Description:
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.
Title
- Brief Title: A Study of Prexasertib (LY2606368) in Participants With Extensive Stage Disease Small Cell Lung Cancer
- Official Title: A Phase 2 Study of LY2606368 in Patients With Extensive Stage Disease Small Cell Lung Cancer
Clinical Trial IDs
- ORG STUDY ID:
16015
- SECONDARY ID:
I4D-MC-JTJH
- SECONDARY ID:
2015-005069-21
- NCT ID:
NCT02735980
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| Prexasertib | LY2606368 | Prexasertib (Platinum Resistant Disease) |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Prexasertib (Platinum Sensitive Disease) | Experimental | 105 mg/m^2 Intravenous (IV) prexasertib administered of every 14 days with extensive stage disease small cell lung cancer (ED-SCLC) who had platinum-sensitive disease (has prior platinum based therapy with subsequent progression greater or less than 90 days after last dose of platinum based therapy). | |
| Prexasertib (Platinum Resistant Disease) | Experimental | 105 mg/m^2 IV prexasertib administered of every 14 days with extensive stage disease small cell lung cancer (ED-SCLC) who had resistant/refractory disease (did not have an objective response to platinum-based therapy or had progression greater than 90 days after the last dose of platinum). | |
| Prexasertib Exploratory Addendum (Platinum Sensitive Disease) | Experimental | 40 mg/m^2 IV prexasertib Day 1, 2, and Day 3 of a 14 day cycle in participants with ED-SCLC platinum sensitive disease. | |
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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR]) |
| Time Frame: | Baseline to 10 months |
| Safety Issue: | |
| Description: | ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions |
Secondary Outcome Measures
| Measure: | Pharmacokinetics(PK): Maximum Concentration (Cmax) of Prexasertib Cohort 1 and Cohort 2 |
| Time Frame: | Cycle 1,3, 5, and 7: Day 1, Day 2 and Day 3- Prior to start of infusion, end of infusion plus 10 minutes, Day 8: anytime |
| Safety Issue: | |
| Description: | Pharmacokinetics(PK): Maximum Concentration of Prexasertib. The same dose was administered to Cohort 1 and Cohort 2 and were combined for analysis. |
| Measure: | Pharmacokinetics(PK): Maximum Concentration of Prexasertib Cohort 3 (40 mg/m^2, Protocol Addenda) |
| Time Frame: | Cycle 1,3, 5, and 7: Day 1, Day 2 and Day 3- Prior to start of infusion, end of infusion plus 10 minutes, Day 8: anytime |
| Safety Issue: | |
| Description: | Pharmacokinetics(PK): Maximum Concentration of Prexasertib |
| Measure: | Pharmacokinetics: Area Under the Concentration Curve of Prexasertib |
| Time Frame: | Cycle 1,3, 5, and 7: Day 1, Day 2 and Day 3- Prior to start of infusion, end of infusion plus 10 minutes, Day 8: anytime |
| Safety Issue: | |
| Description: | Pharmacokinetics: Area Under the Concentration Curve of Prexasertib |
| Measure: | 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 to 28 months |
| Safety Issue: | |
| Description: | Disease control rate (DCR) is defined as the percentage of participants achieving a best overall response of CR, PR, or SD as determined by RECIST 1.1. CR is defined as a disappearance of all target lesions and any pathological lymph nodes must have reduction in short axis to <10 mm and normalization of tumor marker results; PR is defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters; SD is defined as neither sufficient shrinking to qualify as PR nor sufficient increase to qualify for PD. |
| Measure: | Progression-Free Survival (PFS) |
| Time Frame: | Baseline to Disease Progression or Death (up to 9 months) |
| Safety Issue: | |
| Description: | PFS defined as the from randomization date to the first evidence of disease progression as defined by RECIST v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of first dose, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date. |
| Measure: | Duration of Response (DoR) |
| Time Frame: | Date of CR or PR to Date of Disease Progression or Death Due to Any Cause up to 9 months |
| Safety Issue: | |
| Description: | DoR the time from the date of an objective response until Progressive Disease (PD): was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. |
| Measure: | Overall Survival (OS) |
| Time Frame: | Baseline up to 28 months |
| Safety Issue: | |
| Description: | OS defined as from randomization date to the date of death due to any cause. For each participant who is not known to have died as of the data-inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive. |
| Measure: | Change From Baseline in Lung Cancer Symptom Scale Score (LCSS) |
| Time Frame: | Baseline up to 9 months |
| Safety Issue: | |
| Description: | LCSS is a 9-item questionnaire, six measuring major symptoms for lung malignancies (appetite, fatigue, cough, dyspnea, hemoptysis and pain), and 3 summation items related to total symptomatic distress, activity status and overall quality of life. Participant responses were measured using visual analogue scales (VAS) with 100-mm lines. The LCSS total score was defined as the mean of the 9 items of the scale, each scored between 0 (for best outcome) to 100 (for worst outcome). |
| Measure: | Change From Baseline on the Average Symptom Burden Index (ASBI) |
| Time Frame: | Baseline up to 9 months |
| Safety Issue: | |
| Description: | ABSI was the mean score for the six major lung cancer symptoms (appetite, fatigue, cough, dyspnea, hemoptysis and pain), each scored between 0 (for best outcome) to 100 (for worst outcome). |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Completed |
| Lead Sponsor: | Eli Lilly and Company |
Trial Keywords
Last Updated
March 17, 2020
