SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT02342353

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

A Phase I/II Study of Pacritinib in Patients With EGFR Mutant NSCLC After EGFR TKI

The goal of the study is to find the best dose of pacritinib when given in combination with erlotinib.

NCT02342353 Non-Small Cell Lung Cancer Nonsmall Cell Lung Cancer Carcinoma, Non-Small-Cell Lung
MeSH: Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO: Neoplasm of the lung Non-small cell lung carcinoma

2 Interventions

Name: Pacritinib

Type: Drug

Phase I (pacritinib and erlotinib) Phase II (pacritinib and erlotinib)

Name: Erlotinib

Type: Drug

Phase I (pacritinib and erlotinib) Phase II (pacritinib and erlotinib)


Primary Outcomes

Description: The maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity during the first cycle. Dose escalations will proceed until the MTD has been reached. A patient is evaluable for DLT assessment only during Cycle 1 of treatment. If the patient is not able to be treated on Day 1 of Cycle 2, then s/he is still considered in Cycle 1 active treatment and can experience a DLT. Once the patient has been treated in Cycle 2, s/he will no longer be evaluated for DLTs in all subsequent cycles.

Measure: Dose-limiting toxicities and maximum tolerated dose (MTD) - Phase I only

Time: Completion of cycle 1 of all Phase I patients (estimated to be 1 year)

Description: Partial response + complete response per RECIST 1.1 criteria Study terminated prior to enrolling any phase II participants Complete response (CR) = disappearance of all target lesions, non-target lesions, and normalization of tumor marker level Partial response (PR) = at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline of sum diameters

Measure: Response rate - Phase II only

Time: Up to 5 years

Secondary Outcomes

Description: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.

Measure: Adverse events (toxicities)

Time: 30 days post completion of treatment (estimated to be 9 months)

Description: Percentage of patients who achieve complete response, partial response, or stable disease per RECIST 1.1 criteria. Complete response (CR) = disappearance of all target lesions, non-target lesions, and normalization of tumor marker level Partial response (PR) = at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline of sum diameters Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

Measure: Disease control rate (DCR)

Time: Up to 5 years

Description: PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progressive disease (PD) = at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study, appearance of one or more non-target lesion(s) and/or unequivocal progression of existing non-target lesions

Measure: Progression-free survival (PFS)

Time: Up to 5 years

Description: Overall survival is defined as the time interval from date of diagnosis to date of death from any cause.

Measure: Overall survival (OS)

Time: Up to 5 years

Purpose: Treatment

Allocation: Non-Randomized

Parallel Assignment


There is one SNP

SNPs


1 T790M

Patients with mutations in T790M are eligible if they have progressed after treatment with a third generation EGFR tyrosine kinase inhibitor (osimertinib), but otherwise patients must have EGFR T790M negative or unknown status. --- T790M ---

Patients with mutations in T790M are eligible if they have progressed after treatment with a third generation EGFR tyrosine kinase inhibitor (osimertinib), but otherwise patients must have EGFR T790M negative or unknown status. --- T790M --- --- T790M ---



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