Roll-over Study to Allow Access to Certinib (LDK378) for Patients Who Are on Ceritinib Treatment in a Novartis-sponsored Study

Last updated: June 12, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Not Recruiting

Phase

4

Condition

Neoplasms

Treatment

ceritinib

Clinical Study ID

NCT02584933
CLDK378A2X01B
  • Ages 12-100
  • All Genders

Study Summary

The rollover study will provide ceritinib to patients who are currently receiving treatment with ceritinib within a Novartis-sponsored study and in the opinion of the investigator, would benefit from continued treatment with ceritinib.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient is currently receiving treatment with ceritinib within a Novartis-sponsoredstudy which has fulfilled the requirements for the primary objective and, in theopinion of the Investigator, would benefit from continued treatment.

  • Patient has demonstrated compliance, as assessed by the investigator, with theparent study protocol requirements.

  • Willingness and ability to comply with scheduled visits, treatment plans and anyother study procedures.

  • Written informed consent obtained prior to enrolling in the roll-over study andreceiving study medication. If consent cannot be expressed in writing, it must beformally documented and witnessed via an independent trusted witness.

Exclusion

Exclusion Criteria:

  • Patient has been permanently and prematurely discontinued from ceritinib studytreatment in the parent study due to any reason.

  • Patient currently has unresolved toxicities for which ceritinib dosing has beeninterrupted in the parent study.

  • Pregnant or nursing (lactating) women, where pregnancy is defined as the state of afemale after conception and until the termination of gestation, confirmed by apositive serum hCG laboratory test.

  • Women of child-bearing potential, defined as all women physiologically capable ofbecoming pregnant, unless they are using highly effective methods of contraceptionduring dosing and for 3 months afer stopping ceritinib treatment.

  • Sexually active males unless they use a condom during intercourse while taking drugand for 3 months after stopping ceritinib and should not father a child for at least 3 months after the last dose of treatment.

Study Design

Total Participants: 233
Treatment Group(s): 1
Primary Treatment: ceritinib
Phase: 4
Study Start date:
December 11, 2015
Estimated Completion Date:
June 09, 2027

