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Report for Clinical Trial NCT02857270
Developed by Shray Alag, 2020-2021.
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 orally
Type: Drug
Group Labels: 8 Japan Part 1 Japan Part 2 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: 1 LY3214996 + Nab-Paclitaxel + Gemcitabine
Name: Gemcitabine
Description: Administered IV
Type: Drug
Group Labels: 1 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 Cetuximab 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 ---