Continued Access to Ceritinib for Cancer

Not currently recruiting at 91 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on providing continued access to a cancer treatment called ceritinib. Researchers are testing ceritinib to determine if it remains beneficial for individuals who have already used it in a previous study and are experiencing positive outcomes. Those who participated in a Novartis study with ceritinib and whose doctors believe they can continue to benefit from it may be suitable candidates. Participants should also be willing to adhere to the study schedule and follow the treatment plan. As a Phase 4 trial, this study involves an FDA-approved treatment and aims to understand its benefits for more patients.

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.

What is the safety track record for ceritinib?

Research has shown that ceritinib, a treatment for certain types of lung cancer, is considered safe, as the FDA has approved it for these conditions. When a treatment reaches Phase 4 trials, earlier studies have generally found it to be safe. Ceritinib is already in medical use, indicating it has been evaluated for safety and effectiveness.

Patients taking ceritinib have experienced side effects such as nausea, diarrhea, and fatigue, which are common with many cancer treatments. However, the Phase 4 status of this trial indicates that ceritinib is well-tolerated enough for widespread use, and ongoing studies continue to gather more detailed safety information. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Ceritinib is unique because it specifically targets the ALK (anaplastic lymphoma kinase) gene, which is altered in certain types of cancer, such as non-small cell lung cancer (NSCLC). Unlike standard chemotherapy, which attacks rapidly dividing cells broadly, ceritinib offers a more targeted approach, potentially leading to fewer side effects. Researchers are excited about ceritinib as it has shown promise in overcoming resistance to earlier ALK inhibitors, providing a new option for patients who may not respond to initially available treatments.

What is the effectiveness track record for ceritinib in cancer treatment?

Research has shown that ceritinib effectively treats non-small cell lung cancer (NSCLC) with ALK-positive mutations. Studies have found that ceritinib significantly reduces tumor size and slows disease progression in these patients. Those treated with ceritinib often experience a longer period before their cancer worsens compared to those who did not receive this treatment. Ceritinib blocks the proteins that enable cancer cells to grow and spread. This treatment is already approved and has proven effective for these specific cancer mutations. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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]

Citations

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Humanized 3F8 Anti-GD2 Monoclonal Antibody Dosing ... This phase 1 clinical trial found hu3F8 to be associated with modest toxic effects, low immunogenicity, and substantial antineuroblastoma ...

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Clinical Trial: NCT02502786 - Osteosarcoma The purpose of this study is to find out what effect an antibody called Humanized 3F8 (Hu3F8) and a drug called GM-CSF have on the patient.