A Phase 1 Dose-Escalation Study of LY2606368 in Combination With Ralimetinib in Patients With Advanced or Metastatic Cancer
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 9
- Locations
- 3
- Primary Endpoint
- Maximum Tolerated Dose (MTD) of Prexasertib and Ralimetinib
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: prexasertib (Drug)
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.
Intervention: ralimetinib (Drug)
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.
Intervention: prexasertib (Drug)
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.
Intervention: ralimetinib (Drug)
Outcomes
Primary Outcomes
Maximum Tolerated Dose (MTD) of Prexasertib and Ralimetinib
Time Frame: Cycle 1 (28 Days)
Secondary Outcomes
- 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))
- 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))
- 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))