Phase 2
N=8
A Rollover Study of ARRY-371797 in Patients With LMNA-Related Dilated Cardiomyopathy
LMNA-Related Dilated Cardiomyopathy
Bottom Line
View on ClinicalTrials.gov: NCT02351856 ↗Enrolled (actual)
8
Serious AEs
75.0%
Results posted
Mar 2022
Primary outcome: Primary: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) — 6; 8 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ARRY-371797, p38 inhibitor, oral (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
6; 8 | — |
| PRIMARY Number of Participants With Change From Baseline Value in Clinical Laboratory Hematology Test Results to Worst Value |
3; 4; 1; 6; 1; 1 | — |
| PRIMARY Number of Participants With Change From Baseline Value in Clinical Laboratory Chemistry Test Results to Worst Value |
6; 1; 1; 7; 1; 8 | — |
| PRIMARY Number of Participants With Abnormal Physical Examination Findings |
8 | — |
| PRIMARY Number of Participants With Abnormalities in Vital Signs |
6 | — |
| PRIMARY Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings |
8 | — |
| SECONDARY Change From Baseline in Six Minute Walk Test (6MWT) Distance at Day 1, Weeks 24, 48, 72, 96 and Early Termination Visit |
319.5; 55.3; 32.2; 55.8; 42.6; 10.8 | — |
| SECONDARY Change From Baseline in Left Ventricular End Systolic Index (LVESVI) and Left Ventricular End Diastolic Volume Index (LVEDVI) at Day 1, Weeks 24, 48, 72, 96 and Early Termination Visit |
45.25; 1.83; -0.01; -1.31; -1.36; -0.39 | — |
| SECONDARY Change From Baseline in Left Ventricular Mass (LVM) at Day 1, Weeks 24, 48, 72, 96 and Early Termination Visit |
169.97; 4.38; 12.39; 7.46; 20.87; 15.25 | — |
| SECONDARY Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Day 1, Weeks 24, 48, 72, 96 and Early Termination Visit |
37.88; 0.10; 1.50; 0.10; 4.27; 1.71 | — |
| SECONDARY Change From Baseline in Left Ventricular Mass (LVM) to Volume Ratio at Day 1, Weeks 24, 48, 72, 96 and Early Termination Visit |
1.32; -0.04; 0.03; 0.05; 0.14; 0.21 | — |
| SECONDARY Change From Baseline in Right Ventricular End Diastolic Diameter at Day 1, Weeks 24, 48, 72, 96 and Early Termination Visit |
3.79; 0.30; 0.02; 0.59; 0.14; 0.26 | — |
| SECONDARY Change From Baseline in Right Ventricular Fractional Area at Day 1, Weeks 24, 48, 72, 96 and Early Termination Visit |
22.14; 8.25; 8.67; 7.85; 8.22; 1.95 | — |
| SECONDARY Change From Baseline in 36-Item Short-Form (SF-36) Health Survey Score at Day 1, Weeks 24, 48, 72, 96 and Early Termination Visit |
39.97; -0.74; -0.50; -2.97; -3.57; -5.94 | — |
| SECONDARY Change From Baseline in Quality of Life by Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores at Day 1, Weeks 24, 48, 72, 96 and Early Termination Visit |
60.42; 0.60; 8.33; -0.83; 13.83; 12.17 | — |
| SECONDARY Mean Plasma Concentration of ARRY-371797 and Metabolites (AR00420643, AR00428028, AR00486705) |
4.7136; 54.053; 3.9258; 109.10; 4.9345; 41.653 | — |
Summary
This is a rollover study designed to investigate the safety and effectiveness of investigational study drug ARRY-371797 in patients who previously received ARRY-371797 in a study for patients with LMNA-related dilated cardiomyopathy sponsored by Array BioPharma and may, in the Investigator's opinion, derive benefit from continued treatment.
Eligibility Criteria
Key Inclusion Criteria
- Received ARRY-371797 as treatment for a genetic dilated cardiomyopathy secondary to LMNA mutations in a clinical study sponsored by Array BioPharma.
- May, in the opinion of the Investigator, benefit from continued ARRY-371797 treatment.
- Additional criteria exist.
Key Exclusion Criteria
- Discontinued treatment in the parent study for any reason other than study completion or Sponsor termination of the study.
- Additional criteria exist.
Data sourced from ClinicalTrials.gov (NCT02351856). 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.