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.
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
Interventions
Drug | Synonyms | Arms |
---|
Oraxol | Paclitaxel and HM30181AK-US | ORAXOL |
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
Name | Type | Description | Interventions |
---|
ORAXOL | Experimental | Oraxol (paclitaxel + HM30181AK-US) Oraxol paclitaxel - supplied as 30-mg capsules
Oraxol HM30181 methanesulfonate monohydrate - supplied as 15-mg HM30181AK-US tablets | |
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 ≥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
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: | Athenex, Inc. |
Last Updated
March 25, 2020