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NCT ID: NCT02978716 Terminated - Breast Cancer Clinical Trials

Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Gemcitabine and Carboplatin in Metastatic Triple Negative Breast Cancer (mTNBC)

Start date: February 2, 2017
Phase: Phase 2
Study type: Interventional

This was a study to investigate the potential clinical benefit of trilaciclib (G1T28) in preserving the bone marrow and the immune system, and enhancing chemotherapy antitumor efficacy when administered prior to carboplatin and gemcitabine (GC therapy) for participants with metastatic triple negative breast cancer. The study was an open-label and 102 participants were randomly assigned (1:1:1 fashion) to 1 of the 3 following treatment groups: - Group 1: GC therapy (Days 1 and 8 of 21-day cycles) only (n=34) - Group 2: GC therapy (Days 1 and 8) plus trilaciclib (G1T28) on Days 1 and 8 of 21-day cycles (n=33) - Group 3: GC therapy (Days 2 and 9) plus trilaciclib (G1T28) on Days 1, 2, 8, and 9 of 21-day cycles (n=35) The study included 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day of first dose with study treatment and completes at the Post-Treatment Visit.

NCT ID: NCT02978443 Terminated - Mucosal Melanoma Clinical Trials

A Biomarker Study in Advanced Mucosal or Acral Lentiginous Melanoma Receiving Nivolumab in Combination With Ipilimumab

Start date: July 26, 2017
Phase: Phase 2
Study type: Interventional

Participants with advanced or metastatic mucosal melanoma (cohort A) and acral lentiginous melanoma (cohort B) eligible for treatment with nivolumab in combination with ipilimumab followed by nivolumab therapy will submit tissue blocks from tumors of malignant melanoma for histopathology review and immunohistochemistry analysis at Georgetown University-Lombardi Comprehensive Cancer Center. Pretreatment blood will be drawn and stored in the Melanoma Research Foundation Breakthrough Consortium Virtual Repository at each participating institution. At the end of participation, samples will be sent to Georgetown University-Lombardi Comprehensive Cancer Center for processing and storage. An optional pretreatment biopsy of an accessible tumor lesion will be performed in a subset of enrolled patients. Patients will receive nivolumab in combination with ipilimumab according to the standard FDA approved treatment regimen.

NCT ID: NCT02978378 Terminated - Acute Kidney Injury Clinical Trials

Renal Biomarkers to Predict Recovery Following Venoarterial Extracorporeal Membrane Oxygenation

Start date: May 1, 2017
Phase:
Study type: Observational

The investigators objective is to assess the utility of renal biomarkers in predicting renal recovery following institution of Venoarterial Extracorporeal Membrane Oxygenation (VA-ECMO). Tissue biomarkers of renal injury may provide a real-time indication of renal function and the likelihood of renal recovery in patients having cardiogenic shock and requiring VA-ECMO. In these patients, traditional markers of kidney function (urine output and serum Creatinine level) do not accurately represent renal function.

NCT ID: NCT02978235 Terminated - Multiple Myeloma Clinical Trials

A Dose Finding Study Followed by a Safety and Efficacy Study for Patients With Multiple Myeloma or Lymphoma

Start date: March 1, 2017
Phase: Phase 1
Study type: Interventional

The Phase 1 portion of this study will determine the safety of TAS4464 and the most appropriate dose for patients with Multiple Myeloma or Lymphoma.

NCT ID: NCT02978222 Terminated - Ovarian Cancer Clinical Trials

Folate Receptor Alpha Peptide Vaccine With GM-CSF Versus GM-CSF Alone in Patients With Platinum Sensitive Ovarian Cancer

Start date: July 20, 2017
Phase: Phase 2
Study type: Interventional

This is a double-blind, randomized, parallel groups Phase II trial. Patients with platinum-sensitive advanced ovarian cancer, defined as a lack of progression by RECIST v1.1 criteria following completion of standard-of-care chemotherapy, including a minimum of 4 cycles of a platinum-containing regimen. Patients will be randomized to either the vaccine regimen with GM-CSF adjuvant or GM-CSF adjuvant alone as a control group. Treatment will be administered as a consolidation therapy within one year of the last administration of platinum, targeting the first remission.

NCT ID: NCT02977286 Terminated - Constipation Clinical Trials

Naloxegol to Prevent Lower Gastrointestinal Paralysis in Critically Ill Adults Administered Opioids

Start date: January 1, 2017
Phase: Phase 4
Study type: Interventional

This study evaluates the addition of naloxegol (Movantik) to a laxative protocol in critically ill adults requiring scheduled opioid (e.g. fentanyl) therapy. Half of the participants will receive naloxegol and a laxative protocol and half the participants will receive a placebo and a laxative protocol.

NCT ID: NCT02976038 Terminated - Clinical trials for Primary Mitochondrial Disease

Open-Label Extension Trial to Characterize the Long-term Safety and Tolerability of Elamipretide in Subjects With Genetically Confirmed Primary Mitochondrial Myopathy (PMM)

Start date: December 2016
Phase: Phase 2
Study type: Interventional

This is a Phase 2 Open-Label extension study to evaluate the long term safety and tolerability of daily elamipretide injections in patients with genetically confirmed Primary Mitochondrial Disease who previously participated in the SPIMM-202 Clinical Trial

NCT ID: NCT02975557 Terminated - Dry Eye Clinical Trials

Brimonidine Eye Drops for Treatment of Ocular Graft-vs-Host Disease (oGVHD)

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

The objective of this study is to establish whether patients with dry eye disease (DED) are able to tolerate receiving Brimonidine: 0.15% eye drops two times a day for twelve weeks (primary tolerability objective) and to investigate the preliminary efficacy of Brimonidine 0.15% topical eye drop solution in treating Meibomian Gland Dysfunction (MGD) (primary efficacy objective). Meibomian Gland dysfunction can happen with numerous conditions such as Rosacea, Sjögren's syndrome, and oGVHD. In order to limit the influence of differing etiologies on the outcome of this trial, the investigator has limited the screening to MGD that accompanies oGVHD.

NCT ID: NCT02975336 Terminated - Clinical trials for Systemic Lupus Erythematosus

A Phase II Study of M2951 in SLE

Start date: January 4, 2017
Phase: Phase 2
Study type: Interventional

M2951 is an investigational drug under evaluation for treatment of autoimmune and inflammatory disorders. The purpose of the study was to assess the Safety and Efficacy of M2951 in participants with Systemic Lupus Erythematosus (SLE).

NCT ID: NCT02975271 Terminated - Burns Clinical Trials

Study of the Efficacy, Safety & Tolerability of Serlopitant for Pruritus (Itch) After Burn Injury

AUBURN
Start date: November 2016
Phase: Phase 2
Study type: Interventional

Study of the Efficacy, Safety & Tolerability of Serlopitant for Pruritus (Itch) After Burn Injury