NCT02860780

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2016

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 9, 2016

Completed
1 day until next milestone

Study Start

First participant enrolled

August 10, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2017

Completed
Last Updated

December 14, 2018

Status Verified

November 1, 2017

Enrollment Period

9 months

First QC Date

August 5, 2016

Last Update Submit

December 12, 2018

Conditions

Advanced CancerMetastatic CancerColorectal CancerNon-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Maximum Tolerated Dose (MTD) of Prexasertib and Ralimetinib

    Cycle 1 (28 Days)

Secondary Outcomes (8)

  • Pharmacokinetics (PK): Maximum Concentration (Cmax) of Prexasertib

    Cycle 1 Day 1 through Cycle 3 Day 1 (28 Day Cycles)

  • PK: Area Under the Curve (AUC) of Prexasertib

    Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)

  • 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)

  • +3 more secondary outcomes

Study Arms (2)

Part A: prexasertib + ralimetinib

EXPERIMENTAL

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: prexasertibDrug: ralimetinib

Part B1: prexasertib + ralimetinib (colorectal cancer)

EXPERIMENTAL

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: prexasertibDrug: ralimetinib

Interventions

prexasertibDRUG

Administered IV

Also known as: LY2606368
Part A: prexasertib + ralimetinibPart B1: prexasertib + ralimetinib (colorectal cancer)
ralimetinibDRUG

Administered orally

Also known as: LY2228820
Part A: prexasertib + ralimetinibPart B1: prexasertib + ralimetinib (colorectal cancer)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Carolinas Medical Center

Charlotte, North Carolina, 28204, United States

Location

Sarah Cannon Research Institute SCRI

Nashville, Tennessee, 37203, United States

Location

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, 50937, Germany

Location

Related Links

MeSH Terms

Conditions

Neoplasm MetastasisColorectal NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

prexasertibralimetinib

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • 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 DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2016

First Posted

August 9, 2016

Study Start

August 10, 2016

Primary Completion

May 15, 2017

Study Completion

May 15, 2017

Last Updated

December 14, 2018

Record last verified: 2017-11

Locations

DE(1)US(2)