PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT04488107: Safety, Tolerability, Pharmacokinetics and Antitumor Activity of FCN-437c
Official title: A Multicenter, Open, Single Arm Dose-escalation and Dose-expansion Study: to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of FCN-437c Alone or in Combination With Letrozole in ER+/ HER2- Advanced Breast Cancer
Conditions: Breast Neoplasms
Summary: This is a multicenter, open, single arm dose escalation and dose expansion clinical study to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of FCN-437c alone or in combination with letrozole in women with ER +/ HER2 - advanced breast cancer.
Interventions:
description: - FCN-437c is a selective and potent CDK4/6 dual inhibitor, with broad antitumor activity in preclinical pharmacology models, favorable physical and pharmacokinetic (PK) properties, and acceptable toxicity profile in nonclinical studies.
name: FCN-437c
other_name: Dose-escalation and expansion
type: Drug
description: * Letrozole is the latest generation of aromatase inhibitor. Letrozole lowers estrogen levels in postmenopausal women, which may slow the growth of certain types of breast tumors that need estrogen to grow in the body.<br/>* Letrozole is used to treat breast cancer in postmenopausal women. It is often given to women who have been taking tamoxifen (Nolvadex, Soltamox) for 5 years.
name: Letrozole 2.5mg
other_name: Dose-escalation
type: Drug
Study arms:
design_group_description: * This study plans to start escalating from 50 mg QD, through 100 mg, 200 mg, 300 mg, 450 mg, to 600 mg.<br/>* Participants will receive FCN-437c in sequential 28-day cycles which are made up of monotherapy QD for 21 days followed by a 7 day rest period.<br/>* Participants must be histologically or cytologically diagnosed with ER+/ HER2- advanced breast cancer.
design_group_title: Dose escalation cohort of FCN-437c
design_group_type: Experimental
design_group_description: * The dose expansion stage will be initiated after escalating to MTD.<br/>* Six patients will be treated with FCN-437c combined with letrozole.<br/>* DLT assessment and PK blood collection will be completed in the first 28-day cycle.<br/>* If DLT does not occur in the first three patients, 15 additional patients were enrolled to complete the expansion study of MTD group.<br/>* If one DLT occurs in the first three patients, three additional patients will be enrolled onal patients were enrolled and completed the MTD group.<br/>* Patients will be evaluated every 8 weeks until disease progression, intolerable toxicity, death, investigator's decision or patient's voluntary withdrawal from the study.
design_group_title: Dose expansion cohort of FCN-437c + letrozole
design_group_type: Experimental
Sponsor: Jinzhou Ahon Pharmaceutical Co., Ltd.
Collaborators: Sir Run Run Shaw Hospital
Zhejiang Cancer Hospital
Fudan University
Drug name mappings:
name: 来曲唑
lang: CN
name: Letrozole
lang: EN
name: レトロゾール
lang: JP
name: 枸橼酸伏维西利
lang: CN
name: Fovinaciclib
lang: EN
Clinical trial NCT03330795: Bilateral Orthotopic Lung Transplant - Bone Marrow Transplant
Official title: Bilateral Orthotopic Lung Transplant in Tandem With CD3+ and CD19+ Cell Depleted Bone Marrow Transplant From Partially HLA Matched Cadaveric Donors (RTB-003)
Conditions: Primary Immunodeficiency
PID
Summary: The purpose of this study is to determine whether bilateral orthotopic lung transplantation (BOLT) followed by cadaveric partially-matched CD3+/CD19+ depleted bone marrow transplant (BMT) is safe and effective for individuals aged 10 through 45 years with the diagnosis of primary immunodeficiency (PID) and end-stage lung disease.
The enrollment goal: 8 participants who receive both BOLT and BMT.
Interventions:
description: Negative selection for CD3/CD19 will be performed on a CliniMACS? depletion device within 36 hours of collection, and cryopreserved for later marrow transplantation. BMT conditioning and transplantation will start at least 8 weeks or more post lung transplant - once the participant is clinically judged suitable to undergo BMT conditioning and transplantion.
name: CD3/CD19 neg allogeneic BMT
other_name: CD3+/CD19+ depleted HSCT
type: Biological
Study arms:
design_group_description: Participants may receive a double lung transplant followed by a bone marrow (hematopoietic stem cells) transplant, if a partially HLA-matched organ offer is accepted. The lungs and allogeneic hematopoietic stem cells will be from the same partially HLA-matched cadaveric donor. Prior to marrow transplantation, the marrow will be negatively selected for CD3/CD19 using a CliniMACS? depletion device.
design_group_title: CD3/CD19 neg allogeneic BMT
design_group_type: Experimental
Sponsor: National Institute of Allergy & Infectious Diseases
Collaborators: Pharmaceutical Product Development LLC
University of Pittsburgh
Drug name mappings:
name: CD3/CD19 neg allogeneic BMT(National Institute of Allergy & Infectious Diseases)
lang: EN
Clinical trial NCT07460986: A PHASE IB/II STUDY TO EVALUATE SAFETY AND EFFICACY OF BEXMARILIMAB IN COMBINATION WITH DOXORUBICIN IN METASTATIC SOFT-TISSUE SARCOMA
Official title: A PHASE IB/II STUDY TO EVALUATE SAFETY AND EFFICACY OF BEXMARILIMAB IN COMBINATION WITH DOXORUBICIN IN METASTATIC SOFT-TISSUE SARCOMA
Conditions: Sarcoma of Soft Tissue
Summary: This trial will Study a type of sarcoma defined metastatic soft-tissue sarcoma (STS). Participants will be treated with bexmarilimab, a CLEVER-1 antibody plus doxorubicin, a chemotherapy. The main purpose of the Study is to analyze the safety (to find out how safe or toxic a treatment is to appropriately manage the risks) and efficacy (to find out how effective a treatment is) of bexmarilimab combined with doxorubicin in participants who have STS.
Interventions:
description: RP2D of bexmarilimab administered as IV infusion on D1 of 21-day cycle for 6 cycles.
name: bexmarilimab
type: Drug
description: 75 mg/m2 doxorubicin administered as IV infusion on D1 of 21-day cycle for 6 cycles.
name: Doxorubicin
type: Drug
Study arms:
design_group_description: Participants will be randomized based on histological subtype, age (≥ 60 years old vs <60 years old) and ECOG status (0 vs 1) to receive RP2D of bexmarilimab plus doxorubicin (arm A) for 6 cycles. Then, participants will receive RP2D of bexmarilimab monotherapy (arm A) until unacceptable toxicity, disease progression, death, discontinuation from the Study treatment for any other reason, whichever occurs first.
design_group_title: Phase II: Arm A
design_group_type: Experimental
design_group_description: Participants will be randomized based on histological subtype, age (≥ 60 years old vs <60 years old) and ECOG status (0 vs 1) to receive doxorubicin monotherapy (arm B).
design_group_title: Phase II: Arm B
design_group_type: Active Comparator
design_group_description: Participants will receive 3 different doses (1 mg/kg, 3 mg/kg or 6 mg/kg) of bexmarilimab administered as IV infusion on day 1 (D1) of each 21-day cycle plus 75 mg/m2 doxorubicin administered as IV infusion on D1 of 21-day cycle in order to find the RP2D for bexmarilimab when administered in combination with doxorubicin.
design_group_title: Phase Ib: Dose escalation
design_group_type: Experimental
design_group_description: Participants will be randomized based on histological subtype to receive receive 2 different doses (based on dose escalation data) of bexmarilimab plus doxorubicin for 6 cycles. Then, participants will receive RP2D of bexmarilimab monotherapy until unacceptable toxicity, disease progression, death, discontinuation from the Study treatment for any other reason, whichever occurs first.
design_group_title: Phase Ib: Dose expansion
design_group_type: Experimental
Sponsor: Medica Scientia Innovation Research SL
Collaborators: Faron Pharmaceuticals Oy
Drug name mappings:
name: 盐酸多柔比星
lang: CN
name: Doxorubicin Hydrochloride
lang: EN
name: ドキソルビシン塩酸塩
lang: JP
name: 贝马瑞利单抗
lang: CN
name: Bexmarilimab
lang: EN
Clinical trial NCT01317992: Ibudilast in the Treatment of Medication Overuse Headache
Official title: Ibudilast in the Treatment of Medication Overuse Headache: A Double-blind, Randomised, Placebo-controlled Pilot Study
Conditions: Medication Overuse Headache
Summary: The purpose of this study is to determine if ibudilast is effective in reverting patients with medication overuse headache suffering chronic daily headache back to their original episodic headache pattern.
Interventions:
description: Ibudilast 4 x 10 mg capsules, orally, twice daily for 8 weeks.
name: Ibudilast
type: Drug
description: Placebo 4 capsules, orally, twice daily for 8 weeks.
name: Placebo
type: Drug
Study arms:
design_group_description: To receive ibudilast 40mg twice daily for 8 weeks.
design_group_title: Ibudilast
design_group_type: Experimental
design_group_description: To receive placebo twice daily for 8 weeks.
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: University of Adelaide
Collaborators: University of South Australia
Drug name mappings:
name: 异丁司特
lang: CN
name: Ibudilast
lang: EN
name: イブジラスト
lang: JP
Clinical trial NCT05718037: Phase I Clinical Trial of a Candidate Herpes Zoster Vaccine
Official title: A Phase I, Randomized, Observer-blinded Study to Evaluate the Safety, Tolerability, and Immunogenicity of BV211 in Adult Volunteers
Conditions: Herpes Zoster
Summary: This is a phase I, randomized, observer-blinded study to evaluate the safety, tolerability, and immunogenicity of BV211(a herpes zoster vaccine) in Adult Volunteers.
Interventions:
description: 0.5mL, Intramuscular
name: Recombinant Zoster Vaccine
other_name: BV211
type: Biological
description: 0.5mL, Intramuscular
name: Placebo
type: Biological
description: 0.5mL, Intramuscular
name: Zoster Vaccine Recombinant, Adjuvanted
other_name: Shingrix
type: Biological
Study arms:
design_group_description: Young adult subjects received low dose of BV211
design_group_title: LY
design_group_type: Experimental
design_group_description: Young adult subjects received high dose of BV211
design_group_title: HY
design_group_type: Experimental
design_group_description: Young adult subjects received placebo
design_group_title: Placebo
design_group_type: Placebo Comparator
design_group_description: Old adult subjects received low dose of BV211
design_group_title: LO
design_group_type: Experimental
design_group_description: Old adult subjects received high dose of BV211
design_group_title: HO
design_group_type: Experimental
design_group_description: Old adult subjects received control vaccine
design_group_title: Control Vaccine
design_group_type: Active Comparator
Sponsor: Bravovax Co., Ltd.
Collaborators: Shanghai Bovo Biotechnology Co., Ltd.
Drug name mappings:
name: Recombinant Zoster Vaccine(BravoVax)
lang: EN
Clinical trial NCT05160415: A Study of EDG-5506 in Adult Males With Becker Muscular Dystrophy
Official title: A Phase 1b, Open-label Study of the Safety and Pharmacokinetics of EDG-5506 in Adults With Becker Muscular Dystrophy
Conditions: Becker Muscular Dystrophy
Summary: The ARCH study was an open-label, single-center, Phase 1b study of sevasemtem (EDG-5506) to assess the safety and pharmacokinetics (PK) of sevasemten in adults with Becker muscular dystrophy (BMD).
Sevasemten is an investigational product intended to protect and improve function of dystrophic muscle fibers.
Interventions:
description: Daily oral dose of 10 mg daily until Visit 8 (Day 57), followed by 15 mg daily until Visit 13 (Month 6), followed by 20 mg until Visit 21 (Month 15), followed by 10 mg daily to Visit 27 (Month 24).
name: Sevasemten
other_name: EDG-5506
type: Drug
Study arms:
design_group_description: Drug: Sevasemten
design_group_title: Treatment
design_group_type: Experimental
Sponsor: Edgewise Therapeutics, Inc.
Collaborators: Medpace, Inc.
Drug name mappings:
name: Sevasemten
lang: EN
Clinical trial NCT03258359: Personalized Adoptive Cellular Therapy Targeting MDS Stem Cell Neoantigens (PACTN)
Official title: A Phase 1 Clinical Trial of Personalized, Adoptive Cellular Immunotherapy Targeting Patient-specific Neoplastic Stem Cell Neoantigens (PACTN) in Patients With Myelodysplastic Syndromes (MDS)
Conditions: Myelodysplastic Syndromes
Summary: This study will evaluate the safety of autologous T cells that have been immunized ex vivo with patient-specific MDS stem cell neoantigens in patients with MDS.
Interventions:
description: To treat patients with MDS who have failed treatment with hypomethylating agents or have relapsed after treatment with hypomethylating agents or have declined hypomethylating therapy.
name: PACTN
type: Biological
Study arms:
design_group_description: Open label 3+3 dose escalation phase 1 trial; 200 to 1000 mL of immunized T cells infused at 0.3, 1, and 3 x 10e7 nucleated cells/kg body weight.
design_group_title: PACTN
design_group_type: Experimental
Sponsor: Persimmune, Inc.
Collaborators: University of California San Diego
Drug name mappings:
name: Autologous T cell therapy (PersImmune)
lang: EN
Clinical trial NCT00072410: Radiolabeled Monoclonal Antibody in Treating Patients With Advanced Ovarian Epithelial Cancer
Official title: Single-Dose, Cohort Study of Increasing Doses of Yttrium-90 Conjugated to Humanized Monoclonal Antibody 3S193 (90Y-hu3S193) in Patients With Advanced Ovarian Cancer
Conditions: Ovarian Cancer
Summary: RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver radioactive tumor-killing substances to them without harming normal cells. Giving radiolabeled monoclonal antibody directly into the abdominal cavity may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of giving radiolabeled monoclonal antibody therapy directly into the abdominal cavity in treating patients who have advanced ovarian epithelial cancer.
Interventions:
description: Patients received a single dose of 10 mg of hu3S193 radiolabeled with the intended dose (mCi) of 90Y.
name: 90Y-hu3S193
other_name: humanized monoclonal antibody 3S193 radiolabeled with 90Y
type: Biological
description: Patients received a single dose of 5 mCi 111In-hu3S193 together with the 90Y-hu3S193.
name: 111In-hu3S193
other_name: humanized monoclonal antibody 3S193 radiolabeled with 111In
type: Biological
Study arms:
design_group_description: Patients received a single intraperitoneal (IP) dose of 10 mg of hu3S193 radiolabeled with 10 millicuries (mCi) 90Y and 5mCi 111In-hu3S193 to enable imaging after dosing.
design_group_title: Cohort 1
design_group_type: Experimental
design_group_description: Patients received a single intraperitoneal (IP) dose of 10 mg of hu3S193 radiolabeled with 15 millicuries (mCi) 90Y and 5mCi 111In-hu3S193 to enable imaging after dosing.
design_group_title: Cohort 2
design_group_type: Experimental
Sponsor: Ludwig Institute for Cancer Research Ltd.
Collaborators: National Cancer Institute
Drug name mappings:
name: Anti-Lewis Y monoclonal antibody(Ludwig Institute for Cancer Research)
lang: EN
Clinical trial NCT05178693: Lutathera and ASTX727 in Neuroendocrine Tumours
Official title: The Epigenetic Modification of Somatostatin Receptor-2 to Improve Therapeutic Outcome With Lutathera in Patients With Metastatic Neuroendocrine Tumours.
Conditions: Neuroendocrine Tumors
Summary: Patients entered into the study will receive ASTX727 orally for 5 days, prior to receiving Lutathera treatment on Day 8, to determine whether pre-treatment with ASTX727 results in re-expression of somatostatin receptor-2 in patients with metastatic neuroendocrine tumours. The study will use [68Ga]-DOTA-TATE PET to image epigenetic modification of the receptor locus.
