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

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.

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