A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Activity of Oraxol in Subjects With Advanced Malignancies
This trial is active, not recruiting.
|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|
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|
|Aurora, CO||University of Colorado Cancer Center||no longer recruiting|
|Aurora, CO||University of Colorado Cancer Center - Anschutz Cancer Pavilion||no longer recruiting|
|Baltimore, MD||Johns Hopkins University||no longer recruiting|
|Baltimore, MD||Johns Hopkins University / Sidney Kimmel Cancer Center||no longer recruiting|
|Buffalo, NY||Roswell Park Cancer Institute||no longer recruiting|
|Intervention model||single group assignment|
To determine the maximum tolerated dose (MTD) of Oraxol in subjects with advanced malignancies
time frame: one year
To determine the recommended Phase 2 dose (RP2D) of Oraxol
time frame: one year six months
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.
|Official title||A Dose-regimen Finding Study to Evaluate Safety, Tolerability, Pharmacokinetics and Activity of Oraxol in Subjects With Advanced Malignancies|
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