A Study of Prexasertib (LY2606368) in Combination With Ralimetinib in Participants With Advanced or Metastatic Cancer

Eli Lilly and Company9 enrolled

Overview

The main purpose of this study is to evaluate the safety of the study drug prexasertib in combination with ralimetinib in participants with advanced or metastatic cancer.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Cancer Metastatic Cancer Colorectal Cancer Non-small Cell Lung Cancer

Interventions

prexasertibDRUG

Administered IV

ralimetinibDRUG

Administered orally

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Advanced or metastatic cancer. * Able to swallow tablets. * For Part B, you will need to have colon cancer or non-small cell lung (NSCLC) cancer with KRAS and/or BRAF mutations. * Discontinued all previous treatments for cancer and recovered from the acute effects from the therapy. Exclusion Criteria: * Active infection (fungal, viral, or bacterial). * Active cancer in your brain or spinal cord. * Acute or chronic leukemia. * Serious heart condition. * Disease that requires immunosuppressant therapy. * Diagnosis of inflammatory bowel disease. * Major small bowel resection that interferes with your body's ability to absorb the oral medicine. * Participated in other clinical trials investigating prexasertib or ralimetinib. * Pregnant or breastfeeding. * Other pre-existing conditions or medical history which your doctor will explain to you.

Locations (3)

Carolinas Medical Center

Charlotte, North Carolina, United States

Sarah Cannon Research Institute SCRI

Nashville, Tennessee, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Cologne, Germany

Outcomes

Primary Outcomes

Maximum Tolerated Dose (MTD) of Prexasertib and Ralimetinib

Time frame: Cycle 1 (28 Days)

Secondary Outcomes

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Prexasertib

Time frame: Cycle 1 Day 1 through Cycle 3 Day 1 (28 Day Cycles)

PK: Area Under the Curve (AUC) of Prexasertib

Time frame: Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)

PK: Cmax of Ralimetinib

Time frame: Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)

PK: AUC of Ralimetinib

Time frame: Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)

Best Overall Response (BOR): Percentage of Participants with Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD), or Not Evaluable (NE)

Time frame: Baseline to Earliest Objective Progression or Start of New Anticancer Therapy (Estimated up to 32 Weeks)

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

Time frame: Baseline through Measured Progressive Disease (Estimated up to 32 Weeks)

Duration of Response (DOR)

Time frame: Date of CR or PR to Date of Objective Progression or Death Due to Any Cause (Estimated up to 32 Weeks)

Progression Free Survival (PFS)

Time frame: Baseline to Objective Progression or Death Due to Any Cause (Estimated Up to 32 Weeks)

Data from ClinicalTrials.gov

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