Continued Access to Ceritinib for Cancer

Recruiting in Palo Alto (17 mi)

+72 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Novartis Pharmaceuticals

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?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

This trial is for patients already taking ceritinib in a Novartis study, who could benefit from continuing it. They must have followed previous study rules well and agree to future procedures. It's not for those with unresolved side effects from ceritinib, pregnant or breastfeeding women, or those not using effective birth control.

Inclusion Criteria

I am currently on ceritinib in a Novartis study and my doctor thinks I should continue.

Patient has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements

I am willing and able to follow the study's schedule and procedures.

+1 more

Exclusion Criteria

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

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

I stopped taking ceritinib due to side effects that haven't gone away.

+2 more

Participant Groups

The trial provides ongoing access to ceritinib for cancer patients benefiting from it in prior Novartis studies. The focus is on the continued effectiveness and safety of ceritinib as a treatment option.

1Treatment groups

Experimental Treatment

Group I: ceritinibExperimental Treatment1 Intervention

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.

Ceritinib is already approved in United States for the following indications:

🇺🇸 Approved in United States as Danyelza for: