PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT02894008: A Study of a New Leishmania Vaccine Candidate ChAd63-KH
Official title: A Phase IIa Safety Study to Assess the Safety and Immunogenicity of a New Leishmania Vaccine Candidate ChAd63-KH
Conditions: Leishmaniasis, Cutaneous
Summary: This is a study to assess the safety of a new candidate Leishmania vaccine ChAd63-KH in patients with persistent post kala azar dermal leishmaniasis (PKDL).
This is a Phase II trial in patients with PKDL, to assess the safety and compare the humoral and cellular immune responses generated by the candidate vaccine in patients, and observe any clinical changes in the disease over a 42 day period following vaccination.
Study design: Eight adult volunteers will receive 1x10(10)vp and the subsequent eight volunteers will receive 7.5 x10(10)vp. Adolescents will be vaccinated with either 1x10(10)vp or 7.5 x10(10)vp, to be determined by evaluation of all available data after DSMB & CTSC review.
Interventions:
description: ChAd63-KH in adults and adolescents with persistent PKDL.
name: ChAd63-KH
type: Drug
Study arms:
design_group_description: Single intramuscular dose of ChAd63-KH, 1 x10(10)vp or, following safety review, 7.5 x 10(10)vp in adults
design_group_title: ChAd63- KH
design_group_type: Experimental
design_group_description: Single intramuscular dose of ChAd63-KH, 1x10(10)vp or, following safety review, 7.5 x 10(10)vp in adolescents
design_group_title: ChAd63-KH
design_group_type: Experimental
Sponsor: The University of York
Collaborators: University of Khartoum
Drug name mappings:
name: ChAd63-KH(The University of York)
lang: EN
Clinical trial NCT00023621: Celecoxib in Preventing Basal Cell Carcinoma in Patients With Basal Cell Nevus Syndrome
Official title: A Phase II Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Celecoxib in Subjects With Basal Cell Nevus Syndrome
Conditions: Non-melanomatous Skin Cancer
Summary: RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. The use of celecoxib may be an effective way to prevent the development of basal cell carcinoma.
PURPOSE: Randomized phase II trial to determine the effectiveness of celecoxib in preventing basal cell carcinoma in patients who have basal cell nevus syndrome.
Interventions:
name: celecoxib
type: Drug
Study arms:
Sponsor: The University of California, San Francisco
Collaborators: National Cancer Institute
Drug name mappings:
name: 塞来昔布
lang: CN
name: Celecoxib
lang: EN
name: セレコキシブ
lang: JP
Clinical trial NCT01417000: Safety and Efficacy of Combination Listeria/GVAX Immunotherapy in Pancreatic Cancer
Official title: A Phase 2, Randomized, Multicenter, Open-Label Study of the Efficacy and Immune Response of the Sequential Administration of GVAX Pancreas Vaccine Alone or Followed by CRS-207 in Adults With Metastatic Pancreatic Adenocarcinoma
Conditions: Metastatic Pancreatic Cancer
Summary: Test the safety, immune response and efficacy of GVAX pancreas vaccine (with cyclophosphamide) and CRS-207 compared to GVAX pancreas vaccine (with cyclophosphamide) alone in adults who have failed or refused prior treatment for metastatic pancreatic cancer.
Interventions:
name: GVAX Pancreas
other_name: GVAX
type: Biological
name: CRS-207
type: Biological
name: Cyclophosphamide
other_name: Cy
Cytoxan
type: Drug
Study arms:
design_group_description: 200 mg per square meter (mg/m^2) cyclophosphamide (Cy) administered by intravenous (IV) infusion on Day 1 of Weeks 1 and 4; GVAX pancreas vaccine (GVAX, 5 × 10e8 cells) administered by intradermal injection on Day 2 of Weeks 1 and 4; CRS-207 (1 × 10e9 colony forming units [CFU]) administered by IV infusion on Day 1 of Weeks 7, 10, 13, 16.
design_group_title: Cy/GVAX + CRS-207
design_group_type: Experimental
design_group_description: 200 mg/m^2 Cy administered by IV infusion on Day 1 of Weeks 1, 4, 7, 10, 13, 16; GVAX (5 × 10e8 cells) administered by intradermal injection on Day 2 of Weeks 1, 4, 7, 10, 13, 16.
design_group_title: Cy/GVAX
design_group_type: Experimental
Sponsor: Aduro BioTech, Inc.
Collaborators: The Johns Hopkins University
Drug name mappings:
name: CRS-207
lang: EN
name: 环磷酰胺
lang: CN
name: Cyclophosphamide
lang: EN
name: シクロホスファミド水和物
lang: JP
name: Enistimagene Setitucel/Damistimagene Matitucel
lang: EN
Clinical trial NCT00872716: Quetiapine in Specific Phobia
Official title: Anxiolytic Effects of Single-dose Quetiapine XR Administration on Clinical Symptoms and Amygdala Activation During Exposure in Patients With Simple Phobia
Conditions: Specific Phobia
Summary: The study hypothesis is that quetiapine XR has anxiolytic properties. The study aims to investigate the putative anxiolytic properties of quetiapine XR in patients with anxiety disorders. Therefore, in a proof-of-concept design patients with simple phobia will be selected to investigate specific anxiolytic and antipanic activity during acute anxiety. Moreover, in a combined fMRI/visual stimulus presentation paradigm activity of fear-network associated brain structures such as the amygdala will be investigated under treatment with quetiapine XR or placebo. Additionally, genetic factors potentially mediating anxiolytic properties of quetiapine will be studied.
Interventions:
description: 100 mg single-dose Quetiapine XR
name: Quetiapine XR
other_name: - ATC-Code: N05A H04
- Seroquel Prolong
- Seroquel XR
type: Drug
description: Placebo
name: Placebo
other_name: no other name
type: Other
Study arms:
design_group_description: 100 mg single-dose Quetiapine XR
design_group_title: Quetiapine XR
design_group_type: Experimental
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: Universitätsklinikum Münster
Collaborators: AstraZeneca PLC
Drug name mappings:
name: 富马酸喹硫平
lang: CN
name: Quetiapine Fumarate
lang: EN
name: クエチアピンフマル酸塩
lang: JP
Clinical trial NCT04130854: INNATE: Immunotherapy During Neoadjuvant Therapy for Rectal Cancer
Official title: INNATE: Immunotherapy During Neoadjuvant Therapy for Rectal Cancer, a Phase II Randomized Multi-center Trial With and Without APX005M, an Anti-CD40 Agonist
Conditions: Locally Advanced Rectal Adenocarcinoma
Summary: Determine the complete pathologic complete response (pCR) rate in patients with locally advanced rectal adenocarcinoma.
Interventions:
description: 1. APX005M 0.3mg/kg intravenously on day 3 of radiation and on day 3 of cycles 1-5 of mFOLFOX<br/>2. Short course radiation therapy 5 Gy x 5 days<br/>3. Oxaliplatin 85mg/m2 intravenous day 1 of each cycle<br/>4. Leucovorin 400mg/m2 IV Day 1 of each cycle<br/>5. 5-FU 2400 mg/m2 continuous infusion over 46 hours of each cycle
name: APX005M, mFOLFOX, and Radiation Therapy 5Gy x 5 days
type: Drug
description: 1. Short course radiation therapy 5 Gy x 5 days<br/>2. Oxaliplatin 85mg/m2 intravenous day 1 of each cycle<br/>3. Leucovorin 400mg/m2 IV Day 1 of each cycle<br/>4. 5-FU 2400 mg/m2 continuous infusion over 46 hours of each cycle
name: mFOLFOX and Radiation Therapy 5Gy x 5 days
type: Drug
Study arms:
design_group_description: On Day 3 of Cycles 1-5 of each mFOLFOX treatment, participants will receive another dose of APX005M. The sequence of administration of APX005M in combination with mFOLFOX. In Cycle 6, participants will receive only mFOLFOX. After completing the last planned dose of mFOLFOX, participants will be considered off-protocol directed therapy and undergo planned TME, per institutional standards, and proceed to the follow-up portion of this study.
design_group_title: APX005M on day 3 of RT & day 3 of cycles 1-5 of mFOLFOX
design_group_type: Experimental
design_group_description: Participants randomized to Arm 2 will receive short-course RT and mFOLFOX regimen, except that participants will not receive any of the study drug. After completing the last planned dose of mFOLFOX, participants will be considered off-protocol directed therapy and undergo planned TME, per institutional standards, and proceed to the follow-up portion of this study.
design_group_title: Radiation Therapy 5Gy x 5 days, mFOLFOX
design_group_type: Active Comparator
Sponsor: The University of Texas Southwestern Medical Center
Collaborators: National Cancer Institute
Apexigen America, Inc.
