PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT04714619: CB-103 Plus NSAI In Luminal Advanced Breast Cancer
Official title: CB-103 Plus NSAI In Luminal Advanced Breast Cancer: CAILA Study
Conditions: Advanced Breast Cancer
Summary: Multicenter, single-arm, open label, phase II clinical trial with safety run-in to evaluate the safety, tolerability, pharmacokinetics and efficacy of CB-103 in combination with a non-steroidal aromatase inhibitor (NSAI), anastrozole or letrozole, in Hormone Receptor-positive and Human Epidermal Growth Factor Receptor 2 (HER2)-negative advanced breast cancer patients who have achieved clinical benefit during prior NSAI-based treatment.
Interventions:
description: Patients will receive CB-103 capsules orally (QD) in combination with NSAI therapy (letrozole or anastrozole, continuing prior therapy) also orally once daily, and based on a 28-day treatment cycle.<br/>A run-in phase for safety and tolerability of CB-103 in combination with anastrozole or letrozole will be conducted as an initial step of the phase II trial to confirm the safe dose of CB-103 in combination with NSAI given at standard dose.<br/>Patients will receive treatment until disease progression (as defined by RECIST v.1.1), symptomatic deterioration, unacceptable toxicity, death, consent withdrawal or study termination, whichever occurs first.
name: CB-103
other_name: Anastrozole
Letrozole
type: Drug
Study arms:
design_group_description: Hormone Receptor (HR)-positive and HER2-negative advanced breast cancer, including metastatic (ABC).Approximately 80 patients
design_group_title: CB-103 + NSAI therapy
design_group_type: Experimental
Sponsor: Medica Scientia Innovation Research SL
Collaborators: Cellestia Biotech AG
Drug name mappings:
name: Limantrafin
lang: EN
Clinical trial NCT03542266: CC486-CHOP in Patients With Previously Untreated Peripheral T-cell Lymphoma
Official title: A Multi-center Phase II Study of CC486-CHOP in Patients With Previously Untreated Peripheral T-cell Lymphoma
Conditions: Previously Untreated Peripheral T-cell Lymphoma
Summary: This is a phase II, multi-center study to determine the efficacy and safety of first-line CC-486 plus CHOP in patients with PTCL who have received no prior systemic therapy. The study has a sample size of 20, and follows two-stage minimax design for primary efficacy analysis.
Interventions:
description: CC-486 at 300 mg once daily is to be administered Cycle 1, Day -6 to 0 and Cycles 1 to 5, Day 8 to 21. Antiemetic prophylaxis is recommended before dosing. All efforts should be made to administer CC-486 on all scheduled days of the Cycle 1 priming dosing (7 days, Cycle 1 Day -6 to Cycle 1 Day 0) and the Cycle 1-5 dosing (14 days, Day 8-21). A dose missed earlier in a day can be administered later that day as long as it is taken at least 8 hours before the next scheduled dose. Any missed dose should not be taken beyond the last scheduled day of CC-486 administration for the cycle, but should be returned by the subject for CC 486 accountability. If vomiting occurs after a dose of CC-486 is administrated, that dose should not be made up later that day.
name: CC-486 Administration
other_name: Oral Azacitidine
type: Drug
description: CHOP is to be administered on Days 1 to 5 of Cycles 1-6. Chemotherapy can be administer within +72h or -24h of Day 1 of each scheduled Cycle. Preparation and infusion rate are according to the package insert and local practice. The doses to be used are:<br/>Cyclophosphamide: 750 mg/m2 IV on day 1 Doxorubicin: 50 mg/m2 IV on day 1 Vincristine: 1.4 mg/m2 IV (not to exceed 2.0 mg total) on day 1 Prednisone: 100 mg PO days 1-5
name: CHOP Administration
type: Drug
Study arms:
design_group_description: CC486 +CHOP
design_group_title: CC486 +CHOP
design_group_type: Experimental
Sponsor: Weill Medical College of Cornell University
Collaborators: Celgene Corp.
Drug name mappings:
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: 泼尼松
lang: CN
name: Prednisone
lang: EN
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: 硫酸长春新碱
lang: CN
name: Vincristine Sulfate
lang: EN
name: ビンクリスチン硫酸塩
lang: JP
name: 阿扎胞苷
lang: CN
name: Azacitidine
lang: EN
name: アザシチジン
lang: JP
Clinical trial NCT00534469: Auto BMT for Non-M3 AML in 1st Remission in Pts </=60y of Age Using Busulfan/FTBI & VP16 as a Prep R
Official title: Autologous Bone Marrow Transplantation for Non-M3 Acute Myeloid Leukemia (AML) in First Remission in Patients </=60 Years of Age Using Busulfan/Fractionated Total Body Irradiation (FTBI) and VP16 as the Preparative Regimen
Conditions: Leukemia
Summary: RATIONALE: Giving chemotherapy before an autologous stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient's blood and/or bone marrow and stored. More chemotherapy and radiation therapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and radiation therapy. Giving aldesleukin after transplant may help keep cancer cells from coming back after transplant.
PURPOSE: This phase II trial is studying the side effects and how well giving busulfan and etoposide together with total-body irradiation followed by autologous stem cell transplant and aldesleukin works in treating patients with acute myeloid leukemia in first remission.
Interventions:
name: aldesleukin
other_name: Proleukin
type: Biological
name: filgrastim
other_name: Neupogen
type: Biological
name: busulfan
other_name: Busulfex IV
Myleran
type: Drug
name: cytarabine
other_name: Cytosar-U
ara-C
arabinofuranosyl cytidine
cytosine arabinoside
type: Drug
name: etoposide
other_name: Etophosphos
Toposar
VP-16
Vepesid
type: Drug
name: idarubicin
other_name: 4-demethoxydaunorubicin
Idamycin
Zavedos
type: Drug
name: autologous hematopoietic stem cell transplantation
type: Procedure
name: bone marrow transplantation
type: Procedure
name: peripheral blood stem cell transplantation
type: Procedure
name: total-body irradiation
type: Radiation
Study arms:
design_group_description: This study was designed as a single-arm study.<br/>Strata were:<br/>HD ARA-C w/ Idarubicin, CR<6 months N = 24 patients. HD ARA-C w/ Idarubicin, CR>6 months N=1. HD ARA-C consolidation, CR<6 months N=5. HD ARA-C consolidation, CR>6 months N= 0.
design_group_title: HD ARA-C with or without Idarubicin
design_group_type: Experimental
Sponsor: City of Hope National Medical Center
Collaborators: National Cancer Institute
Drug name mappings:
name: 依托泊苷
lang: CN
name: Etoposide
lang: EN
name: エトポシド
lang: JP
name: 白消安
lang: CN
name: Busulfan
lang: EN
name: ブスルファン
lang: JP
name: 非格司亭 （安进）
lang: CN
name: Filgrastim (Amgen)
lang: EN
name: フィルグラスチム（遺伝子組換え）
lang: JP
name: 阿地白介素
lang: CN
name: Aldesleukin
lang: EN
name: 阿糖胞苷
lang: CN
name: Cytarabine
lang: EN
name: シタラビン
lang: JP
name: 盐酸伊达比星
lang: CN
name: Idarubicin Hydrochloride
lang: EN
name: イダルビシン塩酸塩
lang: JP
Clinical trial NCT03797326: Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) in Previously Treated Participants With Select Solid Tumors (MK-7902-005/E7080-G000-224/LEAP-005)
Official title: A Multicenter, Open-label Phase 2 Study of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) in Previously Treated Subjects With Selected Solid Tumors (LEAP-005)
Conditions: Advanced Solid Tumors
Triple Negative Breast Cancer
Ovarian Cancer
Gastric Cancer
Colorectal Cancer
Glioblastoma
Biliary Tract Cancers
Pancreatic Cancer
Summary: The purpose of this study is to determine the safety and efficacy of combination therapy with pembrolizumab (MK-3475) and lenvatinib (E7080/MK-7902) in participants with triple negative breast cancer (TNBC), ovarian cancer, gastric cancer, colorectal cancer (CRC), glioblastoma (GBM), biliary tract cancers (BTC), or pancreatic cancer.
