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Report for Clinical Trial NCT02454842

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase 2 Study of TH-4000 (Tarloxotinib) in Patients With EGFR-Mutant, T790M-Negative, Advanced Non-Small Cell Lung Cancer Progressing on an EGFR Tyrosine Kinase Inhibitor

This phase 2 study is designed to evaluate the safety and activity of TH-4000 (Tarloxotinib), a hypoxia-activated prodrug, in patients with EGFR-Mutant, T790M-Negative, Advanced non-small cell lung cancer (NSCLC).

NCT02454842 Non-small Cell Lung Cancer NSCLC Non-squamous NSCLC
MeSH: Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO: Neoplasm of the lung Non-small cell lung carcinoma

1 Interventions

Name: TH-4000 (Tarloxotinib)

Description: TH-4000 (Tarloxotinib) is a hypoxia-activated prodrug

Type: Drug

TH-4000 (Tarloxotinib)


Primary Outcomes

Measure: Number of participants with response rate as evaluated by RECIST criteria

Time: Approximately 12 months

Secondary Outcomes

Measure: Incidence of adverse events (AEs)

Time: Up to 30 days after last dose

Measure: Type of adverse events (AEs)

Time: Up to 30 days after last dose

Measure: Severity of adverse events (AEs)

Time: Up to 30 days after last dose

Measure: Duration of response (DOR) calculated for all patients achieving an objective response

Time: Approximately 12 months

Measure: Progression-free survival (PFS)

Time: Approximately 12 months

Measure: Overall Survival (OS)

Time: Approximately 12 months

Description: Time to peak plasma concentration (Tmax), maximum plasma concentration (Cmax), area under concentration-time curve (AUC)

Measure: Time to peak plasma concentration (Tmax)

Time: Cycle 1 Day 1 predose and up to 24 hours post dose

Measure: Maximum plasma concentration (Cmax)

Time: Cycle 1 Day 1 predose and up to 24 hours post dose

Measure: Area under concentration-time curve (AUC)

Time: Cycle 1 Day 1 predose and up to 24 hours post dose

Measure: QTc Interval

Time: Screening, Cycle 1 Day 1, 8, 15 & 22, Day 1 of subsequent cycles

Other Outcomes

Measure: Hypoxic volume as measured by Positron Emission Tomography (PET) hypoxia imaging

Time: Baseline

Purpose: Treatment

Single Group Assignment


There is one SNP

SNPs


1 T790M

A Phase 2 Study of TH-4000 (Tarloxotinib) in Patients With EGFR-Mutant, T790M-Negative, Advanced Non-Small Cell Lung Cancer Progressing on an EGFR Tyrosine Kinase Inhibitor. --- T790M ---

Study for Treatment of Patients With EGFR Mutant, T790M-negative NSCLC This phase 2 study is designed to evaluate the safety and activity of TH-4000 (Tarloxotinib), a hypoxia-activated prodrug, in patients with EGFR-Mutant, T790M-Negative, Advanced non-small cell lung cancer (NSCLC). --- T790M ---

Study for Treatment of Patients With EGFR Mutant, T790M-negative NSCLC This phase 2 study is designed to evaluate the safety and activity of TH-4000 (Tarloxotinib), a hypoxia-activated prodrug, in patients with EGFR-Mutant, T790M-Negative, Advanced non-small cell lung cancer (NSCLC). --- T790M --- --- T790M ---