Drug name mappings:
name: Sotigalimab
lang: EN
Clinical trial NCT02384382: A Positron Emission Tomography/Computed Tomography (PET/CT) Bone Imaging Study in Patients Receiving Enzalutamide for Castration-Resistant Prostate Cancer (CRPC)
Official title: A PHASE 2, OPEN-LABEL, SINGLE-ARM STUDY OF 18F-SODIUM FLUORIDE PET/CT BONE IMAGING IN ENZALUTAMIDE-TREATED CHEMOTHERAPY-NAÏVE PATIENTS WITH BONE-METASTATIC CASTRATION-RESISTANT PROSTATE CANCER
Conditions: Prostate Carcinoma Metastatic to the Bone
Castration Resistant Prostate Cancer
Summary: The purpose of this study is to evaluate 18F-sodium fluoride positron-emission tomography / computed tomography (18F-NaF PET/CT) imaging as a method for determining treatment response in metastatic bone lesions in patients who are receiving enzalutamide for castration-resistant prostate cancer.
Interventions:
name: Enzalutamide
other_name: MDV3100
Xtandi
type: Drug
Study arms:
design_group_description: Enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily
design_group_title: Enzalutamide monotherapy
design_group_type: Experimental
Sponsor: Pfizer Inc.
Collaborators: Medivation LLC (California)
Astellas Pharma, Inc.
Drug name mappings:
name: 恩扎卢胺
lang: CN
name: Enzalutamide
lang: EN
name: エンザルタミド
lang: JP
Clinical trial NCT02660489: Effect of OC459 on the Response to Rhinovirus Challenge in Asthma
Official title: Effect of the CRTH2 Antagonist OC459 on the Response to Rhinovirus Challenge in Asthma
Conditions: Asthma
Rhinovirus
Picornaviridae Infections
Common Cold
Summary: The aim of this study is to assess the effectiveness of a CRTH2 receptor antagonist, OC459, in preventing or attenuating the worsening of asthma symptoms during rhinovirus infection. The study is a double blind, randomised trial in which half the subjects will receive OC459 and the other half placebo, before being inoculated with rhinovirus, that would normally induce a worsening of asthma symptoms i.e. an exacerbation.
Interventions:
name: OC459
other_name: OC000459
type: Drug
name: Placebo
type: Drug
description: Inoculation with rhinovirus serotype 16
name: Rhinovirus
type: Other
Study arms:
design_group_description: OC459 50mg once daily for 5 weeks
design_group_title: OC459 (CRTH2 antagonist)
design_group_type: Experimental
design_group_description: Placebo tablet once daily for 5 weeks
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: Imperial College London
Collaborators: The Medical Research Council
Atopix Therapeutics Ltd.
Drug name mappings:
name: Timapiprant
lang: EN
Clinical trial NCT00267709: Visilizumab for Treatment of Perianal Fistulas in Crohn's Disease
Official title: A Phase 2a, Open-label Study of Visilizumab for Treatment of Perianal Fistulas in Patients With Crohn's Disease
Conditions: Crohn's Disease
Summary: The purpose of the study is to evaluate an intravenous (by injection) investigational medication to treat Crohn's disease in patients with at least one perianal fistula. The research is being conducted at up to 5 clinical research sites in the US and Europe and is open to both men and women ages 18 to 70 years old. Participants in the study will have a number of visits to a research site over a 17 month period. All study-related care and medication is provided to qualified participants at no cost: this includes all visits, examinations and laboratory work.
Visilizumab is a humanized antibody (antibodies are proteins that are normally made by the immune system to help defend the body from infections and other foreign substances) that is directed against T cells. Visilizumab selectively attacks problematic T cells and, in doing so, it may prevent them from causing inflammation. Visilizumab has also been observed to have a suppressive effect on the body's immune system (system in the body that reacts to foreign or occasionally one's own proteins).
Interventions:
name: Visilizumab
type: Drug
Study arms:
Sponsor: Abbott Biotherapeutics Corp.
Collaborators: PDL BioPharma, Inc.
