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