LOTUS-CC: An Observational Research Study to Uncover Subtypes of Cancer Cachexia
NCT06073431 · Advanced Colorectal Carcinoma, Advanced Lung Non-Small Cell Carcinoma, Advanced Pancreatic Adenocarcinoma
RecruitingThis study evaluates cancer-related weight and muscle mass loss, symptoms, and physical function (cachexia) in patients undergoing treatment for colorectal, lung, or pancreatic cancer that cannot be removed by surgery (unresectable) or is stage IV. Patients with these cancer types are at risk for developing cancer cachexia (CC), which is defined as weight loss, muscle loss, and fat loss due to cancer. CC has been associated with reduced physical performance, impaired quality of life, and poorer survival. Many studies that have evaluated treatments for cancer-related weight and muscle loss have aimed to treat all patients with weight loss exactly the same and, unfortunately, have not been successful. Like different cancer types, weight and muscle loss related to cancer may have different causes in different individuals and the best treatment strategy for this condition may not be a one-size-fits-all approach. Information gathered from this study may help researchers develop new diagnostic criteria for CC and design better treatments and clinical trials for cancer-related weight and muscle loss in the future to improve the quality of life in patients with advanced colorectal, lung, or pancreatic cancer.
Phase—
TypeObservational
Age18 Years
WhereFort Smith, Arkansas, United States + 224 more
SponsorUniversity of Rochester
▾Tap for detailsClick for full details — eligibility, all locations, contacts SYNERGY-AI: Artificial Intelligence Based Precision Oncology Clinical Trial Matching and Registry
NCT03452774 · Cancer, Metastatic,
Cancer, Cancer of Pancreas
RecruitingInternational registry for cancer patients evaluating the feasibility and clinical utility of an Artificial Intelligence-based precision oncology clinical trial matching tool, powered by a virtual tumor boards (VTB) program, and its clinical impact on pts with advanced cancer to facilitate clinical trial enrollment (CTE), as well as the financial impact, and potential outcomes of the intervention.
Phase—
TypeObservational
AgeAny
WhereBirmingham, Alabama, United States + 67 more
SponsorMassive Bio, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Alpha Radiation Emitters Device (DaRT) With Chemotherapy for the Treatment of Locally Advanced and Metastatic Pancreatic Cancer
RecruitingThis is a multi-center clinical study enrolling up to 30 participants (15 patients in each cohort). The primary objective of the study is to evaluate the safety of Alpha DaRT in combination with chemotherapy, based on the cumulative incidence rate, severity and outcome of device related AEs. Classification of AEs will be done according to CTCAE V5. The secondary objectives of the study are to: * Assess efficacy of the Alpha DaRT sources in combination with chemotherapy, determined by overall and progression-free survival. * Assess pain control * Assess rate of surgical resection in Cohort 1.
PhaseNA
TypeInterventional
Age18 Years – 120 Years
WhereGilbert, Arizona, United States + 14 more
SponsorAlpha Tau Medical LTD.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma ( RASolute 305 )
RecruitingThe purpose of this study is to evaluate the efficacy of an investigational RAS(ON) inhibitor administered in combination with chemotherapy compared to placebo in combination with chemotherapy.
PhasePhase 3
TypeInterventional
Age18 Years
WhereAtlanta, Georgia, United States
SponsorRevolution Medicines, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts APOLLO: A Randomized Phase II Double-Blind Study of Olaparib Versus Placebo Following Curative Intent Therapy in Patients With Resected Pancreatic Cancer and a Pathogenic BRCA1, BRCA2 or PALB2 Mutation
NCT04858334 · Pancreatic Acinar Cell Carcinoma, Pancreatic Adenosquamous Carcinoma, Pancreatic Squamous Cell Carcinoma
RecruitingThis phase II trial investigates how well the addition of olaparib following completion of surgery and chemotherapy works in treating patients with pancreatic cancer that has been surgically removed (resected) and has a pathogenic mutation in BRCA1, BRCA2, or PALB2. Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep tumor cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy.
PhasePhase 2
TypeInterventional
Age18 Years
WhereAnchorage, Alaska, United States + 453 more
SponsorNational Cancer Institute (NCI)
▾Tap for detailsClick for full details — eligibility, all locations, contacts Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
RecruitingThe purpose of this study is to evaluate the safety and efficacy of atebimetinib in combination with modified GnP compared with SOC GnP alone.
PhasePhase 3
TypeInterventional
Age18 Years
WherePhoenix, Arizona, United States + 9 more
SponsorImmuneering Corporation
▾Tap for detailsClick for full details — eligibility, all locations, contacts This phase III trial compares the effect of dose-escalated radiation therapy to usual care in patients with locally advanced unresectable pancreatic ductal adenocarcinoma who have received an initial 4-6 months of chemotherapy. Usual care options include additional chemotherapy, observation, or standard lower-dose radiation therapy. These treatments may delay tumor growth but have not been shown to improve survival. Radiation therapy uses high energy X-rays to kill cancer cells and shrink tumors. Dose-escalated radiation therapy involves the precise delivery of higher doses to the tumor, often over a shorter period of time. This trial assesses whether using dose-escalated radiation therapy can prolong survival.
PhasePhase 3
TypeInterventional
Age18 Years
WhereGilbert, Arizona, United States + 278 more
SponsorNRG Oncology
▾Tap for detailsClick for full details — eligibility, all locations, contacts Testing the Use of Chemotherapy After Surgery for High-Risk Pancreatic Neuroendocrine Tumors
NCT05040360 · Metastatic Malignant Neoplasm in the Liver, Pancreatic Neuroendocrine Tumor, Stage I Pancreatic Neuroendocrine Tumor AJCC v8
RecruitingThis phase II trial studies the effect of capecitabine and temozolomide after surgery in treating patients with high-risk well-differentiated pancreatic neuroendocrine tumors. Chemotherapy drugs, such as capecitabine and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving capecitabine and temozolomide after surgery could prevent or delay the return of cancer in patients with high-risk well-differentiated pancreatic neuroendocrine tumors.
PhasePhase 2
TypeInterventional
Age18 Years
WhereAnchorage, Alaska, United States + 447 more
SponsorSWOG Cancer Research Network
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy
NCT05477576 · GEP-NET, Gastroenteropancreatic Neuroendocrine Tumor, Gastroenteropancreatic Neuroendocrine Tumor Disease
RecruitingThis study aims to determine the safety, pharmacokinetics (PK) and recommended Phase 3 dose (RP3D) of RYZ101 in Part 1, and the safety, efficacy, and PK of RYZ101 compared with investigator-selected standard of care (SoC) therapy in Part 2 in subjects with inoperable, advanced, well-differentiated, somatostatin receptor expressing (SSTR+) gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that have progressed following treatment with Lutetium 177-labelled somatostatin analogue (177Lu-SSA) therapy, such as 177Lu-DOTATATE or 177Lu-DOTATOC (177Lu-DOTATATE/TOC), or 177Lu-high affinity \[HA\]-DOTATATE.
PhasePhase 3
TypeInterventional
Age18 Years
WherePhoenix, Arizona, United States + 53 more
SponsorRayzeBio, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
RecruitingThis study collects blood and tissue samples from patients with cancer and without cancer to evaluate tests for early cancer detection. Collecting and storing samples of blood and tissue from patients with and without cancer to study in the laboratory may help researchers develop tests for the early detection of cancers.
Phase—
TypeObservational
Age40 Years – 75 Years
WhereAnchorage, Alaska, United States + 745 more
SponsorAlliance for Clinical Trials in Oncology
▾Tap for detailsClick for full details — eligibility, all locations, contacts Comparing the Clinical Impact of Pancreatic Cyst Surveillance Programs and Associated Biomarkers
NCT04239573 · Pancreatic Neoplasm
RecruitingThe purpose of this study is to compare two approaches for monitoring pancreatic cysts as well as to identify associated biomarkers. The study doctors want to compare more frequent monitoring versus less frequent monitoring as well as identify biomarkers which may improve risk detection of transformation to pancreatic cancer. The study doctors want to learn which monitoring method and which biomarkers lead to better outcomes for patients.
Phase—
TypeObservational
Age50 Years – 75 Years
WhereBirmingham, Alabama, United States + 423 more
SponsorECOG-ACRIN Cancer Research Group
▾Tap for detailsClick for full details — eligibility, all locations, contacts Increasing Germline Genetic Testing for Patients With Cancer
RecruitingGermline testing for hereditary cancer syndromes is underutilized across most health care settings. Using a learning health care approach, the Genomics-enabled Learning Health Systems (gLHS) network aims to evaluate the impact of a suite of implementation strategies to increase germline test ordering by oncology care teams (i.e., mainstreaming) for eligible patients with breast, pancreatic or colorectal cancer. Secondarily, the study will investigate completion of testing by eligible patients, as well as impact on overall rates of germline test ordering in patients with cancer. The network will bundle and deploy different implementation strategies across the clinical sites in three 6-month phases. A maintenance phase after the implementation periods will measure genetic testing rates without any additional implementation strategies to determine persistence of effects. The implementation strategies address clinician-level factors, and thus oncologists and their team members (e.g. advanced practice providers, nurse navigators, case managers) will be the focus of evaluating the impact of implementation strategies. Strategies that will be considered include provider education, audit and feedback reports, facilitation, peer support, and electronic health record (EHR) system optimization to support germline testing. Using the RE-AIM QuEST framework, outcomes will be assessed using mixed methods separately for each eligible cancer type. Data collection from the EHR, other relevant data sources, and qualitative provider feedback will be used to assess ordering and completion of tests and the effect of the implementation strategies on germline testing rates in oncology clinics.
PhaseNA
TypeInterventional
AgeAny
WhereLos Angeles, California, United States + 9 more
SponsorJosh Peterson
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma
NCT07522073 · Solid Tumors
RecruitingThe purpose of this study is to evaluate the efficacy and safety of standard chemotherapy with or without INCB161734 in participants with metastatic pancreatic ductal adenocarcinoma (PDAC).
PhasePhase 3
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 214 more
SponsorIncyte Corporation
▾Tap for detailsClick for full details — eligibility, all locations, contacts Relacorilant With Nab-Paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma
NCT07259317 · Adenocarcinoma, Carcinoma, Pancreatic Ductal
RecruitingThis is a Phase 2, single-arm study to evaluate the safety and efficacy of relacorilant in combination with nab-paclitaxel and gemcitabine in patients with previously untreated metastatic pancreatic adenocarcinoma (PDAC).
PhasePhase 2
TypeInterventional
Age18 Years
WhereScottsdale, Arizona, United States + 9 more
SponsorCorcept Therapeutics
▾Tap for detailsClick for full details — eligibility, all locations, contacts Studying Chemotherapy With or Without Panitumumab for Unresectable, Locally Advanced, or Metastatic Pancreatic Cancer Without KRAS Mutations
NCT06998940 · Locally Advanced Pancreatic Adenocarcinoma, Metastatic Pancreatic Adenocarcinoma,
Stage III Pancreatic Cancer AJCC v8 RecruitingThis phase III trial compares the effect of adding panitumumab to standard chemotherapy (with nanoliposomal Irinotecan, leucovorin, and 5-fluorouracil \[5-FU\] or irinotecan, leucovorin, and 5-FU or nab-paclitaxel and gemcitabine) versus standard chemotherapy alone in treating patients with KRAS wild type (WT) pancreatic ductal adenocarcinoma that cannot be removed by sugery (unresectable) or that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Panitumumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Chemotherapy drugs, such as nanoliposomal irinotecan, leucovorin, 5-FU, irinotecan, nab-paclitaxel and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Adding panitumumab to standard chemotherapy may be effective in treating patients with unresectable, locally advanced, or metastatic KRAS WT pancreatic ductal adenocarcinoma.
PhasePhase 3
TypeInterventional
Age18 Years
WhereAnchorage, Alaska, United States + 273 more
SponsorSWOG Cancer Research Network
▾Tap for detailsClick for full details — eligibility, all locations, contacts Determining the Link Between Dietary Patterns, Fecal Microbiome and Response to Neoadjuvant Chemotherapy
NCT06595160 · Borderline Resectable Pancreatic Ductal Adenocarcinoma, Resectable Pancreatic Ductal Adenocarcinoma,
Stage I Pancreatic Cancer AJCC v8 RecruitingThis study explores the relationship between pre-treatment dietary patterns, fecal microbiome, and response to chemotherapy in patients with pancreatic ductal adenocarcinoma.
Phase—
TypeObservational
Age18 Years
WhereAtlanta, Georgia, United States
SponsorEmory University
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Find a Suitable Dose of ASP5834 in Adults With Solid Tumors
NCT07094204 · Solid Tumor,
Non-Small-Cell Lung Cancer, Pancreatic Ductal Adenocarcinoma
RecruitingGenes contain genetic code which tell the body which proteins to make. Many types of cancer are caused by changes, or mutations, in a gene called KRAS. Researchers are looking for ways to stop the actions of abnormal proteins made from the mutated KRAS gene. ASP5834 is being studied in people with solid tumors who have certain KRAS gene mutations. Some people with solid tumors of the colon or rectum (colorectal cancer), will be given ASP5834 with panitumumab. Panitumumab is a treatment for colorectal cancer. In this study, the researchers will learn how ASP5834 is processed by and acts upon the body. This information will help find a suitable dose of ASP5834 and check for any potential medical problems from the treatment. The main aims of this study are to check the safety of ASP5834 given by itself or given with panitumumab, and how well it is tolerated; and to find a suitable dose of ASP5834 given by itself or given with panitumumab. People in this study will be adults with locally advanced, unresectable, or metastatic solid tumors with certain KRAS gene mutations. Locally advanced means the cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body. They either haven't responded to standard treatment or couldn't be given standard treatment. The key reasons people cannot take part are if they have specific uncontrollable cancers such as symptomatic or untreated cancers in nervous system, have specific heart conditions, swelling and irritation of lung tissues (pneumonitis or interstitial lung disease, also called ILD), infections, or have recently had a stroke or a bleed on the brain. In this study, ASP5834 is being given to humans for the first time. This is an open-label study. This means that people in this study and clinic staff will know that they will receive ASP5834 by itself or ASP5834 with panitumumab. This study will be in 2 parts: Part 1 is called Dose Escalation. Different small groups of people will receive lower to higher doses of either: ASP5834 by itself or ASP5834 with panitumumab. Only people who have colorectal cancer will receive ASP5834 with panitumumab. People with any type of solid tumor will receive ASP5834 by itself. For each dose, all medical problems will be recorded. A medical expert panel will check the results and decide if the next group can receive a higher dose of ASP5834. The panel will do this until the planned maximum number of people are treated or until suitable doses have been selected for Part 2. Part 2 is called Dose Expansion. Other different small groups of people will receive ASP5834 or ASP5834 with panitumumab. They will receive the most suitable doses worked out from Part 1. In both parts of the study, the study treatments ASP5834 and panitumumab will be given through a vein. This is called an infusion. Each study treatment cycle is either 21 days or 28 days long. People will continue study treatment until: they have medical problems from the study treatment they can't tolerate; their cancer gets worse; they start other cancer treatment; or they ask to stop study treatment. People will visit the clinic on certain days during their study treatment, with extra visits during the first 2 cycles of study treatment. The study doctors will check for any medical problems from ASP5834. Also, people in the study will have a health check. On some visits they will also have scans to check for any changes in their cancer. Tumor samples will be taken at certain visits during study treatment with the option of a tumor sample being taken if people's cancer gets worse or the cancer comes back. People will visit the clinic shortly after stopping treatment for a health check. After this, people will have health checks every couple of months to check the condition of their cancer. The number of visits and checks done will depend on the health of each person and whether they completed their study treatment or not. It is expected that people will be in this study for about 1 year.
PhasePhase 1
TypeInterventional
Age18 Years
WhereSanta Monica, California, United States + 19 more
SponsorAstellas Pharma Inc
▾Tap for detailsClick for full details — eligibility, all locations, contacts Biospecimen Collection to Identify Gene Mutations for High Risk Pancreatic Cancer in Pediatric Patients, INSPPIRE 2 Study
NCT06651580 · Chronic Pancreatitis, Exocrine Pancreas Carcinoma, Recurrent Acute Pancreatitis
RecruitingThis clinical trial collects blood, saliva, urine, or stool samples to help identify possible genetic mutations that may increase a person's chance at developing pancreatic cancer. Finding genetic markers among pediatric patients with acute recurrent pancreatitis and chronic pancreatitis may help identify patients who are at risk of pancreatic cancer.
Phase—
TypeObservational
Age17 Years
WhereLos Angeles, California, United States + 25 more
SponsorM.D. Anderson Cancer Center
▾Tap for detailsClick for full details — eligibility, all locations, contacts Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen
NCT07087054 · Carcinoid Syndrome, Carcinoid, Carcinoid Tumor
RecruitingA Phase 3, randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of paltusotine treatment vs placebo as well as the long-term safety of paltusotine in adults with carcinoid syndrome due to well-differentiated neuroendocrine tumors. The purpose of this study is to continue the evaluation of the safety, efficacy, and pharmacokinetics (PK) of paltusotine in participants with carcinoid syndrome.
PhasePhase 3
TypeInterventional
Age18 Years
WhereGilbert, Arizona, United States + 50 more
SponsorCrinetics Pharmaceuticals Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Test Different Doses of BI 765049 in People With Advanced Cancer of the Colon, Rectum, Stomach, or Pancreas
NCT06882746 · Colorectal Carcinoma, Gastric Carcinoma, Pancreatic Ductal Adenocarcinoma
RecruitingThis study is open to adults with advanced cancer of the colon, rectum, stomach, or pancreas, that is the cancer cannot be removed by surgery or has spread. People can take part in this study if their previous treatment was not successful, or no other treatment exists. The study aims to find the highest dose for the study medicine called BI 765049 that people with advanced cancer can tolerate. Another purpose is to find the most suitable dose and best way of administration of BI 765049 for further clinical development. BI 765049 may help the immune system fight cancer. Participants receive BI 765049 at least once every 3 weeks. Participants may continue to get BI 765049 treatment as long as they benefit from treatment and can tolerate it. Participants in this study also get additional medication before and after treatment with BI 765049 for better tolerability. If participants take this medication at home, they have daily phone visits. Participants regularly visit the study site. The study visits include several overnight stays at the hospital. At the visits, study doctors check participants' health, take necessary laboratory tests, and note any unwanted effects. Unwanted effects are any health problems that the doctors think were caused by the study medicine or treatment. To find the highest dose of BI 765049 that participants can tolerate, researchers look at the number of participants with certain severe health problems. These are severe health problems that happen within the time from when a person first receives the intended target dose, until one week after they receive it for the second time.
PhasePhase 1
TypeInterventional
Age18 Years
WhereLos Angeles, California, United States + 2 more
SponsorBoehringer Ingelheim
▾Tap for detailsClick for full details — eligibility, all locations, contacts