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

A Phase 1 Dose-Escalation Study of LY2606368 in Combination With Ralimetinib in Patients With Advanced or Metastatic Cancer

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 Overview

• Status: Completed
• Conditions: Colorectal Cancer; Metastatic Cancer; Non-small Cell Lung Cancer; Advanced Cancer
• Intervention / Treatment: Drug: prexasertib; Drug: ralimetinib

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Köln, Germany, 50937
    • 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.
• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Carolinas Medical Center
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Sarah Cannon Research Institute SCRI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Part A: prexasertib + 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.	Drug: prexasertib; Administered IV; Other Names: LY2606368; Drug: ralimetinib; Administered orally; Other Names: LY2228820
EXPERIMENTAL: Part B1: prexasertib + ralimetinib (colorectal cancer); 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.	Drug: prexasertib; Administered IV; Other Names: LY2606368; Drug: ralimetinib; Administered orally; Other Names: LY2228820

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum Tolerated Dose (MTD) of Prexasertib and Ralimetinib	Cycle 1 (28 Days)

Secondary Outcome Measures

Outcome Measure	Time Frame
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)
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)
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)

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Publications and helpful links

Helpful Links

• Click here for more information about this study: A Study of Prexasertib (LY2606368) in Combination With Ralimetinib in Participants With Advanced or Metastatic Cancer

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 10, 2016
• Primary Completion (ACTUAL): May 15, 2017
• Study Completion (ACTUAL): May 15, 2017

Study Registration Dates

• First Submitted: August 5, 2016
• First Submitted That Met QC Criteria: August 5, 2016
• First Posted (ESTIMATE): August 9, 2016

Study Record Updates

• Last Update Posted (ACTUAL): December 14, 2018
• Last Update Submitted That Met QC Criteria: December 12, 2018
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplastic Processes; Neoplasms; Neoplasm Metastasis; Neoplasms, Second Primary
• Other Study ID Numbers: 16379; I4D-MC-JTJL (OTHER: Eli Lilly and Company); 2015-005611-33 (EUDRACT_NUMBER)