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NCT ID: NCT04029480 Active, not recruiting - Clinical trials for Type 2 Diabetes Mellitus

Ertugliflozin Type 2 Diabetes Mellitus (T2DM) Pediatric Study (MK-8835/PF-04971729) (MK-8835-059)

Start date: October 8, 2019
Phase: Phase 3
Study type: Interventional

This study will evaluate the safety and efficacy of ertugliflozin (MK-8835) in pediatric participants with T2DM on metformin with/without insulin. The primary hypothesis of the study is that the addition of ertugliflozin reduces hemoglobin A1C (HbA1C) more than the addition of placebo after 24 weeks of treatment.

NCT ID: NCT04027647 Active, not recruiting - NSCLC Stage IV Clinical Trials

Phase 2 Study of Dacomitinib in NSCLC

Start date: September 11, 2019
Phase: Phase 2
Study type: Interventional

This is a multi-national, multi-centre, single-arm, open-label, Phase 2 clinical study of the efficacy and safety of first-line treatment with dacomitinib, with or without dose titration, in subjects with newly diagnosed stage IIIB/IIIC/IV or recurrent EGFR-mutation-positive non-small cell lung cancer (NSCLC). National Cancer Centre Singapore is the lead sponsor acting in a coordinating capacity and the rest of the participating sites are sponsors of their own individual sites.

NCT ID: NCT04015180 Active, not recruiting - Clinical trials for Retinopathy of Prematurity (ROP)

Extension Study to Evaluate the Long-term Outcomes of Subjects in Study 20090

FIREFLEYE next
Start date: March 18, 2020
Phase: Phase 3
Study type: Interventional

This is a follow-up study to evaluate the long term outcome of babies treated in the FIREFLEYE study.

NCT ID: NCT04003636 Active, not recruiting - Clinical trials for Biliary Tract Carcinoma

Pembrolizumab (MK-3475) Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin for First-Line Advanced and/or Unresectable Biliary Tract Carcinoma (BTC) (MK-3475-966/KEYNOTE-966)

KEYNOTE-966
Start date: September 24, 2019
Phase: Phase 3
Study type: Interventional

This is a study of pembrolizumab plus gemcitabine/cisplatin versus placebo plus gemcitabine/cisplatin as first-line therapy in participants with advanced and/or unresectable biliary tract carcinoma. The primary hypothesis is pembrolizumab plus gemcitabine/cisplatin is superior to placebo plus gemcitabine/cisplatin with respect to overall survival (OS).

NCT ID: NCT03997123 Active, not recruiting - Clinical trials for Triple Negative Breast Neoplasms

Capivasertib+Paclitaxel as First Line Treatment for Patients With Locally Advanced or Metastatic TNBC

CAPItello-290
Start date: June 25, 2019
Phase: Phase 3
Study type: Interventional

Phase III Study of Capivasertib + Paclitaxel versus Placebo + Paclitaxel as First line Treatment for Patients with Locally Advanced or Metastatic Triple-negative Breast Cancer (TNBC)

NCT ID: NCT03974022 Active, not recruiting - Clinical trials for Non-Small Cell Lung Cancer

Assessing an Oral EGFR Inhibitor, Sunvozertinib in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR or HER2 Mutation (WU-KONG1)

Start date: July 9, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This study will treat patients with advanced NSCLC with EGFR or HER2 mutation who have progressed following prior therapy. This is the first time this drug is tested in patients, and so it will help to understand what type of side effects may occur with the drug treatment. It will also measure the levels of drug in the body and preliminarily assess its anti-cancer activity as monotherapy.

NCT ID: NCT03940703 Active, not recruiting - Clinical trials for Non-small Cell Lung Cancer

A Study of Tepotinib Plus Osimertinib in Osimertinib Relapsed MET Amplified NSCLC (INSIGHT 2)

Start date: September 19, 2019
Phase: Phase 2
Study type: Interventional

This study was to assess the antitumor activity, safety, tolerability, and pharmacokinetics (PK) of the Mesenchymal-epithelial Transition Factor (MET) inhibitor tepotinib combined with the 3rd generation EGFR inhibitor osimertinib in participants with advanced or metastatic non-small cell lung cancer (NSCLC).

NCT ID: NCT03924895 Active, not recruiting - Clinical trials for Urinary Bladder Cancer, Muscle-invasive

Perioperative Pembrolizumab (MK-3475) Plus Cystectomy or Perioperative Pembrolizumab Plus Enfortumab Vedotin Plus Cystectomy Versus Cystectomy Alone in Participants Who Are Cisplatin-ineligible or Decline Cisplatin With Muscle-invasive Bladder Cancer (MK-3475-905/KEYNOTE-905/EV-303)

Start date: July 24, 2019
Phase: Phase 3
Study type: Interventional

This is a study of perioperative pembrolizumab or enfortumab vedotin in combination with pembrolizumab in participants who are cisplatin-ineligible or decline cisplatin with muscle-invasive bladder cancer (MIBC). The primary hypothesis is that perioperative pembrolizumab plus radical cystectomy (RC) plus pelvic lymph node dissection (PLND) and perioperative enfortumab vedotin in combination with pembrolizumab plus RC+PLND will achieve superior event-free survival (EFS) compared with RC+PLND alone. With Amendment 5, outcome measures for programmed cell death ligand 1 (PD-L1) combined positive score (CPS) were removed. With Amendment 8, the primary outcome measure of pathologic complete response (pCR) rates was changed to a secondary outcome measure.

NCT ID: NCT03914326 Active, not recruiting - Clinical trials for Diabetes Mellitus, Type 2

A Heart Disease Study of Semaglutide in Patients With Type 2 Diabetes

SOUL
Start date: June 17, 2019
Phase: Phase 3
Study type: Interventional

The researchers are doing this study to look whether the type 2 diabetes medicine, semaglutide, has a positive effect on heart disease. Participants will either get semaglutide tablets or placebo tablets ("dummy" medicine) - which treatment is decided by chance. Participants must take one tablet with water every morning on an empty stomach and not eat or drink anything for at least 30 minutes. The study will last for about 3.5-5 years. Participants will have up to 25 clinic visits and 1 phone call with the study doctor. Women cannot be in the study if pregnant, breast-feeding or if they plan to become pregnant during the study period.

NCT ID: NCT03904693 Active, not recruiting - Clinical trials for Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH)

Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed-dose Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH)

A DUE
Start date: July 29, 2019
Phase: Phase 3
Study type: Interventional

Combination therapy in pulmonary arterial hypertension (PAH) has been the subject of active investigation for more than a decade, with the benefit of targeting different pathways known to be involved in the pathogenesis of the disease. Adherence to prescribed therapy has an impact on clinical outcomes. Reducing the pill/tablet count and frequency has a major impact on patients' adherence to therapies and therefore the observed clinical outcomes. One way to simplify treatment is to use fixed-dose combination (FDC) products that combine multiple treatments targeting different pathways into a single tablet. This study aims to demonstrate that the FDC of macitentan and tadalafil is more effective than therapy with 10 mg of macitentan alone or 40 mg of tadalafil alone. This phase 3 study will evaluate the efficacy and safety at 16 weeks of an FDC (macitentan 10 mg and tadalafil 40 mg) against these two PAH-approved therapies given as monotherapy to further confirm the added value of the FDC.