Clinical Trials /

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

NCT02730481

Description:

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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: KX-ORAX-004
  • NCT ID: NCT02730481

Conditions

  • Solid Tumor

Interventions

DrugSynonymsArms
OraxolPaclitaxel and HM30181AK-USORAXOL

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
ORAXOLExperimentalOraxol (paclitaxel + HM30181AK-US) Oraxol paclitaxel - supplied as 30-mg capsules Oraxol HM30181 methansulfonate monohydrate - supplied as 15-mg HM30181AK-US tablets
  • Oraxol

Eligibility Criteria

        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 ≥10 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 14 days or 5 half-lives of the first study dosing day, whichever
             is longer

          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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Maximum tolerated dose (MTD) of Oraxol
Time Frame:20 weeks
Safety Issue:
Description:The highest dose at which no more than 1 of 6 subjects experience a dose-limiting toxicity (DLT) during treatment

Secondary Outcome Measures

Measure:Evaluate tumor response
Time Frame:At baseline and every 8 weeks through study completion, approximately 24 months
Safety Issue:
Description:RECIST v1.1 criteria defined as complete response, partial response, stable disease or progressive disease
Measure:Number of Participants with abnormal laboratory values and/or adverse events that are related to treatment
Time Frame:4 weeks
Safety Issue:
Description:Number of Participants with abnormal laboratory values and/or adverse events that are related to treatment
Measure:The amount of Oraxol in the blood stream
Time Frame:3 weeks
Safety Issue:
Description:The measurement of Oraxol levels in the blood stream over time
Measure:The recommended Phase 2 dose of paclitaxel as Oraxol
Time Frame:24 months
Safety Issue:
Description: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)

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Kinex Pharmaceuticals Inc

Last Updated

November 14, 2016