Clinical trial NCT02860780: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Cancer
Metastatic Cancer
Colorectal Cancer
Non-small Cell Lung Cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2016-08-09
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Maximum Tolerated Dose (MTD) of Prexasertib and Ralimetinib
timeFrame: Cycle 1 (28 Days)
Secondary outcomes:
measure: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Prexasertib
timeFrame: Cycle 1 Day 1 through Cycle 3 Day 1 (28 Day Cycles)
measure: PK: Area Under the Curve (AUC) of Prexasertib
timeFrame: Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
measure: PK: Cmax of Ralimetinib
timeFrame: Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
measure: PK: AUC of Ralimetinib
timeFrame: Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
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)
timeFrame: Baseline to Earliest Objective Progression or Start of New Anticancer Therapy (Estimated up to 32 Weeks)
measure: Disease Control Rate (DCR): Percentage of Participants who Exhibit SD, CR or PR
timeFrame: Baseline through Measured Progressive Disease (Estimated up to 32 Weeks)
measure: Duration of Response (DOR)
timeFrame: Date of CR or PR to Date of Objective Progression or Death Due to Any Cause (Estimated up to 32 Weeks)
measure: Progression Free Survival (PFS)
timeFrame: Baseline to Objective Progression or Death Due to Any Cause (Estimated Up to 32 Weeks)
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Nashville
country: United States
facility: Sarah Cannon Research Institute SCRI
state: Tennessee
city: Köln
country: Germany
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: