LEE011 for Patients With CDK4/6 Pathway Activated Tumors (SIGNATURE)

Novartis

Status and phase: Completed; Phase 2

Conditions: Tumors With CDK4/6 Pathway Activation

Treatments: Drug: LEE011

Study type: Interventional

Funder types: Industry

Identifiers

NCT02187783

CLEE011XUS03

Details and patient eligibility

About

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.

Enrollment: 106 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 < 50 at rest), tachycardia (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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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106 participants in 1 patient group

LEE011

Experimental group

Description:

LEE011 600 mg (hard gelatin capsules) was administered orally once daily for 3 weeks on/1 week off. A complete treatment cycle was defined as 28 days.

Treatment:

Drug: LEE011