A Phase II Study to Evaluate the Efficacy and Safety of Oral Ceritinib in Patients With ALK-positive NSCLC Metastatic to the Brain and/or to Leptomeninges

Completed · Phase 2

Conditions studied: ALK-positive Non-small Cell Lung Cancer

In brief

This was a phase II, multi-center, open-label, five-arm study in which the efficacy and safety of oral ceritinib treatment was assessed in patients with NSCLC metastatic to the brain and/or to leptomeninges harboring a confirmed ALK rearrangement, using the FDA approved Vysis ALK Break Apart FISH Probe Kit (Abbott Molecular Inc.) test and scoring algorithm (including positivity criteria). If documentation of ALK rearrangement as described above was not locally available, a test to confirm ALK rearrangement was performed by a Novartis designated central laboratory. Patients waited for the central laboratory result of the ALK rearrangement status before initiating treatment with ceritinib.

Key facts

Study ID

NCT02336451

Run by

Novartis Pharmaceuticals

People needed

156

Starts

2015-04-01

Expected to finish

2019-02-06

Last updated by the study team

2020-04-21

Who can join

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

You may qualify if…

• Histologically or cytologically confirmed diagnosis of metastatic NSCLC according to the 7th edition of the AJCC Cancer Staging Manual. In addition, the NSCLC must harbor an ALK rearrangement, as assessed using the FDA approved Vysis ALK Break Apart FISH Probe Kit (Abbott Molecular Inc.) test and scoring algorithm (including positivity criteria). If documentation of ALK rearrangement as described above was not locally available, a test to confirm ALK rearrangement was to be performed by a Novartis designated central laboratory. Patients had to wait for the central laboratory result of the ALK rearrangement status before initiating treatment with ceritinib
• At least one extracranial measurable lesion as defined by RECIST 1.1. A previously irradiated site lesion could only be counted as a target lesion if there was clear sign of progression since the irradiation.
• Patients could or could not have neurological symptoms but must have been able to swallow and retain oral medication.
• Patients had to be neurologically stable within at least 1 week prior to the first dose of study drug.
• Patients could have received prior chemotherapy, crizotinib (other ALK inhibitors were not allowed), biologic therapy or other investigational agents.
• Patients must have recovered from all toxicities related to prior anticancer therapies to grade ≤ 1 (CTCAE v 4.03). Patients with any grade of alopecia were allowed to enter the study.
• Patient had life expectancy ≥ 6 weeks.
• Patient had a WHO performance status 0-2.
• Patients in Arm 1 to 4 had to also meet the following inclusion criteria:
• Patients had to have active brain metastases from NSCLC, confirmed by Gadolinium-enhanced MRI without concomitant leptomeningeal carcinomatosis. Dose of steroids had to be stable for 5 days before the baseline brain MRI.
• Patients in Arm 5 had to also meet the following inclusion criteria:
• Patients must have been diagnosed with leptomeningeal carcinomatosis.

You may not qualify if…

• Patients who needed whole brain radiation to control the brain metastases. Patients were not eligible unless treated brain lesions were progressive or new brain lesions were observed since the post whole brain radiation therapy MRI.
• Planning of any brain local treatment (including but not limited to surgery, stereotactic radiosurgery, whole brain radiation, intrathecal chemotherapy) following the administration of the first dose of study drug.
• Patient with a concurrent malignancy or history of a malignant disease other than NSCLC that had been diagnosed and/or required therapy within the past 3 years. Exceptions to this exclusion included the following: completely resected basal cell and squamous cell skin cancers, and completely resected carcinoma in situ of any type.
• Patient had impairment of GI function or GI disease that could significantly alter the absorption of ceritinib (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, or malabsorption syndrome).
• Patient was receiving unstable or increasing doses of corticosteroids.
• Patient had other severe, acute, or chronic medical conditions including uncontrolled diabetes mellitus or psychiatric conditions or laboratory abnormalities that in the opinion of the investigator could increase the risk associated with study participation, or that could interfere with the interpretation of study results.

Where it is running

• Stanford Universtiy Medical Center SC-5 — Stanford, California, United States
• Memorial Hospital of South Bend — South Bend, Indiana, United States
• Dana Farber Cancer Institute SC-12 — Boston, Massachusetts, United States
• The Ohio State University Comprehensive Cancer Center Ohio State University — Columbus, Ohio, United States
• Southwestern Regional Medical Center — Tulsa, Oklahoma, United States
• Seattle Cancer Care Alliance — Seattle, Washington, United States
• Novartis Investigative Site — Auckland, Australia
• Novartis Investigative Site — Leuven, Belgium
• Novartis Investigative Site — Salvador, Estado de Bahia, Brazil
• Novartis Investigative Site — Natal, Rio Grande do Norte, Brazil
• Novartis Investigative Site — Porto Alegre, Rio Grande do Sul, Brazil
• Novartis Investigative Site — Itajaí, Santa Catarina, Brazil
• Novartis Investigative Site — Barretos, São Paulo, Brazil
• Novartis Investigative Site — São Paulo, São Paulo, Brazil
• Novartis Investigative Site — São Paulo, Brazil
• Novartis Investigative Site — Toronto, Ontario, Canada
• Novartis Investigative Site — Marseille, Bouches Du Rhone, France
• Novartis Investigative Site — Paris, France
• Novartis Investigative Site — Rennes, France
• Novartis Investigative Site — Saint-Herblain Cédex, France
• Novartis Investigative Site — Strasbourg, France
• Novartis Investigative Site — Villejuif, France
• Novartis Investigative Site — Bad Berka, Germany
• Novartis Investigative Site — Cologne, Germany
• USC Kenneth Norris Comprehensive Cancer Center SC-3 — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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