Interventions:
description: Administered as an IV infusion on Day 1 Q3W.
name: Pembrolizumab
other_name: Keytruda®
MK-3475
type: Biological
description: Administered orally once a day during each 21-day cycle.
name: Lenvatinib
other_name: E7080
LENVIMA™
MK-7902
type: Drug
Study arms:
design_group_description: Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) plus lenvatinib 20 mg via oral capsule once a day (QD). Pembrolizumab will be administered for up to 35 cycles (up to 2 years). Lenvatinib will be administered until progressive disease or unacceptable toxicity (up to at least 2 years).
design_group_title: Pembrolizumab + Lenvatinib (Arm 1)
design_group_type: Experimental
design_group_description: Participants receive lenvatinib 24 mg via oral capsule QD, to be administered until progressive disease or unacceptable toxicity (up to at least 2 years).
design_group_title: Lenvatinib Monotherapy (Arm 2)
design_group_type: Experimental
Sponsor: Merck Sharp & Dohme Corp.
Collaborators: Eisai, Inc.
Drug name mappings:
name: 帕博利珠单抗
lang: CN
name: Pembrolizumab
lang: EN
name: ペムブロリズマブ（遺伝子組換え）
lang: JP
name: 甲磺酸仑伐替尼
lang: CN
name: Lenvatinib mesylate
lang: EN
name: レンバチニブメシル酸塩
lang: JP
Clinical trial NCT06498986: A Study of BL-B01D1 in Combination With Osimertinib Mesylate Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer
Official title: A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 in Combination With Osimertinib Mesylate Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer
Conditions: Non-small Cell Lung Cancer
Summary: This phase II clinical study is a study to explore the efficacy and safety of BL-B01D1 in combination with Osimertinib Mesylate Tablets in patients with histologically and/or cytologically confirmed locally advanced or metastatic non-small cell lung cancer.
Interventions:
description: Administration by intravenous infusion for a cycle of 3 weeks.
name: BL-B01D1
other_name: BMS-986507
iza-bren
izalontamab brengitecan
type: Drug
description: Oral administration, 80mg daily for a cycle of 3 weeks.
name: Osimertinib Mesylate Tablets
type: Drug
Study arms:
design_group_description: Participants receive BL-B01D1+Osimertinib Mesylate Tablets in 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-B01D1+Osimertinib Mesylate Tablets
design_group_type: Experimental
Sponsor: Sichuan Baili Pharmaceuticals Co.,Ltd
Collaborators: Baili Bio Chengdu Pharmaceutical Co. Ltd.
Drug name mappings:
name: 伦康依隆妥单抗
lang: CN
name: Izalontamab Brengitecan
lang: EN
name: 甲磺酸奥希替尼
lang: CN
name: Osimertinib mesylate
lang: EN
name: オシメルチニブメシル酸塩
lang: JP
Clinical trial NCT02857582: Transplantation of Cultured Gut Microflora to Repeat Antibiotic-induced Diarrhea Due to Clostridium Difficile
Official title: Transplantation of Cultured Gut Microflora to Repeat Antibiotic-induced Diarrhea Due to Clostridium Difficile
Conditions: Clostridium Difficile
Summary: Patients who have received antibiotics and thereafter developed diarrhea are investigated for presence of Clostridium difficile toxin. Primary treatment is given with oral metronidazole/vancomycin. In case of relapse, secondary treatment is given with either cultured gut microbiota rectally or oral vancomycin in sequence. In those cases where secondary treatment with vancomycin fails cultured gut microbiota is given as final treatment. As an extension treatment, all failures were treated with cluttered gut microbiota through the upper route. In both cases As an alternative cultured gut microbiota may be given via the duodenal route. Follow-up is carried out after 7, 30 and 90 days with interview and stool collection for analysis of Clostridium difficile.
