Palm Beach Gardens,, Florida
Product Surveillance Registry
Phase
N/ASpan
1466 weeksSponsor
MedtronicSarasota, Florida
Recruiting
Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products
All Medtronic market-released leads and all market-released IPG, ICD and CRT devices are eligible to be included in this study.
Phase
N/ASpan
3027 weeksSponsor
MedtronicSarasota, Florida
Recruiting
A Study of DS-1471a In Subjects With Advanced Solid Tumors
The objectives of this multinational, multicenter, open-label, 2-part, dose-escalation and dose-expansion, FIH study of participants with locally advanced or metastatic solid tumors are to evaluate the safety, maximum tolerated dose (MTD), recommended dose for expansion phase, preliminary efficacy, PK, and immunogenicity of DS-1471a.
Phase
1Span
200 weeksSponsor
Daiichi Sankyo Co., Ltd.Sarasota, Florida
Recruiting
Tailoring Therapy in Post-surgical Patients With Low-risk Endometrial Cancer
PRIMARY OBJECTIVE: I. Estimate the rate of pelvic recurrence at 3 years in patients who are treated with a de-escalated adjuvant treatment directed by tumour molecular status. SECONDARY OBJECTIVES: I. Estimate the rate of isolated vaginal recurrence, para-aortic recurrence and distant metastasis at 3 years. II. Estimate the recurrence-free, endometrial cancer-specific and overall survival. III. Describe the impact of molecular classification on patient decisional conflict and fear of recurrence. TERTIARY OBJECTIVES: I. Evaluate health economic impact of molecular classification-tailored adjuvant therapy on the cost of treating endometrial cancer. II. Evaluate quality of life. III. Determine if variability in adjuvant treatment given to patients with endometrial cancer is decreased by molecular classification-tailored adjuvant therapy as compared to recent clinical practice data. IV. To assess if additional molecular parameters can further refine prognosis within POLE-mutated and p53wt/no specific molecular profile (NSMP) endometrial cancer (EC). OUTLINE: Patients are assigned to 1 of 2 sub-studies. SUB-STUDY A: Patients are assigned to 1 of 2 cohorts. COHORT A1: Patients with POLE-mutated early-stage EC undergo observation on study. COHORT A2: Patients with higher-risk POLE-mutated EC undergo observation or external beam radiation therapy (EBRT) and/or vaginal brachytherapy over 3-5 fractions. SUB-STUDY B: Patients with p53 wildtype/NSMP ER+ EC undergo observation or vaginal brachytherapy over 3-5 fractions. All patients undergo chest x-ray and computed tomography (CT) or magnetic resonance imaging (MRI) or positron emission tomography (PET)/CT scans during screening and as clinically indicated throughout the trial. After completion of study treatment, patients are followed up at 3 and 6 months, then every 6 months for 3 years, and then every year.
Phase
2Span
103 weeksSponsor
NRG OncologySarasota, Florida
Recruiting
A Phase 1 of CTX-8371 in Patients With Advanced Malignancies
This Phase 1, open-label, first-in-human study will evaluate the safety, tolerability, immunogenicity, and pharmacokinetic profile of CTX-8371 monotherapy. Preliminary anti-tumor activity of CTX-8371 will also be assessed. The study will be conducted in 2 cohorts: Dose escalation and Dose expansion. The Dose Escalation Cohort will utilize a 3+3 design to evaluate five dose levels (0.1-10 mg/kg) of CTX-8371 given as an IV infusion once every 2 weeks. Patients in the Dose Expansion Cohort will receive CTX-8371 as an IV infusion at a dose(s) based on data from the Dose Escalation Cohort.
Phase
1Span
111 weeksSponsor
Compass TherapeuticsSarasota, Florida
Recruiting
Sarasota, Florida
Recruiting
Study of LY3537982 in Cancer Patients With a Specific Genetic Mutation (KRAS G12C)
This is an open-label, multicenter Phase 1/2 study to evaluate safety, tolerability, and preliminary efficacy of oral LY3537982 in patients with KRAS G12C-mutant solid tumors. This study will be conducted in 4 parts: Phase 1a dose escalation, Phase 1b dose expansion, Phase 1b dose optimization, and Phase 2. KRAS G12C mutations will be identified through standard of care testing.
Phase
1/2Span
302 weeksSponsor
Eli Lilly and CompanySarasota, Florida
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
PRIMARY OBJECTIVE: I. To compare the non-inferiority of bilateral salpingectomy (BLS) with delayed oophorectomy to bilateral salpingo-oophorectomy (BSO) to reduce the risk of ovarian cancer among individuals with deleterious BRCA1 germline mutations. SECONDARY OBJECTIVES: I. To prospectively assess estrogen deprivation symptoms in pre-menopausal BLS patients as measured by the Functional Assessment of Cancer Therapy - Endocrine Symptom (FACT-ES) subscale compared to pre-menopausal patients in the BSO arm. II. To determine if health-related quality of life (QOL) (FACT) is negatively impacted by menopausal symptoms (menopausal symptom checklist-Menopausal Symptom Checklist [MSCL]) and sexual dysfunction (Female Sexual Function Index [FSFI]) in pre-menopausal patients who have undergone BLS, in comparison to normative data (MSCL/FACT-ES) and data from pre-menopausal BSO patients. III. To determine if health-related QOL (FACT) is negatively impacted by cancer distress (Impact of Event Scale [IES]) in individuals who have undergone BLS, in comparison to BSO patients. IV. To assess medical decision making, as measured by the Shared Decision Making Questionnaire (SDM-Q-9) and Decision Regret Scale (DRS), and determine factors associated with the risk of reducing surgical treatment choice. V. To assess adverse events, graded using Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. EXPLORATORY OBJECTIVES: I. Sexual dysfunction, as measured by selected Patient-Reported Outcomes Measurement Information System (PROMIS) screener and external sexual function items (pre-menopausal patients). II. To estimate the cost-effectiveness of BLS compared to BSO for ovarian cancer risk reduction. III. To assess medical decision making, as measured by the Risk-Reducing Medical Decision Making (RR-MDM) survey, a targeted set of questions on risk reducing surgical treatment choice. TRANSLATIONAL RESEARCH OBJECTIVE: I. To bank tissue and blood biospecimens for future research. OUTLINE: Patients choose between 1 of 2 groups. GROUP I: Patients undergo bilateral salpingectomy. Patients may then undergo oophorectomy after initial surgery. GROUP II: Patients undergo bilateral salpingo-oophorectomy. Patients in both groups also undergo a pelvic or transvaginal ultrasound during screening and blood sample collection throughout the trial. After completion of study, patients are followed up at 10-60 days, 6, 12, and 24 months, and then annually for up to 20 years.
Phase
N/ASpan
1391 weeksSponsor
NRG OncologySarasota, Florida
Recruiting
ImPACT Normative Extension
Phase
N/ASpan
401 weeksSponsor
ImPACT Applications, Inc.Sarasota, Florida
Recruiting
Healthy Volunteers
Phase 1/2 Study of MRTX849 in Patients With Cancer Having a KRAS G12C Mutation KRYSTAL-1
This study will evaluate the safety, tolerability, pharmacokinetics, metabolites, pharmacodynamics, and clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors with a KRAS G12C mutation. MRTX849 (adagrasib) is an orally-available small molecule inhibitor of KRAS G12C.
Phase
1/2Span
366 weeksSponsor
Mirati Therapeutics Inc.Sarasota, Florida
Recruiting