Drug name mappings:
name: 维西珠单抗
lang: CN
name: Visilizumab
lang: EN
Clinical trial NCT03401112: A Study of IMR-687 in Adult Participants With Sickle Cell Anemia (Homozygous HbSS or Sickle-β0 Thalassemia)
Official title: A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study of IMR-687 in Adult Patients With Sickle Cell Anaemia (Homozygous HbSS or Sickle-β0 Thalassemia)
Conditions: Sickle Cell Disease
Summary: Study of IMR-687 in adult participants with sickle cell anemia (SCA) (homozygous HbSS or sickle-β0 thalassemia).
Interventions:
description: Oral administration of IMR-687 once daily with or without HU.
name: IMR-687
type: Drug
description: Oral administration of placebo once daily with or without HU.
name: Placebo
type: Drug
Study arms:
design_group_description: A starting dose of IMR-687 50 mg with dose escalation after 4 or 12 weeks, up to 100 mg was administered to participants. Duration of administration was 16 (Week 17) or 24 weeks (Week 25).
design_group_title: IMR-687 50 mg/100 mg
design_group_type: Experimental
design_group_description: A starting dose of IMR-687 100 mg with dose escalation after 4 or 12 weeks, up to 200 mg was administered to participants. Duration of administration was 24 weeks (Week 25).
design_group_title: IMR-687 100 mg/200 mg
design_group_type: Experimental
design_group_description: Matching placebo was administered for 16 (Week 17) or 24 weeks (Week 25).
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: Cardurion Pharmaceuticals, Inc.
Collaborators: Imara, Inc.
Drug name mappings:
name: Tovinontrine
lang: EN
Clinical trial NCT07206849: Study of Tovorafenib in High-Grade Glioma and Diffuse Intrinsic Pontine Glioma (DIPG)
Official title: A Phase 2 Study of Tovorafenib in Pediatric and Young Adult Patients Newly Diagnosed With High-Grade Glioma (HGG), Including Diffuse Intrinsic Pontine Glioma (DIPG), Which Harbor Alterations in the Mitogen-Activated Protein Kinase (MAPK) Pathway
Conditions: High Grade Glioma (HGG) of the Brain With BRAF Aberration
High Grade Glioma (III or IV)
Diffuse Intrinsic Pontine Glioma
High Grade Glioma
WHO Grade 3 Glioma
WHO Grade 4 Glioma
Metastatic Brain Tumor
Summary: The goal of this study is to determine the efficacy of the study drugs tovorafenib to treat pediatric and young adult patients newly diagnosed with a high-grade glioma (HGG), including DIPG, that have genetic changes in pathways (MAPK) that this drug targets.
The main question the study aims to answer is whether tovorafenib can prolong the life of patients diagnosed with HGG, including DIPG.
Interventions:
description: Tovorafenib will be given orally once weekly (QW) throughout each cycle.
name: Tovorafenib
type: Drug
Study arms:
design_group_description: Patients with intracranial, localized, non-pontine, and non-thalamic HGG harboring a BRAFV600 mutation (who do not meet criteria for Strata B or C).
design_group_title: Stratum A - localized HGG
design_group_type: Experimental
design_group_description: Patients with DIPG/DMG as defined in Section 4.1.3 OR patients with localized, non-pontine, non-thalamic HGG harboring a MAPK alteration not included in Stratum A (KIAA1549:BRAF fusion, KRAS/NRAS, CRAF/RAF1, other RAF mutation, or FGFR alteration) OR patients with primary spinal tumors.
design_group_title: Stratum B - DIPG
design_group_type: Experimental
design_group_description: Patients with metastatic HGG (including metastatic DIPG/DMG) harboring a MAPK alteration (BRAFV600, KIAA1549:BRAF fusion, KRAS/NRAS, CRAF/RAF1, other RAF mutation, or FGFR alteration).
design_group_title: Stratum C - metastatic HGG
design_group_type: Experimental
Sponsor: Nationwide Children's Hospital
Collaborators: Day One Biopharmaceuticals, Inc.
Drug name mappings:
name: Tovorafenib
lang: EN
Clinical trial NCT02506517: A Study of Afatinib in Patients With Advanced Cancer With Changes in the HER Gene
Official title: Molecular Basket Trial In Multiple Malignancies With Common Target Pathway Aberrancies
Conditions: Solid Tumors
Summary: This is a phase 2 study (the second phase in testing a new drug) to see how useful an investigational drug called afatinib is in patients with advanced cancer with changes in the HER gene.
Afatinib is a drug that is approved by Health Canada for the treatment of advanced lung cancer with changes in the HER gene. Afatinib works by attaching to and blocking a protein called HER from working. HER is an important protein that contributes to the growth of cancer cells.
Interventions:
name: Afatinib
other_name: GIOTRIF
type: Drug
Study arms:
design_group_description: Afatinib, orally, at a dose of 40 mg once a day, every day of each 28 day cycle.
design_group_title: Afatinib
design_group_type: Experimental
Sponsor: University Health Network
Collaborators: Boehringer Ingelheim GmbH
Drug name mappings:
name: 马来酸阿法替尼
lang: CN
name: Afatinib Dimaleate
lang: EN
name: アファチニブマレイン酸塩
lang: JP
Clinical trial NCT01388933: A Safety and Efficacy Study of Daikenchuto (TU-100) to Treat Crohn's Disease
Official title: A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study of Daikenchuto (TU-100) in Subjects With Moderate Crohn's Disease
Conditions: Crohn's Disease
Summary: The purpose of this study is to determine whether Daikenchuto(TU-100)is effective in the treatment of Crohn's disease.
Interventions:
description: 15g daily, orally as 5g three times daily for 8 consecutive weeks
name: TU-100
other_name: Daikenchuto
type: Drug
description: 15g as 5g three times daily, orally for 8 consecutive weeks
name: Matching Placebo
other_name: Placebo
type: Drug
Study arms:
design_group_description: 15g TU-100 (oral, daily) for 8 consecutive weeks (administered as 5g three times daily)
design_group_title: TU-100
design_group_type: Experimental
design_group_description: Matching placebo given 5g three times daily orally for 8 consecutive weeks
design_group_title: Matching placebo
design_group_type: Placebo Comparator
Sponsor: Tsumura USA, Inc.
Collaborators: Syneos Health, Inc.
Drug name mappings:
name: Daikenchuto(Tsumura)
lang: EN
Clinical trial NCT03347838: Nivolumab for the Reversal of Squamous Dysplasia in High Risk Current and Former Smokers
Official title: PD-1 Immune Checkpoint Inhibition for the Reversal of Squamous Dysplasia in High Risk Current and Former Smokers With or Without a History of Lung Cancer
Conditions: Bronchial Dysplasia
Tobacco Smoking
History of Non-Small Cell Lung Cancer
History of Head and Neck Cancer
Summary: The goal of this clinical research study is to determine whether the PD-1 inhibitor (Programmed cell death protein 1) nivolumab improves premalignant bronchial dysplastic lesions in subjects that are at high risk for the development of lung cancer, including those with a prior smoking history, or history of lung cancer or head and neck cancer. The safety and tolerability of nivolumab will also be studied.
Interventions:
description: Nivolumab is a human monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2.
name: Nivolumab
other_name: BMS-936558
MDX1106
ONO-4538
Opdivo
type: Drug
Study arms:
design_group_description: 240 mg IV every 2 weeks for 4 doses
design_group_title: Nivolumab Injection [Opdivo]
design_group_type: Experimental
Sponsor: University of Colorado Denver
Collaborators: Bristol Myers Squibb Co.
Drug name mappings:
name: 纳武利尤单抗
lang: CN
name: Nivolumab
lang: EN
name: ニボルマブ（遺伝子組換え）
lang: JP
Clinical trial NCT01594177: Dual Blockage With Afatinib and Trastuzumab as Neoadjuvant Treatment for Patients With Locally Advanced or Operable Breast Cancer Receiving Taxane-anthracycline Containing Chemotherapy
Official title: Dual Blockage With Afatinib and Trastuzumab as Neoadjuvant Treatment for Patients With Locally Advanced or Operable Breast Cancer Receiving Taxane-anthracycline Containing Chemotherapy
Conditions: Unilateral HER2 Positive Breast Cancer
Summary: Anthracycline/taxane based combination chemotherapy of at least 18 weeks represents the standard of care in the neoadjuvant setting. In HER2 positive disease trastuzumab is given simultaneously. Neoadjuvant anthracycline-taxane-based chemotherapy given simul-taneously with trastuzumab achieves a pCR rate of approx. 40%. Recent data showed that a double blockade of the HER2 receptor (e.g. trastuzumab + lapatinib; trastuzumab + pertuzumab) given together with a few cycles of chemotherapy can increase the pCR rate by approximately 20%. So far, there is uncertainty, if afatinib (BIBW 2992), an irreversible HER family blocker can lead to an even more complete blockade of the HER2 pathway when given in combination with trastuzumab. The neoadjuvant setting provides the unique opportunity to assess precisely and at short term the effect of systemic treatment by assessing the pCR at surgery. It also allows treating patients with HER2 positive breast cancer before surgery without standard trastuzumab treatment, as, according to current guideline, trastuzumab can also be given sequentially after surgery. The aim of the study is to show that chemotherapy + trastuzumab + afatinib can achieve significant pCR rates.
Interventions:
description: 20 mg daily for 17 weeks (first two weeks every second day).
name: Afatinib
type: Drug
description: First cycle: loading dose 8 mg/kg (day 1 q day 22), thereafter maintenance dose for 9 cycles: 6 mg/kg (day 1 q day 22).
name: Trastuzumab
other_name: HERCEPTIN
type: Drug
description: 80 mg/m² i.v. given weekly on day 1 q day 8 for 12 weeks.
name: Paclitaxel
type: Drug
description: 90 mg/m² i.v. given on day 1 q day 22 for 4 cycles.
name: Epirubicin
type: Drug
description: 600 mg/m² i.v. given on day 1 q day 22 for 4 cycles.
name: Cyclophosphamide
type: Drug
Study arms:
design_group_description: Afatinib-Trastuzumab (6 weeks) followed by Afatinib*-Paclitaxel-Trastuzumab (12 weeks) followed by Epirubicin-Cyclophosphamide-Trastuzumab (12 weeks). *only 11 weeks.
design_group_title: Treatment arm
design_group_type: Experimental
Sponsor: GBG Forschungs GmbH
Collaborators: Boehringer Ingelheim GmbH
Drug name mappings:
name: 曲妥珠单抗
lang: CN
name: Trastuzumab
lang: EN
name: トラスツズマブ（遺伝子組換え）
lang: JP
name: 马来酸阿法替尼
lang: CN
name: Afatinib Dimaleate
lang: EN
name: アファチニブマレイン酸塩
lang: JP
name: 环磷酰胺
lang: CN
name: Cyclophosphamide
lang: EN
name: シクロホスファミド水和物
lang: JP
name: 紫杉醇
lang: CN
name: Paclitaxel
lang: EN
name: パクリタキセル
lang: JP
name: 盐酸表柔比星
lang: CN
name: Epirubicin Hydrochloride
lang: EN
name: エピルビシン塩酸塩
lang: JP
Clinical trial NCT06798558: Neoadjuvant Lu-177-PSMA-617 in Patients With High Risk Localized Prostate Cancer Undergoing Radical Prostatectomy
Official title: Phase II Study of Neoadjuvant Lu-177-PSMA-617 in Patients With High Risk Localized Prostate Cancer Undergoing Radical Prostatectomy
Conditions: Prostate Adenocarcinoma
Summary: Male adults with a confirmed diagnosis of prostate adenocarcinoma who meet criteria for localized high risk prostate cancer according to the NCCN guidelines and who are eligible for prostatectomy will be invited to participate. Criteria for high-risk prostate cancer include patients with preoperative prostate biopsy score of Gleason 8 (GS8) (Grade group 4 [GG4]) or higher. Patients also need to have a positive PSMA scan on 68-Ga-PSMA-11 PET/CT scan.
Interventions:
description: Lu-17-PSMA-617 administration
name: Lu-17-PSMA-617
type: Drug
Study arms:
design_group_description: Patients will receive 2 cycles of Lu-177-PSMA-617 (PluvictoⓇ) administered at the dose of 7.4 GBq (±10%), once every 6 weeks (±1 week)
design_group_title: Lu-177-PSMA-617 Treatment
design_group_type: Experimental
Sponsor: Hackensack Meridian Health, Inc.
Collaborators: Georgetown Lombardi Comprehensive Cancer Center
Novartis AG
Drug name mappings:
name: 镥[177Lu] 特昔维匹肽
lang: CN
name: Lutetium (177 Lu) Vipivotide Tetraxetan
lang: EN
name: ルテチウムビピボチドテトラキセタン（１７７Ｌｕ）
lang: JP