PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT02421367: Study of Varying Injection Schedules of TDENV-PIV Vaccine With AS03B Adjuvant and Placebo in Healthy US Adults
Official title: A Phase 1/2, Randomized, Observer-blind Study of Varying Injection Schedules of a Tetravalent Dengue Virus Purified Inactivated Vaccine (TDENV-PIV) With AS03B Adjuvant and Placebo in Healthy Adults in the US
Conditions: Dengue
Summary: This study is being conducted to evaluate the safety and immunogenicity and antibody persistence of the candidate dengue vaccine.
Interventions:
description: Tetravalent dengue virus purified inactivated vaccine (1 µg/virus type)
name: TDENV-PIV with AS03B adjuvant. Placebo: 0.9% Sodium Chloride Solution.
type: Biological
Study arms:
design_group_description: The intervention is a tetravalent dengue virus purified inactivated vaccine (1µg/DENV type) with adjuvant, AS03B.<br/>The placebo is sodium chloride.<br/>TDENV-PIV vaccine and placebo will be administered in a single 0.5 mL dose intramuscularly in the non-dominant (whenever possible) deltoid region of the upper arm.<br/>The intervention will be administered on Day 0 and Day 28. The placebo will be administered on Day 84 and Day 168.
design_group_title: TDENV-PIV (0-1)
design_group_type: Experimental
design_group_description: The intervention is a tetravalent dengue virus purified inactivated vaccine (1µg/DENV type) with adjuvant, AS03B.<br/>The placebo is sodium chloride.<br/>TDENV-PIV vaccine and placebo will be administered in a single 0.5 mL dose intramuscularly in the non-dominant (whenever possible) deltoid region of the upper arm.<br/>The intervention will be administered on Day 0, Day 28, and Day 168. The placebo will be administered on Day 84.
design_group_title: TDENV-PIV (0-1-6)
design_group_type: Experimental
design_group_description: The intervention is a tetravalent dengue virus purified inactivated vaccine (1µg/DENV type) with adjuvant, AS03B.<br/>The placebo is sodium chloride.<br/>TDENV-PIV vaccine and placebo will be administered in a single 0.5 mL dose intramuscularly in the non-dominant (whenever possible) deltoid region of the upper arm.<br/>The intervention will be administered on Day 84 and Day 168. The placebo will be administered on Day 0 and Day 28.
design_group_title: TDENV-PIV (0-3)
design_group_type: Experimental
Sponsor: U S Army Medical Research & Development Command
Collaborators: Walter Reed Army Institute of Research
GSK Plc
Drug name mappings:
name: Tetravalent dengue virus purified inactivated vaccine(Walter Reed Army Institute of Research)
lang: EN
Clinical trial NCT01078142: Temsirolimus, Bendamustine and Rituximab for Relapsed Follicular Lymphoma or Mantle Cell Lymphoma
Official title: A Phase I/II Trial to Evaluate the Safety, Feasibility and Efficacy of the Addition of Temsirolimus to a Regimen of Bendamustine and Rituximab for the Treatment of Patients With Follicular Lymphoma or Mantle Cell Lymphoma in First to Third Relapse
Conditions: Follicular Lymphoma
Mantle Cell Lymphoma
Summary: This is a multicenter, open label, single arm, phase I/II study. There will be no placebo usage within this trial.
Phase I:
Primary: To establish a maximum tolerated dose of the addition of Temsirolimus to a regimen of Bendamustine and Rituximab (BERT) in patients with relapsed follicular lymphoma and mantle cell lymphoma.
Phase II:
Primary: To evaluate the ORR in patients with MCL or FL treated with the established BERT dose Secondary: To determine the complete remission rate, progression free survival rate and overall survival rate and to investigate safety and tolerability of BERT.
Interventions:
description: Phase I:<br/>Temsirolimus 25 - 50 - 75mg, day 1,8,15 Bendamustin 90/m2, day 1,2 Rituximab 375/m2, day 1 Phase II at established dose, repeat day 28-42 (max)
name: Temsirolimus, Rituximab, Bendamustin
other_name: Mabthera, Rituxan, Torisel, Bendamustin, Ribomustin, Trenda
type: Drug
Study arms:
design_group_description: Bendamustin, Rituximab, Temsirolimus
design_group_title: Single arm
design_group_type: Experimental
Sponsor: The Johannes Gutenberg University of Mainz
Collaborators: Mundipharma Pte Ltd.
