search
Back to results

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

Primary Purpose

Advanced Cancer, Metastatic Cancer, Colorectal Cancer

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
prexasertib
ralimetinib
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Carolinas Medical Center
  • Sarah Cannon Research Institute SCRI
  • 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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Part A: prexasertib + ralimetinib

Part B1: prexasertib + ralimetinib (colorectal cancer)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Maximum Tolerated Dose (MTD) of Prexasertib and Ralimetinib

Secondary Outcome Measures

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Prexasertib
PK: Area Under the Curve (AUC) of Prexasertib
PK: Cmax of Ralimetinib
PK: AUC of Ralimetinib
Best Overall Response (BOR): Percentage of Participants with Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD), or Not Evaluable (NE)
Disease Control Rate (DCR): Percentage of Participants who Exhibit SD, CR or PR
Duration of Response (DOR)
Progression Free Survival (PFS)

Full Information

First Posted
August 5, 2016
Last Updated
December 12, 2018
Sponsor
Eli Lilly and Company
search

1. Study Identification

Unique Protocol Identification Number
NCT02860780
Brief Title
A Study of Prexasertib (LY2606368) in Combination With Ralimetinib in Participants With Advanced or Metastatic Cancer
Official Title
A Phase 1 Dose-Escalation Study of LY2606368 in Combination With Ralimetinib in Patients With Advanced or Metastatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
August 10, 2016 (Actual)
Primary Completion Date
May 15, 2017 (Actual)
Study Completion Date
May 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Cancer, Metastatic Cancer, Colorectal Cancer, Non-small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part A: prexasertib + ralimetinib
Arm Type
Experimental
Arm Description
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.
Arm Title
Part B1: prexasertib + ralimetinib (colorectal cancer)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
prexasertib
Other Intervention Name(s)
LY2606368
Intervention Description
Administered IV
Intervention Type
Drug
Intervention Name(s)
ralimetinib
Other Intervention Name(s)
LY2228820
Intervention Description
Administered orally
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose (MTD) of Prexasertib and Ralimetinib
Time Frame
Cycle 1 (28 Days)
Secondary Outcome Measure Information:
Title
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Prexasertib
Time Frame
Cycle 1 Day 1 through Cycle 3 Day 1 (28 Day Cycles)
Title
PK: Area Under the Curve (AUC) of Prexasertib
Time Frame
Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
Title
PK: Cmax of Ralimetinib
Time Frame
Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
Title
PK: AUC of Ralimetinib
Time Frame
Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
Title
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)
Title
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)
Title
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)
Title
Progression Free Survival (PFS)
Time Frame
Baseline to Objective Progression or Death Due to Any Cause (Estimated Up to 32 Weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Sarah Cannon Research Institute SCRI
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
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.
City
Köln
ZIP/Postal Code
50937
Country
Germany

12. IPD Sharing Statement

Links:
URL
https://www.lillytrialguide.com/en-US/studies/solid-tumor/JTJL#?postal=
Description
Click here for more information about this study: A Study of Prexasertib (LY2606368) in Combination With Ralimetinib in Participants With Advanced or Metastatic Cancer

Learn more about this trial

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

We'll reach out to this number within 24 hrs