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

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ClinicalTrials.gov Identifier: NCT02735980
Recruitment Status : Active, not recruiting
First Posted : April 13, 2016
Last Update Posted : November 21, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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.

Condition or disease Intervention/treatment Phase
Small Cell Lung Cancer Drug: Prexasertib Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 131 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of LY2606368 in Patients With Extensive Stage Disease Small Cell Lung Cancer
Actual Study Start Date : May 18, 2016
Actual Primary Completion Date : July 31, 2017
Estimated Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Prexasertib (Platinum Sensitive Disease)
Intravenous (IV) prexasertib administered on day 1 of every 14 day cycle
Drug: Prexasertib
Administered IV
Other Name: LY2606368

Experimental: Prexasertib (Platinum Resistant Disease)
IV prexasertib administered on day 1 of every 14 day cycle
Drug: Prexasertib
Administered IV
Other Name: LY2606368

Experimental: Prexasertib Exploratory Addendum (Platinum Sensitive Disease)
IV prexasertib
Drug: Prexasertib
Administered IV
Other Name: LY2606368




Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. Pharmacokinetics: Maximum Concentration of Prexasertib [ Time Frame: Cycle 1 Predose through Cycle 7 End of Infusion Day 1 (14 day cycles) ]
  2. Pharmacokinetics: Area Under the Concentration Curve of Prexasertib [ Time Frame: Cycle 1 Predose through Cycle 7 End of Infusion Day 1 (14 day cycles) ]
  3. 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) ]
  4. Progression-Free Survival [ Time Frame: Baseline to Disease Progression or Death (estimated at up to 28 months) ]
  5. 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) ]
  6. Overall Survival [ Time Frame: Baseline to Date of Death from Any Cause (estimated at up to 28 months) ]
  7. Change From Baseline in Lung Cancer Symptom Scale Score [ Time Frame: Baseline, Short Term Follow-Up (estimated at up to 28 months) ]
  8. Change from Baseline on the Average Symptom Burden Index (ASBI) [ Time Frame: Baseline, Short Term Follow-Up (estimated at up to 28 months) ]


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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:

  • Have ED-SCLC and have received a prior platinum-based regimen
  • Participants in Cohort 1 and in the addendum 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

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): NCT02735980


  Show 41 Study Locations
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

Additional Information:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02735980     History of Changes
Other Study ID Numbers: 16015
I4D-MC-JTJH ( Other Identifier: Eli Lilly and Company )
2015-005069-21 ( EudraCT Number )
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: November 21, 2018
Last Verified: November 16, 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Eli Lilly and Company:
SCLC
LY2606368
CHK1

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms