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20 Diseases |  |
18 Trials |
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18 Trials |  |
1690 News |  |
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- ||| Zykadia (ceritinib) / Novartis
Trial completion date, Metastases: LDK378 Versus Chemotherapy in ALK Rearranged (ALK Positive) Patients Previously Treated With Chemotherapy (Platinum Doublet) and Crizotinib (clinicaltrials.gov) - Dec 20, 2018
P3, N=232, Active, not recruiting, Sponsor: Novartis Pharmaceuticals
Trial completion date: Feb 2021 --> May 2021
- || Zykadia (ceritinib) / Novartis
Enrollment closed, Metastases: ASCEND-8: 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) (clinicaltrials.gov) - Dec 20, 2018
P1, N=318, Active, not recruiting, Sponsor: Novartis Pharmaceuticals
Trial completion date: Feb 2021 --> May 2021 Recruiting --> Active, not recruiting
- ||| Zykadia (ceritinib) / Novartis
Trial completion, Enrollment change, Metastases: Ceritinib Rare Indications Study in ALK+ Tumors (clinicaltrials.gov) - Dec 4, 2018
P2, N=22, Completed, Sponsor: Novartis Pharmaceuticals
Recruiting --> Active, not recruiting Recruiting --> Completed | N=106 --> 22
- | Alunbrig (brigatinib) / Takeda
Journal: The brigatinib experience: a new generation of therapy for ALK-positive non-small-cell lung cancer. (Pubmed Central) - Nov 29, 2018
Brigatinib, a next-generation ALK inhibitor, shows promising activity in ALK-rearranged NSCLC that have previously received crizotinib with response rates in ALTA ranging from 42-50%, intracranial response 42-67% and median progression-free survival 9.2-12.9 months. Randomized Phase III trial, ALTA-1 L is investigating brigatinib in ALK inhibitor-naive patients.
- | Zykadia (ceritinib) / Novartis, Adcetris (brentuximab vedotin) / Takeda, Pfizer
Trial initiation date: Ceritinib With Brentuximab Vedotin in Treating Patients With ALK-Positive Anaplastic Large Cell Lymphoma (clinicaltrials.gov) - Nov 13, 2018
P1/2, N=30, Recruiting, Sponsor: University of Washington
Randomized Phase III trial, ALTA-1 L is investigating brigatinib in ALK inhibitor-naive patients. Initiation date: Jun 2018 --> Jan 2018
- | Biomarker, New P2 trial: NRG-LU003: Targeted Treatment for ALK Positive Patients Who Have Previously Been Treated for Non-squamous Non-small Cell Lung Cancer (clinicaltrials.gov) - Nov 13, 2018
P2, N=660, Not yet recruiting, Sponsor: National Cancer Institute (NCI)
- | Trial initiation date, PARP Biomarker, Metastases: MatchMel: Molecular Profiling and Matched Targeted Therapy for Patients With Metastatic Melanoma (clinicaltrials.gov) - Nov 2, 2018
P4, N=1000, Not yet recruiting, Sponsor: Melanoma Institute Australia
Initiation date: Jun 2018 --> Jan 2018 Initiation date: Aug 2018 --> Feb 2019
- | Zykadia (ceritinib) / Novartis
Enrollment open: Ceritinib Plus Docetaxel in ALK-Negative, EGFR WT Advanced NSCLC (clinicaltrials.gov) - Nov 2, 2018
P1, N=48, Recruiting, Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Initiation date: Aug 2018 --> Feb 2019 Not yet recruiting --> Recruiting
- | Zykadia (ceritinib) / Novartis, Kisqali (ribociclib) / Novartis
Trial completion, Combination therapy: Study of Safety and Efficacy of LEE011 and Ceritinib in Patients With ALK-positive Non-small Cell Lung Cancer. (clinicaltrials.gov) - Oct 25, 2018
P1, N=27, Completed, Sponsor: Novartis Pharmaceuticals
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- | Zykadia (ceritinib) / Novartis
Journal: Fast, Food and Ceritinib in ALK-Positive NSCLC. (Pubmed Central) - Oct 19, 2018
Active, not recruiting --> Completed No abstract available
- | Zykadia (ceritinib) / Novartis
Enrollment open: Phase I Study of LDK378 in Pediatric, Malignancies With a Genetic Alteration in Anaplastic Lymphoma Kinase (ALK) (clinicaltrials.gov) - Oct 3, 2018
P1, N=85, Recruiting, Sponsor: Novartis Pharmaceuticals
No abstract available Active, not recruiting --> Recruiting
- | Zykadia (ceritinib) / Novartis
Trial completion date: ASCEND-4: LDK378 Versus Chemotherapy in Previously Untreated Patients With ALK Rearranged Non-small Cell Lung Cancer (clinicaltrials.gov) - Oct 2, 2018
P3, N=375, Active, not recruiting, Sponsor: Novartis Pharmaceuticals
Active, not recruiting --> Recruiting Trial completion date: Jul 2019 --> Apr 2022
- | Zykadia (ceritinib) / Novartis
Trial completion date, Metastases: LDK378 Versus Chemotherapy in ALK Rearranged (ALK Positive) Patients Previously Treated With Chemotherapy (Platinum Doublet) and Crizotinib (clinicaltrials.gov) - Oct 2, 2018
P3, N=232, Active, not recruiting, Sponsor: Novartis Pharmaceuticals
Trial completion date: Jul 2019 --> Apr 2022 Trial completion date: Jul 2020 --> Feb 2021
- | Zykadia (ceritinib) / Novartis
Trial primary completion date, Metastases: ASCEND-8: 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) (clinicaltrials.gov) - Sep 25, 2018
P1, N=318, Recruiting, Sponsor: Novartis Pharmaceuticals
Trial completion date: Jul 2020 --> Feb 2021 Trial primary completion date: Oct 2019 --> Jun 2016
- | Review, Journal: Directed Therapies in Anaplastic Lymphoma Kinase-rearranged Non-small Cell Lung Cancer. (Pubmed Central) - Sep 16, 2018
Of considerable importance when considering such therapies is the ability of each to overcome mutations conferring acquired resistance, as well as penetrate the central nervous system (CNS), the most common site of metastasis and traditionally the most difficult to breach. Herein is a review of the efficacy, indications, and degree of CNS penetration for the ALK-targeting agents crizotinib, ceretinib, alectinib, brigatinib, and lorlatinib, as well as a summary of ongoing clinical trials comparing these drugs.
- | Alunbrig (brigatinib) / Takeda
Trial initiation date, Metastases: ALTA-2: A Study of Brigatinib in Participants With Anaplastic Lymphoma Kinase-Positive (ALK+), Advanced Non-Small-Cell Lung Cancer (NSCLC) Progressed on Alectinib or Ceritinib (clinicaltrials.gov) - Aug 17, 2018
P2, N=103, Not yet recruiting, Sponsor: Ariad Pharmaceuticals
Herein is a review of the efficacy, indications, and degree of CNS penetration for the ALK-targeting agents crizotinib, ceretinib, alectinib, brigatinib, and lorlatinib, as well as a summary of ongoing clinical trials comparing these drugs. Initiation date: Jun 2018 --> Oct 2018
- | Zykadia (ceritinib) / Novartis
Trial primary completion date: ASCEND-3: LDK378 in Crizotinib na (clinicaltrials.gov) - Aug 14, 2018
P2, N=125, Completed, Sponsor: Novartis Pharmaceuticals
Initiation date: Jun 2018 --> Oct 2018 Trial primary completion date: Jun 2014 --> Jan 2018
- | Alunbrig (brigatinib) / Takeda
New trial, Metastases: A Study to Determine Progression-free Survival (PFS) and Evaluate Participant Experience for Participants With Metastatic Anaplastic Lymphoma Kinase-positive (ALK+) Non-Small Cell Lung Cancer (NSCLC) Treated With Anaplastic Lymphoma Kinase (ALK) Inhibitors (clinicaltrials.gov) - Aug 13, 2018
P=N/A, N=400, Recruiting, Sponsor: Millennium Pharmaceuticals, Inc.
