A Study of Prexasertib (LY2606368) in Participants With Extensive Stage Dis... | Not Recruiting
A Study of Prexasertib (LY2606368) ... | Not Recruiting
A Study of Prexasertib (LY2606368) in Participants With Extensive Stage Disease Small Cell Lung Cancer

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Medical Conditions
  • Small Cell Lung Cancer
Primary Contact Details
Unfortunately contact details are not available for this trial.
Recruitment Status
Not Recruiting
Trial source and source ID number
NCT02735980
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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.
Research Details
    Sorry, this information is not available
Phase
Phase 2
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Drug : Prexasertib

Study Arm Groups : Prexasertib (Platinum Sensitive Disease), Prexasertib (Platinum Resistant Disease)

Intervention Type
See Interventions above
Primary Outcome Measures
    Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR): Overall Response Rate (ORR); Baseline through Disease Progression or Death (estimated at up to 28 months)
Secondary Outcome Measures
    Pharmacokinetics: Maximum Concentration of Prexasertib; Cycle 1 Predose through Cycle 7 End of Infusion Day 1 (14 day cycles); Pharmacokinetics: Area Under the Concentration Curve of Prexasertib; 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); Baseline through Disease Progression or Death from Any Cause (estimated at up to 28 months); Progression-Free Survival; Baseline to Disease Progression or Death (estimated at up to 28 months); Duration of Response; Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (estimated at up to 28 months); Overall Survival; Baseline to Date of Death from Any Cause (estimated at up to 28 months); Change From Baseline in Lung Cancer Symptom Scale Score; Baseline, Short Term Follow-Up (estimated at up to 28 months); Change from Baseline on the Average Symptom Burden Index (ASBI); Baseline, Short Term Follow-Up (estimated at up to 28 months)
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
All
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
Participant Inclusion 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
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Royal Free Hospital
London
NW1 2BU
Sheffield
S10 2SJ
Oxford Vaccine Group, Centre for Clinical Vaccinology and Tropical Medicine
Oxford
Oxford
OX3 7LJ
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.
Leicester
LE1 5WN
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
France, Germany, Greece, Korea, Republic of, Netherlands, Spain, Turkey, Ukraine, United Kingdom, United States
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
A Phase 2 Study of LY2606368 in Patients With Extensive Stage Disease Small Cell Lung Cancer
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
16015
Sponsor(s)
Eli Lilly and Company
Key Dates

Recruitment Start Date

May 2016

Recruitment End Date

Apr 2018

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

31 Mar 2016

Date updated in source

14 Jul 2017