Interventions:
description: Cedazuridine 100mg + 35mg decitabine
name: ASTX727
type: Drug
description: Peptide receptor radionuclide therapy (PRRT)
name: Lutathera
other_name: lutetium Lu 177 dotatate
type: Radiation
Study arms:
design_group_title: Treatment
design_group_type: Experimental
Sponsor: Imperial College London
Collaborators: Advanced Accelerator Applications SA
Drug name mappings:
name: 地西他滨/西达尿苷
lang: CN
name: Decitabine/Cedazuridine
lang: EN
name: (177镥)镥氧奥曲肽
lang: CN
name: Lutetium Dotatate LU-177
lang: EN
name: ルテチウムオキソドトレオチド(177Lu)
lang: JP
Clinical trial NCT07053319: SGLT2i, Pioglitazone, and Ketone Production in T2D
Official title: Protocol lV: SGLT2 Inhibitors, Pioglitazone and Ketone Production in Type 2 Diabetes Mellitus
Conditions: Type 2 Diabetes
Summary: To examine whether the empagliflozin-induced stimulation of EGP, lipolysis, and ketone production in T2D individuals can be blocked by pioglitazone (which has direct hepatic and adipose tissue effects).
Interventions:
description: A medication used in the management and treatment of type 2 diabetes mellitus. It is in the sodium-glucose co-transporter (SGLT-2) class of medications.
name: Empagliflozin 25 MG plus Pioglitazone placebo
other_name: Empagliflozin
Placebo-Inert tablet
type: Drug
description: Placebo-Inert tablet
name: Pioglitazone 15 mg increased to 30 mg after 2 weeks plus Empagliflozin Placebo
other_name: Pioglitazone, a medication used in the management and treatment of type 2 diabetes mellitus. It is in the thiazolidinedione class of medications
Placebo for empagliflozin
type: Drug
description: Pioglitazone, a medication used in the management and treatment of type 2 diabetes mellitus. It is in the thiazolidinedione class of medications
name: Empagliflozin 25 mg/d plus Pioglitazone (15/30 mg/d)
other_name: Empagliflozin, a medication used in the management and treatment of type 2 diabetes mellitus. It is in the sodium-glucose co-transporter (SGLT-2) class of medications.
Empagliflozin/Pioglitazone
type: Drug
description: Placebo-Inert tablet
name: Pioglitazone placebo + Empagliflozin placebo
other_name: Placebo/Placebo
type: Drug
Study arms:
design_group_description: Empagliflozin 25 mg/day plus pioglitazone placebo
design_group_title: Empagliflozin plus Pioglitazone placebo
design_group_type: Experimental
design_group_description: Pioglitazone, 15 mg/day, increased to 30 mg after 2 weeks plus empagliflozin placebo
design_group_title: Pioglitazone plus Empagliflozin Placebo
design_group_type: Placebo Comparator
design_group_description: Empagliflozin(25mg/day) plus pioglitazone (15/30 mg/d)
design_group_title: Empagliflozin plus Pioglitazone
design_group_type: Experimental
design_group_description: empagliflozin placebo plus pioglitazone placebo
design_group_title: Empagliflozin placebo + pioglitazone placebo
design_group_type: Experimental
Sponsor: University of Texas Health Science Center At San Antonio
Collaborators: National Institute of Diabetes & Digestive & Kidney Diseases
Drug name mappings:
name: 盐酸吡格列酮
lang: CN
name: Pioglitazone Hydrochloride
lang: EN
name: ピオグリタゾン塩酸塩
lang: JP
name: 恩格列净
lang: CN
name: Empagliflozin
lang: EN
name: エンパグリフロジン
lang: JP
Clinical trial NCT02811016: Inhaled Budesonide and Acute Mountain Sickness
Official title: Effect of Inhaled Budesonide on the Incidence and Severity of Acute Mountain Sickness at 4559 m
Conditions: Acute Mountain Sickness
Summary: The primary objective of the study is to investigate the effect of inhaled budesonide on the incidence of AMS. The primary study question to ask is:
1. Does inhaled budesonide reduce the incidence of AMS after rapid and active ascent to 4559 m?
In addition, the secondary study questions to ask are:
1. Does inhaled budesonide reduce the severity of AMS after rapid and active ascent to 4559 m?
2. Are the effects of inhaled budesonide on AMS incidence and severity related to its plasma concentration?
Study medication Inhaled budesonide at 2 different concentrations (2 x 200 µg, 2 x 800 µg) versus placebo
Study design
* Prospective, controlled, single-center study on 51 healthy volunteers at 4559 m [Capanna Regina Margherita (Margherita Hut), Italy]
* With regard to the intervention (inhaled budesonide) double-blinded and randomized
Interventions:
description: 200 µg inhaled at 7:00 a.m. and 7 p.m.
name: Budesonide 200
other_name: Pulmicort Turbohaler
type: Drug
description: 800 µg inhaled at 7:00 a.m. and 7 p.m.
name: Budesonide 800
other_name: Pulmicort Turbohaler
type: Drug
description: Placebo Inhalation at 7:00 a.m. and 7 p.m.
name: Placebo
other_name: Lactose-Monohydrate
type: Drug
Study arms:
design_group_description: inhaled budesonide 200 µg bid
design_group_title: budesonide 200
design_group_type: Experimental
design_group_description: inhaled budesonide 800 µg bid
design_group_title: budesonide 800
design_group_type: Experimental
design_group_description: inhaled placebo bid
design_group_title: placebo
design_group_type: Placebo Comparator
Sponsor: Gemeinnützige Salzburger Landeskliniken Betriebsgesellschaft
Collaborators: University Hospital Heidelberg
Drug name mappings:
name: 布地奈德
lang: CN
name: Budesonide
lang: EN
name: ブデソニド
lang: JP
Clinical trial NCT02467647: The Effects of Huang-Lian-Jie-Du-Tang（HLJDT) on the Survival of Patients With Multiple Myeloma in Maintain Therapy
Official title: Phase 1 Study of the Effects of Huang-Lian-Jie-Du-Tang（HLJDT) on the Survival of Patients With Multiple Myeloma in Maintain Therapy
Conditions: Multiple Myeloma
Summary: To investigate the efficacy of the combination of Thalidomide and Huang-Lian-Jie-Du-Tang on the patients with multiple myeloma in maintain therapy.
Interventions:
name: Thalidomide
type: Drug
name: HLJDT
type: Drug
Study arms:
design_group_description: Arm A: HLJDT 150ml three times per day for 6 months and Thalidomide 100mg once per day for 6 months
design_group_title: A
design_group_type: Experimental
design_group_description: Arm B: Thalidomide 100mg oral once per day for 6 months
design_group_title: B
design_group_type: Active Comparator
Sponsor: Wuhan University
Collaborators: Shanghai Tongji Hospital
Drug name mappings:
name: 沙利度胺
lang: CN
name: Thalidomide
lang: EN
name: サリドマイド（JAN）
lang: JP
name: 黄连解毒汤
lang: CN
name: Huanglian JieDu Decoction
lang: EN
Clinical trial NCT06503783: A Study of BL-M17D1 in Patients With Locally Advanced or Metastatic HER2 Positive/Negative Breast Cancer and Other Solid Tumors
Official title: A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-M17D1 in Patients With Locally Advanced or Metastatic HER2 Positive/Negative Breast Cancer and Other Solid Tumors
Conditions: Breast Cancer
Solid Tumor
Summary: This study is an open, multicenter, dose-escalation and expansion-enrollment nonrandomized phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of BL-M17D1 in patients with locally advanced or metastatic HER2 positive/negative breast cancer and other solid tumors.
Interventions:
description: Administration by intravenous infusion for a cycle of 3 weeks.
name: BL-M17D1
type: Drug
Study arms:
design_group_description: Participants receive BL-M17D1 as intravenous infusion for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
design_group_title: BL-M17D1
design_group_type: Experimental
Sponsor: Sichuan Baili Pharmaceuticals Co.,Ltd
Collaborators: Baili Bio Chengdu Pharmaceutical Co. Ltd.
Drug name mappings:
name: BL-M17D1
lang: EN