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

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ClinicalTrials.gov Identifier: NCT02730481
Recruitment Status : Completed
First Posted : April 6, 2016
Last Update Posted : September 13, 2021
Information provided by (Responsible Party):
Athenex, Inc.

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.

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: Oraxol Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Dose Regimen-Finding Study to Evaluate the Safety, Tolerability, Maximum Tolerated Dose, Pharmacokinetics, and Activity of Oraxol in Subjects With Advanced Malignancies
Actual Study Start Date : March 2016
Actual Primary Completion Date : March 2021
Actual Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

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

Drug: Oraxol
Oraxol will be supplied as paclitaxel capsules and HM30181AK-US tablets.
Other Name: Paclitaxel and HM30181AK-US

Primary Outcome Measures :
  1. Maximum tolerated dose (MTD) of Oraxol [ Time Frame: 20 weeks ]
    The highest dose at which no more than 1 of 6 subjects experience a dose-limiting toxicity (DLT) during treatment

Secondary Outcome Measures :
  1. Evaluate tumor response [ Time Frame: At baseline and every 8 weeks through study completion, approximately 24 months ]
    RECIST v1.1 criteria defined as complete response, partial response, stable disease or progressive disease

  2. Number of Participants with abnormal laboratory values and/or adverse events that are related to treatment [ Time Frame: 4 weeks ]
    Number of Participants with abnormal laboratory values and/or adverse events that are related to treatment

  3. The amount of Oraxol in the blood stream [ Time Frame: 3 weeks ]
    The measurement of Oraxol levels in the blood stream over time

  4. The recommended Phase 2 dose of paclitaxel as Oraxol [ Time Frame: 24 months ]
    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)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Signed written informed consent
  2. ≥18 years of age
  3. 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
  4. Measurable disease as per RECIST v1.1 criteria
  5. 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
  6. 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
  7. 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
  8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
  9. Life expectancy of at least 3 months
  10. 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.
  11. 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:

  1. Have not recovered to ≤ Grade 1 toxicity from previous anticancer treatments or previous investigational products (IPs)
  2. Received IPs within 30 days or 5 half lives of the first study dosing day
  3. Are currently receiving other medications or radiation intended for the treatment of their malignancy
  4. Women of childbearing potential who are pregnant or breastfeeding
  5. Currently taking a concomitant medication
  6. Require therapeutic use of anticoagulation medications
  7. 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
  8. 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
  9. History of hypersensitivity to paclitaxel, not attributed to a hypersensitivity type reaction to Cremophor

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02730481

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United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
United States, Texas
Cancer Therapy &Research Center @ UTHSCSA
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Athenex, Inc.
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Study Director: E D Kramer, MD Kinex Pharmaceuticals Inc.
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Responsible Party: Athenex, Inc.
ClinicalTrials.gov Identifier: NCT02730481    
Other Study ID Numbers: KX-ORAX-004
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: September 13, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action