CenterWatch
  • Search Clinical Trials
  • Clinical Trial Listings
  • Volunteer
  • Learn About Clinical Trials

Bowling Green, Kentucky

< 2 Miles
Filters

Type

Distance
Age
0
0
Gender
Trial Phase
Sponsor
  • A Phase 2 Study of EIK1001 in Combo With Pembrolizumab and Chemotherapy in Patients With Stage 4 NSCLC

    This is a multicenter open-label phase 2 trial that aim to assess the safety, tolerability, and efficacy of EIK1001 in combination with standard of care in participants with both confirmed stage 4 squamous and non-squamous NSCLC who have not received prior systemic therapy for the advanced disease. The study includes dose finding and evaluates adverse events and efficacy.

    Phase

    2

    Span

    204 weeks

    Sponsor

    Eikon Therapeutics

    Bedford, Texas

    Recruiting

  • Mirvetuximab Soravtansine With Bevacizumab Versus Bevacizumab as Maintenance in Platinum-sensitive Ovarian, Fallopian Tube, or Peritoneal Cancer

    Mirvetuximab Soravtansine (MIRV) is an investigational antibody drug conjugate designed to selectively kill cancer cells. The antibody (protein) part of MIRV targets tumors by delivering a cell-killing drug to the tumor cells carrying a tumor-associated protein called folate receptor alpha (FRα). It is being developed as maintenance therapy for the treatment of subjects with recurrent platinum-sensitive, highgrade epithelial ovarian, primary peritoneal, or fallopian tube cancers with high folate receptor-alpha expression. Patients must have confirmation of FRα positivity by the Ventana FOLR1 Assay.

    Phase

    3

    Span

    331 weeks

    Sponsor

    AbbVie

    Bedford, Texas

    Recruiting

  • A Trial of Robotic Versus Open Hysterectomy Surgery in Cervix Cancer

    This is a multi-center, open-label, randomized, non-inferiority clinical trial with the hypothesis that robotically assisted hysterectomy with tumor containment prior to colpotomy is non-inferior to abdominal hysterectomy with respect to disease free survival. At the commencement of surgery, a thorough inspection of all peritoneal surfaces should be performed. The location of any suspected metastatic disease should be documented in the operative report and a biopsy should be performed to confirm the diagnosis. If intraperitoneal disease is detected, the radical hysterectomy should be abandoned. In patients with macroscopic evidence of metastatic disease to the lymph nodes, intraoperative frozen section should be performed to confirm the presence of metastatic disease. Intraoperative management will be left to the discretion of the surgeon. Patients who have confirmed macroscopic lymph node metastases intraoperatively will be excluded from final analysis and replaced due to the controversy surrounding the decision to perform a radical hysterectomy in this setting. Patients in whom the hysterectomy is abandoned will be deemed non-evaluable and excluded from final analysis and will be replaced. For all patients, the surgeon should document operative time from incision to close, detailed description of operative findings, intraoperative complications, and blood loss. For patients randomized to the robotic arm, the surgeon should document the use of and specify the type of vaginal manipulator and the reason for conversion to laparotomy (if applicable). Transcervical manipulators are not permitted. Standard arm: Radical or simple hysterectomy is performed as per standard technique (peon radical hysterectomy (Piver type 2 or 3 or Querleu & Morrow Type B or C) with salpingectomy +/- oophorectomy. Ovaries may be removed or preserved +/- transposition. Prior to colpotomy, the vagina must be closed over the tumor (ie, Wertheim clamps, contour stapling device). Study arm: Radical or simple hysterectomy is performed as per standard robotic technique (Querleu & Morrow Type B or C) with salpingectomy +/- oophorectomy. Ovaries may be removed or preserved +/- transposition. Colpotomy may be made intracorporally or vaginally. Vagina must be closed prior to intracorporeal colpotomy (see below, #10)

    Phase

    N/A

    Span

    389 weeks

    Sponsor

    GOG Foundation

    Bedford, Texas

    Recruiting

  • MammaPrint, BluePrint, and Full-genome Data Linked With Clinical Data to Evaluate New Gene EXpression Profiles

    The FLEX Registry will include all patients with stage I-III breast cancer who have received MammaPrint and BluePrint testing in any clinical setting. Study arm appendices will specify treatment arm, inclusion criteria, and number of patients needed. Approximately 30,000 patients from 125+ US based institutions will be enrolled. Treatment is at the discretion of the physician adhering to NCCN approved regimens of a recognized alternative. Clinical data will be collected and entered online at the time points listed: patient enrollment, time of treatment, 1 year post-treatment, and 3, 5, and 10 years post diagnosis. Objectives: - Create a large scale, population-based registry of full genome expression data and clinical data to investigate new gene associations with prognostic and/or predictive value - Utilize shared registry infrastructure to examine smaller groups of interest - Generate hypotheses for targeted subset analyses and trials based on full genome data FLEX is an observational (phase IV) study.

    Phase

    N/A

    Span

    1079 weeks

    Sponsor

    Agendia

    Bedford, Texas

    Recruiting

  • An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2)

    This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm of the study is 7 years. Eligible patients must have intermediate-high or high risk of recurrence as defined by specified clinical and biologic criteria. Concurrent use of abemaciclib is permitted in both arms. The primary endpoint of the study is Invasive breast cancer-free survival (IBCFS) and main secondary endpoints include Invasive disease-free survival (IDFS), Distant relapse-free survival (DRFS), Overall survival (OS), Safety and Clinical Outcome Assessments (COAs). Patients will be followed for 10 years from randomization of the last patient.

    Phase

    3

    Span

    709 weeks

    Sponsor

    AstraZeneca

    Bedford, Texas

    Recruiting

  • Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7

    The Phase 2 portion of this study will evaluate the efficacy and safety of MRTX849 as monotherapy and in combination with pembrolizumab. There will be 3 cohorts of patients, all of whom have KRAS G12C mutation, have advanced or metastatic NSCLC, and are candidates for first-line treatment. 2 cohorts have PD-L1 TPS score <1% and are randomized to MRTX849 monotherapy or MRTX849 in combination with pembrolizumab. The 3rd cohort has PD-L1 TPS score of 1% or higher and is treated with MRTX849 and pembrolizumab The Phase 3 portion of the study will randomize patients with squamous or nonsquamous NSCLC with KRAS G12C mutation and TPS >=50% in the first-line setting to adagrasib plus pembrolizumab or pembrolizumab. Primary efficacy objective is to compare efficacy between experimental and comparator arms. Secondary and exploratory objectives include evaluation of secondary efficacy endpoints, safety and tolerability, adagrasib PK, PROs, and correlative genomic biomarkers for the combination regimen in the study population. MRTX849 is an orally available small molecule inhibitor of KRAS G12C, and Pembrolizumab (KEYTRUDA®) is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2.

    Phase

    2/3

    Span

    465 weeks

    Sponsor

    Mirati Therapeutics Inc.

    Bedford, Texas

    Recruiting

  • Subcutaneous Progesterone in Frozen- Thawed Single Euploid Blastocyst Transfer.

    Phase

    3

    Span

    194 weeks

    Sponsor

    IBSA Institut Biochimique SA

    Bedford, Texas

    Recruiting

  • A Study of TRK-950 When Used in Combination With Ramucirumab and Paclitaxel in Patients With Gastric Cancer

    This study will assess and compare the efficacy, safety, pharmacokinetics (PK), optimal dose and anti-drug antibodies (ADA) and neutralizing antibodies (NAbs) development of TRK-950 at two separate dose levels in combination with RAM + PTX as compared with RAM + PTX treatment alone in participants with gastric or gastro-esophageal junction (GEJ) adenocarcinoma. The primary objective is progression free survival (PFS). Secondary objectives are overall survival, objective response rate, best overall response, duration of response, disease control rate, safety, pharmacokinetics, and immunogenicity of TRK-950 when used in combination with RAM+PTX.

    Phase

    2

    Span

    143 weeks

    Sponsor

    Toray Industries, Inc

    Bedford, Texas

    Recruiting

  • 53-Week Study Evaluating the Safety and Efficacy of Intra-articular Injections of TPX-100 With Mild to Severe Tibio-Femoral Osteoarthritis of the Knee

    This multicenter, double-blind, placebo controlled, randomized study is designed to investigate the safety and efficacy of TPX-100 administered in 4 weekly doses of 200 mg per dose in subjects with tibio-femoral osteoarthritis. The B-score as determined by MRI analysis is the final inclusion criteria, which will be determined by MRI-based assessment. A standardized screening MRI will be obtained on otherwise eligible candidates. For enrolled subjects, the Screening MRI will serve as the Baseline MRI. Enrolled subjects will be assigned randomly to receive either TPX-100 or PBS placebo, 4 weekly IA injections administered into the target knee by fluoroscopy or ultrasound guidance. Subjects will undergo follow-up knee MRIs at Week 27 and Week 53 after the first injection. All MRIs will be read by computer-based, standardized methods, blind to treatment assignment and temporal sequence, to provide the imaging outcome measures. Subjects will complete PROs at Week 1 (Baseline), Week 27 and Week 53. A clinical safety evaluation will be performed at Week 13, and a safety tele-visit or telephone call will be performed at Week 36. Adverse events, regardless of causation, and concomitant medications will be documented at all study visits and at the Week 37 tele-visit/telephone call. Clinical laboratory assessments will be obtained at Screening, Baseline (Week 1), and Weeks 2, 3, 4; and at the in-person follow up visits. All enrolled subjects will be assigned randomly to receive either TPX-100 or PBS placebo, in 4 weekly IA injections administered into the target knee by fluoroscopy or ultrasound guidance.

    Phase

    2

    Span

    110 weeks

    Sponsor

    OrthoTrophix, Inc

    Bedford, Texas

    Recruiting

  • FebriDx® Method Comparison Study Protocol

    A prospective, multi-center, blinded observational study to demonstrate that the FebriDx test meets the CLIA statutory criteria for waiver by providing sufficient assurance that the addition of a new operator population (untrained) and environment of use (waived) will not adversely impact the performance or safety of the test. The study aims to: - Demonstrate that FebriDx® Test is accurate and the operator can perform the test with a negligible risk of erroneous result. - As a secondary objective, ease-of-use objective data and subjective feedback relating to the device and its operator interface will be collected at the end of the study and assessed for comparability.

    Phase

    N/A

    Span

    26 weeks

    Sponsor

    Lumos Diagnostics

    Bedford, Texas

    Recruiting

1-10 of 16
CenterWatch

5000 Centregreen Way, Suite 200
Cary, NC, 27513, USA

Phone: 609.945.0101

  • Disclaimer
  • Privacy Policy
  • Term of Use
  • Do Not Sell My Personal Information