A Study of Prexasertib (LY2606368) in Combination With Ralimetinib in Participants With Advanced or Metastatic Cancer
NCT ID: NCT02860780
Last Updated: 2018-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
9 participants
INTERVENTIONAL
2016-08-10
2017-05-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
prexasertib
Administered IV
ralimetinib
Administered orally
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.
prexasertib
Administered IV
ralimetinib
Administered orally
Interventions
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prexasertib
Administered IV
ralimetinib
Administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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
Eli Lilly and Company
Locations
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Carolinas Medical Center
Charlotte, North Carolina, United States
Sarah Cannon Research Institute SCRI
Nashville, Tennessee, United States
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.
Cologne, , Germany
Countries
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Related Links
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Click here for more information about this study: A Study of Prexasertib (LY2606368) in Combination With Ralimetinib in Participants With Advanced or Metastatic Cancer
Other Identifiers
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I4D-MC-JTJL
Identifier Type: OTHER
Identifier Source: secondary_id
2015-005611-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
16379
Identifier Type: -
Identifier Source: org_study_id