A Study of Prexasertib (LY2606368) in Participants With Extensive Stage Disease Small Cell Lung Cancer

ID: NCT02735980
Status: Recruiting
Phase: Phase 2
Start Date: May 01, 2016
First Submitted: March 31, 2016
Last Updated: February 23, 2018
Results: N/A
Organization: Eli Lilly and Company
Sponsors & Collaborators: Eli Lilly and Company
Location: Australia, Belgium, France, Germany, Greece, Israel, Italy, Korea, Republic of, Netherlands, Spain, Turkey, Ukraine, United Kingdom, United States
Conditions: Small Cell Lung Cancer
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of prexasertib when given to participants with extensive stage disease small cell lung cancer (ED-SCLC). The study will evaluate how the body processes the drug and how the drug affects the body. The study will also evaluate the association between tumor response and the participant's perceived quality of life.

Detailed Description

Condition or disease Intervention/treatment Phase

Small Cell Lung Cancer

Drug: Prexasertib
Other Names
LY2606368
Phase 2

Tracking Information

First Submitted DateMarch 31, 2016
Last Update Posted DateFebruary 23, 2018
Start DateMay 01, 2016
Anticipated Completion DateJune 01, 2018
Primary Completion DateAugust 01, 2017
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR): Overall Response Rate (ORR) [Time Frame: Baseline through Disease Progression or Death (estimated at up to 28 months)]

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Pharmacokinetics: Maximum Concentration of Prexasertib [Time Frame: Cycle 1 Predose through Cycle 7 End of Infusion Day 1 (14 day cycles)]

  • Pharmacokinetics: Area Under the Concentration Curve of Prexasertib [Time Frame: Cycle 1 Predose through Cycle 7 End of Infusion Day 1 (14 day cycles)]

  • Disease Control Rate: Percentage of Participants with a Best Overall Response of CR, PR, or Stable Disease (SD) [Time Frame: Baseline through Disease Progression or Death from Any Cause (estimated at up to 28 months)]

  • Progression-Free Survival [Time Frame: Baseline to Disease Progression or Death (estimated at up to 28 months)]

  • Duration of Response [Time Frame: Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (estimated at up to 28 months)]

  • Overall Survival [Time Frame: Baseline to Date of Death from Any Cause (estimated at up to 28 months)]

  • Change From Baseline in Lung Cancer Symptom Scale Score [Time Frame: Baseline, Short Term Follow-Up (estimated at up to 28 months)]

  • Change from Baseline on the Average Symptom Burden Index (ASBI) [Time Frame: Baseline, Short Term Follow-Up (estimated at up to 28 months)]

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleA Study of Prexasertib (LY2606368) in Participants With Extensive Stage Disease Small Cell Lung Cancer
Official TitleA Phase 2 Study of LY2606368 in Patients With Extensive Stage Disease Small Cell Lung Cancer
Brief Summary

The purpose of this study is to evaluate the safety and efficacy of prexasertib when given to participants with extensive stage disease small cell lung cancer (ED-SCLC). The study will evaluate how the body processes the drug and how the drug affects the body. The study will also evaluate the association between tumor response and the participant's perceived quality of life.

Detailed Description

Study TypeInterventional
Study PhasePhase 2
Estimated Enrollment
116
Allocation
Non-Randomized
Interventional Model
Parallel Assignment
Masking
None (Open Label)
Primary Purpose
Treatment
Conditions
Small Cell Lung Cancer
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: Prexasertib

Administered IV

Other Names
LY2606368
Study Groups/Cohorts
Prexasertib (Platinum Sensitive Disease)
Intravenous (IV) prexasertib administered on day 1 of every 14 day cycle

Prexasertib (Platinum Resistant Disease)
IV prexasertib administered on day 1 of every 14 day cycle

Study Arms
Experimental Prexasertib (Platinum Resistant Disease)
IV prexasertib administered on day 1 of every 14 day cycle
Drug : Prexasertib
Administered IV

Experimental Prexasertib (Platinum Sensitive Disease)
Intravenous (IV) prexasertib administered on day 1 of every 14 day cycle
Drug : Prexasertib
Administered IV

Arm Intervention/Treatment
Experimental Prexasertib (Platinum Resistant Disease)
IV prexasertib administered on day 1 of every 14 day cycle
Drug : Prexasertib
Experimental Prexasertib (Platinum Sensitive Disease)
Intravenous (IV) prexasertib administered on day 1 of every 14 day cycle
Drug : Prexasertib

Recruitment Information

Recruitment Status:Recruiting
Enrollment116
Completion DateJune 01, 2018
Eligibility Criteria: Inclusion Criteria:
- Have ED-SCLC and have received a prior platinum-based regimen
- Participants in Cohort 1 must have had an objective response to prior platinum-based therapy with subsequent progression ≥90 days after the last dose of platinum
- Participants in Cohort 2 must have either not had an objective response to prior platinum based therapy or had progression <90 days after the last dose of platinum
- Have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group scale

Exclusion Criteria:
- Have received more than 2 prior therapies for ED-SCLC (including immunotherapy, targeted therapies, or chemotherapy)
- Have symptomatic central nervous system (CNS) malignancy or metastasis. Asymptomatic participants with treated CNS metastases are eligible for this study if they are not currently receiving corticosteroids to treat CNS metastases
- Have previously completed or withdrawn from this study or any other study investigating prexasertib or a checkpoint kinase I (CHK1) inhibitor or have shown hypersensitivity to any of the components of the prexasertib formulation
- Have a serious cardiac condition
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
Australia
Belgium
France
Germany
Greece
Israel
Italy
Korea, Republic of
Netherlands
Spain
Turkey
Ukraine
United Kingdom
United States

Administrative Information

NCT Number:NCT02735980
Other Study ID Numbers
16015
I4D-MC-JTJH
2015-005069-21
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Eli Lilly and Company
Collaborators
Not Available
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