Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Carcinoma

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Lymphoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Lymphosarcoma

Antineoplastic Agents

All Drugs and Chemicals

Ensartinib

Protein Kinase Inhibitors

Enzyme Inhibitors

Esteban Sanchez

Danielle Pancirer

Heather Wakelee, M.D.

Virginia Schmidt

Alden Chiu, M.D.

Lara Edens

Sally York, MD

Kristen Schumacher

Anne Traynor, M.D.

This is an open-label, multicenter, intermediate-sized expanded access treatment protocol to the existing IND 111,695 for ensartinib (X-396). The treatment plan is designed to provide ensartinib to participants with anaplastic lymphoma kinase (ALK)-rearranged non-small cell lung cancer (NSCLC).

Open-label, multi-center, intermediate-sized expanded access treatment protocol for X396-CLI-101 (Phase I/II, First-in-Human, Dose-Escalation Study of X-396 in Patients with Advanced Solid Tumors and Expansion Phase in Patients with ALK+ Non-Small Cell Lung Cancer)

Expanded Access to Ensartinib for Participants With ALK+ NSCLC

Expanded Access Intermediate-Size Patient Population Protocol

Xcovery Holdings, Inc.

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Crizotinib

Alectinib

Any ALK inhibitor like crizotinib, alectinib and so on.

ALK Inhibitor

Yuan-sheng Zang, Prof.

Zhan Wang, Prof.

Wei-ping Dai

This clinical trial aims to evaluate the efficacy, safety of ALK inhibitor in Metastatic Colorectal Cancer Patients with ALK mutation.

ALK Inhibitor in Metastatic Colorectal Cancer With ALK Mutation.

Evaluation of tumor burden based on RECIST criteria every 2 month.

Shanghai Changzheng Hospital

ALK inhibitor in Metastatuc Colorectal Cancer with ALK mutation.

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Amino Acids

Belizatinib

Tyrosine

Number of cycles until progression or unacceptable toxicity develops.

TSR-011

Dmitri Bobilev, MD

TSR-011 is a potent small molecule inhibitor of tyrosine kinases involved in cancer, including:

1. Anaplastic lymphoma kinase (ALK)
2. The tropomyosin-related kinases TRKA, TRKB, and TRKC

This is a sequential, open-label, non-randomized study with dose escalation in Phase 1, followed by expansion at a recommended phase 2 dose.

A Phase I/IIa Open-Label, Dose Escalation and Cohort Expansion Trial of Oral TSR-011 in Patients With Advanced Solid Tumors and Lymphomas

Phase 1, during the dose-escalation phase

Phase 1, during the dose escalation phase

Tesaro, Inc.

Skin and Connective Tissue Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Anti-Infective Agents

Formaldehyde

The screening portion of the trial will test archival tumor material for the presence of ALKATI using a Nanostring-based RNA assay for any patients deemed to be current or future candidates for this trial. This will require approximately 5 formalin-fixed paraffin- embedded (FFPE) slides of 5-8 micron thickness. For the treatment portion of the study, all patients will receive ensartinib orally at a dose of 225mg daily.

Ensartinib will be given at a dose of 225mg daily in the form of 100mg and 25mg capsules. Patients will receive treatment continuously in 28 day cycles. Patients will then have the same tumor specimen biopsied again at day 15. Treatment will continue until disease progression, unacceptable toxicity, or patient choice to discontinue therapy.

a custom chip with probes targeting the ATI site in ALK, providing a reproducible, quantitative measure of ALKATI

ALKATI by Customized Nanostring Assay

Alexander Shoushtari

The purpose of this study is to test the effects of the study drug, ensartinib, on the patient and the cancer. Ensartinib is a new, investigational type of treatment for melanoma with a particular type of abnormality.

This single arm, single center, open label Phase 2 trial will utilize a Simon 2 stage design.

Treating Patients With Melanoma and ALK Alterations With Ensartinib

A Phase 2 Study of the ALK Inhibitor Ensartinib for Patients With Melanomas Harboring ALK Alterations or Aberrant ALK Expression

CBR is defined as any confirmed objective response by Response Evaluation in Solid Tumor (RECIST) 1.1, or stable disease until the 24 week assessment.

Memorial Sloan Kettering Cancer Center

ALK inhibitor treatment on ALK fusion positive NSCLC patients

ALK inhibitor

Yutao LIU, Doctor

The application of ALK inhibitors in the first-line cancer treatment can significantly increase the PFS and ORR of patients those with EML4-ALK fusion. The contemporary clinical ALK fusion detection are mainly via FISH and ICH while biopsies are needed. For locations where are difficult to take biopsies, these routine examinations can hardly been adopted. Apart from these, part of ALK fusion patients are resistant to ALK inhibitors, also making an accurate and efficient prognostic indicator for efficacy evaluation and identifying high-risk recurrent population an urgent priority.

The bilayer membrane structure of exosome helps maintain its internal genetic stability, making detection of EML4-ALK fusion via plasma exosomes in advanced NSCLC patients a feasible way, which might provide a non-invasive and more convenient approach for NSCLC diagnosis and efficacy monitoring. Firstly, this study will evaluate the performance of exosome EML4-ALK fusion detection in NSCLC diagnosis, which sensitivity and specificity would be compared with the FDA approved IHC (ALK \[D5F3\] CDx Assay) test. Subsequently, this study would monitor the dynamic changes of EML4-ALK fusion in exosome examination diagnosed ALK fusion positive NSCLC patients both before and after treatment. It aims to prospectively evaluate the potential value of this approach on efficacy and prognosis prediction in NSCLC therapy and determining whether exosome ALK fusion could assess the curative effect more accurately than imaging examination and tumor markers. Thirdly, FISH diagnosed EML4-ALK positive NSCLC patients will be divided into the positive or negative subgroup according to their post-treatment exosome ALK fusion expression which were determined at 2-3 months after ALK inhibitor were adopted. The prognostic value of monitoring exosome EML4-ALK fusion expression is assessed through the comparison of patients PFS and OS.

The Study of Exosome EML4-ALK Fusion in NSCLC Clinical Diagnosis and Dynamic Monitoring

the ORR of those NSCLC patients receive ALK inhibitors treatment according to exosome ALK fusion diagnosis and FISH examination

the PFS of those NSCLC patients receive ALK inhibitors treatment according to exosome ALK fusion diagnosis and FISH examination

Chinese Academy of Medical Sciences

Physician

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Expanded Access to Ensartinib for Participants With ALK+ NSCLC	NCT04146571	Non-Small Cell ... ALK Gene Rearra...	Ensartinib	18 Years -	Xcovery Holdings, Inc.
ALK Inhibitor in Metastatic Colorectal Cancer With ALK Mutation.	NCT03792568	Colorectal Canc...	ALK Inhibitor	18 Years - 70 Years	Shanghai Changzheng Hospital
A Phase I/IIa Open-Label, Dose Escalation and Cohort Expansion Trial of Oral TSR-011 in Patients With Advanced Solid Tumors and Lymphomas	NCT02048488	Solid Tumors Lymphomas	TSR-011	18 Years -	Tesaro, Inc.
Treating Patients With Melanoma and ALK Alterations With Ensartinib	NCT03420508	Melanoma	Ensartinib ALKATI by Custo...	18 Years -	Memorial Sloan Kettering Cancer Center
The Study of Exosome EML4-ALK Fusion in NSCLC Clinical Diagnosis and Dynamic Monitoring	NCT04499794	Untreated Advan... FISH Identified...	ALK inhibitor	18 Years -	ChineseAMS

Spots Global Cancer Trial Database for alk inhibitor