- | Alunbrig (brigatinib) / Takeda
Enrollment open, Metastases: A Study to Determine Progression-free Survival (PFS) and Evaluate Participant Experience for Participants With Metastatic Anaplastic Lymphoma Kinase-positive (ALK+) Non-Small Cell Lung Cancer (NSCLC) Treated With Anaplastic Lymphoma Kinase (ALK) Inhibitors (clinicaltrials.gov) - Aug 13, 2018
P=N/A, N=400, Recruiting, Sponsor: Millennium Pharmaceuticals, Inc.
Trial primary completion date: Jun 2014 --> Jan 2018 Not yet recruiting --> Recruiting
- | Zykadia (ceritinib) / Novartis
New P1 trial: Ceritinib Plus Docetaxel in ALK-Negative, EGFR WT Advanced NSCLC (clinicaltrials.gov) - Aug 1, 2018
P1, N=48, Not yet recruiting, Sponsor: H. Lee Moffitt Cancer Center and Research Institute
- | Zykadia (ceritinib) / Novartis
Trial completion, Trial completion date: LDK378 in Patients With ALK Positive NSCLC Previously Treated With Alectinib. (clinicaltrials.gov) - Jul 31, 2018
P2, N=20, Completed, Sponsor: Novartis Pharmaceuticals
Not yet recruiting --> Recruiting Active, not recruiting --> Completed | Trial completion date: Dec 2018 --> May 2018
- | Zykadia (ceritinib) / Novartis
Enrollment closed, Trial completion date, Trial primary completion date: Phase I Study of LDK378 in Pediatric, Malignancies With a Genetic Alteration in Anaplastic Lymphoma Kinase (ALK) (clinicaltrials.gov) - Jul 23, 2018
P1, N=83, Active, not recruiting, Sponsor: Novartis Pharmaceuticals
Active, not recruiting --> Completed | Trial completion date: Dec 2018 --> May 2018 Recruiting --> Active, not recruiting | Trial completion date: May 2018 --> Mar 2019 | Trial primary completion date: May 2018 --> Mar 2019
- | Zykadia (ceritinib) / Novartis
Trial completion: ASCEND-3: LDK378 in Crizotinib na (clinicaltrials.gov) - Jul 20, 2018
P2, N=126, Completed, Sponsor: Novartis Pharmaceuticals
Recruiting --> Active, not recruiting | Trial completion date: May 2018 --> Mar 2019 | Trial primary completion date: May 2018 --> Mar 2019 Active, not recruiting --> Completed
- || Zykadia (ceritinib) / Novartis, Kisqali (ribociclib) / Novartis, NN1213 / Novo Nordisk
Trial primary completion date: NEPENTHE: Next Generation Personalized Neuroblastoma Therapy (clinicaltrials.gov) - Jul 19, 2018
P1, N=105, Recruiting, Sponsor: Yael P Mosse
Active, not recruiting --> Completed Trial primary completion date: May 2018 --> Jul 2020
- | Piqray (alpelisib) / Novartis, Zykadia (ceritinib) / Novartis, Tabrecta (capmatinib) / Novartis
Trial completion date, Trial primary completion date, Metastases: A Phase II, Open Label, Multiple Arm Study of AUY922, BYL719, INC280, LDK378 and MEK162 in Chinese Patients With Advanced Non-small Cell Lung Cancer (clinicaltrials.gov) - Jul 11, 2018
P2, N=67, Active, not recruiting, Sponsor: Novartis Pharmaceuticals
Trial primary completion date: May 2018 --> Jul 2020 Trial completion date: Aug 2018 --> Feb 2019 | Trial primary completion date: Aug 2018 --> Feb 2019
- || Zykadia (ceritinib) / Novartis, Mekinist (trametinib) / Novartis, BeiGene
Enrollment open: Study of Trametinib + Ceritinib in Patients With Unresectable Melanoma (clinicaltrials.gov) - Jun 21, 2018
