Non Small Cell Lung CancerPhase 1/2NCT01588145
Phase I/II Trial to Evaluate Safety, Tolerability and Pharmacokinetic Profile of HM61713 in NSCLC Patients
A Phase 1/2 study testing HM61713 in people with Non Small Cell Lung Cancer, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
Trial summary
The main objective of this study is to evaluate the safety and tolerability of HM61713. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- HM61713
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 273 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2012to Aug 2017
- Phase
- Phase 1/2
- 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 with histologically or cytologically confirmed diagnosis of advanced NSCLC
- Patients with EGFR mutation-positive tumor
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Estimated life expectancy of at least 12 weeks
- Subjects with adequate bone marrow (WBC ≥4,000/mm3, Platelet ≥100,000/mm3, Hemoglobin≥9.0g/dL, ANC≥1,500/mm3), renal (Creatinine≤1.5 mg/dl) and hepatic [aspartate aminotransferase (AST)/ alanine aminotransferase (ALT)/ alkaline phosphatase (ALP)≤3 x ULN, Total bilirubin ≤2.0 mg/dL] function. No significant heart and lung disease.
- ※ For subjects with a liver metastases, AST/ALT/ALP≤ 5 x ULN is allowed; and for subjects with bone marrow metastases, ALP≤ 5 x ULN is allowed
Show all 21Show fewer
- Patients with amylase level ≤ 1.5 x ULN
- Subjects who have provided voluntary consent to participate in the study, and signed the written consent document
- <Dose escalation part>
- Malignancy that has progressed after at least two prior chemotherapy regimens, including EGFR-TKI
- <Expansion part 1>
- Patients with disease progression despite anticancer therapy with EGFR-TKI (e.g., erlotinib, gefitinib, neratinib, afatinib, dacomitinib)
- Patients who have provided voluntary consent for collection of tumor tissue taken and archived after the last anticancer therapy or collection of new tissue specimen and signed the written consent document
- <Expansion part 2> \& <Phase 2>
- Patients with disease progression despite anticancer therapy with EGFR TKI (e.g., erlotinib, gefitinib, neratinib, afatinib, dacomitinib) (Except treatment with EGFR mutation selective inhibitor, the same class of drug as investigational drug in this study)
- T790M mutation-positive confirmed in tissue collected after PD is confirmed during or after the last anticancer therapy
- At least one measurable target lesion allowing repeated measurement according to RECIST ver1.1 as of screening
- <Phase 1 Expansion part 3>
- Patients with disease progression despite anticancer therapy with EGFR TKI (e.g., erlotinib, gefitinib, neratinib, afatinib, dacomitinib) (Except treatment with EGFR mutation selective inhibitor, the same class of drug as investigational drug in this study)
- T790M mutation-negative confirmed in tissue collected after progressive disease (PD) is confirmed during or after the last anticancer therapy
- At least one measurable target lesion allowing repeated measurement according to RECIST ver1.1 as of screening
Who cannot join
- Hematologic malignancies
- Symptomatic or uncontrolled central nervous system metastases
- Interstitial lung disease, including pulmonary fibrosis
- LVEF < 40% or NYHA Class III or IV heart failure
- History of pancreatitis
- History or current evidence, of any psychiatric or congenital disorder, including dementia or epilepsy
Show all 9Show fewer
- Compromised organ function, infection or allergy
- Pregnant or breast-feeding women, or women of child-bearing potential who do not use an appropriate method of contraception (male patients should also use an appropriate method of contraception during the study period)
- Patients who had received other investigational product within 30 days prior to screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I/II Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of HM61713 in NSCLC Patients With EGFR Mutation
The main objective of this study is to evaluate the safety and tolerability of HM61713.
Read the detailed description
Besides the main objective, there are 3 other objectives as follows:
- To evaluate the anti-cancer effect of HM61713 in NSCLC patients with EGFR mutation
- To investigate the pharmacokinetic profile of HM61713 and its metabolites after oral administration
- To investigate biomarkers related to the safety and efficacy of HM61713
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- HM61713
- Keywords
- NSCLC, HM61713, EGFR-TKI, Phase II, olmutinib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HM61713Drug
Also called Olmutinib
BID or QD, PO X 21 day cycle Number of cycles: until progression or unacceptable toxicity develops
| Study group | Role | What they receive |
|---|---|---|
| HM61713 | Experimental | Not described Receives: Drug: HM61713 |
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 24 during Cycle 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2012 (estimated)
- Study startMar 2012
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 273 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dong-Wan Kim, MD PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01588145
- Sponsor's protocol ID
- HM-EMSI-101
- Status last verified
- Apr 2018
- First submitted
- 26 Apr 2012
- Last updated
- 24 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of HM61713 in NSCLC Patients With EGFR Mutation
- ClinicalTrials.gov ID
- NCT01588145
- Acronym / sponsor ID
- HM-EMSI-101
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- NSCLC, HM61713, EGFR-TKI, Phase II, olmutinib
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 273 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 30 Apr 2012 (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 evaluate the safety and tolerability of HM61713.
Detailed description
Besides the main objective, there are 3 other objectives as follows:
- To evaluate the anti-cancer effect of HM61713 in NSCLC patients with EGFR mutation
- To investigate the pharmacokinetic profile of HM61713 and its metabolites after oral administration
- To investigate biomarkers related to the safety and efficacy of HM61713
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HM61713 | Experimental | Drug: HM61713 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Patients with histologically or cytologically confirmed diagnosis of advanced NSCLC
- Patients with EGFR mutation-positive tumor
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Estimated life expectancy of at least 12 weeks
- Subjects with adequate bone marrow (WBC ≥4,000/mm3, Platelet ≥100,000/mm3, Hemoglobin≥9.0g/dL, ANC≥1,500/mm3), renal (Creatinine≤1.5 mg/dl) and hepatic [aspartate aminotransferase (AST)/ alanine aminotransferase (ALT)/ alkaline phosphatase (ALP)≤3 x ULN, Total bilirubin ≤2.0 mg/dL] function. No significant heart and lung disease.
Key exclusion criteria (9 listed)
- Hematologic malignancies
- Symptomatic or uncontrolled central nervous system metastases
- Interstitial lung disease, including pulmonary fibrosis
- LVEF < 40% or NYHA Class III or IV heart failure
- History of pancreatitis
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 |
|---|---|---|
| HM61713Also: OlmutinibBID or QD, PO X 21 day cycle Number of cycles: until progression or unacceptable toxicity develops | Drug | HM61713 |
Primary outcome
Safety and tolerability
Time frame: Dose limiting Toxicity will be evaluated on Day 24 during Cycle 1
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 24 Apr 2018.
Related trials for Non Small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
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.
Dong-Wan Kim, MD PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HM61713 in people with Non Small Cell Lung Cancer, 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 21 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 24 Apr 2018. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 24 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 24 Apr 2018.