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A Study of Prexasertib (LY2606368) in Combination With Ralimetinib in Participants With Advanced or Metastatic Cancer

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT02860780
Collaborator
(none)
9
Enrollment
3
Locations
2
Arms
9.1
Actual Duration (Months)
3
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
9 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1 Dose-Escalation Study of LY2606368 in Combination With Ralimetinib in Patients With Advanced or Metastatic Cancer
Actual Study Start Date :
Aug 10, 2016
Actual Primary Completion Date :
May 15, 2017
Actual Study Completion Date :
May 15, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: prexasertib
Administered IV
Other Names:
  • LY2606368

    • Drug: ralimetinib
    Administered orally
    Other Names:
  • LY2228820

    		•
    Experimental: 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.

    Drug: prexasertib
    Administered IV
    Other Names:
  • LY2606368

    • Drug: ralimetinib
    Administered orally
    Other Names:
  • LY2228820

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maximum Tolerated Dose (MTD) of Prexasertib and Ralimetinib [Cycle 1 (28 Days)]

    Secondary Outcome Measures

    1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of Prexasertib [Cycle 1 Day 1 through Cycle 3 Day 1 (28 Day Cycles)]

    2. PK: Area Under the Curve (AUC) of Prexasertib [Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)]

    3. PK: Cmax of Ralimetinib [Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)]

    4. PK: AUC of Ralimetinib [Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)]

    5. 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)]

    6. Disease Control Rate (DCR): Percentage of Participants who Exhibit SD, CR or PR [Baseline through Measured Progressive Disease (Estimated up to 32 Weeks)]

    7. 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)]

    8. Progression Free Survival (PFS) [Baseline to Objective Progression or Death Due to Any Cause (Estimated Up to 32 Weeks)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Carolinas Medical Center Charlotte North Carolina United States 28204
    2 Sarah Cannon Research Institute SCRI Nashville Tennessee United States 37203
    3 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. Köln Germany 50937

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • Study Director: 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), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT02860780
    Other Study ID Numbers:
    • 16379
    • I4D-MC-JTJL
    • 2015-005611-33
    First Posted:
    Aug 9, 2016
    Last Update Posted:
    Dec 14, 2018
    Last Verified:
    Nov 1, 2017
    Additional relevant MeSH terms:
    Neoplasm Metastasis
    Neoplasms
    Neoplasms, Second Primary

    Study Results

    No Results Posted as of Dec 14, 2018