P2, N=27, Recruiting, Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Trial completion date: Aug 2018 --> Feb 2019 | Trial primary completion date: Aug 2018 --> Feb 2019 Not yet recruiting --> Recruiting
- | Zykadia (ceritinib) / Novartis
Trial completion date, Trial primary completion date, Combination therapy, Metastases: Ceritinib and Combination Chemotherapy in Treating Patients With Advanced Solid Tumors or Locally Advanced or Metastatic Pancreatic Cancer (clinicaltrials.gov) - Jun 15, 2018
P1, N=96, Recruiting, Sponsor: Roswell Park Cancer Institute
Not yet recruiting --> Recruiting Trial completion date: Jun 2018 --> Dec 2018 | Trial primary completion date: May 2018 --> Nov 2018
- || Zykadia (ceritinib) / Novartis
Trial primary completion date: Roll-over Study to Allow Access to Certinib (LDK378) for Patients Who Are on Ceritinib Treatment in a Novartis-sponsored Study (clinicaltrials.gov) - Jun 12, 2018
P4, N=150, Recruiting, Sponsor: Novartis Pharmaceuticals
Trial completion date: Jun 2018 --> Dec 2018 | Trial primary completion date: May 2018 --> Nov 2018 Trial primary completion date: Mar 2018 --> Dec 2020
- | Zykadia (ceritinib) / Novartis
Trial completion date, Metastases: Ceritinib Rare Indications Study in ALK+ Tumors (clinicaltrials.gov) - Jun 12, 2018
P2, N=106, Recruiting, Sponsor: Novartis Pharmaceuticals
Trial primary completion date: Mar 2018 --> Dec 2020 Trial completion date: Mar 2019 --> Jul 2018
- | Nexavar (sorafenib) / Bayer, Amgen
Clinical, Journal: Inhibition of insulin-like growth factor 1 receptor enhances the efficacy of sorafenib in inhibiting hepatocellular carcinoma cell growth and survival. (Pubmed Central) - Jun 9, 2018
Our study provides a biochemical basis for evaluation of a new combination treatment that includes IGF1R inhibitors, such as ceritinib and sorafenib, in patients with HCC. (Hepatology Communications 2018;2:732-746).
- |||| Alunbrig (brigatinib) / Takeda
New P2 trial, Metastases: ALTA-2: A Study of Brigatinib in Participants With Anaplastic Lymphoma Kinase-Positive (ALK+), Advanced Non-Small-Cell Lung Cancer (NSCLC) Progressed on Alectinib or Ceritinib (clinicaltrials.gov) - May 27, 2018
P2, N=103, Not yet recruiting, Sponsor: Ariad Pharmaceuticals
- | Retrospective data, Review, Journal: Systematic review and meta-analysis of selected toxicities of approved ALK inhibitors in metastatic non-small cell lung cancer. (Pubmed Central) - May 19, 2018
ALK inhibitors have an acceptable safety profile with a low risk of treatment-related deaths. Important differences in toxicity profile were detected amongst the different drugs.
- | Journal: Signature program: a platform of basket trials. (Pubmed Central) - May 17, 2018
The Signature Program presents a unique and successful approach for rapid signal finding across multiple tumors and allowed various agents to be evaluated in patients with rare alterations. Incorporating these program features in conventional studies could lead to improved trial efficiencies and patient outcomes.
