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

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ClinicalTrials.gov Identifier: NCT02860780
Recruitment Status : Completed
First Posted : August 9, 2016
Last Update Posted : December 14, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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
Advanced Cancer Metastatic Cancer Colorectal Cancer Non-small Cell Lung Cancer Drug: prexasertib Drug: ralimetinib Phase 1

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Study Type : Interventional  (Clinical Trial)
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 : August 10, 2016
Actual Primary Completion Date : May 15, 2017
Actual Study Completion Date : May 15, 2017

Resource links provided by the National Library of Medicine


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 Name: LY2606368

Drug: ralimetinib
Administered orally
Other Name: 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 Name: LY2606368

Drug: ralimetinib
Administered orally
Other Name: LY2228820




Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) of Prexasertib and Ralimetinib [ Time Frame: Cycle 1 (28 Days) ]

Secondary Outcome Measures :
  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of Prexasertib [ Time Frame: Cycle 1 Day 1 through Cycle 3 Day 1 (28 Day Cycles) ]
  2. PK: Area Under the Curve (AUC) of Prexasertib [ Time Frame: Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles) ]
  3. PK: Cmax of Ralimetinib [ Time Frame: Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles) ]
  4. PK: AUC of Ralimetinib [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: Baseline through Measured Progressive Disease (Estimated up to 32 Weeks) ]
  7. Duration of Response (DOR) [ Time Frame: 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) [ Time Frame: Baseline to Objective Progression or Death Due to Any Cause (Estimated Up to 32 Weeks) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02860780


Locations
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United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28204
United States, Tennessee
Sarah Cannon Research Institute SCRI
Nashville, Tennessee, United States, 37203
Germany
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
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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

Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02860780     History of Changes
Other Study ID Numbers: 16379
I4D-MC-JTJL ( Other Identifier: Eli Lilly and Company )
2015-005611-33 ( EudraCT Number )
First Posted: August 9, 2016    Key Record Dates
Last Update Posted: December 14, 2018
Last Verified: November 2017

Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes