Trial record 1 of 1 for:    NCT01967043
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A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Activity of Oraxol in Subjects With Advanced Malignancies

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Kinex Pharmaceuticals Inc
Sponsor:
Collaborator:
Atlantic Research Group
Information provided by (Responsible Party):
Kinex Pharmaceuticals Inc
ClinicalTrials.gov Identifier:
NCT01967043
First received: September 18, 2013
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Solid Tumor
Drug: Oraxol
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Dose-regimen Finding Study to Evaluate Safety, Tolerability, Pharmacokinetics and Activity of Oraxol in Subjects With Advanced Malignancies

Resource links provided by NLM:


Further study details as provided by Kinex Pharmaceuticals Inc:

Primary Outcome Measures:
  • To determine the maximum tolerated dose (MTD) of Oraxol in subjects with advanced malignancies [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine the recommended Phase 2 dose (RP2D) of Oraxol [ Time Frame: one year six months ] [ Designated as safety issue: No ]

Estimated Enrollment: 34
Study Start Date: October 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oraxol Arm 1

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.

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 2

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.

Drug: Oraxol
Oraxol (Paclitaxel + HM30181AK). Paclitaxel will be supplied as 30 mg capsules and HM30181AK-US will be supplied as 15 mg tablets.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01967043

Contacts
Contact: John Goldfinch, MBA, CRM 7168988629 jgoldfinch@kinexpharma.com

Locations
United States, Colorado
University of Colorado Cancer Center Recruiting
Aurora, Colorado, United States, 800045
Principal Investigator: Antonio Jimeno, MD, PhD         
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21205
Principal Investigator: Nilofer Azad, MD         
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Principal Investigator: Wen Wee Ma, MBBS         
Sponsors and Collaborators
Kinex Pharmaceuticals Inc
Atlantic Research Group
Investigators
Study Director: Min-Fun Rudolf Kwan, MD Kinex Pharmaceuticals Inc
  More Information

No publications provided

Responsible Party: Kinex Pharmaceuticals Inc
ClinicalTrials.gov Identifier: NCT01967043     History of Changes
Other Study ID Numbers: ORAX-01-13-US
Study First Received: September 18, 2013
Last Updated: February 18, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 19, 2014