SNPMiner Trials: Clinical Trial Report
Report for Clinical Trial NCT02857270
Developed by Shray Alag, 2019.
SNP Clinical Trial Gene
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.
Name: LY3214996
Description: Administered orallyType: 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 orallyType: Drug
LY3214996 + Midazolam
Name: Abemaciclib
Description: Administered orallyType: Drug
LY3214996 + Abemaciclib Japan Part 2
Name: Nab-paclitaxel
Description: Administered IVType: Drug
LY3214996 + Nab-Paclitaxel + Gemcitabine Japan Part 3
Name: Gemcitabine
Description: Administered IVType: Drug
LY3214996 + Nab-Paclitaxel + Gemcitabine Japan Part 3
Name: Encorafenib
Description: Administered orallyType: Drug
LY3214996 + Encorafenib + Cetuximab
Name: Cetuximab
Description: Administered IVType: 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
- Part E: Metastatic BRAF V600E colorectal cancer (dose escalation and dose
expansion). --- V600E ---
HPO Nodes