Overview

This trial is active, not recruiting.

Condition solid tumor
Treatment oraxol
Phase phase 1
Sponsor Kinex Pharmaceuticals Inc
Collaborator Atlantic Research Group
Start date October 2013
End date February 2016
Trial size 34 participants
Trial identifier NCT01967043, ORAX-01-13-US

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
HM30181AK-US tablet administered as a single oral dose of 15 mg on Days 1, 8, and 15 of each cycle Paclitaxel administered as a fixed oral daily dose of 270 mg (nine 30 mg capsules) starting on Days 1, 8, and 15 of each cycle. Depending on the cohort, subjects will receive 2, 3, 4, or 5 consecutive days of paclitaxel per week.
oraxol
Oraxol (Paclitaxel + HM30181AK). Paclitaxel will be supplied as 30 mg capsules and HM30181AK-US will be supplied as 15 mg tablets.
(Experimental)
HM30181AK-US tablet administered as a single oral dose of 15 mg daily with each dose of Paclitaxel Paclitaxel administered as a fixed oral daily dose of 270 mg (nine 30 mg capsules) starting on Days 1, 8, and 15 of each cycle. Depending on the cohort, subjects will receive 2, 3, 4, or 5 consecutive days of paclitaxel per week.
oraxol
Oraxol (Paclitaxel + HM30181AK). Paclitaxel will be supplied as 30 mg capsules and HM30181AK-US will be supplied as 15 mg tablets.

Primary Outcomes

Measure
To determine the maximum tolerated dose (MTD) of Oraxol in subjects with advanced malignancies
time frame: one year

Secondary Outcomes

Measure
To determine the recommended Phase 2 dose (RP2D) of Oraxol
time frame: one year six months

Eligibility Criteria

Male or female participants at least 18 years old.

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 a medication known to be clinically significant P-gp inhibitors or inducers. Subjects who are taking such medications but who are otherwise eligible may be enrolled if they discontinue the medication 1 week before dosing and remain off that medication during treatment with Oraxol. 11. Subjects who are not currently taking a medication known to be clinically significant inhibitors (gemfibrozil) or inducers (rifampin) of CYP2C8 12. Women must be postmenopausal (> 12 months without menses) or surgically sterile (ie, by hysterectomy and/or bilateral oophorectomy) or must be using effective contraception 13. Subjects who are not currently taking a medication known to be strong inhibitors or inducers of CYP3A4. 14. Subjects who are not currently taking a medication known to be P-gp substrate. 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.

Additional Information

Official title A Dose-regimen Finding Study to Evaluate Safety, Tolerability, Pharmacokinetics and Activity of Oraxol in Subjects With Advanced Malignancies
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Kinex Pharmaceuticals Inc.
Location data was received from the National Cancer Institute and was last updated in March 2016.