Clinical trials: Gene Mutations
KRAS G12D Mutations, Pancreatic Ductal Adenocarcinoma (PDAC)
To Evaluate the Safety and Efficacy of RNK08954 in Patients With Metastatic Pancreatic Ductal Adenocarcinoma.
This is a multicenter, open-label, phase Ⅱa study to explore the safety, tolerability, and preliminary efficacy of RNK08954 in metastatic pancreatic ductal adenocarcinoma harboring a KRAS G12D mutation.
- Trial name
- NCT07303465
- Testing
- RNK08954
- Where
- 2 sites in China
- Volunteers
- 60 people
- Sponsor
- Ranok Therapeutics (Hangzhou) Co., Ltd.
Acute Myeloid Leukemia (AML), FMS-like Tyrosine Kinase-3 (FLT3) Mutations
Expanded Access Study of Gilteritinib (ASP2215) in Patients With FMS-like Tyrosine Kinase 3 (FLT3) Mutated Relapsed or Refractory Acute Myeloid Leukemia (AML) or FLT3-Mutated AML in Complete Remission (CR) With Minimal Residual Disease (MRD)
The purpose of this study is to provide expanded access to ASP2215 for subjects with FLT3-mutated relapsed or refractory AML or FLT3-mutated AML in composite complete remission (CRc) (complete remission [CR], complete remission…
- Trial name
- NCT03070093
- Testing
- gilteritinib
- Where
- 39 sites in United States, Canada and 1 more
- Sponsor
- Astellas Pharma Global Development, Inc.
Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)
YK-029A as First-Line Treatment Versus Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations
The purpose of this study is to compare the effectiveness of YK-029A as first-line treatment with that of platinum-based chemotherapy in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose…
- Trial name
- NCT05767892
- Testing
- YK-209A tablet, Pemetrexed+carboplatin/Cisplatin
- Where
- 52 sites in China
- Volunteers
- 350 people
- Sponsor
- Suzhou Puhe Pharmaceutical Technology Co., LTD
Attention Deficit Hyperactivity Disorder
PART B: Efficacy and Safety of AEVI-001 in Children and Adolescents With ADHD and Without mGluR Mutations
This is PART B of a 2-part, 6-week, double-blind, dose-optimization, parallel-group study in children and adolescents (ages 6-17 years) with ADHD with and without CNVs in specific genes implicated in glutamatergic signaling and…
- Trial name
- NCT03609619
- Testing
- AEVI-001
- Where
- United States
- Volunteers
- 109 people
- Sponsor
- Aevi Genomic Medicine, LLC, a Cerecor company
Inherited Retinal Dystrophy Associated With RPE65 Mutations
Efficacy and Safety of LX101 for Inherited Retinal Dystrophy Associated With RPE65 Mutations
The purpose of the study is to evaluate the efficacy and safety of LX101 in subjects with biallelic RPE65 mutation-associated inherited retinal dystrophy.
- Trial name
- NCT07054632
- Testing
- LX101
- Where
- 4 sites in China
- Volunteers
- 30 people
- Sponsor
- Innostellar Biotherapeutics Co.,Ltd
Congenital Hearing Loss Secondary to Biallelic Mutations in the Otoferlin Gene (OTOF), Biallelic Mutations in the Gap Junction Beta 2 (GJB2) Gene
A Natural History Study in Pediatric Participants With Hearing Loss Due to OTOF, GJB2, or GJB2/GJB6 Mutations
This is an observational study to examine the characteristics of gene-related hearing loss in pediatric participants with biallelic otoferlin (OTOF) Mutations, Gap Junction Beta 2 (GJB2) Mutations, or Digenic GJB2/Gap Junction…
- Conditions
- Congenital Hearing Loss Secondary to Biallelic Mutations in the Otoferlin Gene (OTOF), Biallelic Mutations in the Gap Junction Beta 2 (GJB2) Gene, Digenic Mutations in GJB2/Gap Junction Beta 6 (GJB6) Genes
- Trial name
- ENSEMBLE (NCT06019481)
- Where
- 2 sites in United States
- Sponsor
- Regeneron Pharmaceuticals
Urinary Bladder Neoplasms
A Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)
The purpose of this study is to evaluate recurrence-free survival (RFS) in participants treated with erdafitinib vs Investigator's Choice, for participants with high-risk non-muscle-invasive bladder cancer (NMIBC) who harbor…
- Trial name
- NCT04172675
- Testing
- Erdafitinib, Investigator Choice (Gemcitabine), Investigator Choice (Mitomycin C)
- Where
- 150 sites in United States, Argentina and 15 more
- Volunteers
- 107 people
- Sponsor
- Janssen Research & Development, LLC
Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)
TAK-788 as First-Line Treatment Versus Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations
The purpose of this study is to compare effectiveness of TAK-788 as first-line treatment with that of platinum-based chemotherapy in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors…
- Trial name
- NCT04129502
- Testing
- TAK-788, Pemetrexed, Cisplatin
- Where
- 134 sites in United States, Australia and 22 more
- Volunteers
- 354 people
- Sponsor
- Takeda
Non-Small Cell Lung Cancer
Study of Oral EGFR Inhibitor DZD6008 Combined With Sunvozertinib in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN8)
This study will treat patients with advanced NSCLC harboring EGFR mutations. This is the first study to test DZD6008 combined with sunvozertinib in patients, which will help to understand what type of side effects with the…
- Trial name
- NCT07079475
- Testing
- DZD6008, Sunvozertinib, Osimertinib
- Where
- 14 sites in China
- Volunteers
- 220 people
- Sponsor
- Dizal Pharmaceuticals
HER2 Gene Mutation
To Evaluate IAH0968 in Combination With CAPEOX in HER2-positive Metastatic Colorectal Cancer
The Phase IIa of this clinical study, a dose-escalation study of IAH0968 in combination with CAPEOX, is designed for safety and tolerability in subjects with HER2-positive advanced or metastatic solid tumors.
- Trial name
- NCT05673512
- Testing
- Injection of IAH0968 + CAPEOX
- Where
- China
- Volunteers
- 279 people
- Sponsor
- SUNHO（China）BioPharmaceutical CO., Ltd.
Non-small Cell Lung Cancer
Resistance & Activating Mutations Diagnosed Among NSCLC Community Dwelling EGFR Mutation Positive Patients
The study is being done to determine if non-invasive testing (urine and plasma testing) is as effective as tissue testing in identifying epidermal growth factor receptor (EGFR) T790M mutation status.
- Trial name
- RADIANCE (NCT03137264)
- Testing
- Other
- Where
- 23 sites in United States, Canada
- Volunteers
- 44 people
- Sponsor
- AstraZeneca
Acquired Immunodeficiency Syndrome, HIV Infections
Safety and Efficacy of Cobicistat-boosted Darunavir in HIV Infected Adults
This study is to evaluate the safety and tolerability of cobicistat-boosted darunavir plus two fully active nucleoside analogue reverse transcriptase inhibitors in HIV 1 infected, antiretroviral treatment-naive and…
- Trial name
- NCT01440569
- Testing
- COBI, DRV, NRTIs
- Where
- 49 sites in United States, Puerto Rico
- Volunteers
- 314 people
- Sponsor
- Gilead Sciences
HRAS Mutations or Peripheral T Cell Lymphoma (PTCL)
Expanded Access to Tipifarnib
Requests for single patient expanded access to tipifarnib may be considered for adult patients with HRAS mutations or peripheral T Cell Lymphoma (PTCL).
- Trial name
- Kuraoncology (NCT04809233)
- Testing
- Tipifarnib
- Sponsor
- Kura Oncology, Inc.
