SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT02857270

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

A Phase 1 Study of an ERK1/2 Inhibitor (LY3214996) Administered Alone or in Combination With Other Agents in Advanced Cancer

The purpose of this study is to determine the safety of an extracellular signal regulated kinase (ERK1/2) inhibitor LY3214996 administered alone or in combination with other agents in participants with advanced cancer.

NCT02857270 Advanced Cancer Metastatic Melanoma Metastatic Non-small Cell Lung Cancer Metastatic Pancreatic Ductal Adenocarcinoma Colorectal Cancer
MeSH: Carcinoma, Non-Small-Cell Lung Colorectal Neoplasms Adenocarcinoma
HPO: Neoplasm of the large intestine Non-small cell lung carcinoma

7 Interventions

Name: LY3214996

Description: Administered orally

Type: Drug

LY3214996 Dose Escalation LY3214996 + Midazolam LY3214996 Monotherapy LY3214996 + Abemaciclib LY3214996 + Nab-Paclitaxel + Gemcitabine LY3214996 + Encorafenib + Cetuximab Japan Part 1 Japan Part 2 Japan Part 3

Name: Midazolam

Description: Administered orally

Type: Drug

LY3214996 + Midazolam

Name: Abemaciclib

Description: Administered orally

Type: Drug

LY3214996 + Abemaciclib Japan Part 2

Name: Nab-paclitaxel

Description: Administered IV

Type: Drug

LY3214996 + Nab-Paclitaxel + Gemcitabine Japan Part 3

Name: Gemcitabine

Description: Administered IV

Type: Drug

LY3214996 + Nab-Paclitaxel + Gemcitabine Japan Part 3

Name: Encorafenib

Description: Administered orally

Type: Drug

LY3214996 + Encorafenib + Cetuximab

Name: Cetuximab

Description: Administered IV

Type: Drug

LY3214996 + Encorafenib + Cetuximab


Primary Outcomes

Measure: Number of Participants with LY3214996 Dose Limiting Toxicities (DLTs)

Time: Cycle 1 (21 Days)

Secondary Outcomes

Measure: Pharmacokinetics (PK): Area Under the Concentration-Time Curve (AUC) of LY3214996 Administered as Monotherapy and when Administered in Combination with Nab-Paclitaxel Plus Gemcitabine, Abemaciclib and Encorafenib Plus Cetuximanb

Time: Cycle 1 Day 1 through Cycle 2 Day 1 (up to 28 Day Cycles)

Measure: PK: AUC of Gemcitabine when Administered with LY3214996

Time: Cycle 1 Day 1 through Cycle 1 Day 15 (28 Day Cycles)

Measure: PK: AUC of Nab-Paclitaxel when Administered with LY3214996

Time: Cycle 1 Day 1 through Cycle 1 Day 15 (28 Day Cycles)

Measure: PK: AUC of Abemaciclib and its Metabolites when Administered with LY3214996

Time: Cycle 1 Day 1 through Cycle 2 Day 1 (up to 22 Day Cycles)

Measure: PK: AUC of Encorafenib when Administered with LY3214996

Time: Cycle 1 Day 1 through Cycle 2 Day 1 (up to 22 Day Cycles)

Measure: PK: AUC of Cetuximab when Administered with LY3214996

Time: Cycle 1 Day 1 through Cycle 2 Day 1 (up to 22 Day Cycles)

Measure: PK: AUC of Midazolam and its 1'-Hydroxymidazolam Metabolite when Administered Alone and in Combination with LY3214996

Time: Cycle 1 Day 1 through Cycle 1 Day 16 (21 Day Cycles)

Measure: Objective Response Rate (ORR): Percentage of Participants With a Complete (CR) or Partial Response (PR)

Time: Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Estimated up to 6 Months)

Measure: Duration of Response (DoR)

Time: Date of Complete Response (CR) or Partial Response (PR) to Date of Objective Disease Progression or Death Due to Any Cause (Estimated up to 12 Months)

Measure: Time to First Response (TTR)

Time: Baseline to Date of CR or PR (Estimated up to 6 Months)

Measure: Progression Free Survival (PFS)

Time: Baseline to Progressive Disease or Death of Any Cause (Estimated up to 12 Months)

Measure: Disease Control Rate (DCR): Percentage of Participants who Exhibit Stable Disease (SD), CR or PR

Time: Baseline through Measured Progressive Disease (Estimated up to 6 Months)

Measure: Overall Survival (OS) (Dose Expansion Arms Only)

Time: Baseline to Date of Death from Any Cause (Estimated up to 2 Years)

Purpose: Treatment

Allocation: Non-Randomized

Parallel Assignment


There is one SNP

SNPs


1 V600E

- Part E: Metastatic BRAF V600E colorectal cancer (dose escalation and dose expansion). --- V600E ---



HPO Nodes


HPO:
Neoplasm of the large intestine
Genes 71
FOXE1 PMS1 CDKN2A KRAS MST1 TGFBR2 STK11 MSH6 TCF4 BMPR1A PMS2 KLLN MLH3 DLC1 NRAS BRCA1 BRCA2 PDGFRA DOCK8 PIK3CA GPR35 POLD1 NTHL1 POLE SRC BUB1 SH3KBP1 BUB1B CHEK2 APC MLH1 PRKAR1A FLCN COL14A1 AKT1 RPS19 RPS20 HABP2 MSH2 FGFR3 MSH3 KEAP1 GREM1 MINPP1 SEMA4A CTNNB1 DCC BUB3 PTEN MDM2 CEP57 ENG AAGAB TRIP13 KIT EPCAM DICER1 RNF43 PALLD EP300 PALB2 SEC23B MUTYH SDHA TP53 SDHB SDHC SDHD AXIN2 SMAD4 FAN1
Non-small cell lung carcinoma
Genes 2
TP53 BAP1