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

NCT01967043 | Completed Phase 1 DMC

• 1 other identifier: ORAX-01-13-US
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (1)

• To determine the maximum tolerated dose (MTD) of Oraxol in subjects with advanced malignancies

  one year

Secondary Outcomes (1)

• To determine the recommended Phase 2 dose (RP2D) of Oraxol

  one year six months

Study Arms (2)

Oraxol Arm 1

EXPERIMENTAL

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.

Drug: Oraxol

Oraxol Arm 2

EXPERIMENTAL

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.

Drug: Oraxol

Interventions

Oraxol DRUG

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

Oraxol Arm 1; Oraxol Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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.

Sponsors & Collaborators

• Kinex Pharmaceuticals Inc.: lead
• Atlantic Research Group: collaborator

Study Sites (3)

University of Colorado Cancer Center

Aurora, Colorado, 800045, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Study Officials

• Min-Fun Rudolf Kwan, MD

  Kinex Pharmaceuticals Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2013
• First Posted: October 22, 2013
• Study Start: October 1, 2013
• Primary Completion: February 1, 2016
• Study Completion: September 1, 2016
• Last Updated: December 16, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)