A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Activity of Oraxol in Subjects With Advanced Malignancies
This trial has been completed.
|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||completed|
|Aurora, CO||University of Colorado Cancer Center - Anschutz Cancer Pavilion||no longer recruiting|
|Baltimore, MD||Johns Hopkins University||completed|
|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.
- Signed written informed consent
- ≥ 18 years of age
- 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.
- Measurable disease as per RECIST Version 1.1 criteria.
- 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
- 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
- Adequate renal function as demonstrated by serum creatinine ≤ 1.5 x ULN, or 24-hr urine creatinine clearance calculation >60 mL/min
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Life expectancy of at least 3 months
- Subjects who are not currently taking prohibited medication
- Women must be postmenopausal (> 12 months without menses) or surgically sterile (ie, by hysterectomy and/or bilateral oophorectomy) or must be using effective contraception
- Have not recovered to ≤ Grade 1 toxicity from previous anticancer treatments or previous investigational agents
- Received investigational agents within 14 days or 5 half-lives of the first study dosing day, whichever is longer.
- Women of childbearing potential who are pregnant or breast feeding.
- 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
- Significant or uncontrolled cardiovascular disease or bleeding disorder
- 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
- 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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