Evaluate Oral Topotecan With HM30181A Monotherapy in Patients With Advanced Malignancies

Solid Tumor Clinical Trial

Official title:

A Dose Regimen-Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of Oral Topotecan With HM30181A Monotherapy in Patients With Advanced Malignancies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03987685
• Other study ID #: KX-ORATOP-001
• Status: Completed
• Phase: Phase 1
• Start date: July 19, 2018
• Est. completion date: January 9, 2021

Study information

• Verified date: May 2019
• Source: Athenex, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multicenter, nonrandomized, open-label, safety, tolerability and pharmacokinetic (PK) study to determine the MTD and optimal dosing of Oratopo. No control group has been included.

Description:

This is a multicenter, open-label, safety, tolerability, pharmacokinetic, and activity study. Eligible subjects will be adults with advanced solid tumor malignancies. In the treatment period groups of 3 to 6 subjects will receive a single dose of oral Oratopo will be administered and will be followed for toxicity. Dose escalation will continue until an MTD is reached, or nonlinear increases in exposure are confirmed, or a maximum dose of Oratopo is reached.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 9, 2021
• Est. primary completion date: January 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Signed written informed consent

• Male and female adults =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

• Topotecan monotherapy is a reasonable treatment in the judgement of the Investigator

• Measurable disease as per RECIST v1.1 criteria

• Able to swallow oral medication as an intact dosage form

• Adequate hematologic status as demonstrated by not requiring transfusion support or granulocyte colony-stimulating factor (G-CSF)levels maintained

• Adequate liver function.

• Adequate renal function

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

• Life expectancy of at least 3 months

• Females must be postmenopausal (>12 months without menses) or surgically sterile (ie, by hysterectomy and/or bilateral oophorectomy) or, if sexually active, must be using effective contraception (ie, oral contraceptives, intrauterine device, double barrier method of condom and spermicide) and agree to continue use of contraception for 30 days after their last dose of study drug.

• Sexually active male patients must use a barrier method of contraception during the study and agree to continue the use of male contraception for at least 30 days after the last dose of study drug.

Exclusion Criteria:

• Currently taking a prohibited concomitant medication, other than a premedication, that are Strong inhibitors or strong inducers of cytochrome P450

• Unresolved toxicity from prior chemotherapy

• Planning to receive other medical, surgical, or radiological cancer treatments during the course of this study

• Received investigational agents within 14 days or 5 half-lives prior to the first study dosing day, whichever is longer

• Require therapeutic use of anticoagulants.

• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, clinically significant myocardial infarction unstable angina pectoris, clinically significant cardiac arrhythmia, bleeding disorder, chronic pulmonary disease requiring oxygen, or psychiatric illness/social situations that would limit compliance with study requirements.

• Major surgery to the upper GI tract

• Hypersensitivity to topotecan or allergy to HM30181A or its excipients.

• Any other condition which the Investigator believes would make participation in the study not acceptable

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

Drug:
• Oratopo
Oral topotecan will be supplied in topotecan capsules and oral HM30181A-US tablets

Locations

Country	Name	City	State
United Kingdom	Cancer Research UK Clinical Trials Unit- The Beatson West of Scotland Cancer Centre	Glasgow
United Kingdom	Sir Bobby Robson Cancer Trials Research Centre, Freeman Hospital	Newcastle
United States	HonorHealth Research Institute	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Athenex, Inc.

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of Maximum Tolerated Dose (MTD)	dose limiting toxicities occuring in the first cycle of therapy	Day 1 through 21
Secondary	Safety assessment using Adverse Events of Oratopo	Safety assessment using Adverse Events of Oratopo	Weekly, from randomization throughout the study for approximately 24 months
Secondary	Pharmacokinetics of Oratopo	Plasma concentrations of Oratopo	At the end of Cycle 1 (each cycle is 21 days)