Protocol #: 16-456
Status
Recruiting
Description
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.
Condition
Advanced Cancer
Metastatic Melanoma
Metastatic Non-small Cell Lung Cancer
Metastatic Pancreatic Ductal Adenocarcinoma
Colorectal Cancer
Interventions
LY3214996
Midazolam
Abemaciclib
Nab-paclitaxel
Gemcitabine
Encorafenib
Cetuximab
Phase
Phase 1
Study Type
Interventional
Further Study Details
Primary Outcome:
Number of Participants with LY3214996 Dose Limiting Toxicities (DLTs)
Secondary Outcome:
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
PK: AUC of Gemcitabine when Administered with LY3214996
PK: AUC of Nab-Paclitaxel when Administered with LY3214996
PK: AUC of Abemaciclib and its Metabolites when Administered with LY3214996
PK: AUC of Encorafenib when Administered with LY3214996
PK: AUC of Cetuximab when Administered with LY3214996
PK: AUC of Midazolam and its 1'-Hydroxymidazolam Metabolite when Administered Alone and in Combination with LY3214996
Objective Response Rate (ORR): Percentage of Participants With a Complete (CR) or Partial Response (PR)
Duration of Response (DoR)
Time to First Response (TTR)
Progression Free Survival (PFS)
Disease Control Rate (DCR): Percentage of Participants who Exhibit Stable Disease (SD), CR or PR
Overall Survival (OS) (Dose Expansion Arms Only)
Estimated Enrollment
272
Study Start Date
September 29, 2016
Eligibility
Gender: All
Minimum Age: 18 Years
Maximum Age: N/A
Health Volunteers: No
Criteria
Eli Lilly and Company
Information Provided By
Eli Lilly and Company
Official Title
A Phase 1 Study of an ERK1/2 Inhibitor (LY3214996) Administered Alone or in Combination With Other Agents in Advanced Cancer
Clinicaltrials.gov Identifier
NCT02857270

 

 

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.

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