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NCT02860780 Clinical Trial

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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02860780
Other study ID # 16379
Secondary ID I4D-MC-JTJL2015-
Status Completed
Phase Phase 1
First received
Last updated
Start date August 10, 2016
Est. completion date May 15, 2017

Study information
Verified date November 2017
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 9
Est. completion date May 15, 2017
Est. primary completion date May 15, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• prexasertib
Administered IV
• ralimetinib
Administered orally

Locations
Country Name City State
Germany 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
United States Carolinas Medical Center Charlotte North Carolina
United States Sarah Cannon Research Institute SCRI Nashville Tennessee

Sponsors (1)
Lead Sponsor Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Maximum Tolerated Dose (MTD) of Prexasertib and Ralimetinib Cycle 1 (28 Days)
Secondary Pharmacokinetics (PK): Maximum Concentration (Cmax) of Prexasertib Cycle 1 Day 1 through Cycle 3 Day 1 (28 Day Cycles)
Secondary PK: Area Under the Curve (AUC) of Prexasertib Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
Secondary PK: Cmax of Ralimetinib Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
Secondary PK: AUC of Ralimetinib Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
Secondary 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)
Secondary Disease Control Rate (DCR): Percentage of Participants who Exhibit SD, CR or PR Baseline through Measured Progressive Disease (Estimated up to 32 Weeks)
Secondary 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)
Secondary Progression Free Survival (PFS) Baseline to Objective Progression or Death Due to Any Cause (Estimated Up to 32 Weeks)
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