Wyeth AB
Drug name mappings:
name: 盐酸苯达莫司汀
lang: CN
name: Bendamustine Hydrochloride
lang: EN
name: ベンダムスチン塩酸塩
lang: JP
name: 利妥昔单抗
lang: CN
name: Rituximab
lang: EN
name: リツキシマブ（遺伝子組換え）
lang: JP
name: 替西罗莫司
lang: CN
name: Temsirolimus
lang: EN
name: テムシロリムス
lang: JP
Clinical trial NCT05668741: A Phase 1/2 Study of VX-522 in Participants With Cystic Fibrosis (CF)
Official title: A Phase 1/2 Dose Escalation Study Evaluating the Safety, and Tolerability and Efficacy of VX-522 in Subjects 18 Years of Age and Older With Cystic Fibrosis and a CFTR Genotype Not Responsive to CFTR Modulator Therapy
Conditions: Cystic Fibrosis
Summary: The purpose of this study is to evaluate the safety, and tolerability and efficacy of VX-522 in participants 18 years of age and older with cystic fibrosis and a cystic fibrosis transmembrane conductance regulator (CFTR) genotype not responsive to CFTR modulator therapy.
Interventions:
description: Oral inhalation using nebulizer.
name: VX-522 mRNA therapy
type: Drug
description: Tablet for oral administration.
name: IVA
other_name: VX-770
ivacaftor
type: Drug
Study arms:
design_group_description: Participants grouped into different cohorts will receive a single ascending dose of VX-522.
design_group_title: Single Ascending Dose (SAD)
design_group_type: Experimental
design_group_description: Participants will receive multiple ascending doses of VX-522.
design_group_title: Multiple Ascending Dose (MAD) Cohort 1: VX-522
design_group_type: Experimental
design_group_description: Following run-in period with ivacaftor (IVA), participants will receive multiple ascending doses of VX-522 with IVA.
design_group_title: MAD Cohort 1: VX-522+ IVA
design_group_type: Experimental
design_group_description: Following run-in period with ivacaftor (IVA), participants will receive multiple ascending doses of VX-522 with IVA.
design_group_title: MAD Cohort 2: VX-522+ IVA
design_group_type: Experimental
Sponsor: Vertex Pharmaceuticals, Inc.
Collaborators: Moderna, Inc.
Drug name mappings:
name: 艾伐卡托
lang: CN
name: Ivacaftor
lang: EN
name: VX-522
lang: EN
Clinical trial NCT00314262: Phase I/II Study of Chemoprevention With EGFR and COX-2 Inhibitor
Official title: Phase I/II Study of Chemoprevention With Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor Erlotinib (OSI-774, Tarceva) and Cyclooxygenase-2 (COX-2) Inhibitor (Celecoxib) in Premalignant Lesions of Head and Neck of Former Smokers
Conditions: Precancerous Conditions
Summary: Evaluate effect on cells and patient response to study medications, assess side effects of these medications, and evaluate chemicals in cells that may tell how the drug works, before, and after receiving the study medications.
Interventions:
description: Erlotinib given orally, once daily (dose escalation from 50 mg, 75 mg, or 100 mg) continuously for 6 months in the phase I portion.<br/>Celecoxib given 400 mg orally BID continuously for 6 months.
name: Erlotinib & Celecoxib
other_name: OSI-774, Tarceva
type: Drug
Study arms:
design_group_title: Erlotinib & Celecoxib
design_group_type: Experimental
Sponsor: Emory University
Collaborators: National Institutes of Health
Drug name mappings:
name: 盐酸厄洛替尼
lang: CN
name: Erlotinib Hydrochloride
lang: EN
name: エルロチニブ塩酸塩
lang: JP
name: 塞来昔布
lang: CN
name: Celecoxib
lang: EN
name: セレコキシブ
lang: JP
Clinical trial NCT00879138: Efficacy and Safety of VA106483 in Elderly Males
Official title: A Double-blind, Placebo-controlled Dose Response Study to Investigate Pharmacodynamics and Pharmacokinetics of Single and Repeated Oral Doses of VA106483 in Elderly Male Subjects
Conditions: Nocturia
Summary: A double blind, placebo-controlled, dose ranging study in males over the age of 65, who have a history of nocturia. The study will investigate pharmacodynamic outcomes (urine volumes and osmolality, circulating coagulation factors and haemodynamics) and pharmacokinetics, of both single and multiple oral doses of VA106483 at three dose levels, under conditions of controlled hydration.
