal function\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n* Life expectancy of at least 3 months.\n* Women must be postmenopausal or surgically sterile.\n* Sexually active male subjects must use a barrier method of contraception during the study.\n* Able to consume the prescribed meals\n\nExclusion Criteria:\n\n* Have not recovered to ≤ Grade 1 toxicity from previous anticancer treatments or previous investigational products (IPs).\n* Received IPs within 21 days or 5 half-lives of the first dosing day, whichever is shorter\n* Are currently receiving other medications or radiation intended for the treatment of their malignancy. Hormonal therapy is allowed.\n* Women of childbearing potential who are pregnant or breastfeeding.\n* Currently taking a concomitant medication, other than a premedication, that is:\n\n * A strong P-glycoprotein (P-gp) inhibitor or inducer.\n * An oral medication with a narrow therapeutic index known to be a P-gp substrate.\n * Medications known to be strong inhibitors or inducers of cytochrome P450 (CYP) 2C8 or medications known to be strong CYP3A4 inhibitors or inducers.\n* 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.\n* Major surgery to the upper gastrointestinal (GI) tract, or have a history of GI disease that may interfere with oral drug absorption.\n* Cirrhosis of the liver or known active hepatitis B, hepatitis C, or HIV\n* History of hypersensitivity to paclitaxel, not attributed to a hypersensitivity-type reaction to Cremophor'}, 'identificationModule': {'nctId': 'NCT03892018', 'briefTitle': 'The Effect of Food on the Pharmacokinetics of Paclitaxel Administered Orally as Oraxol', 'organization': {'class': 'INDUSTRY', 'fullName': 'Athenex, Inc.'}, 'officialTitle': 'An Open-label, Crossover Study of the Effect of Food on the Pharmacokinetics of Paclitaxel Administered Orally as Oraxol', 'orgStudyIdInfo': {'id': 'KX-ORAX-012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Fed/ Fasted Treatment Sequence', 'description': 'Subjects will be assigned a fed/fasted sequence.\n\nFed sequence- subjects will fast overnight and continue fasting until they consume a standardized test meal at a predetermined time after paclitaxel administration.\n\nFasted Sequence- subjects will fast overnight and continue fasting until 4 hours post paclitaxel dose.', 'interventionNames': ['Drug: Oraxol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fasted/ Fed Treatment Sequence', 'description': 'Subjects will be assigned a fasted/fed sequence.\n\nFasted Sequence- subjects will fast overnight and continue fasting until 4 hours post paclitaxel dose.\n\nFed sequence- subjects will fast overnight and continue fasting until they consume a standardized test meal at a predetermined time after paclitaxel administration.', 'interventionNames': ['Drug: Oraxol']}], 'interventions': [{'name': 'Oraxol', 'type': 'DRUG', 'otherNames': ['Paclitaxel and HM30181AK-US'], 'description': 'Oraxol will be supplied as paclitaxel capsules and HM30181AK-US tablets.', 'armGroupLabels': ['Fasted/ Fed Treatment Sequence', 'Fed/ Fasted Treatment Sequence']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G12 0YN', 'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'The Beatson West of Scotland Cancer Care Centre', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'M20 4BX', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'The Christie NHS Foundation Trust', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'NE2 4HH', 'city': 'Newcastle upon Tyne', 'country': 'United Kingdom', 'facility': 'The Northern Institute for Cancer Care', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}], 'overallOfficials': [{'name': 'David Cutler, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Athenex, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Athenex, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}