LDK378 in Crizotinib naïve Adult Patients With ALK-activated Non-small Cell Lung Cancer
Completed · Phase 2
Conditions studied: Non-Small Cell Lung Cancer
In brief
A single-arm, open-label, two-stage multicenter, phase II study. Patients were pre-screened for ALK positive status. Treatment with LDK378 at 750 mg qd was continued until the patient experienced unacceptable toxicity that precluded further treatment, discontinued treatment at the discretion of the investigator or patient, started a new anticancer therapy and/or died. LDK378 was 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. 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. Male and female patients aged 18 or over with ALK-rearranged non-small cell cancer (NSCLC) were screened for eligibility. Patients had to have received no prior crizotinib, and had to be chemotherapy-naïve or been pretreated with cytotoxic chemotherapy (up to three prior lines).
Key facts
- Study ID
- NCT01685138
- Run by
- Novartis Pharmaceuticals
- People needed
- 124
- Starts
- 2012-12-20
- Expected to finish
- 2018-01-22
- Last updated by the study team
- 2019-03-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Washington University School of Medicine Washington University (16) — St Louis, Missouri, 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
- Novartis Investigative Site — St Leonards, New South Wales, Australia
- Novartis Investigative Site — Franston, Victoria, Australia
- Novartis Investigative Site — Genk, Belgium
- Novartis Investigative Site — Leuven, Belgium
- Novartis Investigative Site — Toronto, Ontario, Canada
- Novartis Investigative Site — Saskatoon, Saskatchewan, Canada
- Novartis Investigative Site — Saint-Herblain, France
- Novartis Investigative Site — Hong Kong, Hong Kong
- Novartis Investigative Site — Avellino, AV, Italy
- Novartis Investigative Site — Genova, GE, Italy
- Novartis Investigative Site — Milan, MI, Italy
- Novartis Investigative Site — Rozzano, MI, Italy
- Novartis Investigative Site — Orbassano, TO, Italy
- Novartis Investigative Site — Nagoya, Aichi-ken, Japan
- Novartis Investigative Site — Kashiwa, Chiba, Japan
- Novartis Investigative Site — Fukuoka, Fukuoka, Japan
- Novartis Investigative Site — Akashi, Hyōgo, Japan
- Novartis Investigative Site — Sayama, Osaka, Japan
- Novartis Investigative Site — Sunto Gun, Shizuoka, Japan
- Novartis Investigative Site — Chuo-ku, Tokyo, Japan
- Novartis Investigative Site — Koto Ku, Tokyo, Japan
- Massachusetts General Hospital Mass Gen 5 — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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