Clinical trials: Steinert Disease
Breast Cancer
ATOP TRIAL: T-DM1 in HER2 Positive Breast Cancer
This research study is studying an investigational drug as a possible treatment for breast cancer that is positive for the protein Human Epidermal Growth Factor Receptor 2, also known as HER2-positive breast cancer.
- Trial name
- NCT03587740
- Testing
- T-DM1
- Where
- 14 sites in United States
- Volunteers
- 111 people
- Sponsor
- Dana-Farber Cancer Institute
Locally Advanced Cancer, Metastatic Cancer
Pilot Study of [68Ga]Ga-ABY-025 Imaging in Patients Undergoing Treatment With HER2-targeted Therapy
The purpose of this study is to determine if the radiotracer, [68Ga]Ga-ABY-025, used for PET imaging can help us better identify and visualize lesions or tumors, in patients who are receiving standard of care therapy HER2+…
- Conditions
- Locally Advanced Cancer, Metastatic Cancer, HER2, HER2 + Breast Cancer, HER2 + Gastric Cancer, Squamous Cell Carcinoma of Head and Neck, Esophageal Squamous Cell Carcinoma
- Trial name
- NCT06828588
- Testing
- [68Ga]Ga-ABY-025
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Vanderbilt-Ingram Cancer Center
Myotonic Dystrophy 1
Effects of a 12-week Strength Training Program in Women With Myotonic Dystrophy Type 1
20 women with myotonic dystrophy type 1 (DM1) will complete a 12-week lower-limb strength training program. The training program consist of 3 series of 6 to 8 maximal repetitions of 5 different exercises: Leg extension, leg…
- Trial name
- NCT05400629
- Testing
- Training program
- Where
- Canada
- Volunteers
- 12 people
- Sponsor
- Université de Sherbrooke
Type 1 Diabetes Mellitus
DM1, Effects of Carbo-Counting on Glycemic Control
Carbohydrate counting is the most effective meal-planning strategy in type 1 diabetes (T1DM) to optimize insulin therapy. However, it may lead to weight gain and unhealthy eating habits.
- Trial name
- NCT03554590
- Testing
- carbohydrate counting, insulin therapy according to standard care
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Breast Cancer
T-DM1 and Non-pegylated Liposomal Doxorubicin in Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer
The primary goal is to determine the maximum tolerated dose (MTD) of the combination of T-DM1 and non-pegylated liposomal doxorubicin in metastatic breast cancer (mBC) patients previously treated with taxanes and…
- Trial name
- THELMA (NCT02562378)
- Testing
- Trastuzumab and non-pegylated liposomal doxorubicin
- Where
- 4 sites in France, Spain
- Volunteers
- 15 people
- Sponsor
- MedSIR
Myotonic Dystrophy Type-1, Myotonic Dystrophy Type-2
Assessing Clinical Endpoints and Biomarkers in Myotonic Dystrophy Type-1 and Type 2 (ASCEND-DM)
Background: Myotonic dystrophy is a long-term genetic disorder that affects muscle function. Symptoms include gradually worsening muscle loss and weakness. Muscles often contract and cannot relax.
- Trial name
- NCT03867435
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
Myotonic Dystrophy
Development of Quantitative Muscle Imaging as a Biomarker of Disease Endpoints in Myotonic Dystrophy
Myotonic dystrophy (dystrophia myotonica; DM), the most prevalent form of muscular dystrophy in adults, is characterized by progressive myopathy, myotonia, and multi-systemic involvement.
- Trial name
- DeQoDE-DM (NCT07362875)
- Where
- United States
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Wake Forest University Health Sciences
Myotonic Dystrophy
An Observational Study in Adult Patients With Non-dystrophic Myotonic Disorders
This is a non-interventional, prospective, observational, multicentre study to evaluate the long-term safety and effectiveness of Namuscla in adult patients with NDM.
- Trial name
- NCT04616807
- Testing
- Mexiletine
- Where
- 6 sites in France, Germany and 1 more
- Volunteers
- 53 people
- Sponsor
- Lupin Ltd.
Thrombocytopenia
Herombopag Treated T-DM1 Induced Platelet Reduction
This is a single-arm study planned to enroll 56 breast cancer patients who experienced grade 2 or higher thrombocytopenia following prior chemotherapy and achieved normalization (platelet count ≥100 × 109/L and ≥200 × 109/L)…
- Trial name
- NCT07257809
- Testing
- Herombopag Olamine Tablets
- Where
- China
- Volunteers
- 56 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
DM1, Myotonic Dystrophy 1
Study of AOC 1001 in Adult Myotonic Dystrophy Type 1 (DM1) Patients
AOC 1001-CS1 is a randomized, double-blind, placebo-controlled, Phase 1/2 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple-doses of AOC 1001 Administered Intravenously to…
- Conditions
- DM1, Myotonic Dystrophy 1, Myotonic Dystrophy, Myotonic Dystrophy Type 1 (DM1)
- Trial name
- MARINA (NCT05027269)
- Testing
- AOC 1001
- Where
- 8 sites in United States
- Volunteers
- 39 people
- Sponsor
- Avidity Biosciences, Inc.
