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NCT ID: NCT02679339 Terminated - Clinical trials for Acute-onset Herpes Zoster Pain

Study to Evaluate the Safety and Pharmacokinetics of Topically Applied 40% Lidocaine Gel Compared With Placebo in Subjects With Acute Herpes Zoster (Shingles) Pain

Start date: January 2015
Phase: Phase 1
Study type: Interventional

Study 2022-HZ-011 will utilize a randomized withdrawal (RW), double-blind, placebo controlled design in which the PK and safety of CNTX 2022 (40% anhydrous lidocaine gel) will be evaluated in subjects with acute-onset herpes zoster pain.

NCT ID: NCT02677922 Active, not recruiting - Clinical trials for Leukemia, Myeloid, Acute

A Study to Assess the Safety and Efficacy of Two Combinations of Isocitrate Dehydrogenase (IDH) Mutant Targeted Therapies Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) Harboring IDH Mutations Who Are Not Candidates to Receive Intensive Induction Chemotherapy

Start date: June 3, 2016
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study are 1. to determine the recommended combination dose of AG-120 and AG-221 separately when administered with azacitidine and, 2. to investigate the safety, tolerability, and efficacy of the combinations of AG-120 with azacitidine and AG-221 with azacitidine versus with azacitidine alone in participants with acute myeloid leukemia (AML) with the isocitrate dehydrogenase (IDH) enzyme isoforms 1 or 2 mutations, respectively.

NCT ID: NCT02677896 Active, not recruiting - Clinical trials for Metastatic Hormone Sensitive Prostate Cancer

A Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)

ARCHES
Start date: March 9, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate the efficacy of enzalutamide plus androgen deprivation therapy (ADT) as measured by radiographic progression-free survival (rPFS) based on central review. The study also evaluated the safety of enzalutamide plus ADT in mHSPC.

NCT ID: NCT02676869 Completed - Stage IV Melanoma Clinical Trials

Phase 1 Study of IMP321 (Eftilagimod Alpha) Adjuvant to Anti-PD-1 Therapy in Unresectable or Metastatic Melanoma

TACTI-mel
Start date: April 2016
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the safety, tolerability and recommended phase 2 dose of a new drug, known as IMP321, in combination with pembrolizumab when given to patients with unresectable or metastatic melanoma.

NCT ID: NCT02675569 Recruiting - Clinical trials for End-stage Kidney Failure

ACCESS HD: Comparing Catheters to Fistulas in Elderly Patients Starting Hemodialysis

ACCESS HD
Start date: May 2016
Phase: N/A
Study type: Interventional

This randomized controlled trial (RCT) is multi-center, parallel-arm, and open label. It will test the feasibility and safety of randomizing elderly patients with end-stage kidney failure starting hemodialysis with a tunneled/non-tunneled catheter to one of the following vascular access strategies: (a) attempt at fistula creation (intervention), or (b) continued use of a catheter (comparator). A total number of 100 participants will be enrolled in vanguard phase of the RCT. The rationale for this trial includes: (1) the importance of the intervention question related to the choice of vascular access for patients treated with hemodialysis; (2) lack of evidence from clinical trials for decision-making in this area (only observational studies are available); (3) existing studies which suggest that fistula use is associated with better patient outcomes are very prone to selection bias; (4) need for a clinical trial comparing the impact of the two most frequently chosen strategies for vascular access (catheter and fistula) in the hemodialysis population; and (5) a feasible and safe trial design. The results obtained from this vanguard phase of the RCT will determine the feasibility and safety of conducting a large RCT, which will be powered for the primary outcome of days spent in hospital.

NCT ID: NCT02675465 Active, not recruiting - Pompe Disease Clinical Trials

First-In-Human Study to Evaluate Safety, Tolerability, and PK of Intravenous ATB200 Alone and When Co-Administered With Oral AT2221

Start date: January 2016
Phase: Phase 1/Phase 2
Study type: Interventional

This study is an international, multi-center, study of Pompe disease patients that are currently receiving enzyme-replacement therapy (ERT). The purpose of this study is to find out if the co-administration of investigational new drugs ATB200 and AT2221 is safe in adults with Pompe disease.

NCT ID: NCT02675452 Active, not recruiting - Clinical trials for Relapsed or Refractory Multiple Myeloma

AMG 176 First in Human Trial in Participants With Relapsed or Refractory Multiple Myeloma and Participants With Relapsed or Refractory Acute Myeloid Leukemia

Start date: June 13, 2016
Phase: Phase 1
Study type: Interventional

At least one dose level of AMG 176 will achieve acceptable safety and tolerability in participants with relapsed or refractory multiple myeloma and participants with relapsed or refractory acute myeloid leukemia

NCT ID: NCT02675426 Completed - Clinical trials for Rheumatoid Arthritis

A Study Comparing Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response to csDMARDs Alone

SELECT-NEXT
Start date: December 17, 2015
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are to compare the efficacy, safety, and tolerability of upadacitinib 30 mg once daily (QD) and 15 mg QD versus placebo for the treatment of signs and symptoms of adults with moderately to severely active rheumatoid arthritis who were on a stable dose of csDMARDs and had an inadequate response to csDMARDs.

NCT ID: NCT02675231 Completed - Clinical trials for HER-2 Positive Breast Cancer

A Study of Abemaciclib (LY2835219) in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer

monarcHER
Start date: May 23, 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the effectiveness of abemaciclib plus trastuzumab with or without fulvestrant versus trastuzumab plus physicians choice standard of care chemotherapy in women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 positive (HER2+) locally advanced or metastatic breast cancer after prior exposure to at least two HER2-directed therapies for advanced disease.

NCT ID: NCT02675114 Active, not recruiting - Aortic Stenosis Clinical Trials

PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis

P3
Start date: March 2016
Phase: N/A
Study type: Interventional

To establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) in patients with severe, calcific aortic stenosis who are at low operative risk for standard aortic valve replacement.