Connect with a study center

  • Novartis Investigative Site

    St. Leonards, New South Wales 2065
    Australia

    Site Not Available

  • Novartis Investigative Site

    East Melbourne, Victoria 3002
    Australia

    Site Not Available

  • Novartis Investigative Site

    Franston, Victoria 3199
    Australia

    Site Not Available

  • Novartis Investigative Site

    Melbourne, Victoria 3000
    Australia

    Site Not Available

  • Novartis Investigative Site

    Auckland, 1023
    Australia

    Site Not Available

  • Novartis Investigative Site

    Leuven, 3000
    Belgium

    Site Not Available

  • Novartis Investigative Site

    Natal, RN 59075 740
    Brazil

    Site Not Available

  • Novartis Investigative Site

    Porto Alegre, Rio Grande Do Sul 90610-000
    Brazil

    Site Not Available

  • Novartis Investigative Site

    Sao Paulo, SP 01246 000
    Brazil

    Site Not Available

  • Novartis Investigative Site

    Barretos, Sao Paulo 14784 400
    Brazil

    Site Not Available

  • Novartis Investigative Site

    Sofia, 1303
    Bulgaria

    Site Not Available

  • Novartis Investigative Site

    Guang Zhou, Guangdong 510120
    China

    Site Not Available

  • Novartis Investigative Site

    Guangzhou, Guangdong 510080
    China

    Site Not Available

  • Novartis Investigative Site

    Changchun, Jilin 130012
    China

    Site Not Available

  • Novartis Investigative Site

    Beijing, 100039
    China

    Site Not Available

  • Novartis Investigative Site

    Monteria, 230004
    Colombia

    Site Not Available

  • Novartis Investigative Site

    Brno, Czech Republic 656 53
    Czechia

    Site Not Available

  • Novartis Investigative Site

    France, Villejuif 94800
    France

    Site Not Available

  • Novartis Investigative Site

    Villejuif Cedex, Villejuif 94800
    France

    Site Not Available

  • Novartis Investigative Site

    Paris, 75970
    France

    Site Not Available

  • Novartis Investigative Site

    Saint Herblain, 44805
    France

    Site Not Available

  • Novartis Investigative Site

    Saint Herblain cedex, 44805
    France

    Site Not Available

  • Novartis Investigative Site

    Saint-Herblain, 44805
    France

    Site Not Available

  • Novartis Investigative Site

    Saint-Herblain Cédex, 44805
    France

    Site Not Available

  • Novartis Investigative Site

    Strasbourg Cedex, 67091
    France

    Site Not Available

  • Novartis Investigative Site

    Villejuif, 94800
    France

    Site Not Available

  • Novartis Investigative Site

    Regensburg, Bavaria 93053
    Germany

    Site Not Available

  • Novartis Investigative Site

    Essen, 45147
    Germany

    Site Not Available

  • Novartis Investigative Site

    Heidelberg, 69120
    Germany

    Site Not Available

  • Novartis Investigative Site

    Koeln, 50937
    Germany

    Site Not Available

  • Novartis Investigative Site

    Wuerzburg, 97074
    Germany

    Site Not Available

  • Novartis Investigative Site

    Hong Kong, 999077
    Hong Kong

    Site Not Available

  • Novartis Investigative Site

    Pokfulam, 999077
    Hong Kong

    Site Not Available

  • Novartis Investigative Site

    Shatin,
    Hong Kong

    Site Not Available

  • Novartis Investigative Site

    Shatin New Territories,
    Hong Kong

    Site Not Available

  • Novartis Investigative Site

    Shatin, New Territories,
    Hong Kong

    Site Not Available

  • Novartis Investigative Site

    Avellino, AV 83100
    Italy

    Site Not Available

  • Novartis Investigative Site

    Bergamo, BG 24127
    Italy

    Site Not Available

  • Novartis Investigative Site

    Bologna, BO 40138
    Italy

    Site Not Available

  • Novartis Investigative Site

    Brescia, BS 25123
    Italy

    Site Not Available

  • Novartis Investigative Site

    Meldola, FC 47014
    Italy

    Site Not Available

  • Novartis Investigative Site

    Livorno, LI 57124
    Italy

    Site Not Available

  • Novartis Investigative Site

    Monza, MB 20900
    Italy

    Site Not Available

  • Novartis Investigative Site

    Milano, MI 20162
    Italy

    Site Not Available

  • Novartis Investigative Site

    Rozzano, MI 20089
    Italy

    Site Not Available

  • Novartis Investigative Site

    Modena, MO 41124
    Italy

    Site Not Available

  • Novartis Investigative Site

    Perugia, PG 06129
    Italy

    Site Not Available

  • Novartis Investigative Site

    Aviano, PN 33081
    Italy

    Site Not Available

  • Novartis Investigative Site

    Parma, PR 43100
    Italy

    Site Not Available

  • Novartis Investigative Site

    Orbassano, TO 10043
    Italy

    Site Not Available

  • Novartis Investigative Site

    Napoli, 80131
    Italy

    Site Not Available

  • Novartis Investigative Site

    Novara, 28100
    Italy

    Site Not Available

  • Novartis Investigative Site

    Nagoya, Aichi 464 8681
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kashiwa, Chiba 277 8577
    Japan

    Site Not Available

  • Novartis Investigative Site

    Fukuoka-city, Fukuoka 811-1395
    Japan

    Site Not Available

  • Novartis Investigative Site

    Akashi, Hyogo 673-8558
    Japan

    Site Not Available

  • Novartis Investigative Site

    Koto, Tokyo 135-8550
    Japan

    Site Not Available

  • Novartis Investigative Site

    Koto ku, Tokyo 135 8550
    Japan

    Site Not Available

  • Novartis Investigative Site

    Koto-ku, Tokyo 135-8550
    Japan

    Site Not Available

  • Novartis Investigative Site

    Fukuoka, 811-1395
    Japan

    Site Not Available

  • Novartis Investigative Site

    Seoul, 03722
    Korea, Republic of

    Site Not Available

  • Novartis Investigative Site

    Ashrafieh, 166830
    Lebanon

    Site Not Available

  • Novartis Investigative Site

    Kuching, Sarawak 93586
    Malaysia

    Site Not Available

  • Novartis Investigative Site

    Pulau Pinang, 10990
    Malaysia

    Site Not Available

  • Novartis Investigative Site

    Amsterdam, 1081 HV
    Netherlands

    Site Not Available

  • Novartis Investigative Site

    Groningen, 9713 GZ
    Netherlands

    Site Not Available

  • Novartis Investigative Site

    Gdansk, 80 952
    Poland

    Site Not Available

  • Novartis Investigative Site

    Moscow, 115478
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Saint Petersburg, 192148
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Saint-Petersburg, 197342
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    St Petersburg, 197343
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Singapore, 168583
    Singapore

    Site Not Available

  • Novartis Investigative Site

    Malaga, Andalucia 29010
    Spain

    Site Not Available

  • Novartis Investigative Site

    Barcelona, Catalunya 08035
    Spain

    Site Not Available

  • Novartis Investigative Site

    La Coruna, Galicia 15006
    Spain

    Site Not Available

  • Novartis Investigative Site

    Madrid, 28046
    Spain

    Site Not Available

  • Novartis Investigative Site

    Taichung, 40447
    Taiwan

    Site Not Available

  • Novartis Investigative Site

    Taipei, 11217
    Taiwan

    Site Not Available

  • Novartis Investigative Site

    Taoyuan, 33305
    Taiwan

    Site Not Available

  • Novartis Investigative Site

    Bangkok, 10330
    Thailand

    Site Not Available

  • Novartis Investigative Site

    Songkla, 90110
    Thailand

    Site Not Available

  • Highlands Oncology Group

    Fayetteville, Arkansas 72703
    United States

    Site Not Available

  • Highlands Oncology Group .

    Fayetteville, Arkansas 72703
    United States

    Site Not Available

  • Novartis Investigative Site

    Fayetteville, Arkansas 72703
    United States

    Site Not Available

  • Loma Linda University

    Loma Linda, California 92354
    United States

    Site Not Available

  • Loma Linda University .

    Loma Linda, California 92354
    United States

    Site Not Available

  • Novartis Investigative Site

    Loma Linda, California 92354
    United States

    Site Not Available

  • Novartis Investigative Site

    Aurora, Colorado 80045
    United States

    Site Not Available

  • University of Colorado Cancer Center

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Maryland Oncology Hematology P A

    Rockville, Maryland 20850
    United States

    Site Not Available

  • Maryland Oncology Hematology P A Dept of Assoc Onc Hem

    Rockville, Maryland 20850
    United States

    Site Not Available

  • Maryland Oncology Hematology P A Dept. of Assoc. Onc/Hem

    Rockville, Maryland 20850
    United States

    Completed

  • Maryland Oncology Hematology, P.A. Dept. of Assoc. Onc/Hem

    Rockville, Maryland 20850
    United States

    Completed

  • Novartis Investigative Site

    Rockville, Maryland 20850
    United States

    Site Not Available

  • Essex Oncology of North Jersey PA

    Belleville, New Jersey 07109
    United States

    Site Not Available

  • Novartis Investigative Site

    Belleville, New Jersey 07109
    United States

    Site Not Available

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