Key Eligibility Criteria: - Eastern Cooperative Oncology Group (ECOG) performance status 0-1 - Confirmed recurrent Stage IV NSCLC which progressed while on treatment with EGFR TKI - Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) - Documented evidence of an EGFR mutation known to be associated with an EGFR TKI sensitivity - No T790M mutation or small cell transformation including an assessment from tumor biopsy obtained while on or subsequent to the most recent EGFR TKI therapy - Acceptable laboratory results as indicated by protocol - Acceptable cardiac function as indicated by protocol Key Exclusion Criteria: - Receiving medication that prolongs QT interval, with a risk of causing Torsades de Pointes (TdP) unless ECG meets inclusion criteria while on a stable dose of the medication - Family history of long QTc syndrome - Symptomatic central nervous system (CNS) lesions - Radiation therapy within 2 weeks prior to the first dose of study medication - Major surgery within 4 weeks or minor surgery within 2 weeks prior to the first dose of study medication - Concurrent active malignancy requiring systemic treatment - Any other serious uncontrolled medical disorders or psychological conditions that may interfere with study conduct including but not limited to: clinically significant active infection (e.g., tuberculosis, viral hepatitis, human immunodeficiency virus [HIV]), recent (within 6 months) myocardial infarction or unstable angina, congestive heart failure, poorly-controlled hypertension or diabetes, concurrent active malignancy, or psychiatric condition that may interfere with the patient's ability to follow study procedures - Pregnant or breast-feeding Key Eligibility Criteria: - Eastern Cooperative Oncology Group (ECOG) performance status 0-1 - Confirmed recurrent Stage IV NSCLC which progressed while on treatment with EGFR TKI - Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) - Documented evidence of an EGFR mutation known to be associated with an EGFR TKI sensitivity - No T790M mutation or small cell transformation including an assessment from tumor biopsy obtained while on or subsequent to the most recent EGFR TKI therapy - Acceptable laboratory results as indicated by protocol - Acceptable cardiac function as indicated by protocol Key Exclusion Criteria: - Receiving medication that prolongs QT interval, with a risk of causing Torsades de Pointes (TdP) unless ECG meets inclusion criteria while on a stable dose of the medication - Family history of long QTc syndrome - Symptomatic central nervous system (CNS) lesions - Radiation therapy within 2 weeks prior to the first dose of study medication - Major surgery within 4 weeks or minor surgery within 2 weeks prior to the first dose of study medication - Concurrent active malignancy requiring systemic treatment - Any other serious uncontrolled medical disorders or psychological conditions that may interfere with study conduct including but not limited to: clinically significant active infection (e.g., tuberculosis, viral hepatitis, human immunodeficiency virus [HIV]), recent (within 6 months) myocardial infarction or unstable angina, congestive heart failure, poorly-controlled hypertension or diabetes, concurrent active malignancy, or psychiatric condition that may interfere with the patient's ability to follow study procedures - Pregnant or breast-feeding Non-small Cell Lung Cancer NSCLC Non-squamous NSCLC Lung Neoplasms Carcinoma, Non-Small-Cell Lung A single arm open label multi-center Phase 2 study in which the pharmacokinetics, safety, tolerability and efficacy of TH-4000 (Tarloxotinib) will be assessed in patients with EGFR mutant, T790M negative advanced NSCLC. --- T790M ---

Key Eligibility Criteria: - Eastern Cooperative Oncology Group (ECOG) performance status 0-1 - Confirmed recurrent Stage IV NSCLC which progressed while on treatment with EGFR TKI - Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) - Documented evidence of an EGFR mutation known to be associated with an EGFR TKI sensitivity - No T790M mutation or small cell transformation including an assessment from tumor biopsy obtained while on or subsequent to the most recent EGFR TKI therapy - Acceptable laboratory results as indicated by protocol - Acceptable cardiac function as indicated by protocol Key Exclusion Criteria: - Receiving medication that prolongs QT interval, with a risk of causing Torsades de Pointes (TdP) unless ECG meets inclusion criteria while on a stable dose of the medication - Family history of long QTc syndrome - Symptomatic central nervous system (CNS) lesions - Radiation therapy within 2 weeks prior to the first dose of study medication - Major surgery within 4 weeks or minor surgery within 2 weeks prior to the first dose of study medication - Concurrent active malignancy requiring systemic treatment - Any other serious uncontrolled medical disorders or psychological conditions that may interfere with study conduct including but not limited to: clinically significant active infection (e.g., tuberculosis, viral hepatitis, human immunodeficiency virus [HIV]), recent (within 6 months) myocardial infarction or unstable angina, congestive heart failure, poorly-controlled hypertension or diabetes, concurrent active malignancy, or psychiatric condition that may interfere with the patient's ability to follow study procedures - Pregnant or breast-feeding Key Eligibility Criteria: - Eastern Cooperative Oncology Group (ECOG) performance status 0-1 - Confirmed recurrent Stage IV NSCLC which progressed while on treatment with EGFR TKI - Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) - Documented evidence of an EGFR mutation known to be associated with an EGFR TKI sensitivity - No T790M mutation or small cell transformation including an assessment from tumor biopsy obtained while on or subsequent to the most recent EGFR TKI therapy - Acceptable laboratory results as indicated by protocol - Acceptable cardiac function as indicated by protocol Key Exclusion Criteria: - Receiving medication that prolongs QT interval, with a risk of causing Torsades de Pointes (TdP) unless ECG meets inclusion criteria while on a stable dose of the medication - Family history of long QTc syndrome - Symptomatic central nervous system (CNS) lesions - Radiation therapy within 2 weeks prior to the first dose of study medication - Major surgery within 4 weeks or minor surgery within 2 weeks prior to the first dose of study medication - Concurrent active malignancy requiring systemic treatment - Any other serious uncontrolled medical disorders or psychological conditions that may interfere with study conduct including but not limited to: clinically significant active infection (e.g., tuberculosis, viral hepatitis, human immunodeficiency virus [HIV]), recent (within 6 months) myocardial infarction or unstable angina, congestive heart failure, poorly-controlled hypertension or diabetes, concurrent active malignancy, or psychiatric condition that may interfere with the patient's ability to follow study procedures - Pregnant or breast-feeding Non-small Cell Lung Cancer NSCLC Non-squamous NSCLC Lung Neoplasms Carcinoma, Non-Small-Cell Lung A single arm open label multi-center Phase 2 study in which the pharmacokinetics, safety, tolerability and efficacy of TH-4000 (Tarloxotinib) will be assessed in patients with EGFR mutant, T790M negative advanced NSCLC. --- T790M --- --- T790M ---

