Phase 2
N=106
LEE011 for Patients With CDK4/6 Pathway Activated Tumors (SIGNATURE)
Tumors With CDK4/6 Pathway Activation
Bottom Line
View on ClinicalTrials.gov: NCT02187783 ↗Enrolled (actual)
106
Serious AEs
37.7%
Results posted
Apr 2019
Primary outcome: Primary: Number of Participants With Solid Tumor Response ≥ 16 Weeks for Based Upon Local Investigator Assessments — 0; 3; 16; 71 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LEE011 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Jan 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Solid Tumor Response ≥ 16 Weeks for Based Upon Local Investigator Assessments |
0; 3; 16; 71; 15 | — |
| PRIMARY Clinical Benefit Rate (CBR) of ≥ 16 Weeks FAS |
19 | — |
| PRIMARY Overall Response Rate (ORR) ≥ 16 Weeks. FAS |
3 | — |
| SECONDARY Progression Free Survival (PFS) |
1.8 | — |
| SECONDARY Overall Survival (OS) |
7.7 | — |
| SECONDARY Number of Days for Duration of Response for Responders |
254; 330; 985 | — |
Summary
The purpose of this signal seeking study was to determine whether treatment with LEE011 demonstrates sufficient efficacy in CDK4/6 pathway activated solid tumors and/or hematologic malignancies to warrant further study.
Eligibility Criteria
Inclusion Criteria
- Patient had a confirmed diagnosis of a select solid tumor (except breast cancer (however, triple negative was included), liposarcoma, CRPC, melanoma and teratoma) or hematological malignancy (except mantle cell lymphoma).
- Patient must have been pre-identified as having a tumor with CDK4 amplification or mutation, CDK6 amplification or mutation, Cyclin D1 (CCND1) amplification, Cyclin D3 (CCND3) amplification, or p16 (CDKN2A) mutation
- Patient had received at least one prior treatment for recurrent, metastatic and /or locally advanced disease and for whom no standard therapy options are anticipated to result in a durable remission.
- Patient had progressive and measurable disease as per RECIST 1.1. or other appropriate hematological guidelines.
- Patient had an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
Exclusion Criteria
- Patients had received prior treatment with LEE011.
- Patient had clinically significant resting bradycardia (heart rate 90 at rest), PR interval > 220 msec, QRS interval > 109 msec, or QTcF > 450 msec.
- Patients had primary CNS tumor or CNS tumor involvement
- Patient had received chemotherapy or anticancer therapy ≤ 4 weeks prior to starting study drug
Data sourced from ClinicalTrials.gov (NCT02187783). 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.