Clinical trials: ALK Positive Malignancies
Anaplastic Lymphoma Kinase Positive (ALK +) Anaplastic Large Cell Lymphoma, Inflammatory Myofibroblastic Tumors
Pharmacokinetics, Safety, and Efficacy of Brigatinib Monotherapy in Pediatric and Young Adult Participants With ALK+ Anaplastic Large Cell Lymphoma, Inflammatory Myofibroblastic Tumors or Other Solid Tumors
The purpose of this study is to estimate the maximum tolerated dose (MTD)/ recommended phase 2 dose (RP2D) regimen and characterize the pharmacokinetics (PK) of brigatinib monotherapy (film-coated tablets and age-appropriate…
- Conditions
- Anaplastic Lymphoma Kinase Positive (ALK +) Anaplastic Large Cell Lymphoma, Inflammatory Myofibroblastic Tumors, Solid Tumors
- Trial name
- NCT04260009
- Testing
- Brigatinib, Brigatinib AAF
- Sponsor
- Takeda
ALK-positive Advanced NSCLC
Phase 2 Study of Brigatinib in Japanese Participants With Anaplastic Lymphoma Kinase (ALK)-Positive Non-Small Cell Lung Cancer (NSCLC)
The purpose of this study is to evaluate efficacy and safety of brigatinib in Japanese participants with anaplastic lymphoma kinase (ALK)-positive NSCLC.
- Trial name
- NCT03410108
- Testing
- Brigatinib
- Where
- 33 sites in Japan
- Volunteers
- 104 people
- Sponsor
- Takeda
Non-small Cell Lung Cancer
Safety And Efficacy Of Crizotinib (Regulatory Post Marketing Commitment Plan)
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors…
- Trial name
- NCT01597258
- Testing
- Crizotinib (Xalkori)
- Volunteers
- 2,029 people
- Sponsor
- Pfizer
Anaplastic Lymphoma Kinase-positive, Carcinoma Non-small-cell Lung
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
The primary purpose of this study is to determine the differences in PFS for participants who have been receiving brigatinib as ALK inhibitor therapy for ALK+NSCLC compared to those participants receiving alectinib, ceritinib…
- Trial name
- NCT03546894
- Testing
- Brigatinib, Alectinib, Ceritinib
- Where
- United States
- Volunteers
- 111 people
- Sponsor
- Takeda
ALK-positive Advanced NSCLC
Crizotinib Plus Pembrolizumab In Alk-Positive Advanced Non Small Cell Lung Cancer Patients
The purpose of this study has 2 phases, a Dose Finding Phase will determine the maximum tolerated dose . The Dose Expansion Phase will explore the safety, tolerability, and anti-tumor activity of the combination.
- Trial name
- NCT02511184
- Testing
- Crizotinib, Pembrolizumab
- Where
- 15 sites in United States
- Volunteers
- 9 people
- Sponsor
- Pfizer
Relapsed or Refractory T-cell Lymphomas
A Study to Assess the Safety, Tolerability, Efficacy, and Drug Levels of BMS-986369 (Golcadomide) in Participants With Relapsed or Refractory T-cell Lymphomas in Japan (GOLSEEK-3)
The purpose of this study is to test the safety, tolerability, efficacy, and drug levels of BMS-986369 (Golcadomide) in participants with relapsed or refractory T-cell lymphomas in Japan (GOLSEEK-3).
- Trial name
- NCT06035497
- Testing
- BMS-986369
- Where
- 40 sites in Japan
- Volunteers
- 83 people
- Sponsor
- Bristol-Myers Squibb
Non-Small Cell Lung Cancer
Treatment Registry of Alectinib in Anaplastic Lymphoma Kinase (ALK)-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer in Korea
Alectinib was approved by the Ministry of Food and Drug Safety (MFDS) in Korea in Oct 2016. The purpose of this registry is to investigate and confirm the type and incidence of newly identified adverse events and any other…
- Trial name
- NCT03271554
- Testing
- Alectinib
- Where
- 37 sites in South Korea
- Volunteers
- 355 people
- Sponsor
- Hoffmann-La Roche
ALK-positive Non Small Cell Lung Cancer (NSCLC) and ROS1-positive NSCLC
A Study Of PF-06463922 An ALK/ROS1 Inhibitor In Patients With Advanced Non Small Cell Lung Cancer With Specific Molecular Alterations
Phase 1 and 2 trial to study the safety, pharmacokinetics, pharmacodynamics, patient reported outcomes and efficacy of PF-06463922 in ALK + advanced non-small cell lung cancer patients and ROS1+ advanced non small cell lung…
- Trial name
- NCT01970865
- Testing
- PF-06463922, Crizotinib
- Where
- 77 sites in United States, Australia and 12 more
- Volunteers
- 364 people
- Sponsor
- Pfizer
ALK Fusion-positive Solid or CNS Tumors
A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Participants With ALK Fusion-Positive Solid or CNS Tumors
This study will evaluate the safety, pharmacokinetics, and efficacy of alectinib in children and adolescents with ALK fusion-positive solid or CNS tumors for whom prior treatment has proven to be ineffective or for whom there is…
- Trial name
- NCT04774718
- Testing
- Alectinib
- Where
- 31 sites in United States, Australia and 9 more
- Volunteers
- 42 people
- Sponsor
- Hoffmann-La Roche
ALK-positive Advanced Tumors
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
The purpose of this study was to evaluate the potential inhibitory effects of ceritinib on the CYP3A4- and CYP2C9-mediated metabolism of the probe drugs midazolam and warfarin, respectively, when administered simultaneously as a…
- Trial name
- NCT02422589
- Testing
- ceritinib, warfarin, midazolam
- Where
- 11 sites in United States, Denmark and 2 more
- Volunteers
- 33 people
- Sponsor
- Novartis Pharmaceuticals
Non-small Cell Lung Cancer (NSCLC), Anaplastic Lymphoma Kinase (ALK) Positive
A Study of Gilteritinib in Adults With Advanced ALK-positive Non-small Cell Lung Cancer (NSCLC)
Genes give your body instructions on how to make proteins. Proteins are needed to keep the body working properly. Many types of cancer are caused by changes in certain genes, making them faulty.
