Description:
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.
Title
- Brief Title: Evaluate Oral Topotecan With HM30181A Monotherapy in Patients With Advanced Malignancies
- 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 IDs
- ORG STUDY ID:
KX-ORATOP-001
- NCT ID:
NCT03987685
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Oratopo | oral topotecan + oral HM30181A | Oratopo |
Purpose
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.
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Oratopo | Experimental | To determine the Maximum Tolerated Dose (MTD) of oral topotecan with HM30181A administered once daily for 5 consecutive days every 21 days. | |
Eligibility Criteria
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Determination of Maximum Tolerated Dose (MTD) |
Time Frame: | Day 1 through 21 |
Safety Issue: | |
Description: | dose limiting toxicities occuring in the first cycle of therapy |
Secondary Outcome Measures
Measure: | Safety assessment using Adverse Events of Oratopo |
Time Frame: | Weekly, from randomization throughout the study for approximately 24 months |
Safety Issue: | |
Description: | Safety assessment using Adverse Events of Oratopo |
Measure: | Pharmacokinetics of Oratopo |
Time Frame: | At the end of Cycle 1 (each cycle is 21 days) |
Safety Issue: | |
Description: | Plasma concentrations of Oratopo |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Completed |
Lead Sponsor: | Athenex, Inc. |
Last Updated
July 30, 2021