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

NCT02584933 | Active Not Recruiting Phase 4

• 2 other identifiers: CLDK378A2X01B2024-511040-58-00
• Study Type: interventional
• Target: 233
• Locations: 21 countries
• Sites: 71

Brief 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.

Conditions

ALK Positive Malignancies

Keywords

ALK; Malignancies

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  To collect safety data: adverse events and serious adverse events

  Until no patients are left on study up to 5 years

Study Arms (1)

ceritinib

EXPERIMENTAL

The starting dose of study treatment for patients in this protocol should be the same as the dose provided in the parent ceritinib study at the time of the rollover.

Drug: ceritinib

Interventions

ceritinib DRUG

hard gelatin capsule or hard tablet for oral use up to 750 mg

ceritinib

Eligibility Criteria

• Age: 12 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is currently receiving treatment with ceritinib within a Novartis-sponsored study which has fulfilled the requirements for the primary objective and, in the opinion of the Investigator, would benefit from continued treatment.
• Patient has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements.
• Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures.
• Written informed consent obtained prior to enrolling in the roll-over study and receiving study medication. If consent cannot be expressed in writing, it must be formally documented and witnessed via an independent trusted witness.

You may not qualify if:

• Patient has been permanently and prematurely discontinued from ceritinib study treatment in the parent study due to any reason.
• Patient currently has unresolved toxicities for which ceritinib dosing has been interrupted in the parent study.
• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive serum hCG laboratory test.
• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 3 months afer stopping ceritinib treatment.
• Sexually active males unless they use a condom during intercourse while taking drug and for 3 months after stopping ceritinib and should not father a child for at least 3 months after the last dose of treatment.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (71)

Highlands Oncology Group

Fayetteville, Arkansas, 72703, United States

Location

Loma Linda University

Loma Linda, California, 92354, United States

Location

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

Location

Maryland Oncology Hematology P A

Rockville, Maryland, 20850, United States

Location

Essex Oncology of North Jersey PA

Belleville, New Jersey, 07109, United States

Location

Novartis Investigative Site

Melbourne, Victoria, 3000, Australia

Location

Novartis Investigative Site

Auckland, 1023, Australia

Location

Novartis Investigative Site

Leuven, 3000, Belgium

Location

Novartis Investigative Site

Natal, Rio Grande do Norte, 59075 740, Brazil

Location

Novartis Investigative Site

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Novartis Investigative Site

Barretos, São Paulo, 14784 400, Brazil

Location

Novartis Investigative Site

São Paulo, São Paulo, 01246 000, Brazil

Location

Novartis Investigative Site

Sofia, 1303, Bulgaria

Location

Novartis Investigative Site

Guangzhou, Guangdong, 510080, China

Location

Novartis Investigative Site

Guangzhou, Guangdong, 510120, China

Location

Novartis Investigative Site

Changchun, Jilin, 130012, China

Location

Novartis Investigative Site

Beijing, 100039, China

Location

Novartis Investigative Site

Guangzhou, 510060, China

Location

Novartis Investigative Site

Montería, 230004, Colombia

Location

Novartis Investigative Site

Brno, 656 53, Czechia

Location

Novartis Investigative Site

Paris, 75231, France

Location

Novartis Investigative Site

Paris, 75970, France

Location

Novartis Investigative Site

Saint-Herblain, 44805, France

Location

Novartis Investigative Site

Strasbourg, 67091, France

Location

Novartis Investigative Site

Villejuif, 94800, France

Location

Novartis Investigative Site

Regensburg, Bavaria, 93053, Germany

Location

Novartis Investigative Site

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Novartis Investigative Site

Essen, 45147, Germany

Location

Novartis Investigative Site

Heidelberg, 69120, Germany

Location

Novartis Investigative Site

Würzburg, 97074, Germany

Location

Novartis Investigative Site

Hong Kong, 999077, Hong Kong

Location

Novartis Investigative Site

Bergamo, BG, 24127, Italy

Location

Novartis Investigative Site

Bologna, BO, 40138, Italy

Location

Novartis Investigative Site

Brescia, BS, 25123, Italy

Location

Novartis Investigative Site

Meldola, FC, 47014, Italy

Location

Novartis Investigative Site

Monza, MB, 20900, Italy

Location

Novartis Investigative Site

Milan, MI, 20133, Italy

Location

Novartis Investigative Site

Milan, MI, 20162, Italy

Location

Novartis Investigative Site

Rozzano, MI, 20089, Italy

Location

Novartis Investigative Site

Modena, MO, 41124, Italy

Location

Novartis Investigative Site

Perugia, PG, 06129, Italy

Location

Novartis Investigative Site

Aviano, PN, 33081, Italy

Location

Novartis Investigative Site

Milan, 20141, Italy

Location

Novartis Investigative Site

Naples, 80131, Italy

Location

Novartis Investigative Site

Novara, 28100, Italy

Location

Novartis Investigative Site

Nagoya, Aichi-ken, 464 8681, Japan

Location

Novartis Investigative Site

Fukuoka, Fukuoka, 811-1395, Japan

Location

Novartis Investigative Site

Akashi, Hyōgo, 673-8558, Japan

Location

Novartis Investigative Site

Koto Ku, Tokyo, 135-8550, Japan

Location

Novartis Investigative Site

Beirut, 166830, Lebanon

Location

Novartis Investigative Site

George Town, Pulau Pinang, 10450, Malaysia

Location

Novartis Investigative Site

Kuching, Sarawak, 93586, Malaysia

Location

Novartis Investigative Site

Gdansk, 80-214, Poland

Location

Novartis Investigative Site

Moscow, 115522, Russia

Location

Novartis Investigative Site

Saint Petersburg, 192148, Russia

Location

Novartis Investigative Site

Saint Petersburg, 197343, Russia

Location

Novartis Investigative Site

Singapore, 168583, Singapore

Location

Novartis Investigative Site

Seoul, 03080, South Korea

Location

Novartis Investigative Site

Seoul, 03722, South Korea

Location

Novartis Investigative Site

Seoul, 05505, South Korea

Location

Novartis Investigative Site

A Coruña, 15006, Spain

Location

Novartis Investigative Site

Barcelona, 08035, Spain

Location

Novartis Investigative Site

Madrid, 28046, Spain

Location

Novartis Investigative Site

Madrid, 28050, Spain

Location

Novartis Investigative Site

Málaga, 29010, Spain

Location

Novartis Investigative Site

Taichung, 40447, Taiwan

Location

Novartis Investigative Site

Taichung, 407219, Taiwan

Location

Novartis Investigative Site

Taipei, 10002, Taiwan

Location

Novartis Investigative Site

Taipei, 110, Taiwan

Location

Novartis Investigative Site

Taipei, 11217, Taiwan

Location

Novartis Investigative Site

Taoyuan District, 33305, Taiwan

Location

MeSH Terms

Conditions

Neoplasms

Interventions

ceritinib

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: October 6, 2015
• First Posted: October 23, 2015
• Study Start: December 11, 2015
• Primary Completion (Estimated): June 9, 2027
• Study Completion (Estimated): June 9, 2027
• Last Updated: April 2, 2026

Record last verified: 2026-03

Locations

CO (1); BR (4); CN (5); AU (2); IT (14); JP (4); MY (2); KR (3); TW (6); PL (1); ES (5); SG (1); BU (1); CZ (1); RU (3); DE (5); HK (1); BE (1); LE (1); FR (5); US (5)