A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Activity of Oraxol in Subjects With Advanced Malignancies
Completed · Phase 1
Conditions studied: Solid Tumor
In brief
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.
Key facts
- Study ID
- NCT01967043
- Run by
- Kinex Pharmaceuticals Inc.
- People needed
- 34
- Starts
- 2013-10-01
- Expected to finish
- 2016-09-01
- Last updated by the study team
- 2016-12-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- University of Colorado Cancer Center — Aurora, Colorado, United States
- Johns Hopkins University — Baltimore, Maryland, United States
- Roswell Park Cancer Institute — Buffalo, New York, United States
Full record on ClinicalTrials.gov
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