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Report for Clinical Trial NCT02857270

Developed by Shray Alag, 2020.
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:Adenocarcinoma

7 Interventions

Name: LY3214996

Description: Administered orally
Type: Drug
Group Labels: 9

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

Name: Midazolam

Description: Administered orally
Type: Drug
Group Labels: 1

LY3214996 + Midazolam

Name: Abemaciclib

Description: Administered orally
Type: Drug
Group Labels: 2

Japan Part 2 LY3214996 + Abemaciclib

Name: Nab-paclitaxel

Description: Administered IV
Type: Drug
Group Labels: 2

Japan Part 3 LY3214996 + Nab-Paclitaxel + Gemcitabine

Name: Gemcitabine

Description: Administered IV
Type: Drug
Group Labels: 2

Japan Part 3 LY3214996 + Nab-Paclitaxel + Gemcitabine

Name: Encorafenib

Description: Administered orally
Type: Drug
Group Labels: 1

LY3214996 + Encorafenib + Cetuximab

Name: Cetuximab

Description: Administered IV
Type: Drug
Group Labels: 1

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. --- V600E ---



HPO Nodes