Clinical trial · Interventional
The Effect of Food on the Pharmacokinetics of Paclitaxel Administered Orally as Oraxol
An Open-label, Crossover Study of the Effect of Food on the Pharmacokinetics of Paclitaxel Administered Orally as Oraxol
NCT03892018CI-TRIAL-00066573terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): STUDY HALTED DUE TO FINANCIAL CONTRAINTS
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor, Adult | Adult Solid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oraxol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Fed/ Fasted Treatment Sequence
- description
- 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.
- interventionNames
- Drug: Oraxol
- type
- ACTIVE_COMPARATOR
- label
- Fasted/ Fed Treatment Sequence
- description
- 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.
- interventionNames
- Drug: Oraxol
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.