Key Eligibility Criteria: - Eastern Cooperative Oncology Group (ECOG) performance status 0-1 - Confirmed recurrent Stage IV NSCLC which progressed while on treatment with EGFR TKI - Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) - Documented evidence of an EGFR mutation known to be associated with an EGFR TKI sensitivity - No T790M mutation or small cell transformation including an assessment from tumor biopsy obtained while on or subsequent to the most recent EGFR TKI therapy - Acceptable laboratory results as indicated by protocol - Acceptable cardiac function as indicated by protocol Key Exclusion Criteria: - Receiving medication that prolongs QT interval, with a risk of causing Torsades de Pointes (TdP) unless ECG meets inclusion criteria while on a stable dose of the medication - Family history of long QTc syndrome - Symptomatic central nervous system (CNS) lesions - Radiation therapy within 2 weeks prior to the first dose of study medication - Major surgery within 4 weeks or minor surgery within 2 weeks prior to the first dose of study medication - Concurrent active malignancy requiring systemic treatment - Any other serious uncontrolled medical disorders or psychological conditions that may interfere with study conduct including but not limited to: clinically significant active infection (e.g., tuberculosis, viral hepatitis, human immunodeficiency virus [HIV]), recent (within 6 months) myocardial infarction or unstable angina, congestive heart failure, poorly-controlled hypertension or diabetes, concurrent active malignancy, or psychiatric condition that may interfere with the patient's ability to follow study procedures - Pregnant or breast-feeding Key Eligibility Criteria: - Eastern Cooperative Oncology Group (ECOG) performance status 0-1 - Confirmed recurrent Stage IV NSCLC which progressed while on treatment with EGFR TKI - Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) - Documented evidence of an EGFR mutation known to be associated with an EGFR TKI sensitivity - No T790M mutation or small cell transformation including an assessment from tumor biopsy obtained while on or subsequent to the most recent EGFR TKI therapy - Acceptable laboratory results as indicated by protocol - Acceptable cardiac function as indicated by protocol Key Exclusion Criteria: - Receiving medication that prolongs QT interval, with a risk of causing Torsades de Pointes (TdP) unless ECG meets inclusion criteria while on a stable dose of the medication - Family history of long QTc syndrome - Symptomatic central nervous system (CNS) lesions - Radiation therapy within 2 weeks prior to the first dose of study medication - Major surgery within 4 weeks or minor surgery within 2 weeks prior to the first dose of study medication - Concurrent active malignancy requiring systemic treatment - Any other serious uncontrolled medical disorders or psychological conditions that may interfere with study conduct including but not limited to: clinically significant active infection (e.g., tuberculosis, viral hepatitis, human immunodeficiency virus [HIV]), recent (within 6 months) myocardial infarction or unstable angina, congestive heart failure, poorly-controlled hypertension or diabetes, concurrent active malignancy, or psychiatric condition that may interfere with the patient's ability to follow study procedures - Pregnant or breast-feeding Non-small Cell Lung Cancer NSCLC Non-squamous NSCLC Lung Neoplasms Carcinoma, Non-Small-Cell Lung A single arm open label multi-center Phase 2 study in which the pharmacokinetics, safety, tolerability and efficacy of TH-4000 (Tarloxotinib) will be assessed in patients with EGFR mutant, T790M negative advanced NSCLC. --- T790M --- --- T790M --- --- T790M ---



HPO Nodes


HPO:
Neoplasm of the lung
Genes 61
REST GPC3 WT1 HPGD BRAF PIK3CA TP53 TRIM28 RB1 TRIP13 SLCO2A1 AKT1 CASP8 KRAS TSC1 POU6F2 EWSR1 PRKN LMNA NAB2 TERT TSC2 SLC22A18 BRCA2 PPP2R1B STAT6 STK11 MUC5B ERBB2 TSC2 MBTPS2 BAP1 TSC2 DICER1 PDGFRB PERP EGFR TSC1 DIS3L2 NOTCH3 KEAP1 DICER1 DICER1 WT1 TSC1 C11ORF95 IRF1 CYP2A6 WRN RELA WT1 PTEN SFTPC SFTPA2 ERCC6 TRPV3 TP53 H19 TRIM28 FASLG MAP3K8
Non-small cell lung carcinoma
Genes 3
TP53 TP53 BAP1