13 Clinical Trials for Various Conditions
Background: Anaplastic thyroid cancer (ATC) is one of the most aggressive of all solid tumors; chemotherapy and surgery have had no impact on local control or survival of patients, with a median survival of 3-7 months. Crolibulin (EPC2407) is a microtubulin inhibitor that has been shown to have direct antitumor effects in vivo and in vitro, destabilizing spindles and inducing apoptosis, resulting in the disruption of neovascular endothelial cells with disruption of blood flow to the tumor. Early clinical studies with combretastatin, from which crolibulin is derived, demonstrated efficacy in a subset of patients with ATC. Objectives: The primary objective in the Phase I portion is to assess the safety and tolerability of cisplatin and crolibulin given in a 21-day cycle in dose-seeking cohorts. We will assess the toxicities of crolibulin coadministered with cisplatin, evaluate dose-limiting toxicities (DLTs) and determine the maximum tolerated dose (MTD) for the combination. The primary objective in the Phase II portion is to compare the combination crolibulin plus cisplatin versus cisplatin alone in adults with ATC by assessing the duration of progression-free survival (PFS); comparison of the response rates as evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) will be an important secondary objective. We plan on biochemical and immunohistochemical analysis of several tumor parameters including mitotic index, expression of several proteins including epidermal growth factor receptor (EGFR), vascular endothelial growth factor receptor (VEGFR), BRAF, excision repair cross-complementation group 1 (ERCC1) and tumor protein p53 (TP53). Where sufficient tissue is available we will also perform gene expression analysis, micro ribonucleic acid (microRNA) array analysis, and compare these with 3-deoxy-3 -\[(18)F\] fluorothymidine (FLT)-positron emission tomography (PET) and tumor growth rate constant. Eligibility: Phase I: adults age 18 and older with unresectable, recurrent or metastatic solid tumors. Phase II: adults age 18 and older with anaplastic thyroid cancer. In the phase II portion disease must be evaluable by RECIST. All patients must have adequate hepatic, renal, and bone marrow function. Design: The Phase I component consists of dose-escalation cohorts of three to six patients, in which all patients receive both the study drug crolibulin with cisplatin. The MTD and DLT will be determined based on toxicities during the first three weeks of combined therapy. The Phase II component will be a randomization study, to either crolibulin with cisplatin or cisplatin monotherapy. Patients randomized to cisplatin alone will have the opportunity the opportunity to cross over to the crolibulin arm in the event of tumor progression. Drug administration will take place on days 1, 2, and 3 for crolibulin, and on day 1 for cisplatin, on a 21-day cycle. Maximum number of patients for planned enrollment is 70. During the Phase I portion of the study, dose-seeking cohorts of three to six patients will be enrolled until MTD / DLT is reached for a maximum of three dose cohorts \[up to 24 patients if one assumes an expansion cohort to twelve patients at the recommended phase 2 (RP2) dose\]. During the randomized Phase II trial comparing the activity of the combination of crolibulin plus cisplatin with cisplatin alone it is estimated that a maximum of 40 patients will be enrolled \[1:1 randomization 20 + 20 = 40 patients\], and we will allow for 6 extra patients to be enrolled to compensate for a small number of non-evaluable patients.
This pragmatic, cluster-randomized trial in adult primary care clinics in a healthcare system with a diverse membership will examine the effectiveness of an innovative, multi-faceted intervention, the Addiction Telemedicine Consultant (ATC) service using clinical pharmacists to facilitate alcohol use problems and alcohol use disorder (AUD) pharmacotherapy and specialty addiction treatment entry.
This is an open label, single center, phase 2 trial of adjuvant pembrolizumab after external beam radiation to the primary tumor in patients with stage IVB (disease localized to the neck) ATC. This drug trial will estimate the median progression-free survival (PFS) (from the start of adjuvant pembrolizumab until locoregional progression, development of distant metastatic disease, or death) in stage IVB ATC patients with gross disease, treated with external beam radiation (+/- concomitant chemotherapy) followed by adjuvant pembrolizumab. Patients will be patients enrolled from cohort 1 and 2 (cohort 1: ≥51 Gy; cohort 2: ≤50 Gy).
This is a Phase 1 Clinical Safety Study intended to provide preliminary assessments of the safety, tolerability, and clinical alleviation of symptoms associated with Post Concussion Syndrome (PCS), also known as Chronic Concussive Syndrome (CCS).
The objective of this study is to determine the efficacy of a product combining the probiotic Lactobacillus GG and chamomile in treating infantile colic in exclusively breast fed infants. The study will be performed as a 4 week, placebo controlled, pilot trial with a one week run in period. Thirty subjects will be randomly assigned to each group for a total enrollment of 60 infants.
The primary purpose of the study is to evaluate objective response rate (\[ORR\]: complete response \[CR\] and partial response \[PR\]) by investigator review in participants with anaplastic thyroid cancer (ATC) treated with lenvatinib.
The primary aim of this study is to determine if chronic pain subjects on around-the-clock opioids who are receiving 100 to 220 mg oral morphine sulfate equivalent (MSE) can be safely transitioned on to buprenorphine hydrochloride (HCl) buccal film at 50% of their MSE dose without inducing opioid withdrawal or reversing analgesic effects.
This is a phase I, open label clinical trial to evaluate the safety of Lactobacillus rhamnosus GG (LGG) in elderly subjects. Lactobacilli are part of the normal flora of the intestine. LGG is one of several strains of Lactobacilli that is used as a probiotic or microorganism administered to confer "health benefits". Our research is focused on studying the possible therapeutic effects of LGG. The study hypotheses are: * LGG administered twice daily will be safe and well tolerated in elderly subjects * LGG will colonize the stool of elderly subjects and will modify the diversity and richness of the microbiota in their nasopharyngeal and stool specimens
This study is a single site, Phase I, masked, randomized study to evaluate the safety and tolerability of twice daily dosing of LGG (Lactobacillus GG ATCC 53103) in normal healthy adult volunteers. Study drug capsules (1x10\^10 LGG/capsule or placebo) will be taken by mouth twice a day with cow's milk or soy milk on an outpatient basis. Volunteers will have study visits at baseline, 1 month, 3 months, 6 months, 7 months, and 12 months where they will be asked about any medical problems that have come up since the last study visit, have vital signs taken, review current medication use, and review any signs of potential adverse events. Blood and urine samples will also be collected at these visits, as well as throat and stool samples. Our goal is to assess the safety and tolerability of LGG when administered to healthy adult volunteers twice a day. Assessment of safety will be determined by vital sign measurements, physical examinations, clinical laboratory tests, and from the incidence and severity of adverse events that occur during study participation. Additionally, we will assess whether LGG colonizes the throat and/or gastrointestinal tract of healthy adult volunteers and assess the effect of LGG on the bacteria that normally live in the throat and GI tract by using culture-independent techniques. Volunteers enrolled in this study will also be invited to participate in a companion genetic study that will investigate the host immune response to the bacteria in LGG.
The purpose of this study is to evaluate the safety and tolerability of CFT1946 as well as to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of CFT1946 as monotherapy (Arm A) and in combination with trametinib (CFT1946 + trametinib; Arm B) or Cetuximab (CFT1946 + cetuximab; Arm C).
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of KIN-2787 in adults with BRAF/NRAS-mutated advanced or metastatic solid tumors.
This multicenter study examines the safety and feasibility of the combination of neoadjuvant XL092 and cemiplimab prior to surgical resection in participants with wild-type (WT) anaplastic thyroid cancer (ATC) that has a BRAF mutation (BRAF V600E).
This was a Phase II, open-label, non-randomized, multi-center study of oral dabrafenib in combination with oral trametinib in subjects with rare cancers harboring the BRAF V600E mutation including anaplastic thyroid cancer (ATC), biliary tract cancer (BTC), gastrointestinal stromal tumor (GIST), low grade (WHO G1/G2) glioma (LGG), high grade (WHO G3/G4) glioma (HGG), non-seminomatous germ cell tumors (NSGCT) / non-germinomatous germ cell tumors (NGGCT), adenocarcinoma of the small intestine (ASI), hairy cell leukemia (HCL) and multiple myeloma (MM).