Ceritinib Access for ALK-Positive Tumors
This study provides access to Ceritinib for individuals with ALK-positive tumors, focusing on offering treatment options to those who may benefit from it.
Data Collection
Bronchial Neoplasms+21
+ Carcinoma, Bronchogenic
+ Carcinoma, Non-Small-Cell Lung
Recruiting
Available upon a request by a licensed MDSummary
This study focuses on providing access to a medication called Ceritinib for patients with specific types of cancer known as ALK-positive tumors. ALK-positive tumors are cancers that have a particular genetic characteristic, and Ceritinib is a treatment that targets this. The study includes adults with non-small cell lung cancer (NSCLC) that is ALK-positive, as well as pediatric patients with ALK-positive tumors. This study is significant because it offers patients access to Ceritinib, a potentially beneficial treatment option, especially for those who might not have other effective treatment available. The study involves a Managed Access Program (MAP), which is a way to give patients access to Ceritinib outside of a traditional clinical trial. Participants take Ceritinib orally, and the study monitors their response to the treatment to assess its effectiveness and safety. While the primary outcomes aren't detailed, the study likely observes how well the drug manages the cancer and any side effects it might cause. This type of program is crucial for providing new treatment options to patients who urgently need them, even when the medication is not yet widely available.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 12 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: 1. An independent request was received from a licensed physician. 2. The patient has a serious or life-threatening disease or condition and there is no comparable or satisfactory alternative therapy available for diagnosis, monitoring, or treatment. 3. The patient is not eligible or able to enroll in a clinical trial or continue participation in such trial. 4. There is a potential patient benefit to justify the potential risk of the treatment use, and the potential risk is not unreasonable in the context of the disease or condition to be treated. 5. The patient must meet any other medical criteria established by the medical experts responsible for the product or by the health authority in the country of request (as applicable). 6. Provision of the product will not interfere with the initiation, conduct, or completion of a Novartis clinical trial or overall development program. 7. Managed Access provision is allowed per local laws/regulations.