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NCT ID: NCT01976741 Completed - Neoplasms Clinical Trials

Dose Escalation Pan-FGFR (Fibroblast Growth Factor Receptor) Inhibitor (Rogaratinib)

Start date: December 30, 2013
Phase: Phase 1
Study type: Interventional

- This was the first study where BAY1163877 was given to humans. Impact of the study was to evaluate if patients with advanced solid cancers show advanced clinical benefit under the treatment with the pan FGFR inhibitor. Patients (all comers) received the study drug treatment in a dose-escalation scheme (no placebo group) to determine the safety, tolerability and maximum tolerated dose (MTD) of BAY1163877. The relative bioavailability of liquid service formulation and tablets was determined. - After the MTD was defined patients with solid tumors (all comers), lung cancer (lung adenocarcinoma & squamous non-small cell lung cancer), head and neck cancer or bladder cancer was enrolled according to their FGFR expression profile (biomarker stratification). - The study also assessed the pharmacokinetics, biomarker status, pharmacodynamic parameters and tumor response of BAY1163877. - BAY1163877 was given twice daily as oral application. Treatment was stopped if the tumor continued to grow, if side effects, which the patient cannot tolerate, occurred or if the patient decided to exit treatment.

NCT ID: NCT01972841 Completed - Overactive Bladder Clinical Trials

This Was a Multinational Study Comparing the Efficacy and Safety of Two Medicines , Solifenacin Succinate and Mirabegron Taken Together, or Separately, or a Mock Treatment (Placebo) in Subjects With Symptoms of Overactive Bladder

SYNERGY
Start date: November 5, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study was to examine how well two medicines (solifenacin succinate and mirabegron) combined work compared to each medicine alone in the treatment of bladder problems.

NCT ID: NCT01970865 Completed - Clinical trials for 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

Start date: January 8, 2014
Phase: Phase 1/Phase 2
Study type: Interventional

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 cancer patients .

NCT ID: NCT01969838 Completed - Clinical trials for Primary Myelofibrosis

Momelotinib Versus Ruxolitinib in Subjects With Myelofibrosis

Simplify 1
Start date: December 6, 2013
Phase: Phase 3
Study type: Interventional

This study is to determine the efficacy of momelotinib (MMB) versus ruxolitinib (RUX) in participants with primary myelofibrosis (PMF) or post-polycythemia vera or post-essential thrombocythemia myelofibrosis (post-PV/ET MF) who have not yet received treatment with a Janus kinase inhibitor (JAK inhibitor). Participants will be randomized to receive either MMB or ruxolitinib for 24 weeks during a double-blind treatment phase, after which they will be eligible to receive open-label MMB for up to an additional 216 weeks. After discontinuation of study medication, assessments will continue for 12 additional weeks, after which participants will be contacted for survival follow-up approximately every 6 months for up to 5 years from the date of enrollment or until study termination. For those participants planning to continue treatment with MMB following the end of the study, the Early Study Drug Discontinuation (ESDD), 30-day, 12-Week, and survival follow-up visits are not required.

NCT ID: NCT01966471 Completed - Breast Cancer Clinical Trials

A Study of Trastuzumab Emtansine (Kadcyla) Plus Pertuzumab (Perjeta) Following Anthracyclines in Comparison With Trastuzumab (Herceptin) Plus Pertuzumab and a Taxane Following Anthracyclines as Adjuvant Therapy in Participants With Operable HER2-Positive Primary Breast Cancer

Start date: January 31, 2014
Phase: Phase 3
Study type: Interventional

This two-arm, randomized, open-label, multicenter study will evaluate the efficacy and safety of trastuzumab emtansine in combination with pertuzumab versus trastuzumab in combination with pertuzumab and a taxane as adjuvant therapy in participants with human epidermal growth (HER) factor 2 (HER2)-positive primary invasive breast cancer. Following surgery and anthracycline-based chemotherapy, participants will receive either trastuzumab emtansine at a dose of 3.6 milligrams per kilogram (mg/kg) and pertuzumab at a dose of 420 milligrams (mg) intravenously (IV) every 3 weeks (q3w) or trastuzumab at a dose of 6 mg/kg and pertuzumab at a dose of 420 mg IV q3w in combination with a taxane.

NCT ID: NCT01965106 Completed - Clinical trials for Glaucoma, Angle-closure, Primary, Acute

Phase IIA Double-Masked Randomized Sham-Controlled Trial of QPI-1007 Delivered by a Single Intravitreal Injection to Subjects With Acute Primary Angle-Closure Glaucoma (APACG)

Start date: December 2013
Phase: Phase 2
Study type: Interventional

This study will assess any side effects that may occur when QPI-1007 is injected into the eye in subjects with acute primary angle-closure glaucoma, as well as how long it takes for the body to clear the drug. This study will also test whether QPI-1007, injected into the eye, helps prevent both structural damage of the nerve tissue in the eye and the loss of visual function in subjects with acute primary angle-closure glaucoma.

NCT ID: NCT01964430 Completed - Neoplasms Clinical Trials

Nab-paclitaxel and Gemcitabine vs Gemcitabine Alone as Adjuvant Therapy for Patients With Resected Pancreatic Cancer (the "Apact" Study)

apact
Start date: March 28, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare whether there is a delay or prevention of recurrence or death in participants with surgically removed pancreatic cancer who then take nab-Paclitaxel in combination with gemcitabine compared to those who take gemcitabine alone.

NCT ID: NCT01961674 Completed - Obesity Clinical Trials

Studying the Effect of Capsinoids on Brown Fat Using Infrared Thermal Imaging.

Start date: November 2013
Phase: N/A
Study type: Interventional

The primary hypothesis of this study is that consumption of capsinoids increases brown adipose tissue activity, detectable by infrared thermal imaging. The secondary hypothesis is that consumption of capsinoids can affect an individual's glycaemic response.

NCT ID: NCT01958892 Completed - Clinical trials for Benign Prostatic Hyperplasia

To Compare Outcomes After Transurethral Enucleation of Prostate Versus Transurethral Resection of Prostate

Start date: n/a
Phase: N/A
Study type: Observational

The purpose of the study is to assess whether transurethral enucleation of prostate gives better or equivalent outcomes compared to the gold standard of transurethral resection of the prostate

NCT ID: NCT01958021 Completed - Clinical trials for Advanced, Metastatic Breast Cancer

Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer.(MONALEESA-2)

MONALEESA-2
Start date: December 17, 2013
Phase: Phase 3
Study type: Interventional

This is a multi-center, randomized, double-blinded, placebo controlled trial.