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Generated: December 11, 2018

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CLINICAL TRIALS PROFILE FOR CERITINIB

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Clinical Trials for Ceritinib

Trial ID Title Status Sponsor Phase Summary
NCT02186821 Ceritinib (LDK378) for Patients Whose Tumors Have Aberrations in ALK or ROS1 (SIGNATURE) Completed Novartis Pharmaceuticals Phase 2 The purpose of this signal seeking study is to determine whether treatment with ceritinib demonstrates sufficient efficacy in select pathway-activated solid tumors and/or hematologic malignancies to warrant further study.
NCT02227940 Ceritinib and Combination Chemotherapy in Treating Patients With Advanced Solid Tumors or Locally Advanced or Metastatic Pancreatic Cancer Recruiting National Cancer Institute (NCI) Phase 1 This phase I trial studies the side effects and best dose of ceritinib and combination chemotherapy in treating patients with solid tumors that have spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) or pancreatic cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced) or has spread to other places in the body (metastatic). Ceritinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride, paclitaxel albumin-stabilized nanoparticle formulation, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ceritinib and more than one drug (combination chemotherapy) may be a better treatment for solid tumors or pancreatic cancer.
NCT02227940 Ceritinib and Combination Chemotherapy in Treating Patients With Advanced Solid Tumors or Locally Advanced or Metastatic Pancreatic Cancer Recruiting Roswell Park Cancer Institute Phase 1 This phase I trial studies the side effects and best dose of ceritinib and combination chemotherapy in treating patients with solid tumors that have spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) or pancreatic cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced) or has spread to other places in the body (metastatic). Ceritinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride, paclitaxel albumin-stabilized nanoparticle formulation, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ceritinib and more than one drug (combination chemotherapy) may be a better treatment for solid tumors or pancreatic cancer.
NCT02289144 Ceritinib in Mutation and Oncogene Directed Therapy in Thyroid Cancer Recruiting Novartis Phase 2 This is an, open-label, protocol designed to evaluate the activity of targeted therapy in anaplastic/undifferentiated thyroid cancer. Arm A will evaluate ATC/UTC with mutations or rearrangements detected in the ALK gene. There is no effective treatment for anaplastic thyroid cancer in the locally recurrent or metastatic setting. Ceritinib will be administered to the patient until disease progression by RECIST 1.1, unacceptable toxicity, withdrawal of consent, or discontinuation of the trial for any other reason. The primary focus of this arm of the protocol is identifying ceritinib's activity in anaplastic or undifferentiated thyroid cancer patients. Those patients with mutations identified in their ALK gene by sequencing their tumor samples, or with the established ALK abnormalities will be treated with ALK-inhibitors. These include the Ventana assay and Vysis FISH probe, and patients with tumors positive by this assay will also be considered eligible for therapy on the trial. Therapeutic Portion: ARM A: ALK Abnormality IND Ceritinib 750 mg orally daily on Day 1 Continue q4 weeks x 2 cycles Primary Endpoint: The development of progression; new recurrence or distant metastasis, as well as enlargement of an existing metastasis on radiographic imaging. Secondary Endpoints: 1. Overall response rate for patients treated with ceritinib as part of the study. 2. Death of study participant due to any cause.
NCT02289144 Ceritinib in Mutation and Oncogene Directed Therapy in Thyroid Cancer Recruiting University of Texas Southwestern Medical Center Phase 2 This is an, open-label, protocol designed to evaluate the activity of targeted therapy in anaplastic/undifferentiated thyroid cancer. Arm A will evaluate ATC/UTC with mutations or rearrangements detected in the ALK gene. There is no effective treatment for anaplastic thyroid cancer in the locally recurrent or metastatic setting. Ceritinib will be administered to the patient until disease progression by RECIST 1.1, unacceptable toxicity, withdrawal of consent, or discontinuation of the trial for any other reason. The primary focus of this arm of the protocol is identifying ceritinib's activity in anaplastic or undifferentiated thyroid cancer patients. Those patients with mutations identified in their ALK gene by sequencing their tumor samples, or with the established ALK abnormalities will be treated with ALK-inhibitors. These include the Ventana assay and Vysis FISH probe, and patients with tumors positive by this assay will also be considered eligible for therapy on the trial. Therapeutic Portion: ARM A: ALK Abnormality IND Ceritinib 750 mg orally daily on Day 1 Continue q4 weeks x 2 cycles Primary Endpoint: The development of progression; new recurrence or distant metastasis, as well as enlargement of an existing metastasis on radiographic imaging. Secondary Endpoints: 1. Overall response rate for patients treated with ceritinib as part of the study. 2. Death of study participant due to any cause.
NCT02292550 Study of Safety and Efficacy of LEE011 and Ceritinib in Patients With ALK-positive Non-small Cell Lung Cancer. Recruiting Novartis Pharmaceuticals Phase 1/Phase 2 This is a Phase Ib/II study of the ALK inhibitor ceritinib in combination with the CDK4/6 inhibitor LEE011 in patients with ALK-positive non-small cell lung cancer. The purpose of the study is to determine the MTD/RP2D of the LEE011 and ceritinib combination and evaluate whether the combination is safe and has beneficial effects in ALK-positive advanced non-small cell lung cancer patients.
NCT02299505 Pharmacokinetic and Safety Study of Lower Doses of Ceritinib Taken With a Low-fat Meal Versus 750 mg of Ceritinib in the Fasted State in Adult Patients With (ALK-positive) Metastatic Non-small Cell Lung Cancer (NSCLC) Recruiting Novartis Pharmaceuticals Phase 1 A Phase I study to assess the systemic exposure, effiacy, and safety of 450 mg ceritinib taken with a low-fat meal and 600 mg ceritinib taken with a low-fat meal as compared with that of 750 mg ceritinib taken in the fasted state in adult patients with ALK rearranged (ALK-positive) metastatic non-small cell lung cancer (NSCLC)
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Ceritinib

Condition Name

Condition Name for Ceritinib
Intervention Trials
Non-small Cell Lung Cancer 4
Melanoma 2
Lung Cancer 2
Anaplastic Large Cell Lymphoma, ALK-Positive 1
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Condition MeSH

Condition MeSH for Ceritinib
Intervention Trials
Carcinoma, Non-Small-Cell Lung 12
Lung Neoplasms 8
Adenocarcinoma 3
Glioblastoma 2
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Clinical Trial Locations for Ceritinib

Trials by Country

Trials by Country for Ceritinib
Location Trials
United States 76
Italy 35
Spain 15
Germany 11
Korea, Republic of 9
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Trials by US State

Trials by US State for Ceritinib
Location Trials
Florida 5
Texas 5
California 5
Colorado 4
Massachusetts 4
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Clinical Trial Progress for Ceritinib

Clinical Trial Phase

Clinical Trial Phase for Ceritinib
Clinical Trial Phase Trials
Phase 4 1
Phase 2 13
Phase 1/Phase 2 3
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Clinical Trial Status

Clinical Trial Status for Ceritinib
Clinical Trial Phase Trials
Recruiting 17
Not yet recruiting 7
Active, not recruiting 1
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Clinical Trial Sponsors for Ceritinib

Sponsor Name

Sponsor Name for Ceritinib
Sponsor Trials
Novartis Pharmaceuticals 12
Novartis 6
National Cancer Institute (NCI) 3
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Sponsor Type

Sponsor Type for Ceritinib
Sponsor Trials
Industry 23
Other 23
NIH 3
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