A Study to Evaluate the Safety, Tolerability, MTD, PK, and Activity of Oraxol in Subjects w Adv. Malignancies

NCT02730481 | Completed Phase 1

• 1 other identifier: KX-ORAX-004
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 3

Brief Summary

This is a multicenter, open-label, safety study. Eligible subjects will be adults with advanced malignancies. The study includes a pretreatment and treatment phase. The pretreatment phase consists of screening and baseline periods. The treatment phase consists of 4-week treatment periods and a follow-up period.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose (MTD) of Oraxol

  The highest dose at which no more than 1 of 6 subjects experience a dose-limiting toxicity (DLT) during treatment

  20 weeks

Secondary Outcomes (4)

• Evaluate tumor response

  At baseline and every 8 weeks through study completion, approximately 24 months

• Number of Participants with abnormal laboratory values and/or adverse events that are related to treatment

  4 weeks

• The amount of Oraxol in the blood stream

  3 weeks

• The recommended Phase 2 dose of paclitaxel as Oraxol

  24 months

Study Arms (1)

ORAXOL

EXPERIMENTAL

Oraxol (paclitaxel + HM30181AK-US) Oraxol paclitaxel - supplied as 30-mg capsules Oraxol HM30181 methanesulfonate monohydrate - supplied as 15-mg HM30181AK-US tablets

Drug: Oraxol

Interventions

Oraxol DRUG

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

Also known as: Paclitaxel and HM30181AK-US

ORAXOL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent
• ≥18 years of age
• 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 as demonstrated by not requiring transfusion support or granulocyte-colony stimulating factor (G-CSF) to maintain: ANC ≥1500 cells/mm3, Platelet count ≥100 x 109/L, Hemoglobin ≥9 g/dL
• Adequate liver function as demonstrated by:Total bilirubin of ≤1.5 mg/dL or ≤2.0 mg/dL for subjects with liver metastasis, Alanine aminotransferase ≤3 x upper limit of normal (ULN) or ≤5 x ULN if liver metastasis is present, Alkaline phosphatase ≤3 x ULN or ≤5 x ULN if bone or liver metastasis is present
• Adequate renal function as demonstrated by serum creatinine ≤1.5 x ULN or creatinine clearance calculation ≥60 mL/min as calculated by the Cockcroft and Gault formula
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
• Life expectancy of at least 3 months
• Women must be postmenopausal (\>12 months without menses) or surgically sterile (ie, by hysterectomy and/or bilateral oophorectomy) or must be using effective contraception (ie, oral contraceptives, intrauterine device, double barrier method of condom and spermicide) and agree to continue use of contraception for 30 days after their last dose of study drug.
• Sexually active male subjects must use a barrier method of contraception during the study and agree to continue the use of male contraception for at least 30 days after the last dose of study drug.

You may not qualify if:

• Have not recovered to ≤ Grade 1 toxicity from previous anticancer treatments or previous investigational products (IPs)
• Received IPs within 30 days or 5 half lives of the first study dosing day
• Are currently receiving other medications or radiation intended for the treatment of their malignancy
• Women of childbearing potential who are pregnant or breastfeeding
• Currently taking a concomitant medication
• Require therapeutic use of anticoagulation medications
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, myocardial infarction within the last 6 months, unstable angina pectoris, cardiac arrhythmia, chronic pulmonary disease requiring oxygen, known bleeding disorders, or any concomitant illness or social situation that would limit compliance with study requirements
• Major surgery to the upper gastrointestinal (GI) tract, or have a history of GI disease or other medical condition that, in the opinion of the investigator may interfere with oral drug absorption
• History of hypersensitivity to paclitaxel, not attributed to a hypersensitivity type reaction to Cremophor

Sponsors & Collaborators

• Athenex, Inc.: lead

Study Sites (3)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Cancer Therapy &Research Center @ UTHSCSA

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Interventions

Paclitaxel

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• E D Kramer, MD

  Kinex Pharmaceuticals Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2016
• First Posted: April 6, 2016
• Study Start: March 1, 2016
• Primary Completion: March 1, 2021
• Study Completion: May 1, 2021
• Last Updated: September 13, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)