- Trial name
- NCT07140016
- Testing
- gilteritinib
- Where
- 17 sites in United States, France and 1 more
- Volunteers
- 40 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Non-small Cell Lung Cancer
Ensartinib as Adjuvant Treatment in Anaplastic Lymphoma Kinase (ALK) Positive Non-small Cell Lung Cancer
This double-blind, randomized, placebo-controlled, multicenter, Phase III study is designed to evaluate the efficacy and safety of ensatinib compared with placebo as adjuvant treatment in ALK positive stage II-IIIB non-small cell…
- Trial name
- NCT05341583
- Testing
- Ensartinib
- Where
- China
- Volunteers
- 202 people
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
ALK-positive Non-small-cell Lung Cancer
Study to Evaluate Clinical Real World Outcomes of Lorlatinib After Alectinib in ALK-Positive NSCLC Japanese Patients
To evaluate the clinical real world outcomes of lorlatinib in second/later line setting anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) to TKI sequence sequence treatment after failure of alectinib as a…
- Trial name
- NCT04979988
- Testing
- Lortlatinib
- Where
- 16 sites in Japan
- Volunteers
- 51 people
- Sponsor
- Pfizer
Non-small Cell Lung Cancer
A Study to Evaluate and Compare the Efficacy and Safety of XZP-3621 Versus Crizotinib
This randomized, multicenter, Phase III, open-label study will evaluate the efficacy and safety of XZP-3621 versus crizotinib and to evaluate the pharmacokinetics of XZP-3621 in Chinese participants with treatment-naive…
- Trial name
- NCT05204628
- Testing
- XZP-3621, Crizotinib
- Where
- China
- Volunteers
- 238 people
- Sponsor
- Xuanzhu Biopharmaceutical Co., Ltd.
Carcinoma, Non-Small-Cell Lung
Study of Lorlatinib In People With ALK-positive Non-small Cell Lung Cancer
The purpose of this clinical trial is to learn whether the study medicine (called lorlatinib) is safe and effective for the treatment of non-small cell lung cancer that is caused by an abnormal anaplastic lymphoma kinase (ALK)…
- Trial name
- NCT04362072
- Testing
- Lorlatinib
- Where
- 31 sites in United States, India and 5 more
- Volunteers
- 71 people
- Sponsor
- Pfizer
Anaplastic Lymphoma Kinase (ALK)- Positive Tumors, Non-small Cell Lung Cancer (NSCLC)
Managed Access Programs for LDK378, Ceritinib
The purpose of this registration is to list Managed Access Programs (MAPs) related to LDK378, Ceritinib.
- Trial name
- NCT05100134
- Testing
- ceritinib
- Sponsor
- Novartis Pharmaceuticals
Non-Small-Cell Lung Carcinoma
Anaplastic Lymphoma Kinase (ALK)-Positive Non-small Cell Lung Cancer (NSCLC) Post-alectinib Treatment Patterns
This study aims to understand patient profiles, treatment patterns, and clinical outcomes among ALK-positive NSCLC patients treated with alectinib, and post-alectinib treatment patterns and outcomes.
- Trial name
- NCT04351334
- Testing
- Alectinib
- Where
- United States
- Volunteers
- 161 people
- Sponsor
- Pfizer
Non-small Cell Lung Cancer
Study of Safety, Efficacy and Pharmacokinetics of CT-707 in Patients With ALK-positive Non-small Cell Lung Cancer
This is a Phase I study of the ALK/FAK/Pyk2 inhibitor CT-707 in patients with ALK-positive non-small cell lung cancer. The purpose of the study is to determine the MTD/RP2D of CT-707 and evaluate whether CT-707 is safe and has…
- Trial name
- NCT02695550
- Testing
- CT-707
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Centaurus Biopharma Co., Ltd.
Carcinoma, Non-Small-Cell Lung
Real World Clinical Outcomes of Resected ALK-Positive Early Stage NSCLC Patients Treated With Alectinib as Adjuvant Therapy
This study is a multicenter, prospective, cohort study designed to evaluate the clinical outcomes and characteristics of resected stage II-IIIB anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) adult…
- Trial name
- NCT06862869
- Testing
- Alectinib
- Where
- 44 sites in China
- Volunteers
- 800 people
- Sponsor
- Hoffmann-La Roche
ALK Positive, ALK Positive Non-small Cell Lung Cancer
Study of NXP900 With Lorlatinib in ALK+ Lung Cancer
This is a multi-center, open label, Phase 1b study of NXP900 in combination with lorlatinib in subjects with advanced, ALK-positive non-small cell lung cancer (NSCLC)
- Conditions
- ALK Positive, ALK Positive Non-small Cell Lung Cancer, NSCLC, ALK+ Non-Small-Cell Lung Carcinoma
- Trial name
- NCT07784959
- Testing
- NXP900, Lorlatinib
- Where
- United States
- Volunteers
- 54 people
- Sponsor
- Nuvectis Pharma, Inc.