- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02730481
A Study to Evaluate the Safety, Tolerability, MTD, PK, and Activity of Oraxol in Subjects w Adv. Malignancies
September 6, 2021 updated by: Athenex, Inc.
A Dose Regimen-Finding Study to Evaluate the Safety, Tolerability, Maximum Tolerated Dose, Pharmacokinetics, and Activity of Oraxol in Subjects With Advanced Malignancies
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
38
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Dana Farber Cancer Institute
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New York
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Buffalo, New York, United States, 14263
- Roswell Park Cancer Institute
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Texas
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San Antonio, Texas, United States, 78229
- Cancer Therapy &Research Center @ UTHSCSA
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ORAXOL
Oraxol (paclitaxel + HM30181AK-US) Oraxol paclitaxel - supplied as 30-mg capsules Oraxol HM30181 methanesulfonate monohydrate - supplied as 15-mg HM30181AK-US tablets |
Oraxol will be supplied as paclitaxel capsules and HM30181AK-US tablets.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum tolerated dose (MTD) of Oraxol
Time Frame: 20 weeks
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The highest dose at which no more than 1 of 6 subjects experience a dose-limiting toxicity (DLT) during treatment
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20 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate tumor response
Time Frame: At baseline and every 8 weeks through study completion, approximately 24 months
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RECIST v1.1 criteria defined as complete response, partial response, stable disease or progressive disease
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At baseline and every 8 weeks through study completion, approximately 24 months
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Number of Participants with abnormal laboratory values and/or adverse events that are related to treatment
Time Frame: 4 weeks
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Number of Participants with abnormal laboratory values and/or adverse events that are related to treatment
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4 weeks
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The amount of Oraxol in the blood stream
Time Frame: 3 weeks
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The measurement of Oraxol levels in the blood stream over time
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3 weeks
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The recommended Phase 2 dose of paclitaxel as Oraxol
Time Frame: 24 months
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The totality of information from the number of participants that reach the MTD (outcome #1), the number of participants that experience abnormal laboratory values and/or adverse events that are related to treatment (outcome #3), and the amount of Oraxol in the blood stream in participants (outcome #4)
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: E D Kramer, MD, Kinex Pharmaceuticals Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2016
Primary Completion (Actual)
March 1, 2021
Study Completion (Actual)
May 1, 2021
Study Registration Dates
First Submitted
March 3, 2016
First Submitted That Met QC Criteria
April 5, 2016
First Posted (Estimate)
April 6, 2016
Study Record Updates
Last Update Posted (Actual)
September 13, 2021
Last Update Submitted That Met QC Criteria
September 6, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KX-ORAX-004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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