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A Phase 3, Open-label Study Of Ifinatamab Deruxtecan Versus Docetaxel In Participants With Metastatic Castration-Resistant Prostate Cancer (MCRPC) (IDeate-Prostate01)
Scottsdale/Phoenix, Ariz.,
Jacksonville, Fla.,
Rochester, Minn.
Researchers are looking for new ways to treat metastatic castration-resistant prostate cancer (mCRPC). Researchers have designed a study medicine called ifinatamab deruxtecan (also called I-DXd or MK-2400) to treat mCRPC. The goal of this study is to learn if people who receive I-DXd live longer overall and live longer without the cancer growing or spreading than people who receive chemotherapy,
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Phase III Study Of Ginseng For Cancer Related Fatigue
Mankato, Minn.,
Rochester, Minn.,
Albert Lea, Minn.
Fatigue is among the most challenging symptoms to manage in patients with cancer, both on or off active treatment. This symptom complex meaningfully contributes to psychosocial distress, healthcare costs, and it also interferes with the delivery of anticancer therapies. Unfortunately, there remain very few safe and effective interventions for patients with fatigue who are unable, or choose not to engage in, exercise; however, ginseng has shown promise in some preliminary studies. There is a pressing need to understand under what disease and/or treatment-specific circumstances that interventions, such as ginseng, are effective. The primary goal of this randomized, phase III study is to determine the efficacy of ginseng in patients with cancer, who suffer from significant fatigue.
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A Phase 1/2 First-Time-In-Human, Open-Label, Multicenter, Dose Escalation And Expansion Study Of GSK5458514 PSMA Targeting T Cell Engager Alone Or In Combination With Other Anti-Cancer Agents In Adult Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
The goal of the study is to evaluate how safe and how well the body handles GSK5458514 when administered in participants with prostate cancer. The study will be conducted in two parts - Part 1 (dose escalation phase) and Part 2 (dose expansion phase).
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Large Language Model Chatbots: Multi-turn Question Answering For Oncology Patients
Jacksonville, Fla.,
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
A Study to develop an LLM interface for interaction with patients and assess the performance of LLMs in multi-turn conversations from evaluation metrics encompassing both the patient and oncologist perspectives. To also utilize evaluation data to further improve model performance and compare different models to one another.
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SatisfACtion: A Phase I/II, Open-label, Multi-center Study Of [225Ac]Ac-PSMA-R2 In Men With Heavily Pre-treated PSMA Positive Metastatic Castration Resistant Prostate Cancer (MCRPC) With Or Without Prior 177Lu-labelled PSMA-targeted Radioligand Therapy.
Rochester, Minn.
This is an open label, phase I/II, multi-center study in adult participants with metastatic hormone sensitive prostate cancer (mHSPC) and with metastatic castration resistant prostate cancer (mCRPC) who have received prior anti-cancer treatment and have a positive 68Ga-PSMA-11 PET scan. The purpose of this study is to learn if the study drug, [225Ac]Ac-PSMA-R2, is safe and tolerable, and has anti-tumor activity in treated patients.
Closed for Enrollment
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A Phase 1 Study Of JNJ-69086420, An Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (HK2) For Advanced Prostate Cancer
Jacksonville, Fla.,
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2D\[s\]) of JNJ-69086420 in Part 1 (Dose Escalation) and to determine safety and preliminary signs of clinical activity at the RP2D(s) in Part 2 (Dose Expansion).
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A Phase I, Open-label, Multi-center Study Of Radiation Dosimetry, Safety, And Tolerability Of Extended Lutetium (177Lu) Vipivotide Tetraxetan Treatment In Chemo-naïve Adults With Metastatic Castration-resistant Prostate Cancer
Rochester, Minn.
The purpose of the study is to assess and evaluate dosimetry, safety, and tolerability following administration of up to 12 cycles of (177Lu) vipivotide tetraxetan (also referred to as [177Lu]Lu-PSMA-617 or 177Lu-PSMA-617 and hereafter identified as AAA617) in taxane-naïve adult participants with PSMA-positive mCRPC who progressed on a prior ARPI treatment with normal renal function or mild renal impairment (eGFR ≥ 60ml/min).
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A Phase I/IIa Theranostic Study Of 64Cu-SAR-bisPSMA And 67Cu-SAR-bisPSMA For Identification And Treatment Of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer
Rochester, Minn.