Interventions:
name: VA106483
type: Drug
name: Sugar pill
type: Drug
Study arms:
design_group_title: Sugar pill
design_group_type: Placebo Comparator
design_group_title: VA106483 2 mg
design_group_type: Experimental
design_group_title: VA106483 4 mg
design_group_type: Experimental
design_group_title: VA106483 8 mg
design_group_type: Experimental
Sponsor: Vantia Ltd.
Collaborators: Veeda Clinical Research Ltd.
Drug name mappings:
name: Fedovapagon
lang: EN
Clinical trial NCT00516828: Sorafenib and Low Dose Cytarabine in Older Patients With Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
Official title: A Phase I/II Study of Sorafenib (BAY 43-9006) in Combination With Low Dose ARA-C (CYTARABINE) in Elderly Patients With AML or High-Risk MDS
Conditions: Leukemia
Myelodysplastic Syndromes
Summary: RATIONALE: Sorafenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the cancer. Drugs used in chemotherapy, such as cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with cytarabine may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of giving sorafenib together with cytarabine and to see how well it works in treating older patients with acute myeloid leukemia or high-risk myelodysplastic syndrome.
Interventions:
description: subcutaneously twice daily from Day 1 to 10
name: cytarabine
type: Drug
Study arms:
design_group_description: Cytarabine: subcutaneously twice daily from day 1 - 10. Sorafenib: Days 2-28; at the dose level assigned at registration. Sorafenib will be given orally twice daily.
design_group_title: Sorafenib and Cytarabine
design_group_type: Experimental
Sponsor: NCIC Clinical Trials Group
Collaborators: Bayer AG
Drug name mappings:
name: 阿糖胞苷
lang: CN
name: Cytarabine
lang: EN
name: シタラビン
lang: JP
Clinical trial NCT01016600: Azacitidine and Lenalidomide for Acute Myeloid Leukemia
Official title: Phase I/II Trial of Azacitidine Plus Lenalidomide in the Treatment of Acute Myeloid Leukemia
Conditions: Leukemia, Myeloid, Acute
Summary: Determine toxicity and remission rates of treatment with azacitidine and lenalidomide for patients with Acute Myeloid Leukemia
Interventions:
name: Lenalidomide
other_name: Revlimid
type: Drug
name: Azacitidine
other_name: Vidaza
type: Drug
Study arms:
design_group_description: Induction regimen (total 2 cycles)<br/>Lenalidomide 50 mg PO daily days 1-28<br/>Azacitidine 25 mg/m2 IV days 1-5<br/>Maintenance Regimen<br/>Lenalidomide 10 mg PO daily days 1-28<br/>Azacitidine 75 mg/m2 IV days 1-5
design_group_title: Cohort 1
design_group_type: Experimental
design_group_description: Induction regimen (total 2 cycles)<br/>Lenalidomide 50 mg PO daily days 1-28<br/>Azacitidine 50 mg/m2 IV days 1-5<br/>Maintenance Regimen<br/>Lenalidomide 10 mg PO daily days 1-28<br/>Azacitidine 75 mg/m2 IV days 1-5
design_group_title: Cohort 2
design_group_type: Experimental
design_group_description: Induction regimen (total 2 cycles)<br/>Lenalidomide 50 mg PO daily days 1-28<br/>Azacitidine 75 mg/m2 IV days 1-5<br/>Maintenance Regimen<br/>Lenalidomide 10 mg PO daily days 1-28<br/>Azacitidine 75 mg/m2 IV days 1-5
design_group_title: Cohort 3
design_group_type: Experimental
design_group_description: Induction regimen (total 2 cycles)<br/>Lenalidomide 50 mg PO daily days 1-28<br/>Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5<br/>Maintenance Regimen<br/>Lenalidomide 10 mg PO daily days 1-28<br/>Azacitidine 75 mg/m2 IV days 1-5
design_group_title: Phase II
design_group_type: Experimental
Sponsor: Washington University School of Medicine
Collaborators: Celgene Corp.