HER2-positive Breast Cancer
A Trial Comparing GQ1005 and T-DM1 in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer
This study is designed to compare efficacy and safety of GQ1005 versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer patients previously treated with trastuzumab and taxane.
- Trial name
- NCT07673029
- Testing
- GQ1005, T-DM1
- Where
- 70 sites in China
- Volunteers
- 228 people
- Sponsor
- GeneQuantum Healthcare (Suzhou) Co., Ltd.
Prostatic Neoplasms
MLN2704 in Subjects With Metastatic Androgen-Independent Prostate Cancer
The purpose of the study is to determine the highest dose of MLN2704 that can be given multiple times safely to patients with prostate cancer, and to identify any side effects associated with taking the drug.
- Trial name
- NCT00070837
- Testing
- MLN2704 (DM1 conjugated monoclonal antibody MLN591)
- Where
- 4 sites in United States
- Volunteers
- 46 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Myotonic Dystrophy 1, Myotonic Dystrophy 2
An Ambispective Natural History Study in Myotonic Dystrophy Patients Linking Retrospective Data Captured From the DM-Scope Registry With a Prospective 24-month Follow-up Period
This natural history observational study is being conducted to follow patients with DM1 or DM2 over a 2 year period to study the presence of myotonia, how it's perceived and its impact on patients quality of life.
- Trial name
- Track-DM (NCT07732439)
- Where
- 6 sites in France
- Volunteers
- 100 people
- Sponsor
- Lupin Ltd.
Breast Cancer
A Study of DS-8201a in Metastatic Breast Cancer Previously Treated With Trastuzumab Emtansine (T-DM1)
Some human epidermal growth factor receptor 2 (HER-2) breast cancer patients do not respond or become resistant to current treatment. DS-8201a is a new experimental product that is a combination of an antibody and a drug.
- Trial name
- NCT03248492
- Testing
- DS-8201a
- Where
- 99 sites in United States, Belgium and 7 more
- Volunteers
- 253 people
- Sponsor
- Daiichi Sankyo
Myotonic Dystrophy 1
Evaluation of Cognitive Functions in 20 Patients With Type 1 Myotonic Dystrophy With Virtual Reality Approach
Type 1 myotonic dystrophy (MD1) is a genetic and hereditary disease that primarily affects muscle tissue, resulting in myotonia (difficulty relaxing after contraction) and atrophy (progressive muscle weakening with decreased…
- Trial name
- GoodDiagNMD (NCT06270186)
- Testing
- Type 1 myotonic dystrophy
- Sponsor
- Centre Hospitalier Universitaire de Nice
Type 1 Diabetes
SweMaMi DMI, Microbiome
Dysbiosis is associated with an increased risk of preeclampsia during pregnancy. The microbiome differs between those with and without type 1 diabetes and the cause of type 1 diabetes has been associated with dysbiosis.
- Trial name
- NCT04346524
- Testing
- sampling of microbiome
- Where
- 2 sites in Sweden
- Volunteers
- 100 people
- Sponsor
- Karolinska Institutet
Steinert's Disease, Myotonic Dystrophy 1
Evaluation of the Efficacy and Safety of Metformin in the Myotonic Dystrophy Type 1 (Steinert's Disease)
The study team hypothesize that non-diabetic patients with Myotonic dystrophy type I (DM1) will improve their symptoms, especially their motor deficit which is the main feature of the disease, because of the splicing defect…
- Conditions
- Steinert's Disease, Myotonic Dystrophy 1, Metformin
- Trial name
- METFORMYO (NCT05532813)
- Testing
- Treatment taken
- Where
- France
- Volunteers
- 142 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
T-DM1 and Tucatinib Compared With T-DM1 Alone in Preventing Relapses in People With High Risk HER2-Positive Breast Cancer, the CompassHER2 RD Trial
This phase III trial compares the effect of usual treatment with trastuzumab emtansine (T-DM1) alone vs. T-DM1 in combination with tucatinib.
- Conditions
- Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, HER2 Positive Breast Carcinoma, Invasive Breast Carcinoma
- Trial name
- NCT04457596
- Testing
- Trastuzumab Emtansine, Tucatinib, Questionnaire Administration
- Where
- 1,176 sites in United States, Canada and 1 more
- Volunteers
- 1,056 people
- Sponsor
- Alliance for Clinical Trials in Oncology
Myotonic Dystrophy 1
Chinese Multicenter Clinical Outcome Cohort Study of Myotonic Dystrophy Type 1 (C-DMCOS-DM1)
Myotonic dystrophy type 1 (DM1) is an autosomal dominant multisystem disorder caused by an expanded CTG trinucleotide repeat in the 3' untranslated region of the DMPK gene.
- Trial name
- C-DMCOS-DM1 (NCT06101940)
- Testing
- MRI scan, Electrocardiography, Pulmonary function test
- Where
- 22 sites in China
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Huashan Hospital
Congenital Myotonic Dystrophy, CDM
DMCRN-02-001: Assessing Pediatric Endpoints in DM1
The overall goal of the study is to establish valid clinical endpoint assessments for children with congenital myotonic dystrophy type 1 and develop biomarkers for the condition.
- Trial name
- ASPIRE-DM1 (NCT05224778)
- Where
- 5 sites in United States, Italy
- Volunteers
- 50 people
- Sponsor
- Virginia Commonwealth University