Description: 
            
            
              
                
      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.
    
              
             
           
        
      
        
          
      
        
          
Title
- 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
Clinical Trial IDs
- ORG STUDY ID:
                16379
- SECONDARY ID:
                I4D-MC-JTJL
- SECONDARY ID:
                2015-005611-33
- NCT ID:
                NCT02860780
Conditions
- Advanced Cancer
- Metastatic Cancer
- Colorectal Cancer
- Non-small Cell Lung Cancer
Interventions
| Drug | Synonyms | Arms | 
|---|
| prexasertib | LY2606368 | Part A: prexasertib + ralimetinib | 
| ralimetinib | LY2228820 | Part A: prexasertib + ralimetinib | 
Purpose
      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.
    
Trial Arms
| Name | Type | Description | Interventions | 
|---|
| Part A: prexasertib + ralimetinib | Experimental | 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) | Experimental | 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. |  | 
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.
      | Maximum Eligible Age: | N/A | 
| Minimum Eligible Age: | 18 Years | 
| Eligible Gender: | All | 
| Healthy Volunteers: | No | 
Primary Outcome Measures
| Measure: | Maximum Tolerated Dose (MTD) of Prexasertib and Ralimetinib | 
| Time Frame: | Cycle 1 (28 Days) | 
| Safety Issue: |  | 
| Description: |  | 
Secondary Outcome Measures
| Measure: | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Prexasertib | 
| Time Frame: | Cycle 1 Day 1 through Cycle 3 Day 1 (28 Day Cycles) | 
| Safety Issue: |  | 
| Description: |  | 
| Measure: | PK: Area Under the Curve (AUC) of Prexasertib | 
| Time Frame: | Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles) | 
| Safety Issue: |  | 
| Description: |  | 
| Measure: | PK: Cmax of Ralimetinib | 
| Time Frame: | Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles) | 
| Safety Issue: |  | 
| Description: |  | 
| Measure: | PK: AUC of Ralimetinib | 
| Time Frame: | Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles) | 
| Safety Issue: |  | 
| Description: |  | 
| Measure: | 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) | 
| Safety Issue: |  | 
| Description: |  | 
| Measure: | 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) | 
| Safety Issue: |  | 
| Description: |  | 
| Measure: | 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) | 
| Safety Issue: |  | 
| Description: |  | 
| Measure: | Progression Free Survival (PFS) | 
| Time Frame: | Baseline to Objective Progression or Death Due to Any Cause (Estimated Up to 32 Weeks) | 
| Safety Issue: |  | 
| Description: |  | 
Details
| Phase: | Phase 1 | 
| Primary Purpose: | Interventional | 
| Overall Status: | Completed | 
| Lead Sponsor: | Eli Lilly and Company | 
Last Updated
December 14, 2018