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Evaluate Oral Topotecan With HM30181A Monotherapy in Patients With Advanced Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03987685
Recruitment Status : Recruiting
First Posted : June 17, 2019
Last Update Posted : June 17, 2019
Information provided by (Responsible Party):
Athenex, Inc.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
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 : July 19, 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

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 Name: oral topotecan + oral HM30181A

Primary Outcome Measures :
  1. Determination of Maximum Tolerated Dose (MTD) [ Time Frame: Day 1 through 21 ]
    dose limiting toxicities occuring in the first cycle of therapy

Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: Weekly, from randomization throughout the study for approximately 24 months ]
    Safety assessment using Adverse Events of Oratopo

  2. Pharmacokinetics of Oratopo [ Time Frame: At the end of Cycle 1 (each cycle is 21 days) ]
    Plasma concentrations of Oratopo

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03987685

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Contact: David Cutler, MD 908-340-6996
Contact: Ildiko Bezi 908-340-6996

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United States, Arizona
HonorHealth Research Institute Recruiting
Phoenix, Arizona, United States, 85258
Contact: Jane Wittner, RN    833-354-6667      
Principal Investigator: Frank Tsai, MD         
Sub-Investigator: Michael Gordon, MD         
Sponsors and Collaborators
Athenex, Inc.
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Study Director: David Cutler, MD Athenex, Inc.

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Responsible Party: Athenex, Inc. Identifier: NCT03987685     History of Changes
Other Study ID Numbers: KX-ORATOP-001
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents