The Effect of Food on the Pharmacokinetics of Paclitaxel Administered Orally as Oraxol

Solid Tumor, Adult Clinical Trial

Official title:

An Open-label, Crossover Study of the Effect of Food on the Pharmacokinetics of Paclitaxel Administered Orally as Oraxol

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03892018
• Other study ID #: KX-ORAX-012
• Status: Terminated
• Phase: Phase 1
• Start date: August 5, 2019
• Est. completion date: May 12, 2023

Study information

• Verified date: October 2022
• Source: Athenex, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 29
• Est. completion date: May 12, 2023
• Est. primary completion date: May 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Solid Tumor, Adult

Intervention

Drug:
• Oraxol
Oraxol will be supplied as paclitaxel capsules and HM30181AK-US tablets.

Locations

Country	Name	City	State
United Kingdom	The Beatson West of Scotland Cancer Care Centre	Glasgow
United Kingdom	The Christie NHS Foundation Trust	Manchester
United Kingdom	The Northern Institute for Cancer Care	Newcastle Upon Tyne

Sponsors (1)

Lead Sponsor	Collaborator
Athenex, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the concentration-time profile of Oral Paclitaxel in plasma for 168 hours when taken with or without food.		24 months
Secondary	Comparison of the concentration-time profile of HM30181 in plasma for 168 hours when taken with or without food.		24 months
Secondary	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	At baseline and every 8 weeks through study completion, approximately 24 months
Secondary	Incidence of Adverse Events (Safety and Tolerability)	Evaluate the safety of Oraxol. Number of participants with treatment-related adverse events.	24 months