Solid Tumor
Conditions
Brief summary
This is a standard 3+3 Phase 1b study to determine the MTD of Oraxol (paclitaxel + HM30181 Methanesulfonate monohydrate) in subjects with advanced malignancies that may be metastatic or unresectable with measurable malignant lesion(s) per RECIST Version 1.1 criteria.
Interventions
DRUGOraxol
Oraxol (Paclitaxel + HM30181AK). Paclitaxel will be supplied as 30 mg capsules and HM30181AK-US will be supplied as 15 mg tablets.
Sponsors
Atlantic Research Group
Kinex Pharmaceuticals Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 Version 1.1 criteria. 5. Adequate bone marrow reserve as demonstrated by * Absolute neutrophil count (ANC) ≥1.5 x 10⁹/L * Platelet count ≥ 100 x 10⁹/L * Hemoglobin (Hgb) ≥ 9 g/L 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 (ALT)≤ 3 x upper limit of normal (ULN) or ≤ 5x ULN if liver metastasis is present * ALP ≤ 3 x ULN or ≤ 5 x ULN if bone metastasis is present 7. Adequate renal function as demonstrated by serum creatinine ≤ 1.5 x ULN, or 24-hr urine creatinine clearance calculation \>60 mL/min 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 9. Life expectancy of at least 3 months 10. Subjects who are not currently taking prohibited medication 11. Women must be postmenopausal (\> 12 months without menses) or surgically sterile (ie, by hysterectomy and/or bilateral oophorectomy) or must be using effective contraception
Exclusion criteria
1. Have not recovered to ≤ Grade 1 toxicity from previous anticancer treatments or previous investigational agents 2. Received investigational agents within 14 days or 5 half-lives of the first study dosing day, whichever is longer. 3. Women of childbearing potential who are pregnant or breast feeding. 4. 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 psychiatric illness/social situations that would limit compliance with study requirements 5. Significant or uncontrolled cardiovascular disease or bleeding disorder 6. 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 7. Subjects with a known history of allergy to paclitaxel. Subjects whose allergy was due to the IV solvent (such as Cremophor®) and not paclitaxel will be eligible for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the maximum tolerated dose (MTD) of Oraxol in subjects with advanced malignancies | one year |
Secondary
| Measure | Time frame |
|---|---|
| To determine the recommended Phase 2 dose (RP2D) of Oraxol | one year six months |
Countries
United States
Outcome results
None listed