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

Brief Summary

The purpose of this signal seeking study is to determine whether treatment with LEE011 demonstrates sufficient efficacy in CDK4/6 pathway activated solid tumors and/or hematologic malignancies to warrant further study.

Tracking Information
First Received DateJuly 9, 2014
Last Changed DateJune 22, 2018
Start DateAugust 25, 2014
Actual Primary Completion DateOctober 31, 2017
Primary Outcome Measures

Clinical benefit rate associated with LEE011 treatment [Time Frame: 16 weeks]

Secondary Outcome Measures

Overall Response (OR) of Partial Response (PR) or greater [Time Frame: Baseline and every 8 weeks until disease progression or end of treatment, assessed up to 24 months]

Progression Free Survival (PFS) [Time Frame: Every 8 weeks until death, assessed up to 24 months]

Overall Survival (OS) [Time Frame: Every 8 weeks until death, assessed up to 36 months]

Duration of Response (DOR) [Time Frame: Baseline and every 8 weeks until disease progression or end of treatment, assessed up to 24 months]

Safety and tolerability [Time Frame: Baseline up to 30 days after last study treatment]

Descriptive Information
PhasePhase 2
Study TypeInterventional
  • Tumors With CDK4/6 Pathway Activation
  • Drug: LEE011
Study Arms / Comparison Groups1 / 0
Recruitment Information
Recruitment StatusCompleted
Actual Enrollment106
Ages18 Years - N/A
Accepts Healthy VolunteersNo
Eligibility Criteria

Inclusion Criteria:

- Patient has a confirmed diagnosis of a select solid tumor (except breast cancer (however, triple negative will be 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 has 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 has progressive and measurable disease as per RECIST 1.1. or other appropriate hematological guidelines.

- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

Exclusion Criteria:

- Patients has received prior treatment with LEE011.

- Patient has 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 has primary CNS tumor or CNS tumor involvement

- Patient has received chemotherapy or anticancer therapy ≤ 4 weeks prior to starting study drug

Administrative Information
Responsible PartySponsor
SponsorNovartis Pharmaceuticals
Verification DateJune 2018
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