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Lung Neoplasms

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Respiratory Tract Diseases

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All Drugs and Chemicals

Amino Acids

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Tyrosine Kinase Inhibitors

Tyrosine

HM61713 800 mg (2 x 400 mg tablets) once daily (QD)

800 mg QD continuously in 21-day cycles until disease progression determined by investigator assessment per RECIST version 1.1, and as long as, in the investigator"s opinion, they are benefiting from study treatment and they do not meet any of treatment discontinuation criteria.

HM61713

Keunchil Park, M.D., Ph.D

Pasi A. Jänne, M.D., Ph.D

The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of HM61713 in patients with T790M-positive non-small cell lung cancer (NSCLC) after treatment with an epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI).

This is a single-arm, open-label, Phase 2 study to assess the anti-tumor efficacy of oral single agent HM61713 administered to patients with T790M-positive NSCLC after treatment with an EGFR-TKI as measured by objective response rate (ORR).

Phase II Trial of HM61713 for the Treatment of ≥2nd Line T790M Mutation Positive Adenocarcinoma of the Lung

A Single Arm, Open-label, Phase 2 Study Evaluating the Efficacy, Safety and PK of HM61713 in Patients With T790M-positive NSCLC After Treatment With an Epidermal Growth Factor Receptor-tyrosine Kinase Inhibitor

To assess the anti-tumor efficacy of HM61713 as measured by objective response rate (ORR).

To assess clinical efficacy of HM61713 regarding disease control rate (DCR).

To assess clinical efficacy of HM61713 regarding Duration of overall tumor response (DR).

To assess clinical efficacy of HM61713 regarding Progression-free survival (PFS).

To assess clinical efficacy of HM61713 regarding Overall survival (OS).

To assess clinical efficacy of HM61713 regarding Time to progression (TTP).

To assess clinical efficacy of HM61713 regarding tumor shrinkage.

To determine the pharmacokinetic (PK) profile of HM61713.

To assess patient reported outcomes (PROs) of health-related quality of life (HRQoL), disease/treatment-related symptoms of lung cancer, and general health status.

To evaluate the effect of HM61713 on the QT interval.

To assess the safety and tolerability of HM61713.

Hanmi Pharmaceutical Company Limited

Dimercaprol

Single arm of Olmutinib, staring dose of 800 mg

Patients to be provided with Olmutinib 800mg (2 x 400 mg tablets) once daily (QD)

Olmutinib

Kye Young Lee

The purpose of this study is to evaluate the efficacy of Olmutinib(Olita®) in patients with T790M-positive non-small cell lung cancer (NSCLC) confirmed using DNA extracted from extracellular vesicles of bronchoalveolar lavage fluid.

This is a single-arm, open-label, Phase 2 study to assess the anti-tumor efficacy of Olmutinib(Olita®) administered to patients with T790M-positive NSCLC confirmed using DNA extracted from extracellular vesicles in bronchoalveolar lavage fluid as measured by objective response rate (ORR).

Olmutinib Trial in T790M (+) NSCLC Patients Detected by Liquid Biopsy Using BALF Extracellular Vesicular DNA

Phase II, Multicenter, Single-arm, Open-label Study to Evaluate the Efficacy of Olmutinib(Olita®) in Patients With NSCLC Who Harboring T790M Mutation Confirmed Using DNA Extracted From Extracellular Vesicles in Bronchoalveolar Lavage Fluid

defined as the proportion of patients who achieved complete remission(CR) or partial remission(PR) based on RECIST version 1.1

defined as the proportion of patients with a documented CR, PR, and SD during the treatment cycles according to the RECIST version 1.1

defined as the time from first administration of study drug to determination of tumor progression by RECIST version 1.1 or death due to any cause, whichever occurs first

Konkuk University Medical Center

Professor

BID or QD, PO X 21 day cycle Number of cycles: until progression or unacceptable toxicity develops

Dong-Wan Kim, MD PhD

The main objective of this study is to evaluate the safety and tolerability of HM61713.

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

Phase I/II Trial to Evaluate Safety, Tolerability and Pharmacokinetic Profile of HM61713 in NSCLC Patients

Phase I/II Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of HM61713 in NSCLC Patients With EGFR Mutation

HM61713 600 mg (1 x 400 mg + 1 x 200 mg tablets) once daily (QD)

600 mg QD continuously in 21-day cycles until disease progression determined by investigator assessment per RECIST version 1.1, and as long as, in the investigator"s opinion, they are benefiting from study treatment and they do not meet any of treatment discontinuation criteria.

Hanmi Pharmaceuticals

The purpose of this study is to evaluate the efficacy and safety of olmutinib 600 mg QD in patients with T790M-positive non-small cell lung cancer (NSCLC) after treatment with an epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI).

This is a single-arm, open-label, Phase 1b study to evaluate the efficacy and safety of oral single agent olmutinib administered to patients with T790M-positive NSCLC after treatment with an EGFR-TKI.

Olmutinib 600 mg QD in Patients With T790M-positive NSCLC After Treatment With an EGFR-TKI

A Single-arm, Open-label, Phase 1b Study Evaluating the Efficacy and Safety of Olmutinib 600 mg QD in Patients With T790M-positive NSCLC After Treatment With an EGFR-TKI

Defined as a best overall confirmed response of either CR or PR according to the RECIST version 1.1

Defined as the proportion of patients with a documented CR, PR, and SD during the treatment cycles according to the RECIST version 1.1

Defined as the interval between the date of the first observation of tumor response (CR or PR) and the date of disease progression or death

Defined as the time from first administration of study drug to determination of tumor progression by RECIST version 1.1 or death due to any cause, whichever occurs first

Defined as the time from first administration of study drug to determination of tumor progression by RECIST version 1.1

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase II Trial of HM61713 for the Treatment of ≥2nd Line T790M Mutation Positive Adenocarcinoma of the Lung	NCT02485652	Non Small Cell ...	HM61713	20 Years -	Hanmi Pharmaceutical Company Limited
Olmutinib Trial in T790M (+) NSCLC Patients Detected by Liquid Biopsy Using BALF Extracellular Vesicular DNA	NCT03228277	Non Small Cell ...	Olmutinib	19 Years -	Konkuk University Medical Center
Phase I/II Trial to Evaluate Safety, Tolerability and Pharmacokinetic Profile of HM61713 in NSCLC Patients	NCT01588145	Non Small Cell ...	HM61713	20 Years -	Hanmi Pharmaceutical Company Limited
Olmutinib 600 mg QD in Patients With T790M-positive NSCLC After Treatment With an EGFR-TKI	NCT04510415	Non Small Cell ...	Olmutinib	20 Years -	Hanmi Pharmaceutical Company Limited

Spots Global Cancer Trial Database for olmutinib

Every month we try and update this database with for olmutinib cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for olmutinib

Every month we try and update this database with for olmutinib cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for olmutinib cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.