Advanced Cancer, Metastatic Cancer, Colorectal Cancer, Non-small Cell Lung Cancer
Conditions
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.
Interventions
DRUGprexasertib
Administered IV
DRUGralimetinib
Administered orally
Sponsors
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Tolerated Dose (MTD) of Prexasertib and Ralimetinib | Cycle 1 (28 Days) |
Secondary
| Measure | Time frame |
|---|---|
| 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) |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Prexasertib | Cycle 1 Day 1 through Cycle 3 Day 1 (28 Day Cycles) |
| Disease Control Rate (DCR): Percentage of Participants who Exhibit SD, CR or PR | Baseline through Measured Progressive Disease (Estimated up to 32 Weeks) |
| 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) |
| 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) |
| PK: Area Under the Curve (AUC) of Prexasertib | Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles) |
Countries
Germany, United States
Outcome results
None listed