NeoplasmsPhase 1NCT02405065
Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetics and Anti-tumor Activity of HM95573
A Phase 1 study testing HM95573 in people with Neoplasms, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
Trial summary
The main objective of this study is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose of HM95573. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- HM95573
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Jan 2015to 16 May 2018
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be 20 years of age or older
- Subjects who have provided voluntary consent to participate in the study, and signed the written consent document.
- Estimated life expectancy of at least 12 weeks
- Histologically or cytologically confirmed advanced solid tumor
Who cannot join
- Symptomatic or uncontrolled central nervous system metastases
- Patients who are unable to take tablets orally or have a clinically significant gastrointestinal disorder, which may interfere with administration, metabolism and absorption of the investigational drug.
- Patients who, in the investigator's opinion, are not suitable for the study for any other reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics and Anti-tumor Activity of HM95573 in Solid Tumors
The main objective of this study is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose of HM95573.
Read the detailed description
Besides the main objective, there are 3 other objectives as follows:
- To evaluate the anti-cancer effect of HM95573 in solid tumor patients
- To investigate the pharmacokinetic profile of HM95573 after oral administration.
- To investigate biomarkers related to the safety and efficacy of HM95573.
- Conditions
- Neoplasms
- Being tested
- HM95573
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HM95573Drug
BID or QD, PO X 21 day cycle Number of cycles: until progression or unacceptable toxicity develops
| Study group | Role | What they receive |
|---|---|---|
| HM95573 | Experimental | single arm Receives: Drug: HM95573 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
Measured: Dose limiting Toxicity will be evaluated on Day 28 during Cycle 1
Secondary outcomes (1)
Overall rsponse rate
Measured: 6-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2015 (estimated)
- Study start12 Jan 2015
- Primary completion18 Jan 2017
- Study completion16 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by Hanmi Pharmaceutical Company LimitedThe sponsor's other registered studies.
- 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
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yohan Kim, MD, Study director, Hanmi Pharmaceutical co., ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02405065
- Sponsor's protocol ID
- HM-RAFI-101
- Status last verified
- Aug 2020
- First submitted
- 15 Jan 2015
- Last updated
- 10 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics and Anti-tumor Activity of HM95573 in Solid Tumors
- ClinicalTrials.gov ID
- NCT02405065
- Acronym / sponsor ID
- HM-RAFI-101
- Conditions
- Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 12 Jan 2015 (actual)
- Primary completion
- 18 Jan 2017 (actual)
- Study completion
- 16 May 2018 (actual)
- First posted
- 1 Apr 2015 (estimated)
- 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.
The main objective of this study is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose of HM95573.
Detailed description
Besides the main objective, there are 3 other objectives as follows:
- To evaluate the anti-cancer effect of HM95573 in solid tumor patients
- To investigate the pharmacokinetic profile of HM95573 after oral administration.
- To investigate biomarkers related to the safety and efficacy of HM95573.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HM95573 | Experimental | Drug: HM95573single arm |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients must be 20 years of age or older
- Subjects who have provided voluntary consent to participate in the study, and signed the written consent document.
- Estimated life expectancy of at least 12 weeks
- Histologically or cytologically confirmed advanced solid tumor
Key exclusion criteria (3 listed)
- Symptomatic or uncontrolled central nervous system metastases
- Patients who are unable to take tablets orally or have a clinically significant gastrointestinal disorder, which may interfere with administration, metabolism and absorption of the investigational drug.
- Patients who, in the investigator's opinion, are not suitable for the study for any other reason.
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 |
|---|---|---|
| HM95573BID or QD, PO X 21 day cycle Number of cycles: until progression or unacceptable toxicity develops | Drug | HM95573 |
Primary outcome
Safety and tolerability
Time frame: Dose limiting Toxicity will be evaluated on Day 28 during Cycle 1
1 secondary outcome
Overall rsponse rate
Time frame: 6-12 weeks
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 10 Aug 2020.
- Individual participant dataSharing planned: Undecided
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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.
Yohan Kim, MD study director
Hanmi Pharmaceutical co., ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HM95573 in people with Neoplasms, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
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 4 inclusion and 3 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 10 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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?
Safety and tolerability (time frame: Dose limiting Toxicity will be evaluated on Day 28 during Cycle 1). 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 10 Aug 2020.