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NCT ID: NCT02603185 Recruiting - Clinical trials for Inflammatory Bowel Disease

Phaseâ… First-in-Human Study of Hemay007 in Healthy Volunteers

Start date: January 9, 2017
Phase: Phase 1
Study type: Interventional

This phase I study designed in 3 parts is a randomized, placebo-controlled, sequential ascending-dose study of healthy volunteers. The safety, tolerability and pharmacokinetics of ascending single and multiple dose of Hemay007 will be assessed in Part 1 and Part 3, respectively. Food effect following a single oral dose will be evaluated in Part 2.

NCT ID: NCT02603120 Completed - HIV-1 Infection Clinical Trials

Safety and Efficacy of Switching From Dolutegravir and ABC/3TC or ABC/DTG/3TC to B/F/TAF in HIV-1 Infected Adults Who Are Virologically Suppressed

Start date: November 11, 2015
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the efficacy of switching from a regimen of dolutegravir (DTG) and abacavir/lamivudine (ABC/3TC) or a fixed dose combination (FDC) of abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) to a FDC of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing DTG and ABC/3TC as the FDC ABC/DTG/3TC in virologically suppressed Human Immunodeficiency Virus- 1 (HIV-1) infected adults.

NCT ID: NCT02603107 Completed - HIV-1 Infection Clinical Trials

Study to Evaluate the Safety and Efficacy of Switching From Regimens Consisting of Boosted Atazanavir or Darunavir Plus Either Emtricitabine/Tenofovir or Abacavir/Lamivudine to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed HIV-1 Infected Adults

Start date: November 20, 2015
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the efficacy of switching to a fixed-dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing on a regimen consisting of boosted atazanavir (ATV) or darunavir (DRV) plus either emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or abacavir/lamivudine (ABC/3TC) in HIV-1 infected adults who are virologically suppressed.

NCT ID: NCT02601950 Completed - Synovial Sarcoma Clinical Trials

A Study of Tazemetostat in Adult Participants With Soft Tissue Sarcoma

Start date: December 22, 2015
Phase: Phase 2
Study type: Interventional

This study will include participants with various types of cancer known as soft-tissue sarcomas. Tissues that can be affected by soft tissue sarcomas include fat, muscle, blood vessels, deep skin tissues, tendons and ligaments. Soft tissue cancers are rare and can occur almost anywhere in the body. Part 1 of this trial will study the safety and the level that adverse effects of the study drug tazemetostat in combination with doxorubicin (current front line treatment) can be tolerated (known as tolerability). It is also designed to establish a recommended study drug dosage for the next part of the study. Part 2 will evaluate and compare how long participants live without their disease getting worse when receiving the study drug plus doxorubicin versus doxorubicin plus placebo (dummy treatment).

NCT ID: NCT02601937 Completed - Synovial Sarcoma Clinical Trials

A Phase 1 Study of the EZH2 Inhibitor Tazemetostat in Pediatric Subjects With Relapsed or Refractory INI1-Negative Tumors or Synovial Sarcoma

Start date: January 7, 2016
Phase: Phase 1
Study type: Interventional

This is a Phase I, open-label, dose escalation and dose expansion study with BID (suspension) and TID (tablet) oral dose of tazemetostat. Subjects will be screened for eligibility within 14 days of the planned first dose of tazemetostat. A treatment cycle will be 28 days. Response assessment will be evaluated after 8 weeks of treatment and subsequently every 8 weeks while on study. The study has two parts: Dose Escalation and Dose Expansion. Dose escalation for subjects with the following relapsed/refractory malignancies: - Rhabdoid tumors: - Atypical teratoid rhabdoid tumor (ATRT) - Malignant rhabdoid tumor (MRT) - Rhabdoid tumor of kidney (RTK) - Selected tumors with rhabdoid features - INI1-negative tumors: - Epithelioid sarcoma - Epithelioid malignant peripheral nerve sheath tumor - Extraskeletal myxoid chondrosarcoma - Myoepithelial carcinoma - Renal medullary carcinoma - Other INI1-negative malignant tumors (e.g., dedifferentiated chordoma) (with Sponsor approval) - Synovial Sarcoma with a SS18-SSX rearrangement Dose Escalation cohorts are closed to enrollment. Dose Expansion at the MTD or the RP2D - Cohort 1 - ATRT (closed to enrollment) - Cohort 2 - MRT/RTK/selected tumors with rhabdoid features (closed to enrollment) - Cohort 3 - INI-negative tumors: - Epithelioid sarcoma - Epithelioid malignant peripheral nerve sheath tumor - Extraskeletal myxoid chondrosarcoma - Myoepithelial carcinoma - Renal medullary carcinoma - Chordoma (poorly differentiated or de-differentiated) - Other INI1-negative malignant tumors (e.g., dedifferentiated chordoma) with Sponsor approval - Cohort 4 - Tumor types eligible for Cohorts 1 through 3 or synovial sarcoma with SS18-SSX rearrangement (closed to enrollment)

NCT ID: NCT02601378 Terminated - Uveal Melanoma Clinical Trials

A Phase I Study of LXS196 in Patients With Metastatic Uveal Melanoma.

Start date: February 1, 2016
Phase: Phase 1
Study type: Interventional

This study was to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary anti-tumor activity of LXS196 as a single agent and in combination with HDM201 in patients with metastatic uveal melanoma.

NCT ID: NCT02600234 Active, not recruiting - Heart Failure Clinical Trials

REDUCE LAP-HF RANDOMIZED TRIAL I

Start date: December 2015
Phase: N/A
Study type: Interventional

A study to evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure.

NCT ID: NCT02599961 Terminated - Clinical trials for Glucose Transporter Type 1 Deficiency Syndrome

Study to Assess the Long Term Safety and Efficacy of UX007 in Participants With Glucose Type 1 Deficiency Syndrome (Glut1 DS)

Start date: September 10, 2015
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to evaluate the long-term safety of UX007 in Glut1 DS participants.

NCT ID: NCT02599792 Completed - Healthy Clinical Trials

Healthy Volunteer Solid Oral Dose and Multiple Ascending Dose Evaluation of CTP-656

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

Two-part study to assess CTP-656 dosed as a solid oral dosage form versus Kalydeco and multiple-ascending doses of CTP-656 dosed for 7 days.

NCT ID: NCT02599402 Completed - Melanoma Clinical Trials

Nivolumab Combined With Ipilimumab Followed by Nivolumab Monotherapy as First-Line Treatment for Patients With Advanced Melanoma

CheckMate 401
Start date: December 20, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the effects of combination treatment of Nivolumab with Ipilimumab followed by Nivolumab monotherapy in patients with previously untreated advanced Melanoma.