Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Lymphoma

Lymphoma, Large-Cell, Anaplastic

Lymphosarcoma

Anaplastic Large Cell Lymphoma

Inflammatory Myofibroblastic Tumor

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Crizotinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

crizotinib

Pfizer CT.gov Call Center

The purpose of this continuation study is to provide continued access to crizotinib treatment for eligible participants from a current Pfizer sponsored crizotinib clinical study that is planned to close.

Participants not previously enrolled or who have discontinued study treatment or safety follow-up in a current Pfizer sponsored crizotinib clinical study are not eligible for participation in this continuation study.

Crizotinib Continuation Clinical Study

CRIZOTINIB MASTER PROTOCOL: AN OPEN-LABEL CONTINUATION STUDY FOR PARTICIPANTS CONTINUING FROM PFIZER-SPONSORED CRIZOTINIB CLINICAL STUDIES

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Safety data collection in this study will permit further characterization of the safety profile of crizotinib.

Pfizer

Diseases and Abnormalities at or Before Birth

Symptoms and General Pathology

Glioblastoma

Congenital Abnormalities

Hematologic Neoplasms

Granuloma

Granuloma, Plasma Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Lymphoma, T-Cell

Lymphoma, Non-Hodgkin

Neuroepithelioma

Ceritinib

Patients diagnosed with IMT with a confirmed translocation involving the ALK gene

Patients with a diagnosis of ALCL histologically or cytologically confirmed to be ALK-positive

Patients with GBM with a translocation involving the ALK gene

Patients with any other ALK-positive tumor. Patients in this arm included adenocarcinoma (n= 2), sarcoma (1) and other (2).

Ceritinib was to be administered orally once daily at a dose of 750 mg (5 capsules of 150 mg) on a continuous dosing schedule. A complete treatment cycle was defined as 28 days of once daily continuous treatment with ceritinib.

Ceritinib (LDK378)

This is Proof-of-Concept (POC) study to assess the preliminary antitumor activity and safety and tolerablity using ceritinib (LDK378) in the treatment of life threatening tumors that are characterized by ALK genetic alteration (and/or overexpression in some diseases).

Depending on the tumor type, subjects were to be enrolled into one of the following parallel arms: ALCL (anaplastic large cell lymphoma); IMT (inflammatory myofibroblastic tumor); glioblastoma (GBM), and any other ALK+ tumor. If there were 5 or more subjects of the same tumor type in the "Any other ALK+ tumor" arm, then a separate arm was to be opened for that specific tumor type.

Ceritinib Rare Indications Study in ALK+ Tumors

A Phase II, Open Label, Multi-center, Multi-arm Study of Ceritinib in Patients With Advanced Solid Tumors and Hematological Malignancies Characterized by Genetic Abnormalities of Anaplastic Lymphoma Kinase (ALK)

The DCR is defined as the percentage of patients with complete response (CR), partial response (PR) or stable disease (SD) at 16 weeks from the start of ceritinib treatment. The assessment criteria are: Solid Tumors (RECIST 1.1., Response Evaluation Criteria in Solid Tumors); GBM (RECIST 1.1 and RANO, Response Evaluation in Neuro-Oncology); Hematologic tumors (Cheson).

ORR is defined as the percentage of patients with best overall response of complete response (CR) or partial response (PR) based on local assessment according to RECIST 1.1, RANO or Cheson hematological criteria.

DOR is defined as the time from date of first documented CR or PR to date of first documented disease progression or death due to any cause

TTR is defined as the time from date of the first dose to date of first documented response (CR or PR)

PFS is defined as the time from the date of first dose of ceritinib to the date of first documented disease progression or death from any cause

Deaths due to any cause during treatment and 30 day follow-up

Novartis Pharmaceuticals

Any sign or symptom that occured during the study treatment plus 30 days post treatment

Any Other ALK+ Tumor

All Subjects

Anaplastic Large Cell Lymphoma (ALCL)

Inflammatory Myofibroblastic Tumor (IMT)

Glioblastoma (GBM)

Any Other ALK-positive Tumor

Total

Age, Continuous

18 to <65

65 to <=75

Age, Customized

Sex: Female, Male

Caucasian

Asian

Other

Race/Ethnicity, Customized

Study Director

Disease Control Rate (DCR) Based on Investigator Assessments for Participants With at Least 16 Weeks of Treatment

Overall Response Rate (ORR) Per Investigator Assessment

Glioblastomia (GBM)

Duration of Response (DOR) Per Investigator Assessment

Time to Response (TTR) Per Investigator Assessment

Progression Free Survival (PFS) Per Investigator Assessments

There were no deaths in the ALCL and IMT arms

Percent of Participant Deaths During Treatment and Follow-up

Overall Study

tissue of Inflammatory myofibroblastic tumor lession

Dongsheng Zhang, PhD

Yan Wang, M.M.

