Continued Access to Ceritinib for Cancer

Recruiting at 72 trial locations

Overseen By Novartis Pharmaceuticals

Age: Any Age

Sex: Any

Trial Phase: Phase 4

Sponsor: Novartis Pharmaceuticals

Must be taking: Ceritinib

Disqualifiers: Pregnancy, Unresolved toxicities, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 5 years

233 Participants Needed

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.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on continuing ceritinib treatment for those already on it.

Is ceritinib generally safe for humans?

Ceritinib has been shown to be generally safe in humans, with common side effects including diarrhea, nausea, vomiting, and liver test abnormalities. Most patients tolerate the treatment well, although some may need dose adjustments due to side effects. ^{1 2 3 4 5}

How is the drug ceritinib unique in treating cancer?

Ceritinib is a second-generation ALK inhibitor that is particularly effective in overcoming resistance to crizotinib, a first-generation ALK inhibitor, in non-small cell lung cancer (NSCLC) with ALK rearrangements. It is also effective in treating brain metastases, which makes it unique compared to other treatments. ^{6 7 8 9 10}

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants continue receiving ceritinib treatment as per the previous study protocol

Up to 5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Ceritinib

Trial Overview 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.

Participant Groups

Group I: ceritinib Experimental Treatment 1 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:

• High-risk neuroblastoma in the bone or bone marrow

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Findings from Research

Ceritinib, an ALK inhibitor for advanced non-small cell lung cancer, demonstrated a safety profile consistent with previous studies, with no new adverse events reported beyond those identified at the time of its approval.

The drug showed meaningful efficacy in treating patients who had previously been on other treatments, achieving an overall response rate of 29.55% and a disease control rate of 53.41% over a follow-up period of one year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ceritinib in Japanese patients with anaplastic lymphoma kinase (ALK)+ non-small cell lung cancer: interim analysis results of a post-marketing surveillance study. Kaneda, H., Kizaki, M., Ochi, M., et al.[2021]

Ceritinib is an effective treatment for patients with ALK-positive advanced non-small cell lung cancer (NSCLC) who have previously been treated with crizotinib, showing a response rate of 36-56% in clinical trials and durable responses lasting up to 10 months.

The drug has a manageable safety profile, with common side effects including gastrointestinal issues, fatigue, and liver test abnormalities, making it a valuable option for patients in this specific treatment setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ceritinib: a Review in ALK-Positive Advanced NSCLC. Deeks, ED.[2020]

Ceritinib received accelerated FDA approval for treating ALK-positive metastatic non-small cell lung cancer (NSCLC) based on a trial with 163 patients, showing a 44% objective response rate and a median duration of response of 7.1 months after progression on crizotinib.

Despite common side effects like diarrhea (86%) and nausea (80%), the overall safety profile was deemed acceptable, with a low discontinuation rate of 10%, supporting the drug's favorable benefit-risk analysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FDA approval: ceritinib for the treatment of metastatic anaplastic lymphoma kinase-positive non-small cell lung cancer. Khozin, S., Blumenthal, GM., Zhang, L., et al.[2022]

In a phase 0 trial involving 10 patients with brain metastases or recurrent glioblastoma, ceritinib was well-tolerated with no dose-limiting toxicities observed, indicating a favorable safety profile.

Despite ceritinib's high binding to plasma proteins and tumor tissues, the unbound drug concentrations in the brain were insufficient to effectively modulate its intended targets, suggesting limited efficacy in this setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Phase 0 Trial of Ceritinib in Patients with Brain Metastases and Recurrent Glioblastoma. Mehta, S., Fiorelli, R., Bao, X., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Ceritinib in Japanese patients with anaplastic lymphoma kinase (ALK)+ non-small cell lung cancer: interim analysis results of a post-marketing surveillance study. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of ceritinib in anaplastic lymphoma kinase-rearranged non-small cell lung cancer: A systematic review and meta-analysis. [2021]

3. France pubmed.ncbi.nlm.nih.gov

Ceritinib: a Review in ALK-Positive Advanced NSCLC. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

FDA approval: ceritinib for the treatment of metastatic anaplastic lymphoma kinase-positive non-small cell lung cancer. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Effects of meal type on the oral bioavailability of the ALK inhibitor ceritinib in healthy adult subjects. [2018]

6. India pubmed.ncbi.nlm.nih.gov

Clinical data from the real world: Efficacy analysis of ceritinib (450mg) in ALK-rearrangement non-small-cell lung cancer patients with brain metastases in China. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

The ALK inhibitor ceritinib overcomes crizotinib resistance in non-small cell lung cancer. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

A Phase 0 Trial of Ceritinib in Patients with Brain Metastases and Recurrent Glioblastoma. [2023]

9. Spain pubmed.ncbi.nlm.nih.gov

Ceritinib for the treatment of non-small cell lung cancer. [2018]

10. France pubmed.ncbi.nlm.nih.gov

[Modalities of use of ceritinib (Zykadia™), a 2nd generation ALK inhibitor, in advanced stage non-small cell lung cancer]. [2018]