SNPMiner Trials by Shray Alag


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Report for Mutation G469A

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

There are 2 clinical trials

Clinical Trials


1 A Multi-center Phase II Study of AUY922 in Patients With Stage IV Non-small Cell Lung Cancer (NSCLC) With Driver Molecular Alterations Other Than Sensitive EGFR Mutation, Who Have Progressed After One Line of Systemic Therapy

This is an open-label, single-arm, multicenter phase II trial in patients with stage IV EGFR T790M, EGFR exon 20 and other uncommon, HER2, or BRAF-mutated; ALK, ROS1, or RET-rearranged NSCLC.

NCT01922583 Non-small Cell Lung Cancer (NSCLC) Drug: AUY922
MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Neoplasm of the lung Non-small cell lung carcinoma

G469A, D594G). --- G469A ---

Primary Outcomes

Description: To define the by RECIST 1.1 of AUY922 in patients with stage IV EGFR T790M, EGFR exon 20 and other uncommon, HER2, or BRAF-mutated; ALK, ROS1, or RET-rearranged NSCLC

Measure: Objective response rate

Time: Patients will be followed up for 2 years(post disease progression)

Secondary Outcomes

Description: Patients will be followed for progression-free survival (PFS) and overall survival (OS) which will be analyzed by using a Kaplan-Meier curve. Patients will be followed up for PFS and OS for 2 years.

Measure: Efficacy, progression-free survival (PFS)

Time: Patients will be followed up for PFS and OS for 2 years.(post disease progression)

Description: Patients will be followed for overall survival (OS)

Measure: overall survival (OS)

Time: Patients will be followed up for OS for 2 years.(post disease progression)

2 A Phase I/II Study of Binimetinib With Encorafenib in Patients With Non-V600 Activating BRAF Mutant Advanced Malignancies

The goal of this trial is to test the safety and efficacy of an innovative combination aimed to more profoundly inhibit ERK signaling in tumors.

NCT03843775 Advanced BRAF Mutant Cancers Drug: Binimetinib Drug: Encorafenib

- Patient's tumor must harbor an activating BRAF mutation (listed in Table 4 or approved by the study Principal Investigator) or a fusion involving the kinase domain of BRAF - Mechanistically validated activating non-V600 BRAF mutants - P367L/S - G464V/E - G469A/V/R - L485W - N486_A489delinsK - N486_P490del - E586K - L597Q/V/S - T599TT/TS - T599I/K - V600_K601delinsE - K601E/N/T - K601_S602delinsNT - BRAF kinase duplication - Fusions involving BRAF kinase domain - Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2 - Adequate bone marrow, organ function and laboratory parameters: - Absolute neutrophil count (ANC) ≥ 1.5 x 109/L - Hemoglobin (Hgb) ≥ 8 g/dL with or without transfusions - Platelets (PLT) ≥ 75 x 109/L without transfusions - AST and/or ALT ≤ 2.5 × upper limit of normal (ULN); patient with liver metastases ≤ 5 ×ULN - Total bilirubin ≤ 1.5 × ULN and < 2 mg/dL (Note: Patients who have a total bilirubin level > 1.5 x ULN will be allowed if their indirect bilirubin level is ≤ 1.5 x ULN) - Serum Creatinine ≤ 1.5 x ULN, or calculated creatinine clearance (determined as per Cockcroft-Gault) ≥ 50 mL/min at screening - Adequate cardiac function: - left ventricular ejection fraction (LVEF) ≥ 50% as determined by a multigated acquisition (MUGA) scan or echocardiogram - QTc interval ≤ 480 ms (preferably the mean from triplicate ECGs) - Able to take oral medications - Patient is deemed by the Investigator to have the initiative and means to be compliant with the protocol (treatment and follow-up) - Female patients are either postmenopausal for at least 1 year, are surgically sterile for at least 6 weeks, or must agree to take appropriate precautions to avoid pregnancy from screening through 30 days after the last dose of study drug/treatmentif of childbearing potential (Note: Permitted contraception methods listed in Section 9.3 should be communicated to the patients and their understanding confirmed. --- P367L --- --- G464V --- --- G469A ---

Primary Outcomes

Description: National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 5,

Measure: dose-limiting toxicities (DLTs)

Time: 1 year

Description: Per RECIST Version 1.1

Measure: objective response rate (Phase II)

Time: 1 year


HPO Nodes