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

NCT02584933

Active Not RecruitingPhase 4

Sponsor: Novartis Pharmaceuticals

Conditions: ALK Positive Malignancies

Interventions: ceritinib

Countries: United States, Australia, Belgium, Brazil, Bulgaria, China, Colombia, Czechia

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 overview

Sex: ALL

Age: 12 Years to 100 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
Locations (71)
  • Fayetteville, Arkansas, United States
  • Loma Linda, California, United States
  • Aurora, Colorado, United States
  • Rockville, Maryland, United States
  • Belleville, New Jersey, United States
  • Melbourne, Victoria, Australia
  • Auckland, Australia
  • Leuven, Belgium
  • Natal, Rio Grande do Norte, Brazil
  • Porto Alegre, Rio Grande do Sul, Brazil
  • Barretos, São Paulo, Brazil
  • São Paulo, São Paulo, Brazil
  • Sofia, Bulgaria
  • Guangzhou, Guangdong, China
  • Guangzhou, Guangdong, China
  • Changchun, Jilin, China
  • Beijing, China
  • Guangzhou, China
  • Montería, Colombia
  • Brno, Czechia
  • Paris, France
  • Paris, France
  • Saint-Herblain, France
  • Strasbourg, France
  • Villejuif, France
  • Regensburg, Bavaria, Germany
  • Cologne, North Rhine-Westphalia, Germany
  • Essen, Germany
  • Heidelberg, Germany
  • Würzburg, Germany
  • + 41 more on CT.gov