The aim of this study is to determine the safety and efficacy of 67Cu-SAR-bisPSMA in participants with PSMA-expressing metastatic castrate resistant prostate cancer.
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A Randomized, 2-cohort, Double-blind, Placebo-controlled, Phase III Study Of Saruparib (AZD5305) In Combination With Physician’s Choice New Hormonal Agents In Patients With HRRm And Non-HRRm Metastatic Castration-Sensitive Prostate Cancer (EvoPAR-Prostate01)
Scottsdale/Phoenix, Ariz.,
Jacksonville, Fla.,
Rochester, Minn.
The purpose of this study is to demonstrate superiority of AZD5305 + physician’s choice NHA relative to placebo + physician’s choice NHA by assessment of radiographic progression-free survival (rPFS) in participants with mCSPC.
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A Study of the Natural History of Ado-trastuzumab emtansine (T-DM1)-Induced Peripheral Neuropathy in HER2-positive Breast Cancer Patients
Rochester, Minn.
The purpose of this study is to prospectively evaluate the patient-reported outcomes data of T-DM1 induced peripheral neuropathy like prior research focused on paclitaxel-, paclitaxel/CBDCA-, oxaliplatin-, and cisplatin-induced peripheral neuropathy, to better understand the similarities and differences of chemotherapy-induced peripheral neuropathy (CIPN) symptoms caused by different agents, their pathogenesis, and impacts.
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Investigation Of Associations Between Chemotherapy-Induced Nausea In Patients With Genitourinary, Sarcoma Or Melanoma Cancers And Changes In Gut Microbiome: Potential For Precision Therapeutics
Scottsdale/Phoenix, Ariz.,
Jacksonville, Fla.,
Rochester, Minn.
The purpose of this study is investigate if functions and composition of the gut microbiome are associated with the occurrence of chemotherapy-induced nausea (CIN). Also, to evaluate the feasibility of patient recruitment and retention, as well as specimen collection and to evaluate for changes in alpha and beta diversity as well as composition (i.e. relative abundance) of the gut microbiome from T1 to T2 in patients who do and do not report CIN at T2. In addition, to examine associations between microbial composition functional profiles at T1 and T2 in patients who report CIN at T2.
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MAIN-CAV: Phase III Randomized Trial of Maintenance Cabozantinib and Avelumab vs Maintenance Avelumab After First-Line Platinum-Based Chemotherapy in Patients With Metastatic Urothelial Cancer (MAIN-CAV)
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.,
Jacksonville, Fla.
The purpose of this study is to compare the effect of adding cabozantinib to avelumab versus avelumab alone in treating patients with urothelial cancer that has spread to other places in the body (metastatic). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib and avelumab together may further shrink the cancer or prevent it from returning/progressing.
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Phase 2 Multiple-Dose, Multiple-Arm, Parallel Assignment Study To Evaluate The Safety, Tolerability, And Preliminary Efficacy Of XmAb®20717 Alone Or In Combination With Chemotherapy Or Targeted Therapies In Selected Subjects With Metastatic Castration-Resistant Prostate Cancer
Scottsdale/Phoenix, Ariz.,
Jacksonville, Fla.,
Rochester, Minn.
The purpose of this study is to investigate the safety and clinical activity of XmAb20717 alone or in combination with standard of care anticancer therapies in patients with metastatic castration-resistant prostate cancer (mCRPC) who have been treated with at least 2 prior lines of anticancer therapy.
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Phase 2 Study Of CJNJ-67652000 (Niraparib/Abiraterone Acetate Fixed-Dose Combination) And Prednisone In Patients With Metastatic Castration-Resistant Prostate Cancer Associated With SPOP Mutation With Or Without Homologous Recombination Deficiency
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.,
Jacksonville, Fla.
This phase II trial tests how well abiraterone acetate/niraparib (CJNJ-67652000 [niraparib/abiraterone acetate fixed-dose combination]) and prednisone works in treating patients with castration-resistant prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and who have a mutation in the SPOP gene. CJNJ-67652000 (niraparib/abiraterone acetate fixed-dose combination) is a drug which stops certain cancer cells from being able to repair themselves from damage, leading to the death of the cancer cell. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Giving CJNJ-67652000 and prednisone may kill more tumor cells in patients with metastatic prostate cancer than giving these drugs alone.
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