Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02187783 · ClinicalTrials.gov registry record · Phase 2
LEE011 for Patients With CDK4/6 Pathway Activated Tumors (SIGNATURE)
A Phase 2 study of Tumors With CDK4/6 Pathway Activation, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 106
- Enrollment target
- 20
- Study locations
NCT02187783: Completed Phase 2 study of Tumors With CDK4/6 Pathway Activation, sponsored by Novartis Pharmaceuticals.
NCT02187783 is a Phase 2 study of Tumors With CDK4/6 Pathway Activation that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 106 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02187783, a Phase 2 study of Tumors With CDK4/6 Pathway Activation, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 106 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Clinical benefit (CB) for patients with solid tumors were assessed using RECIST 1.1 and included responses of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) for ≥ 16 weeks. CR and PR (for solid tumors) required a confirmation at least 4 weeks after the initial response observation. For hematologic tumors other appropriate hematological response criteria was applied. CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must ha
Conditions Studied
Interventions
- DRUG LEE011
Study Locations (20)
Connecticut
- Danbury Hospital - Danbury
- Yale University School of Medicine Smilow Cancer Hospital - New Haven
- Whittingham Cancer Center Norwalk Hospital - Norwalk
- Stamford Hospital Med. Oncology Hematology Res. - Stamford
California
- PCR Oncology - Pismo Beach
- University of California Davis Cancer Center UC Davis Cancer (3) - Sacramento
Georgia
- NorthWest Georgia Oncology Centers NW Georgia Oncology - Marietta
- Harbin Clinic Medical Oncology Clin. Res. - Rome
Indiana
- Indiana University Indiana Univ. - Purdue Univ. - Indianapolis
- Northern Indiana Cancer Research Consortium No. Indiana Cancer Res. - South Bend
Alabama
- University of Alabama at Birmingham - Birmingham
Alaska
- Alaska Clinical Research - Anchorage
Arizona
- Arizona Oncology Associates Dept. Of Onc. - Phoenix
Arkansas
- University of Arkansas/ Arkansas Cancer Research Center UA Medical Sciences - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2014-08-25 |
| Est. Completion | 2018-01-17 |
| Phase | Phase 2 |
What the finished NCT02187783 record still lists
NCT02187783 is an interventional study that assigns participants to a tested intervention. The registered 106 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% lower).
The record links to 1 condition, with Tumors With CDK4/6 Pathway Activation appearing as the primary indexed condition, and to 1 intervention - of which LEE011 is the first listed.
NCT02187783 names 20 study sites across 14 states, led by Connecticut, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT02187783 about?
NCT02187783 is a clinical study titled "LEE011 for Patients With CDK4/6 Pathway Activated Tumors (SIGNATURE)". 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.
What is the current status of trial NCT02187783?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 106 participants. The study started on 2014-08-25. Estimated completion is 2018-01-17.
What conditions does trial NCT02187783 study?
This clinical trial studies the following conditions: Tumors With CDK4/6 Pathway Activation.
What interventions are being tested in trial NCT02187783?
The interventions under investigation include: LEE011 (DRUG).
Who is sponsoring clinical trial NCT02187783?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02187783 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02187783's enrollment target sits among peer trials
106 648th of 2000 higher than 1,351 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03181048 · 106 participants · NA
Clinical Trial of Concomitant Hip Arthroscopy During PAO
- NCT04682158 · 106 participants · Phase 2
Propranolol With Standard Chemoradiation for Esophageal Adenocarcinoma
- NCT04724018 · 106 participants · Phase 1
Sacituzumab Govitecan Plus EV in Metastatic UC
- NCT04798274 · 106 participants · NA
Role of GABAergic Transmission in Auditory Processing in Autism Spectrum Disorder
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI