LDK378 in Adult Patients With ALK-activated NSCLC Previously Treated With Chemotherapy and Crizotinib

Completed · Phase 2

Conditions studied: Non-Small Cell Lung Cancer

In brief

A single-arm, open-label, multicenter, phase II study. Treatment with LDK378 750 mg qd continued until the patient experienced unacceptable toxicity that precluded further treatment, discontinued treatment at the discretion of the investigator or patient, started a new anti-cancer therapy and/or died. LDK378 could be continued beyond RECIST-defined progressive disease (PD) as assessed by the investigator if, in the judgment of the investigator, there was evidence of clinical benefit. In these patients tumor assessment would continue as per the schedule of assessments until treatment with LDK378 was permanently discontinued. Patients who discontinued the study medication in the absence of progression continued to be followed for tumor assessment until the time of PD as assessed by the investigator

Key facts

Study ID

NCT01685060

Run by

Novartis Pharmaceuticals

People needed

140

Starts

2012-11-26

Expected to finish

2016-03-29

Last updated by the study team

2017-06-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Patients with known hypersensitivity to any of the excipients of LDK378.
• Patients with symptomatic central nervous system (CNS) metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms.
• History of carcinomatous meningitis.
• Presence or history of a malignant disease other than NSCLC that has been diagnosed and/or required therapy within the past 3 years.
• Clinically significant, uncontrolled heart disease
• Systemic anti-cancer therapy given after the last dose of crizotinib and prior to starting study drug.

Where it is running

• City of Hope National Medical Center Dept of Oncology 2 — Duarte, California, United States
• University of California at Los Angeles Reg-5 — Los Angeles, California, United States
• University of California at San Diego, Moores Cancer Ctr SC — San Diego, California, United States
• Stanford University Medical Center Stanford Cancer Center(2) — Stanford, California, United States
• University of Colorado Hospital SC — Aurora, Colorado, United States
• Emory University School of Medicine/Winship Cancer Institute Dept of Oncology — Atlanta, Georgia, United States
• University of Chicago Medical Center SC — Chicago, Illinois, United States
• University of Kansas Cancer Center DeptofUofKansas CancerCenter-2 — Kansas City, Kansas, United States
• Cancer Center of Kansas Dept of CCK — Wichita, Kansas, United States
• Maryland Oncology Hematology, P.A. SC — Rockville, Maryland, United States
• Massachusetts General Hospital Mass General — Boston, Massachusetts, United States
• Levine Cancer Institute SC 1 — Charlotte, North Carolina, United States
• Sarah Cannon Research Institute Drug Ship - 4 — Nashville, Tennessee, United States
• U of TX Southwestern Medical Center - SimmonsCompCancerCtr Clinical Research Office — Dallas, Texas, United States
• Seattle Cancer Care Alliance SC-1 — Seattle, Washington, United States
• University of Wisconsin Univ Wisc 2 — Madison, Wisconsin, United States
• Novartis Investigative Site — Edmonton, Alberta, Canada
• Novartis Investigative Site — Oshawa, Ontario, Canada
• Novartis Investigative Site — Toronto, Ontario, Canada
• Novartis Investigative Site — Marseille, France
• Novartis Investigative Site — Paris, France
• Novartis Investigative Site — Cologne, North Rhine-Westphalia, Germany
• Novartis Investigative Site — Heidelberg, Germany
• Novartis Investigative Site — Hong Kong, Hong Kong
• Highlands Oncology Group Dept of Highlands Oncology Grp — Fayetteville, Arkansas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.