SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT01312337

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

A Phase II Trial of Gefitinib Monotherapy in Pretreated Patients With Advanced Non-small Cell Lung Cancer Not Harboring Active EGFR Mutations

The investigators will examine efficacy and toxicity of gefitinib in Korean patients with EGFR wild tumors diagnosed with direct sequence test.

NCT01312337 Nonsmall Cell Lung Cancer
MeSH: Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO: Neoplasm of the lung Non-small cell lung carcinoma

1 Interventions

Name: salvage iressa

Description: Iressa 250mg per day until progression

Type: Drug

Iressa for EGFR wild group


Primary Outcomes

Measure: To determine disease control rate at 8 weeks will be 35% or higher in the the study group

Time: 6 months after the enrollment of the last patients

Secondary Outcomes

Measure: The number of patients who live longer than 6 months after enrollment

Time: 6 months after the enrollment of the last patients

Purpose: Treatment

Single Group Assignment


There is one SNP

SNPs


1 L858R

Inclusion Criteria: - Pathologically proven NSCLC - Ineligibile for curative treatment (namely, stage IIIb or IV) - History of one to three prior systemic chemotherapy tumors without active EGFR mutations (exon 19 deletion, L858R mutation in exon 21) - At least one lesion that was unidimensionally measurable by computed tomography (by RECIST 1.1) - 18 years old or older - Performance status ECOG 0-2 - Adequate organ function as evidenced by the following: - Absolute neutrophil count > 1.0 x 109/L - Platelets > 75 x 109/L - Total bilirubin ≤ 1.5 UNL - AST and/or ALT < 5 UNL - Creatinine clearance ≥ 45mL/min Exclusion Criteria: - Previous EGFR TKI therapy history - Systemic anticancer therapy within the previous 3 weeks - Other invasive malignancy within the past 2 years except non-melanoma skin cancer, in situ cervix cancer, or papillary thyroid cancer - Other concurrent illness that would preclude study participation (severe heart disease) - Other concurrent physical condition (e.g., infectious disease) that would preclude study participation - Pregnant or nursing Inclusion Criteria: - Pathologically proven NSCLC - Ineligibile for curative treatment (namely, stage IIIb or IV) - History of one to three prior systemic chemotherapy tumors without active EGFR mutations (exon 19 deletion, L858R mutation in exon 21) - At least one lesion that was unidimensionally measurable by computed tomography (by RECIST 1.1) - 18 years old or older - Performance status ECOG 0-2 - Adequate organ function as evidenced by the following: - Absolute neutrophil count > 1.0 x 109/L - Platelets > 75 x 109/L - Total bilirubin ≤ 1.5 UNL - AST and/or ALT < 5 UNL - Creatinine clearance ≥ 45mL/min Exclusion Criteria: - Previous EGFR TKI therapy history - Systemic anticancer therapy within the previous 3 weeks - Other invasive malignancy within the past 2 years except non-melanoma skin cancer, in situ cervix cancer, or papillary thyroid cancer - Other concurrent illness that would preclude study participation (severe heart disease) - Other concurrent physical condition (e.g., infectious disease) that would preclude study participation - Pregnant or nursing Nonsmall Cell Lung Cancer Lung Neoplasms Carcinoma, Non-Small-Cell Lung null --- L858R ---

Inclusion Criteria: - Pathologically proven NSCLC - Ineligibile for curative treatment (namely, stage IIIb or IV) - History of one to three prior systemic chemotherapy tumors without active EGFR mutations (exon 19 deletion, L858R mutation in exon 21) - At least one lesion that was unidimensionally measurable by computed tomography (by RECIST 1.1) - 18 years old or older - Performance status ECOG 0-2 - Adequate organ function as evidenced by the following: - Absolute neutrophil count > 1.0 x 109/L - Platelets > 75 x 109/L - Total bilirubin ≤ 1.5 UNL - AST and/or ALT < 5 UNL - Creatinine clearance ≥ 45mL/min Exclusion Criteria: - Previous EGFR TKI therapy history - Systemic anticancer therapy within the previous 3 weeks - Other invasive malignancy within the past 2 years except non-melanoma skin cancer, in situ cervix cancer, or papillary thyroid cancer - Other concurrent illness that would preclude study participation (severe heart disease) - Other concurrent physical condition (e.g., infectious disease) that would preclude study participation - Pregnant or nursing Inclusion Criteria: - Pathologically proven NSCLC - Ineligibile for curative treatment (namely, stage IIIb or IV) - History of one to three prior systemic chemotherapy tumors without active EGFR mutations (exon 19 deletion, L858R mutation in exon 21) - At least one lesion that was unidimensionally measurable by computed tomography (by RECIST 1.1) - 18 years old or older - Performance status ECOG 0-2 - Adequate organ function as evidenced by the following: - Absolute neutrophil count > 1.0 x 109/L - Platelets > 75 x 109/L - Total bilirubin ≤ 1.5 UNL - AST and/or ALT < 5 UNL - Creatinine clearance ≥ 45mL/min Exclusion Criteria: - Previous EGFR TKI therapy history - Systemic anticancer therapy within the previous 3 weeks - Other invasive malignancy within the past 2 years except non-melanoma skin cancer, in situ cervix cancer, or papillary thyroid cancer - Other concurrent illness that would preclude study participation (severe heart disease) - Other concurrent physical condition (e.g., infectious disease) that would preclude study participation - Pregnant or nursing Nonsmall Cell Lung Cancer Lung Neoplasms Carcinoma, Non-Small-Cell Lung null --- L858R --- --- L858R ---



HPO Nodes


HPO:
Neoplasm of the lung
Genes 43
WT1 KRAS SLC22A18 STK11 IRF1 AKT1 C11ORF95 PRKN PPP2R1B ERBB2 TRPV3 TSC1 POU6F2 TSC2 EWSR1 RELA KEAP1 REST DIS3L2 SFTPA2 GPC3 MBTPS2 LMNA PTEN BRAF BRCA2 EGFR RB1 TRIP13 PDGFRB TERT SFTPC PIK3CA TRIM28 DICER1 MAP3K8 HPGD SLCO2A1 H19 TP53 NOTCH3 BAP1 WRN
Non-small cell lung carcinoma
Genes 2
TP53 BAP1