Interventions:
description: Secondary treatment for C diff in replacement for regular vancomycin.
name: Cultured human intestinal microbiota
other_name: Anaerobic cultured human intestinal microbiota (ACHIM)
type: Biological
description: Active comparator to treatment with ACHIM
name: Vancomycin
type: Drug
description: Primary treatment for C diff in all treatment arms
name: Metronidazole
type: Drug
Study arms:
design_group_description: Secondary treatment for relapse of Clostridium difficile infection.
design_group_title: Vancomycin
design_group_type: Active Comparator
design_group_description: Cultured intestinal microbiota is experimental treatment for relapse of Clostridium difficile infection.
design_group_title: Cultured human intestinal microbiota1
design_group_type: Experimental
design_group_description: Cultured intestinal microbiota is thirdly experimental treatment for second relapse of Clostridium difficile infection.
design_group_title: Cultured human intestinal microbiota2
design_group_type: Experimental
Sponsor: University of Uppsala
Collaborators: Karolinska Institutet
Drug name mappings:
name: 甲硝唑
lang: CN
name: Metronidazole
lang: EN
name: メトロニダゾール
lang: JP
Clinical trial NCT05548296: A Phase 2 Study of ACR-368 in Endometrial Adenocarcinoma
Official title: A Phase 2 Study of ACR-368 Therapy in Subjects With Endometrial Cancer
Conditions: Endometrial Adenocarcinoma
Summary: This is an open label Phase 2 study to evaluate the efficacy and safety of ACR-368 as monotherapy or with ultra-low dose gemcitabine (ULDG) sensitization in participants with endometrial cancer.
Interventions:
description: ACR-368 is an experimental drug
name: ACR-368
other_name: prexasertib
type: Drug
description: Sensitization of tumor cells is provided through administration of ULDG
name: Gemcitabine
type: Drug
description: Prospective prediction of drug sensitivity based on a pretreatment tumor biopsy
name: OncoSignature
type: Diagnostic Test
Study arms:
design_group_description: ARM 1: Participants with OncoSignature Positive Tumors will enter a Phase 2 Simon 2-Stage Study that will assess the efficacy of ACR-368 as monotherapy.
design_group_title: OncoSignature Positive Tumors
design_group_type: Experimental
design_group_description: Arm 2: Participants with OncoSignature Negative Tumors will receive ACR-368 with ULDG sensitization. The Phase 2 Study will assess the efficacy and safety of ACR-368 with ULDG sensitization.
design_group_title: OncoSignature Negative Tumors
design_group_type: Experimental
design_group_description: Arm 3: Participants who are OncoSignature Unselected will receive ACR-368 with ULDG sensitization. The Phase 2 Study will assess the efficacy and safety of ACR-368 with ULDG sensitization.
design_group_title: OncoSignature Unselected (All-Comers)
design_group_type: Experimental
Sponsor: Acrivon AB
Collaborators: The Gynecologic Oncology Group
Drug name mappings:
name: 普瑞色替
lang: CN
name: Prexasertib Mesylate Hydrate
lang: EN
name: 盐酸吉西他滨
lang: CN
name: Gemcitabine Hydrochloride
lang: EN
name: ゲムシタビン塩酸塩
lang: JP
Clinical trial NCT05748834: Study of Tucatinib and Doxil in Participants With Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Metastatic Breast Cancer
Official title: Phase 2 Single Arm Trial With a Safety Lead-in of Tucatinib in Combination With Doxil for the Treatment of HER2+ Metastatic Breast Cancer
Conditions: Breast Cancer
Summary: This clinical trial is evaluating tucatinib in combination with Doxil in participants with human epidermal growth factor 2 positive (HER2+) locally advanced or metastatic breast cancer. The main goals of this study are to:
* Learn how well the combination of tucatinib and Doxil works
* Learn more about the side effects of the combination of tucatinib and Doxil
Interventions:
description: Participants will receive tucatinib 300mg by mouth twice daily continuously (days 1-28) of each 28 day cycle.
