Evaluate Oral Topotecan With HM30181A Monotherapy in Patients With Advanced Malignancies
NCT ID: NCT03987685
Last Updated: 2022-02-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
10 participants
INTERVENTIONAL
2018-07-19
2021-01-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Oratopo
To determine the Maximum Tolerated Dose (MTD) of oral topotecan with HM30181A administered once daily for 5 consecutive days every 21 days.
Oratopo
Oral topotecan will be supplied in topotecan capsules and oral HM30181A-US tablets
Interventions
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Oratopo
Oral topotecan will be supplied in topotecan capsules and oral HM30181A-US tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Athenex, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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David Cutler, MD
Role: STUDY_DIRECTOR
Athenex, Inc.
Locations
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HonorHealth Research Institute
Phoenix, Arizona, United States
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 Kingdom
Countries
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Other Identifiers
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KX-ORATOP-001
Identifier Type: -
Identifier Source: org_study_id
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