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

Non Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04510415
• Other study ID #: HM-EMSI-103
• Status: Terminated
• Phase: Phase 1
• Start date: March 29, 2018
• Est. completion date: December 11, 2018

Study information

• Verified date: August 2020
• Source: Hanmi Pharmaceutical Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: December 11, 2018
• Est. primary completion date: December 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Provide written informed consent before any study-specific procedures (including special Screening tests) are performed.

• At least 20 years of age at the time of signing informed consent.

• Cytologically or histologically confirmed adenocarcinoma of locally advanced or metastatic NSCLC which is not amenable to curative surgery or radiotherapy.

• Radiologically confirmed disease progression after at least one line of treatment with an EGFR-TKI with or without at least one line of chemotherapy.

• At least one documented EGFR mutation which is known to be related with susceptibility to EGFR-TKIs (including G719X, exon 19 deletion, L858R, and L861Q).

• World Health Organization (WHO) performance score of 0 to 1 with life expectancy of at least 3 months.

• Centrally confirmed T790M mutation positive tumor status from a tumor sample taken after confirmation of disease progression on the most recent anticancer treatment regimen.

• At least one lesion (excluding the brain), not previously irradiated that can be accurately measured per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

• Females of child-bearing potential (not surgically sterilized and between menarche and one-year post-menopause) must agree to use adequate contraception (one of the following listed below) during the study (both men and women as appropriate) and for 3 months after the last dose of study drug.

• Male patients should be documented to be sterile or agree to use barrier contraception i.e. condoms.

• Recovery to = Grade 1 or baseline of any toxicities due to prior treatments, except for stable sensory neuropathy = Grade 2 and alopecia.

Exclusion Criteria:

• Known history of hypersensitivity to active or inactive excipients of HM61713 or drugs with a similar chemical structure of HM61713

• Previous treatment with anticancer therapies, EGFR-TKI (including erlotinib, gefitinib, and afatinib) within 8 days or 5-fold half-life, whichever is the longer, of the first administration of study drug.

• Any non-study related significant surgical procedures within the past 28 days prior to the first administration of study drug

• Spinal cord compression, leptomeningeal carcinomatosis or active symptomatic brain metastases

• History of any other malignancy

• Clinically significant uncontrolled condition(s)

• Active or chronic pancreatitis

• Anyone with cardiac abnormalities or history

• Presence or history of interstitial lung disease (ILD), drug-induced ILD, or presence of radiation pneumonitis.

• Pregnant or breast feeding.

• In the opinion of the investigator, the patient is an unsuitable candidate to receive HM61713.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non Small Cell Lung Cancer

Intervention

Drug:
• Olmutinib
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.

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center	Gyeonggi-do
Korea, Republic of	The Catholic Univ. of Korea Bucheon St.Mary's Hospital	Gyeonggi-do
Korea, Republic of	The Catholic Univ. of Korea St.Vincent's Hospital	Gyeonggi-do
Korea, Republic of	The Catholic Univ. of Korea Uijeongbu St.Mary's Hospital	Gyeonggi-do
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	The Catholic Univ. of Korea Incheon St.Mary's Hospital	Incheon
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	The Catholic Univ. of Korea Seoul St.Mary's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (ORR)	Defined as a best overall confirmed response of either CR or PR according to the RECIST version 1.1	24 months
Secondary	Disease control rate (DCR)	Defined as the proportion of patients with a documented CR, PR, and SD during the treatment cycles according to the RECIST version 1.1	24 months
Secondary	Duration of overall tumor response (DR)	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	24 months
Secondary	Progression-free survival (PFS)	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	24 months
Secondary	Time to progression (TTP)	Defined as the time from first administration of study drug to determination of tumor progression by RECIST version 1.1	24 months