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

Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01967043
• Other study ID #: ORAX-01-13-US
• Status: Completed
• Phase: Phase 1
• First received: September 18, 2013
• Last updated: December 15, 2016
• Start date: October 2013
• Est. completion date: September 2016

Study information

• Verified date: December 2016
• Source: Kinex Pharmaceuticals Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: September 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 10?/L

• Platelet count = 100 x 10?/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.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Solid Tumor

Intervention

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

Locations

Country	Name	City	State
United States	University of Colorado Cancer Center	Aurora	Colorado
United States	Johns Hopkins University	Baltimore	Maryland
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
Kinex Pharmaceuticals Inc	Atlantic Research Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the maximum tolerated dose (MTD) of Oraxol in subjects with advanced malignancies		one year	Yes
Secondary	To determine the recommended Phase 2 dose (RP2D) of Oraxol		one year six months	No