name: Tucatinib
other_name: Tukysa
type: Drug
description: Participants will receive Doxil 40mg/m2 intravenously on day 1 of each 28 day cycle (with a maximum cumulative dose of 550mg/m2).
name: Doxil
other_name: doxorubicin hydrochloride liposome injection
type: Drug
Study arms:
design_group_description: Participants will receive tucatinib 300mg by mouth twice daily continuously in combination with Doxil 40mg/m2 given intravenously on day 1 of each cycle. Cycles will be 28 days. Up to 36 participants will be enrolled in this Phase 2 study.
design_group_title: Tucatinib Experimental Treatment Arm
design_group_type: Experimental
Sponsor: Scri Development Innovations LLC
Collaborators: Pfizer Inc.
Seagen, Inc.
Drug name mappings:
name: 盐酸多柔比星脂质体
lang: CN
name: Doxorubicin Hydrochloride liposomal
lang: EN
name: 妥卡替尼
lang: CN
name: Tucatinib
lang: EN
name: ツカチニブ エタノール付加物
lang: JP
Clinical trial NCT05450965: Study of PLK1 Inhibitor, Onvansertib, in Relapsed Small Cell Lung Cancer
Official title: A Phase 2 Study of PLK1 Inhibitor, Onvansertib, in Relapsed Small Cell Lung Cancer
Conditions: Small-cell Lung Cancer
Small Cell Lung Carcinoma
Summary: This phase II clinical trial will study the safety and efficacy of onvansertib to treat patients with small cell lung cancer (SCLC) who have either not responded to or are unable to tolerate chemotherapy. Onvansertib is a drug that inhibits polo-like kinase 1 (PLK-1), an enzyme that is over-expressed in many cancer cells and is involved in cellular repair.
Interventions:
description: Onvansertib at a dose of 15 mg/m2 orally on Days 1-14 of a 21-day cycle. Treatment will continue until disease progression or intolerable toxicity.
name: Onvansertib
type: Drug
Study arms:
design_group_description: Onvansertib
design_group_title: Single Treatment Arm
design_group_type: Experimental
Sponsor: University of Maryland Baltimore
Collaborators: National Cancer Institute
Cardiff Oncology, Inc.
Drug name mappings:
name: Onvansertib
lang: EN
Clinical trial NCT03841747: Paclitaxel Plus Pembrolizumab vs. Paclitaxel Weekly in ER+ Luminal B Metastatic Breast Cancer
Official title: A Phase II, Randomized Study of Paclitaxel Weekly Plus Pembrolizumab Versus Paclitaxel Weekly in ER-positive, Luminal B Metastatic Breast Cancer
Conditions: Breast Cancer
Summary: PELICAN is a randomised phase II trial that aims to evaluate the efficacy and safety of paclitaxel plus pembrolizumab relative to paclitaxel alone, in patients with locally advanced or metastatic ER-positive, HER2-negative, Luminal B breast cancer who have received no prior chemotherapy for advanced or metastatic disease.
Patients will be randomised (2:1) to one of the two treatment arms:
* Pembrolizumab plus Paclitaxel
* Paclitaxel
Interventions:
description: 200 mg Pembrolizumab IV Q3W.
name: Pembrolizumab
other_name: KEYTRUDA
lambrolizumab
type: Drug
description: 80 mg/m2 paclitaxel IV on Days 1,8, and 15 of each 28 day cycle.
name: Paclitaxel
other_name: Taxol
type: Drug
Study arms:
design_group_description: 200 mg Pembrolizumab IV Q3W plus 80 mg/m2 paclitaxel IV on Days 1,8, and 15 of each 28 day cycle.
design_group_title: Pembrolizumab + Paclitaxel
design_group_type: Experimental
design_group_description: 80 mg/m2 paclitaxel IV on Days 1,8, and 15 of each 28 day cycle.
design_group_title: Paclitaxel
design_group_type: Active Comparator
Sponsor: Queen Mary University of London
Collaborators: Merck Sharp & Dohme Corp.
Istituto Europeo di Oncologia Srl
Drug name mappings:
name: 紫杉醇
lang: CN
name: Paclitaxel
lang: EN
name: パクリタキセル
lang: JP
name: 帕博利珠单抗
lang: CN
name: Pembrolizumab
lang: EN
name: ペムブロリズマブ（遺伝子組換え）
lang: JP
Clinical trial NCT05014646: Leflunomide for the Treatment of High-Risk Smoldering Multiple Myeloma in African-American and European-American Patients
Official title: Phase 2 Trial of Leflunomide in African-American and European-American Patients With High-Risk Smoldering Multiple Myeloma
Conditions: Smoldering Plasma Cell Myeloma
Summary: This phase II trial studies the effects of leflunomide in treating African-American and European-American patients with high-risk smoldering multiple myeloma. Leflunomide is used to decrease the body's immune response and may delay the symptoms of multiple myeloma in patients of African-American and European decent.
Interventions:
description: Given PO
name: Cholestyramine
other_name: Cholybar
Colestyramine
Duolite AP143 Resin
Questran
Questran Light
type: Drug
description: Given PO
name: Leflunomide
other_name: Arava
SU101
type: Drug
Study arms:
design_group_description: Patients receive leflunomide PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
design_group_title: Treatment (leflunomide)
design_group_type: Experimental
Sponsor: City of Hope National Medical Center
Collaborators: National Cancer Institute
Drug name mappings:
name: 考来烯胺
lang: CN
name: Cholestyramine
lang: EN
name: コレスチラミン
lang: JP
name: 来氟米特
lang: CN
name: Leflunomide
lang: EN
name: レフルノミド
lang: JP
Clinical trial NCT05589610: Study of EQ101 in Adult Subjects With Moderate to Severe Alopecia Areata
Official title: An Open-label, Phase 2 Study to Assess the Safety and Efficacy of EQ101 in Adult Subjects With Moderate to Severe Alopecia Areata
Conditions: Alopecia Areata
Alopecia
Alopecia Totalis
Alopecia Universalis
Summary: The purpose of this study is to assess the safety, PK, and PD of EQ101 as well as measure the efficacy of EQ101 at Week 24 compared to Baseline in adult subjects with moderate to severe AA. The study consists of 3 phases: a screening phase of up to 5 weeks, a treatment phase of 24 weeks, and a follow-up phase of 4 weeks. Study drug will be administered via intravenous (IV) push weekly.
Interventions:
description: EQ101, 2 mg/kg, once weekly dosing, for a total of 24 doses
name: EQ101
type: Drug
Study arms:
design_group_description: EQ101 weekly
design_group_title: EQ101
design_group_type: Experimental
Sponsor: Equillium, Inc.
Collaborators: Equillium AUS Pty Ltd.
Drug name mappings:
name: BNZ-1
lang: EN
Clinical trial NCT00000819: A Phase II Randomized, Double-Blind, Placebo-Controlled Trial to Determine the Efficacy of Prednisone Therapy in HIV-Associated Nephropathy (HIVAN)
Official title: A Phase II Randomized, Double-Blind, Placebo-Controlled Trial to Determine the Efficacy of Prednisone Therapy in HIV-Associated Nephropathy (HIVAN)
Conditions: HIV Infections
AIDS-Associated Nephropathy
Summary: To determine the efficacy and safety of prednisone in patients with HIV-associated nephropathy. To determine the effects of prednisone on serum creatinine, urinary protein, and creatinine clearance.
HIV-associated nephropathy is characterized by heavy proteinuria, rapidly progressive renal insufficiency, and distinct nephropathologic changes. The syndrome most often occurs in patients with advanced HIV disease. Little is known about the effects of corticosteroids on the progression of HIV disease. In light of the possible beneficial effects of corticosteroids on HIV-associated nephropathy, a controlled trial using prednisone is warranted.
Interventions:
name: Prednisone
type: Drug
Study arms:
Sponsor: National Institute of Allergy & Infectious Diseases
Collaborators: The Upjohn Co.
Drug name mappings:
name: 泼尼松
lang: CN
name: Prednisone
lang: EN