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

Novartis

Status and phase: Active, not recruiting; Phase 4

Conditions: ALK Positive Malignancies

Treatments: Drug: ceritinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02584933

CLDK378A2X01B

Details and patient eligibility

About

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.

Enrollment: 234 patients

Sex: All

Ages: 12 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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234 participants in 1 patient group

ceritinib

Experimental group

Description:

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.

Treatment:

Drug: ceritinib