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

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ClinicalTrials.gov Identifier: NCT02485652
Recruitment Status : Active, not recruiting
First Posted : June 30, 2015
Last Update Posted : March 12, 2018
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Drug: HM61713 Phase 2

Detailed Description:
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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 162 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2015
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HM61713
HM61713 800 mg (2 x 400 mg tablets) once daily (QD)
Drug: HM61713
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.
Other Name: Olmutinib




Primary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months ]
    To assess the anti-tumor efficacy of HM61713 as measured by objective response rate (ORR).


Secondary Outcome Measures :
  1. 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 [ Time Frame: At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months ]
    To assess clinical efficacy of HM61713 regarding disease control rate (DCR).

  2. 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 [ Time Frame: At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months ]
    To assess clinical efficacy of HM61713 regarding Duration of overall tumor response (DR).

  3. 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 [ Time Frame: At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months ]
    To assess clinical efficacy of HM61713 regarding Progression-free survival (PFS).

  4. Overall survival (OS), defined as the time from first administration of study drug until death from any cause [ Time Frame: From first dose to end of study or date of death from any cause whichever came first, assessed up to 48 months ]
    To assess clinical efficacy of HM61713 regarding Overall survival (OS).

  5. Time to progression (TTP), defined as the time from first administration of study drug to determination of tumor progression by RECIST version 1.1 [ Time Frame: At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months ]
    To assess clinical efficacy of HM61713 regarding Time to progression (TTP).

  6. Tumor shrinkage calculated as absolute change and percentage change from baseline in sum of tumor size at each assessment using RECIST tumor response [ Time Frame: At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months ]
    To assess clinical efficacy of HM61713 regarding tumor shrinkage.

  7. Peak concentration (Cmax) of HM61713 [ Time Frame: Pre-dose (-30 to 0 mins) and 1 hour (± 5 mins), 3, 4, 6 hours (± 10 mins) on Day 1 and Day 15 of Cycle 1 and pre-dose (-30 to 0 mins) only on Day 8 of Cycle 1 and Day 1 of Cycle 2 (Day 22) ]
    To determine the pharmacokinetic (PK) profile of HM61713.

  8. Trough plasma concentration (Ctrough) of HM61713 [ Time Frame: Pre-dose (-30 to 0 mins) and 1 hour (± 5 mins), 3, 4, 6 hours (± 10 mins) on Day 1 and Day 15 of Cycle 1 and pre-dose (-30 to 0 mins) only on Day 8 of Cycle 1 and Day 1 of Cycle 2 (Day 22) ]
    To determine the pharmacokinetic (PK) profile of HM61713.

  9. Area under the plasma concentration time curve over the 24-hour dosing interval (AUC) of HM61713 [ Time Frame: Pre-dose (-30 to 0 mins) and 1 hour (± 5 mins), 3, 4, 6 hours (± 10 mins) on Day 1 and Day 15 of Cycle 1 and pre-dose (-30 to 0 mins) only on Day 8 of Cycle 1 and Day 1 of Cycle 2 (Day 22) ]
    To determine the pharmacokinetic (PK) profile of HM61713.

  10. Patient reported outcomes (PROs) [ Time Frame: At baseline and every 6 weeks from time of discontinuation, assessed up to 24 months ]
    To assess patient reported outcomes (PROs) of health-related quality of life (HRQoL), disease/treatment-related symptoms of lung cancer, and general health status.

  11. ECG/QTc (absolute values and change from baseline) [ Time Frame: Adverse events will be collected from baseline until 28 days after the last dose ]
    To evaluate the effect of HM61713 on the QT interval.

  12. Incidence of reported AEs and abnormal laboratory tests (AEs will be assessed using the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 4). [ Time Frame: Adverse events will be collected from baseline until 28 days after the last dose ]
    To assess the safety and tolerability of HM61713.

  13. QTc interval as assessed by digital ECG with central reading. The QT interval will be rate-corrected using 3 methods: QTcF, QTcB and QTcS. [ Time Frame: Adverse events will be collected from baseline until 28 days after the last dose ]
    To assess the safety and tolerability of HM61713.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: at least 20 years of age
  • 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
  • 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 RECIST version 1.1
  • Adequate hematological and biological function
  • Females of child-bearing potential must agree to use adequate contraception 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
  • Recovery to ≤ Grade 1 or baseline of any toxicities, 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, HM61713, or other drugs that target T790M-positive mutant EGFR with sparing of wild-type, investigational agent(s) within 28 days prior to the first administration of study drug, radiotherapy
  • 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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02485652


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Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
Investigators
Principal Investigator: Keunchil Park, M.D., Ph.D Sungkyunkwan University, Samsung Medical Center, Seoul, Republic of Korea
Principal Investigator: Pasi A. Jänne, M.D., Ph.D Dana-Farber Cancer Institute, Boston, MA, USA

Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT02485652     History of Changes
Other Study ID Numbers: HM-EMSI-202
2015-001435-21 ( EudraCT Number )
First Posted: June 30, 2015    Key Record Dates
Last Update Posted: March 12, 2018
Last Verified: March 2018

Keywords provided by Hanmi Pharmaceutical Company Limited:
NSCLC
EGFR-TKI
non small cell lung cancer
HM61713
T790M-positive
lung cancer
Phase II
Olmutinib

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms