KCT0005540
Terminated
未知
A Phase II, Open-label, Single-arm, Multicenter, Efficacy and Safety of 80 mg Osimertinib in Patients With Leptomeningeal Metastases (LM) Associated With Epidermal Growth Factor Receptor (EGFR) Mutation-positive Non-small Cell Lung Cancer (NSCLC)
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Samsung Medical Center
- Enrollment
- 80
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1 Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- •2 Provision of signed and dated written ICF prior to any mandatory study specific procedures, sampling, and analyses.
- •3 Male and female patients must be at least 18 years of age.
- •4 Patients must have documented (only allowed for EGFRm\+ \[exon 19 deletions or L858R] in pre\-treated patients) and/or confirmed central/local test result showing eligible EGFR mutation status as specified below:
- •\- EGFR TKI pre\-treated patients: EGFRm\+ (exon 19 deletions or L858R), along with valid T790M mutation status
- •5 All patients will be required to have NSCLC associated with at least 1 site of LM as identified by the Investigator that can be assessed by MRI scan and that is suitable for repeat assessments. Measurable INC or EXC disease by RECIST 1\.1 is not required. Concomitant brain metastases and brain metastases previously treated with radiation therapy are allowed. In addition, asymptomatic untreated BM is also allowed.
- •6 EGFR TKI pre\-treated patients must have had at least 1 prior EGFR TKI (eg, gefitinib, erlotinib, icotinib, dacomitinib or afatinib) and may have had other lines of therapy
- •7 If the patients is T790M negative, EXC must be stable following previous EGFR TKI treatment. EXC progression is allowed if patients are T790M positive patients
- •8 ECOG/WHO performance status 0 to 2 with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks.
- •9 Females must be using highly effective contraceptive measures and must have a negative pregnancy test prior to start of dosing if of childbearing potential, or must have evidence of non\-childbearing potential by fulfilling one of the following criteria at screening:
Exclusion Criteria
- •1 EGFR TKI pre\-treated patients whose T790M mutation status cannot be determined.
- •2 EGFR TKI pre\-treated patients with progressing EXC disease who are T790M mutation\-negative. Progressing EXC disease is defined as RECIST 1\.1 PD no more than 3 months prior to enrollment, per Investigator assessment.
- •3 Past medical history of ILD, drug\-induced ILD, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD.
- •4 Significant medical or psychiatric illness that would interfere with compliance and ability to tolerate treatment as outlined in the protocol.
- •5 Any of the following cardiac criteria:
- •\- Mean resting corrected QTc \>470 msec, obtained from ECGs, using the screening clinic ECG machine\-derived QTc value
- •\- Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG (eg, complete left bundle branch block, third degree heart block, and second degree heart block)
- •\- Patients with any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as the following electrolyte abnormalities, heart failure, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first\-degree relatives or any concomitant medication known to prolong the QT interval and cause Torsades de Pointes (TdP):
- •o Hypokalemia (serum potassium \<3\.5 mmol/L)
- •o Hypomagnesemia (serum magnesium \<0\.7 mmol/L)
Outcomes
Primary Outcomes
Not specified
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