- || Piqray (alpelisib) / Novartis, Zykadia (ceritinib) / Novartis, Tabrecta (capmatinib) / Incyte, Novartis
Trial completion date, Trial primary completion date, Metastases: A Phase II, Open Label, Multiple Arm Study of AUY922, BYL719, INC280, LDK378 and MEK162 in Chinese Patients With Advanced Non-small Cell Lung Cancer (clinicaltrials.gov) - May 1, 2018
P2, N=67, Active, not recruiting, Sponsor: Novartis Pharmaceuticals
Incorporating these program features in conventional studies could lead to improved trial efficiencies and patient outcomes. Trial completion date: Apr 2018 --> Aug 2018 | Trial primary completion date: Apr 2018 --> Aug 2018
- | Zykadia (ceritinib) / Novartis, Adcetris (brentuximab vedotin) / Takeda, Pfizer
Trial completion date, Trial primary completion date: Ceritinib With Brentuximab Vedotin in Treating Patients With ALK-Positive Anaplastic Large Cell Lymphoma (clinicaltrials.gov) - Apr 23, 2018
P1/2, N=30, Recruiting, Sponsor: University of Washington
Trial completion date: Apr 2018 --> Aug 2018 | Trial primary completion date: Apr 2018 --> Aug 2018 Trial completion date: Apr 2023 --> Jul 2023 | Trial primary completion date: Apr 2023 --> Jul 2023
- || Zykadia (ceritinib) / Novartis
Trial completion date, Trial primary completion date, Metastases: ASCEND-8: 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) (clinicaltrials.gov) - Apr 18, 2018
P1, N=318, Recruiting, Sponsor: Novartis Pharmaceuticals
Trial completion date: Apr 2023 --> Jul 2023 | Trial primary completion date: Apr 2023 --> Jul 2023 Trial completion date: Oct 2018 --> Oct 2019 | Trial primary completion date: Oct 2018 --> Oct 2019
- | Zykadia (ceritinib) / Novartis
Trial completion, Metastases: A Phase I, Multi-center, Open Label, Drug-drug Interaction Study to Assess the Effect of Ceritinib on the Pharmacokinetics of Warfarin and Midazolam in Patients With ALK-positive Advanced Tumors (clinicaltrials.gov) - Apr 18, 2018
P1, N=33, Completed, Sponsor: Novartis Pharmaceuticals
Trial completion date: Oct 2018 --> Oct 2019 | Trial primary completion date: Oct 2018 --> Oct 2019 Active, not recruiting --> Completed
- | Zykadia (ceritinib) / Novartis, Mekinist (trametinib) / Novartis, BeiGene
New P2 trial: Study of Trametinib + Ceritinib in Patients With Unresectable Melanoma (clinicaltrials.gov) - Apr 17, 2018
P2, N=27, Not yet recruiting, Sponsor: H. Lee Moffitt Cancer Center and Research Institute
- | Zykadia (ceritinib) / Novartis
Enrollment change, Trial completion date, Trial termination, Metastases: A Phase II Trial of LDK378 in ROS1 and /or ALK Over-expressed Advanced Intrahepatic or Hilar Cholangiocarcinoma (clinicaltrials.gov) - Apr 5, 2018
P2, N=9, Terminated, Sponsor: National Health Research Institutes, Taiwan
Active, not recruiting --> Completed N=34 --> 9 | Trial completion date: Jul 2018 --> Jan 2018 | Recruiting --> Terminated; ROS1 in IHC and gene rearrangement result can not match?No tumor response?
- Zykadia (ceritinib) / Novartis
Enrollment change, Trial termination: Study of Oral Ceritinib in Patients With ALK and ROS1 Activated Gastrointestinal Malignancies (clinicaltrials.gov) - Apr 2, 2018
P2, N=4, Terminated, Sponsor: Criterium, Inc.
N=34 --> 9 | Trial completion date: Jul 2018 --> Jan 2018 | Recruiting --> Terminated; ROS1 in IHC and gene rearrangement result can not match?No tumor response? N=30 --> 4 | Recruiting --> Terminated; Lack of Enrollment
- || Zykadia (ceritinib) / Novartis
Trial primary completion date, Metastases: Ceritinib Rare Indications Study in ALK+ Tumors (clinicaltrials.gov) - Mar 20, 2018
P2, N=106, Recruiting, Sponsor: Novartis Pharmaceuticals
N=30 --> 4 | Recruiting --> Terminated; Lack of Enrollment Trial primary completion date: Mar 2019 --> Apr 2018
- | Zykadia (ceritinib) / Novartis