Drug name mappings:
name: 来那度胺
lang: CN
name: Lenalidomide
lang: EN
name: レナリドミド水和物
lang: JP
name: 阿扎胞苷
lang: CN
name: Azacitidine
lang: EN
name: アザシチジン
lang: JP
Clinical trial NCT01283334: A Study of Carboplatin, Cetuximab and RAD001 in Advanced Head and Neck Cancer
Official title: A Phase I/IIB Study of Combination Weekly Carboplatin, Cetuximab and Dose Escalation of RAD001 in Recurrent Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Conditions: Head and Neck Neoplasms
Cancer of the Head and Neck
Summary: The purpose of this study is to test the drug RAD001 in combination with other chemotherapy drugs, Carboplatin and Cetuximab. Because RAD001 has not been used in this combination before, it is not clear which dose will be best when used in combination.
The investigators will test the safety of RAD001 in combination with Carboplatin and Cetuximab and see what effects (good and/or bad) it has on your cancer, and find the highest dose of RAD001 that can be given without causing bad side effects. The doses of Carboplatin and Cetuximab will not be varied as both these drugs are considered to be part of the current standard of care for patients with your condition.
Interventions:
description: Will be given as a 30 minutes intravenous (IV) infusion on days 1, 8, and 15 of each 28 day cycle. The starting dose of carboplatin will be area under the plasma-concentration time curve (AUC) = 2 mg/ml.min. Appropriate dose reductions will be done for toxicity for subsequent cycles.
name: Carboplatin
other_name: Paraplatin
type: Drug
description: Will be given on days 1, 8, 15 and 22 of each 29 day cycle. On week 1, a loading dose of 400 mg/m² will be given. From week 2 onwards, the dose of cetuximab will be 250 mg/m².
name: Cetuximab
other_name: Erbitux
type: Drug
description: For phase I, dose escalation will be 2.5 mg, 5 mg, 7.5 mg or 10 mg given orally on a daily basis.
name: RAD001
other_name: Certican
Everolimus
type: Drug
Study arms:
design_group_description: Treatment arm with carboplatin, cetuximab and RAD001
design_group_title: A
design_group_type: Experimental
Sponsor: Emory University
Collaborators: Novartis AG
Drug name mappings:
name: 西妥昔单抗
lang: CN
name: Cetuximab
lang: EN
name: セツキシマブ（遺伝子組換え）
lang: JP
name: 卡铂
lang: CN
name: Carboplatin
lang: EN
name: カルボプラチン
lang: JP
name: 依维莫司
lang: CN
name: Everolimus
lang: EN
name: エベロリムス
lang: JP
Clinical trial NCT05858814: RC1012 Injection (Allo-DNT Cells) for the Prevention of Relapse in AML Patients After Allo-HSCT
Official title: A Phase I/II Clinical Trial of RC1012 Injection for the Prevention of Relapse in AML Patients After Allogeneic Hematopoietic Stem Cell Transplantation
Conditions: Acute Myeloid Leukemia
Summary: To evaluate the safety and tolerability of RC1012 injection infusion in AML Patients after Allo-HSCT
Interventions:
description: RC1012 injection (allo-DNT cells) are from healthy donors and have been proved to be safe and demonstrated potent cytotoxicity against AML blasts from AML patients in preclinical and preliminary clinical studies. Allo- DNT cells will be collected from healthy donors (NO MHC match needed) and injected into patients. The drug for this study is an off-the-shelf product. Patients DO NOT need to wait for the cell manufacturing.
name: RC1012 injection (allo-DNT cells)
type: Biological
Study arms:
design_group_description: The trial is divided into two parts: Part A is a dose escalation trial with two dose groups (1.0×10^8 cells/kg, 1.5×10^8 cells/kg at day 0, day 28 and day 56), with 6-12 patients planned to be enrolled. Part B is a dose-expansion randomized controlled trial in which 40-60 patients will receive RC1012 infusions at RP2D dose levels.
design_group_title: RC1012 injection (allo-DNT Cells)
design_group_type: Experimental
Sponsor: Guangdong Ruishun Biotechnology Co., Ltd.
