Phase 2
N=133
A Study of Prexasertib (LY2606368) in Participants With Extensive Stage Disease Small Cell Lung Cancer
Small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02735980 ↗Enrolled (actual)
133
Serious AEs
32.8%
Results posted
Mar 2020
Primary outcome: Primary: Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR]) — 5.2; 0; 0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Prexasertib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Jul 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR]) |
5.2; 0; 0 | — |
| SECONDARY Pharmacokinetics(PK): Maximum Concentration (Cmax) of Prexasertib Cohort 1 and Cohort 2 |
722; 735; 732; 1230 | — |
| SECONDARY Pharmacokinetics(PK): Maximum Concentration of Prexasertib Cohort 3 (40 mg/m^2, Protocol Addenda) |
227 | — |
| SECONDARY Pharmacokinetics: Area Under the Concentration Curve of Prexasertib |
126; 1190; 1840 | — |
| SECONDARY Disease Control Rate: Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD) |
31; 20.0; 40.0 | — |
| SECONDARY Progression-Free Survival (PFS) |
1.41; 1.36; 1.58 | — |
| SECONDARY Duration of Response (DoR) |
NA; NA; NA | — |
| SECONDARY Overall Survival (OS) |
5.42; 3.15; 7.26 | — |
| SECONDARY Change From Baseline in Lung Cancer Symptom Scale Score (LCSS) |
-2.8; -4.0 | — |
| SECONDARY Change From Baseline on the Average Symptom Burden Index (ASBI) |
-3.0; -4.4 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02735980). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.