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

NCT ID: NCT01967043

Last Updated: 2016-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2016-09-30

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Oraxol

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Oraxol

Intervention Type: DRUG

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

Interventions

Oraxol

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

Intervention Type: DRUG

Eligibility 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 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Atlantic Research Group

OTHER

Sponsor Role: collaborator

Kinex Pharmaceuticals Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Min-Fun Rudolf Kwan, MD

Role: STUDY_DIRECTOR

Kinex Pharmaceuticals Inc.

Locations

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

Countries

United States

Other Identifiers

ORAX-01-13-US

Identifier Type: -

Identifier Source: org_study_id