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A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Activity of Oraxol in Subjects With Advanced Malignancies

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ClinicalTrials.gov Identifier: NCT01967043
Recruitment Status : Completed
First Posted : October 22, 2013
Last Update Posted : December 16, 2016
Sponsor:
Collaborator:
Atlantic Research Group
Information provided by (Responsible Party):
Athenex, Inc. ( Kinex Pharmaceuticals Inc )

September 18, 2013
October 22, 2013
December 16, 2016
October 2013
February 2016   (Final data collection date for primary outcome measure)
To determine the maximum tolerated dose (MTD) of Oraxol in subjects with advanced malignancies [ Time Frame: one year ]
Same as current
Complete list of historical versions of study NCT01967043 on ClinicalTrials.gov Archive Site
To determine the recommended Phase 2 dose (RP2D) of Oraxol [ Time Frame: one year six months ]
Same as current
Not Provided
Not Provided
 
A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Activity of Oraxol in Subjects With Advanced Malignancies
A Dose-regimen Finding Study to Evaluate Safety, Tolerability, Pharmacokinetics and Activity of Oraxol in Subjects With Advanced Malignancies
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Solid Tumor
Drug: Oraxol
Oraxol (Paclitaxel + HM30181AK). Paclitaxel will be supplied as 30 mg capsules and HM30181AK-US will be supplied as 15 mg tablets.
  • Experimental: Oraxol Arm 1

    HM30181AK-US tablet administered as a single oral dose of xmg on Days x, y, and z of each cycle

    Paclitaxel administered as a fixed oral daily dose of xmg (nine xmg capsules) starting on Days x, y, and z of each cycle. Depending on the cohort, subjects will receive 2, 3, 4, or 5 consecutive days of paclitaxel per week.

    Intervention: Drug: Oraxol
  • Experimental: Oraxol Arm 2

    HM30181AK-US tablet administered as a single oral dose of xmg daily with each dose of Paclitaxel

    Paclitaxel administered as a fixed oral daily dose of xmg (nine xmg capsules) starting on Days x, y, and z of each cycle. Depending on the cohort, subjects will receive 2, 3, 4, or 5 consecutive days of paclitaxel per week.

    Intervention: Drug: Oraxol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
Same as current
September 2016
February 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01967043
ORAX-01-13-US
Yes
Not Provided
Plan to Share IPD: No
Athenex, Inc. ( Kinex Pharmaceuticals Inc )
Kinex Pharmaceuticals Inc
Atlantic Research Group
Study Director: Min-Fun Rudolf Kwan, MD Kinex Pharmaceuticals Inc
Athenex, Inc.
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP