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

Phase 1

Completed

• Conditions: Advanced Cancer; Metastatic Cancer; Colorectal Cancer; Non-small Cell Lung Cancer
• Interventions: Drug: prexasertib; Drug: ralimetinib

• Registration Number: NCT02860780
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-05
• Study First Submitted QC: 2016-08-05
• Study First Posted: 2016-08-09
• Study Start: 2016-08-10
• Primary Completion: 2017-05-15
• Study Completion: 2017-05-15
• Status Verified: 2017-11
• Last Update Submitted: 2018-12-12
• Last Update Posted: 2018-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part B1: prexasertib + ralimetinib (colorectal cancer)	ralimetinib	60 mg prexasertib (LY2696368) given IV and 200 mg ralimetinib given orally. Participants receive prexasertib IV on Days 1 and 15 and ralimetinib every 12 hours (Q12H) Days 1 and 14 of a 28 day cycle.
Part A: prexasertib + ralimetinib	prexasertib	Cohort 1: 60 milligrams (mg) prexasertib (LY2606368) given intravenously (IV) and 100 mg ralimetinib given orally. Cohort 2: 60 mg prexasertib (LY2606368) given intravenously (IV) and 200 mg ralimetinib given orally.
Part A: prexasertib + ralimetinib	ralimetinib	Cohort 1: 60 milligrams (mg) prexasertib (LY2606368) given intravenously (IV) and 100 mg ralimetinib given orally. Cohort 2: 60 mg prexasertib (LY2606368) given intravenously (IV) and 200 mg ralimetinib given orally.
Part B1: prexasertib + ralimetinib (colorectal cancer)	prexasertib	60 mg prexasertib (LY2696368) given IV and 200 mg ralimetinib given orally. Participants receive prexasertib IV on Days 1 and 15 and ralimetinib every 12 hours (Q12H) Days 1 and 14 of a 28 day cycle.

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose (MTD) of Prexasertib and Ralimetinib	Cycle 1 (28 Days)

Secondary Outcome Measures

Name	Time	Method
PK: Cmax of Ralimetinib	Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
PK: AUC of Ralimetinib	Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Prexasertib	Cycle 1 Day 1 through Cycle 3 Day 1 (28 Day Cycles)
PK: Area Under the Curve (AUC) of Prexasertib	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)	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	Baseline through Measured Progressive Disease (Estimated up to 32 Weeks)
Duration of Response (DOR)	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)	Baseline to Objective Progression or Death Due to Any Cause (Estimated Up to 32 Weeks)

Trial Locations

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.; 🇩🇪 Köln, Germany