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

• ClinicalTrials.gov Identifier: NCT02584933
• Recruitment Status: Recruiting
• First Posted: October 23, 2015
• Last Update Posted: November 14, 2022
• Sponsor: Novartis Pharmaceuticals
• Information provided by (Responsible Party): Novartis ( Novartis Pharmaceuticals )

Tracking Information

• First Submitted Date: October 6, 2015
• First Posted Date: October 23, 2015
• Last Update Posted Date: November 14, 2022
• Actual Study Start Date: December 11, 2015
• Estimated Primary Completion Date: June 9, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 21, 2015)

Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Until no patients are left on study up to 5 years ]

To collect safety data: adverse events and serious adverse events

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Roll-over Study to Allow Access to Certinib (LDK378) for Patients Who Are on Ceritinib Treatment in a Novartis-sponsored Study
• Official Title: An Open-label, Multi-center, Phase IV Roll-over Study in Patients With ALK Positive Malignancies Who Have Completed a Novartis-sponsored Ceritinib (LDK378) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Ceritinib
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: ALK Positive Malignancies

Intervention

Drug: ceritinib

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

Study Arms

Experimental: ceritinib

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.

Intervention: Drug: ceritinib

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 1, 2019): 252
• Original Estimated Enrollment (submitted: October 21, 2015): 150
• Estimated Study Completion Date: June 9, 2025
• Estimated Primary Completion Date: June 9, 2025 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 12 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Novartis Pharmaceuticals; 1-888-669-6682

Contact: Novartis Pharmaceuticals; +41613241111

• Listed Location Countries: Australia, Belgium, Brazil, Bulgaria, China, Colombia, Czechia, France, Germany, Hong Kong, Italy, Japan, Korea, Republic of, Lebanon, Malaysia, Poland, Russian Federation, Singapore, Spain, Taiwan, United States
• Removed Location Countries: Netherlands, Thailand

Administrative Information

• NCT Number: NCT02584933
• Other Study ID Numbers: CLDK378A2X01B
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Novartis ( Novartis Pharmaceuticals )
• Original Responsible Party: Same as current
• Current Study Sponsor: Novartis Pharmaceuticals
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Novartis
• Verification Date: November 2022