Evaluate Oral Topotecan With HM30181A Monotherapy in Patients With Advanced Malignancies

• Sponsor: Athenex, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03987685
• Collaborator: (none)
• Enrollment: 10
• Locations: 3
• Arm: 1
• Actual Duration (Months): 29.7
• Patients Per Site: 3.3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Solid Tumor	Drug: Oratopo	Phase 1

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jul 19, 2018
• Actual Primary Completion Date: Jan 9, 2021
• Actual Study Completion Date: Jan 9, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Oratopo To determine the Maximum Tolerated Dose (MTD) of oral topotecan with HM30181A administered once daily for 5 consecutive days every 21 days.	Drug: Oratopo; Oral topotecan will be supplied in topotecan capsules and oral HM30181A-US tablets; Other Names: oral topotecan + oral HM30181A

Outcome Measures

Primary Outcome Measures

1. Determination of Maximum Tolerated Dose (MTD) [Day 1 through 21]

   dose limiting toxicities occuring in the first cycle of therapy

Secondary Outcome Measures

1. Safety assessment using Adverse Events of Oratopo [Weekly, from randomization throughout the study for approximately 24 months]

   Safety assessment using Adverse Events of Oratopo

2. Pharmacokinetics of Oratopo [At the end of Cycle 1 (each cycle is 21 days)]

   Plasma concentrations of Oratopo

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	HonorHealth Research Institute	Phoenix	Arizona	United States	85258
2	Cancer Research UK Clinical Trials Unit- The Beatson West of Scotland Cancer Centre	Glasgow		United Kingdom	G12 0YN
3	Sir Bobby Robson Cancer Trials Research Centre, Freeman Hospital	Newcastle		United Kingdom	NE7 7DN

Sponsors and Collaborators

• Athenex, Inc.

Investigators

• Study Director: David Cutler, MD, Athenex, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Athenex, Inc.
• ClinicalTrials.gov Identifier: NCT03987685
• Other Study ID Numbers: KX-ORATOP-001
• First Posted: Jun 17, 2019
• Last Update Posted: Feb 16, 2022
• Last Verified: May 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Neoplasms; Topotecan

Study Results

No Results Posted as of Feb 16, 2022