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NCT ID: NCT02441465 Completed - Clinical trials for Malignant Melanoma, Cancer

Bioavailability Study of Vemurafenib in Participants With BRAF^V600 Mutation-Positive Malignancies

Start date: August 13, 2015
Phase: Phase 1
Study type: Interventional

The purpose of this study is to characterize the pharmacokinetics (PK) of a single intravenous (IV) infusion of 14C-labeled vemurafenib administered shortly after an oral dose of vemurafenib and following multiple oral doses of vemurafenib twice daily (BID) at steady state as well as to estimate the absolute bioavailability of multiple oral doses of vemurafenib BID at steady state in participants with BRAF^V600 mutation-positive malignancies. The study has two periods: Period A and Period B. During Period A, participants will receive vemurafenib BID orally from Day 1 to Day 20 and during Period B, participants will receive single IV infusion of 14C-labeled vemurafenib along with vemurafenib BID oral dose.

NCT ID: NCT02437890 Completed - Clinical trials for Lupus Erythematosus, Systemic

A Phase II Study to Evaluate Safety and Efficacy of ALX-0061 in Subjects With Systemic Lupus Erythematosus

Start date: July 2015
Phase: Phase 2
Study type: Interventional

Primary objective: To assess the efficacy and safety of different dose regimens of ALX-0061 administered subcutaneously (s.c.) to subjects with moderate to severe active, seropositive systemic lupus erythematosus (SLE) compared to placebo. Secondary objectives: To assess the pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, flare rate, steroid reduction and health-related quality of life, with different dose regimens of ALX-0061.

NCT ID: NCT02437318 Completed - Breast Cancer Clinical Trials

Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment.

SOLAR-1
Start date: July 23, 2015
Phase: Phase 3
Study type: Interventional

To determine whether treatment with alpelisib plus fulvestrant prolongs progression-free survival compared to fulvestrant and placebo in men and postmenopausal women with hormone receptor positive (HR+), HER2-negative advanced breast cancer, who received prior treatment with an Aromatase Inhibitor either as (neo)adjuvant or for advanced disease.

NCT ID: NCT02435992 Completed - Ulcerative Colitis Clinical Trials

Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis

Start date: June 17, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether RPC1063 is effective in the treatment of Ulcerative Colitis (UC).

NCT ID: NCT02435212 Completed - Clinical trials for Transfusion-dependent Anemia

Study to Evaluate Treatment Compliance, Efficacy and Safety of an Improved Deferasirox Formulation (Granules) in Pediatric Patients (2-<18 Years Old) With Iron Overload

Start date: October 21, 2015
Phase: Phase 2
Study type: Interventional

This is a randomized, open-label, multicenter, two arm, phase II study to evaluate treatment compliance and change in serum ferritin of a deferasirox granule formulation and a deferasirox DT formulation in children and adolescents aged ≥ 2 and < 18 years at enrollment with any transfusion-dependent anemia requiring chelation therapy due to iron overload, to demonstrate the effect of improved compliance on iron burden. Randomization will be stratified by age groups (2 to <10 years, 10 to <18 years) and prior iron chelation therapy (Yes/ No). There will be two study phases which include a 1 year core phase where patients will be randomized to a 48 week treatment period to either Deferasirox DT or granules, and an optional extension phase where all patients will receive the granules up to 5 years. Patients who demonstrated benefit to granules or DT in the core phase, and/or express the wish to continue in the optional extension phase on granules, will be offered this possibility until there is local access to the new formulation (granules or FCT) or up to 5 years, whichever occurs first.

NCT ID: NCT02433613 Completed - Atrial Fibrillation Clinical Trials

Postmarket Evaluation of the Phased Radio Frequency Ablation System (GOLD AF Registry)

Start date: March 2015
Phase:
Study type: Observational [Patient Registry]

Prospective, multi-center, single-arm, non-interventional and open-label registry. The purpose of the registry is to document use of Phased Radio Frequency Ablation (RFA) (hereafter "Phased RFA") System in a real world patient population with atrial fibrillation (AF) and evaluate its performance. Gold AF will enroll a minimum of 1,000 patients who undergo Phased RFA in approximately 38 sites in Western, Central Europe, Israel and South Korea.

NCT ID: NCT02433340 Completed - Clinical trials for Rheumatoid Arthritis

Phase 2, Multicenter, Open-Label Extension (OLE) Study With ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Study

Start date: April 2015
Phase: Phase 2
Study type: Interventional

This is a Phase 2, multicenter, 24-week, open-label extension (OLE) study to assess the safety and tolerability of ABT-122 in rheumatoid arthritis (RA) subjects who have completed Study M12-963 Phase 2 RCT.

NCT ID: NCT02432846 Completed - Clinical trials for Renal Cell Carcinoma, Metastatic

Intratumoral Vaccination With Intuvax Pre-nephrectomy Followed by Sunitinib Post-nephrectomy vs Sunitinib Post-nephrectomy in Newly Diagnosed Metastatic Renal Cell Carcinoma (mRCC)

MERECA
Start date: April 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to compare tumor response, progression free survival (PFS) and overall survival (OS) in newly diagnosed mRCC patients treated with Intuvax (INN: ilixadencel) pre-nephrectomy followed by Sunitinib post-nephrectomy vs Sunitinib post-nephrectomy patients.

NCT ID: NCT02430909 Completed - Clinical trials for Rheumatoid Arthritis

Multiple Dose Study of UCB4940 as add-on to Certolizumab Pegol in Subjects With Rheumatoid Arthritis

Start date: April 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, efficacy and body distribution of Bimekizumab (UCB4940) when added to Certolizumab Pegol treatment in patients with Rheumatoid Arthritis. Neither the patient nor the doctor will know the treatment group.

NCT ID: NCT02426125 Completed - Clinical trials for Urothelial Carcinoma

A Study of Ramucirumab (LY3009806) Plus Docetaxel in Participants With Urothelial Cancer

RANGE
Start date: July 13, 2015
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to evaluate the safety and efficacy of the study drug ramucirumab in combination with docetaxel in participants with urothelial cancer who failed prior platinum-based therapy.