Solid TumorPhase 1NCT03987685
Evaluate Oral Topotecan With HM30181A Monotherapy in Patients With Advanced Malignancies
A Phase 1 study testing Oratopo in people with Solid Tumor, run by Athenex, Inc. at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- Oratopo
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 19 Jul 2018to 9 Jan 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United Kingdom2 sites
Cancer Research UK Clinical Trials Unit- The Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN
Sir Bobby Robson Cancer Trials Research Centre, Freeman Hospital
Newcastle, NE7 7DN
United States1 site
HonorHealth Research Institute
Phoenix, Arizona, 85258
About this study
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
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.
Read the 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.
- Conditions
- Solid Tumor
- Being tested
- Oratopo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OratopoDrug
Also called oral topotecan + oral HM30181A
Oral topotecan will be supplied in topotecan capsules and oral HM30181A-US tablets
| Study group | Role | What they receive |
|---|---|---|
| Oratopo | Experimental | To determine the Maximum Tolerated Dose (MTD) of oral topotecan with HM30181A administered once daily for 5 consecutive days every 21 days. Receives: Drug: Oratopo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of Maximum Tolerated Dose (MTD)
dose limiting toxicities occuring in the first cycle of therapy
Measured: Day 1 through 21
Secondary outcomes (2)
Safety assessment using Adverse Events of Oratopo
Safety assessment using Adverse Events of Oratopo
Measured: Weekly, from randomization throughout the study for approximately 24 months
Pharmacokinetics of Oratopo
Plasma concentrations of Oratopo
Measured: At the end of Cycle 1 (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2019
- Study start19 Jul 2018
- Primary completion9 Jan 2021
- Study completion9 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Athenex, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Cutler, MD, Study director, Athenex, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03987685
- Sponsor's protocol ID
- KX-ORATOP-001
- Status last verified
- May 2019
- First submitted
- 8 Jan 2019
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03987685
- Acronym / sponsor ID
- KX-ORATOP-001
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Athenex, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Jul 2018 (actual)
- Primary completion
- 9 Jan 2021 (actual)
- Study completion
- 9 Jan 2021 (actual)
- First posted
- 17 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oratopo | Experimental | Drug: OratopoTo determine the Maximum Tolerated Dose (MTD) of oral topotecan with HM30181A administered once daily for 5 consecutive days every 21 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OratopoAlso: oral topotecan + oral HM30181AOral topotecan will be supplied in topotecan capsules and oral HM30181A-US tablets | Drug | Oratopo |
Primary outcome
Determination of Maximum Tolerated Dose (MTD)
Time frame: Day 1 through 21
dose limiting toxicities occuring in the first cycle of therapy
2 secondary outcomes
Safety assessment using Adverse Events of Oratopo
Time frame: Weekly, from randomization throughout the study for approximately 24 months
Pharmacokinetics of Oratopo
Time frame: At the end of Cycle 1 (each cycle is 21 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Cutler, MD study director
Athenex, Inc.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oratopo in people with Solid Tumor, run by Athenex, Inc. at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of Maximum Tolerated Dose (MTD) (time frame: Day 1 through 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2022.