NCT03987685

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2018

Typical duration for phase_1

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 19, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2019

Completed
5 months until next milestone

First Posted

Study publicly available on registry

June 17, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 9, 2021

Completed
Last Updated

February 16, 2022

Status Verified

May 1, 2019

Enrollment Period

2.5 years

First QC Date

January 8, 2019

Last Update Submit

February 15, 2022

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (1)

  • Determination of Maximum Tolerated Dose (MTD)

    dose limiting toxicities occuring in the first cycle of therapy

    Day 1 through 21

Secondary Outcomes (2)

  • Safety assessment using Adverse Events of Oratopo

    Weekly, from randomization throughout the study for approximately 24 months

  • Pharmacokinetics of Oratopo

    At the end of Cycle 1 (each cycle is 21 days)

Study Arms (1)

Oratopo

EXPERIMENTAL

To determine the Maximum Tolerated Dose (MTD) of oral topotecan with HM30181A administered once daily for 5 consecutive days every 21 days.

Drug: Oratopo

Interventions

OratopoDRUG

Oral topotecan will be supplied in topotecan capsules and oral HM30181A-US tablets

Also known as: oral topotecan + oral HM30181A
Oratopo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

HonorHealth Research Institute

Phoenix, Arizona, 85258, United States

Location

Cancer Research UK Clinical Trials Unit- The Beatson West of Scotland Cancer Centre

Glasgow, G12 0YN, United Kingdom

Location

Sir Bobby Robson Cancer Trials Research Centre, Freeman Hospital

Newcastle, NE7 7DN, United Kingdom

Location

MeSH Terms

Interventions

Topotecan

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • David Cutler, MD

    Athenex, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2019

First Posted

June 17, 2019

Study Start

July 19, 2018

Primary Completion

January 9, 2021

Study Completion

January 9, 2021

Last Updated

February 16, 2022

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

GB(2)US(1)