Trial completion date, Trial primary completion date: An Open-label, Multicenter, Phase II Study of LDK378 in Patients With Non-small Cell Lung Cancer Harboring ROS1 Rearrangement (clinicaltrials.gov) - Mar 15, 2018
P2, N=32, Recruiting, Sponsor: Yonsei University
Trial primary completion date: Mar 2019 --> Apr 2018 Trial completion date: Dec 2017 --> Dec 2018 | Trial primary completion date: Dec 2017 --> Dec 2018
- || Zykadia (ceritinib) / Novartis
Trial primary completion date: Roll-over Study to Allow Access to Certinib (LDK378) for Patients Who Are on Ceritinib Treatment in a Novartis-sponsored Study (clinicaltrials.gov) - Mar 13, 2018
P4, N=150, Recruiting, Sponsor: Novartis Pharmaceuticals
Trial completion date: Dec 2017 --> Dec 2018 | Trial primary completion date: Dec 2017 --> Dec 2018 Trial primary completion date: Dec 2020 --> Mar 2018
- Zykadia (ceritinib) / Novartis
Trial primary completion date: Ceritinib (LDK378) for Patients Whose Tumors Have Aberrations in ALK or ROS1 (SIGNATURE) (clinicaltrials.gov) - Mar 8, 2018
P2, N=47, Completed, Sponsor: Novartis Pharmaceuticals
Trial primary completion date: Dec 2020 --> Mar 2018 Trial primary completion date: Sep 2016 --> Dec 2017
- Zykadia (ceritinib) / Novartis
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: Genomic Landscape of Ceritinib (clinicaltrials.gov) - Mar 5, 2018
P=N/A, N=6, Terminated, Sponsor: Washington University School of Medicine
Trial primary completion date: Sep 2016 --> Dec 2017 N=10 --> 6 | Trial completion date: Apr 2019 --> Feb 2018 | Recruiting --> Terminated | Trial primary completion date: Apr 2019 --> Feb 2018; Changes in treatment plans affecting drug therapy choices
- | Zykadia (ceritinib) / Novartis
Trial primary completion date, Combination therapy, Metastases: Ceritinib and Combination Chemotherapy in Treating Patients With Advanced Solid Tumors or Locally Advanced or Metastatic Pancreatic Cancer (clinicaltrials.gov) - Mar 3, 2018
P1, N=96, Recruiting, Sponsor: Roswell Park Cancer Institute
N=10 --> 6 | Trial completion date: Apr 2019 --> Feb 2018 | Recruiting --> Terminated | Trial primary completion date: Apr 2019 --> Feb 2018; Changes in treatment plans affecting drug therapy choices Trial primary completion date: Feb 2018 --> May 2018
- | Zykadia (ceritinib) / Novartis
Trial completion date, Trial initiation date, Trial primary completion date: Ceritinib (LDK378) for Patients Whose Tumors Have Aberrations in ALK or ROS1 (SIGNATURE) (clinicaltrials.gov) - Mar 3, 2018
P2, N=47, Completed, Sponsor: Novartis Pharmaceuticals
Trial primary completion date: Feb 2018 --> May 2018 Trial completion date: Sep 2016 --> Dec 2017 | Initiation date: Sep 2014 --> Sep 2014 | Trial primary completion date: Sep 2016 --> Sep 2016
- ||| Zolinza (vorinostat) / Merck (MSD), Zykadia (ceritinib) / Novartis
Phase classification, Enrollment change, Trial completion date, Trial primary completion date, Metastases: PEDS-PLAN: Pediatric Precision Laboratory Advanced Neuroblastoma Therapy (clinicaltrials.gov) - Feb 15, 2018
P2, N=500, Recruiting, Sponsor: Giselle Sholler
Trial completion date: Sep 2016 --> Dec 2017 | Initiation date: Sep 2014 --> Sep 2014 | Trial primary completion date: Sep 2016 --> Sep 2016 Phase classification: P1 --> P2 | N=24 --> 500 | Trial primary completion date: Sep 2020 --> Sep 2025 | Trial completion date: Sep 2025 --> Sep 2026
- | Zykadia (ceritinib) / Novartis
New P2 trial: A Study of LDK378 in Patients With Non-small Cell Lung Cancer Harboring ROS1 Rearrangement (clinicaltrials.gov) - Jan 16, 2018
P2, N=46, Not yet recruiting, Sponsor: Yonsei University
- | Zykadia (ceritinib) / Novartis
Journal: Oncogenic ALK Fusion in Rare and Aggressive Subtype of Colorectal Adenocarcinoma as a Potential Therapeutic Target. (Pubmed Central) - Jan 14, 2018
This report provides the first clinical evidence that such patients may benefit from targeted monotherapy with ALK inhibitors. Clin Cancer Res; 22(15); 3831-40.