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Report for Clinical Trial NCT01288430

Developed by Shray Alag, 2020.
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 16
POLE MSH2 DKC1 SMARCA4 NLRP1 POLD1 CDKN1B MLH1 RSPO1 FGFR3 BCL10 APC STK11 PTEN APC KIT
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