SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT01288430

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

A Phase 1, Open-Label, Multiple-Ascending-Dose Study of DS-2248, an Orally Bioavailable Heat Shock Protein 90 Inhibitor, in Subjects With Advanced Solid Tumors

This phase 1 clinical trial is intended to understand the safety and tolerability of a new anticancer drug in subjects with advanced solid tumors. The patients who qualify for the study will receive a once daily dose of the drug taken by mouth and will undergo several tests to measure the drug in the blood and to understand the safety, tolerability and any effect of the drug on the tumor. The antitumor effect of the drug is not known in human.

NCT01288430 Solid Tumors Non-small Cell Lung Carcinoma
MeSH: Carcinoma Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO: Carcinoma Neoplasm of the lung Non-small cell lung carcinoma

1 Interventions

Name: DS-2248

Description: Oral capsules, of various strengths (1, 5 , 20 ,or 50 milligrams), once daily during 21-day cycles, until unacceptable treatment-related toxicity or tumor progression are observed.

Type: Drug

DS-2248


Primary Outcomes

Description: Objective response rate = the sum of complete response [CR] and partial response [PR] rates

Measure: Objective response rate

Time: Baseline to not more than 6 months

Secondary Outcomes

Description: Tumor response will be evaluated every 2 cycles using Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1, if measurable tumors are available. Computed tomography (CT) and/or magnetic resonance imaging (MRI) should be used for tumor assessment unless another modality of disease assessment is necessary for the lesions.

Measure: Progression-free survival

Time: Baseline to not more than 6 months

Description: The various pharmacokinetic parameters will be calculated from plasma concentrations of DS-2248 using non-compartmental analyses.

Measure: Study Part 1 - Determine the plasma pharmacokinetics of DS-2248

Time: Cycle 1 (Days 1, 2, 8, 15); Cycles 2, 3, (Days 1, 8, 15)

Description: The various pharmacokinetic parameters will be calculated from plasma concentrations of DS-2248 using non-compartmental analyses.

Measure: Study Part 2 - Determine the plasma pharmacokinetics of DS-2248

Time: Day 1 for Cycle 3 and subsequent cycles

Description: Disease control rate (DCR) = the sum of complete response rate, partial response rate, and stable disease (SD) rate for a minimum of 12 weeks

Measure: Disease control rate

Time: Baseline to not more than 6 months

Measure: Response duration

Time: Baseline to not more than 6 months

Measure: Duration of stable disease

Time: Baseline to not more than 6 months

Purpose: Treatment

Allocation: Non-Randomized

Single Group Assignment


There are 2 SNPs

SNPs


1 L858R

- Either of the following: A tumor that harbors an EGFR mutation known to be associated with drug sensitivity (i.e., G719X, exon 19 deletion, L858R, L861Q) -OR- Prior objective clinical benefit from EGFR-TKI, as evidenced by complete response (CR), partial response (PR), or stable disease (SD) ≥6 months as defined by RECIST or World Health Organization criteria. --- L858R ---


2 L861Q

- Either of the following: A tumor that harbors an EGFR mutation known to be associated with drug sensitivity (i.e., G719X, exon 19 deletion, L858R, L861Q) -OR- Prior objective clinical benefit from EGFR-TKI, as evidenced by complete response (CR), partial response (PR), or stable disease (SD) ≥6 months as defined by RECIST or World Health Organization criteria. --- L858R --- --- L861Q ---



HPO Nodes


HPO:
Carcinoma
Genes 11
PTEN CDKN1B APC MLH1 MSH2 FGFR3 KIT DKC1 RSPO1 STK11 NLRP1
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