A Study of Abemaciclib (LY2835219) in Participants With Stage IV Squamous Non-small Cell Lung Cancer
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Lung Cancer, Lung Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/3/2019 |
| Start Date: | August 6, 2015 |
| End Date: | August 14, 2019 |
A Randomized Phase 2 Study of Abemaciclib (LY2835219) Versus Docetaxel in Patients With Stage IV Squamous Non-Small Cell Lung Cancer Previously Treated With Platinum-Based Chemotherapy
The main purpose of this study is to evaluate the effectiveness of the study drug known as
abemaciclib versus docetaxel in participants with stage IV squamous non-small cell lung
cancer (NSCLC) previously treated with platinum-based chemotherapy.
abemaciclib versus docetaxel in participants with stage IV squamous non-small cell lung
cancer (NSCLC) previously treated with platinum-based chemotherapy.
Inclusion Criteria:
- Confirmed diagnosis of stage IV NSCLC.
- Have progressed during or after platinum-based chemotherapy for advanced disease.
- Have not received prior treatment with docetaxel.
- Have availability of adequate formalin-fixed paraffin-embedded (FFPE) tumor derived
material.
- Have adequate organ function including hematology, renal, and liver.
- Have good performance score (0-1).
- Have measureable disease per RECIST 1.1.
- Agree to use a reliable medically approved method of birth control.
Exclusion Criteria:
- Have received prior treatment with any cyclin dependent kinase (CDK) 4 and 6 inhibitor
or participated in a clinical trial with a CDK 4 and 6 inhibitor and the treatment
administered is not known.
- Are currently receiving treatment in a clinical trial involving an investigational
product or non-approved use of a drug or device.
- Have the presence of unstable central nervous system (CNS) metastasis.
- Have had major surgery (excluding biopsy) < 28 days of the initial dose of study drug.
We found this trial at
6
sites
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Fayetteville, Arkansas 72703
Principal Investigator: Eric Schaefer
Phone: 479-587-1700
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Olympia, Washington 98502
Principal Investigator: Joseph Ye
Phone: 360-352-2900
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660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Ramaswamy Govindan
Phone: 314-362-5737
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Cancer Center of Kansas The physicians of Cancer Center are hematologists and oncologists. The staff...
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