EGFR Mutation Status in aNSCLC Patients
Asia Pacific and Russia Diagnostic Study for EGFR Testing
Interventional diagnostic, international, multicenter and non-comparative study of EGFR mutation status in aNSCLC patients (locally advanced and/or metastatic disease) with adenocarcinoma and non-adenocarcinoma histologies.
- Trial name
- IGNITE (NCT01788163)
- Testing
- EGFR mutation test
- Where
- 71 sites in Australia, China and 7 more
- Volunteers
- 3,500 people
- Sponsor
- AstraZeneca
Non-Small Cell Lung Cancer (NSCLC)
A Study to Evaluate the Impact of Management Strategies on Gastrointestinal-Related Adverse Events in Participants With Non-Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations Receiving TAK-788
The purpose of the study is to characterize the incidence and severity of TAK-788-associated diarrhea in previously treated participants with locally advanced or metastatic non-small-cell lung cancer (NSCLC) whose tumors harbor…
- Trial name
- NCT04576208
- Testing
- TAK-788, Antidiarrheal prophylaxis
- Sponsor
- Takeda
Advanced or Metastatic Solid Tumors With NTRK, ROS1 or ALK Gene Fusion
An Open Label, Multi-center, Phase I Clinical Study to Evaluate the Safety, Effectiveness and Pharmacokinetic Characteristics of SIM1803-1A in Patients With Locally Advanced/Metastatic Solid Tumors With NTRK, ROS1 or ALK Gene Fusion Mutations.
This research study is done to test the safety, effectiveness and pharmacokinetic characteristics of SIM1803-1A in patients with locally advanced/metastatic solid tumors with NTRK, ROS1 or ALK gene fusion mutations.
- Trial name
- NCT04671849
- Testing
- SIM1803-1A
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Non - Small Cell Lung Cancer NSCLC
A Global Study to Assess the Effects of MEDI4736 (Durvalumab), Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer
This study is a Phase III, randomised, open label, multi-centre study assessing the efficacy and safety of MEDI4736 (durvalumab) versus Standard of Care in NSCLC patients with PD-L1 positive tumours and the combination of…
- Trial name
- ARCTIC (NCT02352948)
- Testing
- MEDI4736 (durvalumab), Vinorelbine, Gemcitabine
- Where
- 201 sites in United States, Australia and 24 more
- Volunteers
- 597 people
- Sponsor
- AstraZeneca
Retinitis Pigmentosa
Safety and Efficacy Study in Patients With Retinitis Pigmentosa Due to Mutations in PDE6B Gene
The study is a Phase I/II, monocentric, open-label, dose-ranging safety and efficacy gene therapy intervention by subretinal administration of AAV2/5-hPDE6B.
- Trial name
- NCT03328130
- Testing
- AAV2/5-hPDE6B
- Where
- France
- Volunteers
- 19 people
- Sponsor
- eyeDNA Therapeutics
Non-small Cell Lung Cancer (NSCLC)
A Spanish Medical Record Review of Clinical Characteristics and Outcomes in Non-small Cell Lung Cancer Participants With EGFR Exon 20 Insertion
The main aim is to evaluate sociodemographic and clinical characteristics of advanced Non-Small Cell Lung Cancer (NSCLC) in adults participants with epidermal growth factor receptor (EGFR) exon 20 insertions mutations during the…
- Trial name
- ermEX-20 (NCT05419700)
- Where
- 15 sites in Spain
- Volunteers
- 76 people
- Sponsor
- Takeda
Carcinoma, Non-Small-Cell Lung, ErbB Receptors
Afatinib Treatment for Patients With EGFR Mutation Positive NSCLC Who Are Age 70 or Older
Continuous treatment until progression or occurence of intolerable Adverse Event (AE) or end of trial. The end of trial is one year after the last patient has entered the study.
- Trial name
- NCT02514174
- Testing
- Afatinib
- Where
- 10 sites in United States
- Volunteers
- 25 people
- Sponsor
- Boehringer Ingelheim