Dongsheng Zhang, MD,PhD

Ya Ding, M.D

Ying Jin, M.D

Yan wang, M.M.

Gene mutation is a research hotspot in the occurrence of multiple malignant tumors. The somatic gene mutations of many different types of tumors not only help to study the tumorigenesis mechanism and molecular diagnosis, but also can be used as an ideal therapeutic target. Large-scale gene profiling studies performed by humans in various types of epithelial tumors have confirmed some new gene mutations. However, there are few reports on the detection of genes related to inflammatory myofibroblastic tumor, and humans have not yet understood its molecular content. Therefore, it is necessary to further use molecular detection methods to explore the molecular markers of IMT to facilitate its follow-up precise treatment plan.

Inflammatory myofibroblastic tumor（IMT）is a rare clinical mesenchymal tissue-derived tumor, which can occur in almost all organs and soft tissues, and is characterized by low-grade or borderline tumors.

The diagnosis of inflammatory myofibroblastic tumor is mainly based on histopathology and immunohistochemistry. The treatment is resistant to conventional chemotherapy and radiotherapy. The only curative treatment is complete surgical resection. When IMT shows typical cellular structural features in pathology, the diagnosis is relatively simple. However, in the presence of atypical features, the accurate diagnosis of IMT is still a challenge. Therefore, it is necessary to explore a better diagnostic method. Secondly, there is no individualized treatment method for aggressive IMT patients who relapse and metastasize after surgery. At present, gene mutation is a research hotspot in the occurrence of various malignant tumors. The somatic gene mutations of many different types of tumors not only help to study the tumorigenesis mechanism and molecular diagnosis, but also can be used as an ideal therapeutic target. Large-scale gene profiling studies performed by humans in various types of epithelial tumors have confirmed some new gene mutations. However, there are few reports on the detection of inflammatory myofibroblastic tumor, and humans have not yet understood its molecular content. Therefore, it is necessary to further use molecular detection methods to explore the molecular markers of IMT to facilitate its follow-up precise treatment plan.

Molecular Profiling and Molecular Labeling of Inflammatory Myofibroblastic Tumor

Study on the Molecular Profile and Molecular Signature of Inflammatory Myofibroblastic Tumor

We sequenced the genes in tissue samples from patients with inflammatory myofibroblastic tumor, and then analyzed the data to obtain a gene map of this type of tumor, and provide data support for the diagnosis and treatment of the disease.

We sequenced tissue samples from patients with inflammatory myofibroblastic tumor, and then analyzed the data to explore molecular markers of this type of tumor, and provide assistance in the diagnosis and targeted therapy of the disease.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Crizotinib Continuation Clinical Study	NCT05160922	NSCLC ALCL IMT	crizotinib	1 Year - 99 Years	Pfizer
Ceritinib Rare Indications Study in ALK+ Tumors	NCT02465528	Tumors With Abe... Anaplastic Larg... Inflammatory My... Glioblastoma	Ceritinib (LDK3...	18 Years -	Novartis
Ceritinib Rare Indications Study in ALK+ Tumors	NCT02465528	Tumors With Abe... Anaplastic Larg... Inflammatory My... Glioblastoma	Ceritinib (LDK3...	18 Years -	Novartis
Molecular Profiling and Molecular Labeling of Inflammatory Myofibroblastic Tumor	NCT04572594	Inflammatory My...		-	Sun Yat-sen University
Crizotinib Continuation Clinical Study	NCT05160922	NSCLC ALCL IMT	crizotinib	1 Year - 99 Years	Pfizer
Crizotinib Continuation Clinical Study	NCT05160922	NSCLC ALCL IMT	crizotinib	1 Year - 99 Years	Pfizer

Spots Global Cancer Trial Database for imt

Every month we try and update this database with for imt cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for imt

Every month we try and update this database with for imt cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for imt cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.