Collaborators: Anhui Shackle Hospital Co., Ltd.
Drug name mappings:
name: RC-1012
lang: EN
Clinical trial NCT07022964: CD5 CAR T-Cell Therapy for r/r T-cell Lymphomas
Official title: A Multicenter, Open-Label, Non-Randomized, Single-Arm Phase I/II Clinical Study of Autologous and New Donor CD7 CAR-T Cells for Relapsed or Refractory Mature T-Cell Lymphomas
Conditions: T-Cell Non-Hodgkin Lymphoma
T-cell Lymphoma (PTCL and CTCL)
Summary: This is a multi-center, open-label, non-randomized, single-arm clinical trial. Refractory/relapse T-NHL patients are treated with autologous and allogeneic CD5 CAR T-cell therapy. The primary objective is to prospectively evaluate the safety of CD5 CAR T cell bridging to HSCT in the treatment of r/r T-NHL. The primary endpoint is the type and incidence of dose limiting toxicity (DLT) within 21 days after CD5 CAR-T cell infusion. A total of 36 subjects is estimated to be enrolled.
Interventions:
description: Approximately 3-5 days prior to CD5 CAR-T cell infusion, subjects are treated with FC regimen (fludarabine and cyclophosphamide) for lymphodepletion. CAR-T cell infusion are performed 48 h after completion of chemotherapy.
name: CD5 CAR-T cells infusion
type: Drug
Study arms:
design_group_description: Enrolled patients were treated with anti-CD7 CAR-T cells, with or without allo-HSCT bridging.
design_group_title: CD5 CAR-T therapy
design_group_type: Experimental
Sponsor: Beijing Gaobo Hospital Co., Ltd.
Collaborators: Ruijin Hospital
Drug name mappings:
name: CD5 CAR T cells(Beijing GoBroad Hospital/Beijing Boren Hospital)
lang: EN
Clinical trial NCT02944162: CAR-pNK Cell Immunotherapy for Relapsed/Refractory CD33+ AML
Official title: Clinical Investigation of Chimeric CD(Cluster of Differentiation)33 Antigen Receptor-modified NK92 Cells in Relapsed and/or Refractory Acute Myeloid Leukemias
Conditions: Acute Myelogenous Leukemia
Acute Myeloid Leukemia
Acute Myeloid Leukemia With Maturation
Acute Myeloid Leukemia Without Maturation
ANLL
Summary: The purpose of this clinical trial is to study genetically engineered NK92 cell therapy in treating patients with CD33 positive acute myeloid leukemias that is relapsed (after stem cell transplantation or intensive chemotherapy) or refractory to further chemotherapy.
Interventions:
description: The allogeneic NK cells (NK-92 cell line for clinical use) are engineered to contain anti-CD33 attached to TCRzeta, CD28 and 4-1BB signaling domains. These modified cells are called chimeric antigen receptor NK cells with specificity for CD33.
name: anti-CD33 CAR-NK cells
other_name: Chimeric antigen receptor NK92 cells with specificity for CD33
type: Biological
Study arms:
design_group_description: Enrolled patients will receive CAR-NK cells immunotherapy with a novel specific chimeric antigen receptor targeting CD33 antigen by infusion.
design_group_title: CAR-NK Cell immunotherapy
design_group_type: Experimental
Sponsor: PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Collaborators: Hefei No. 1 People's Hospital
Drug name mappings:
name: Anti-CD33 CAR-NK92 cells (PersonGen Biomedicine)
lang: EN
Clinical trial NCT07113106: Dose Escalation Trial of CD40.Pan.CoV Vaccine, Adjuvanted or Not, as a Booster in Adult Healthy Volunteers
Official title: A Phase 1/2a Multicenter Trial to Evaluate the Safety and Immunogenicity of the CD40.Pan.CoV Vaccine, Adjuvanted or Not, as a Booster in Adult Participants
Conditions: Healthy Volunteers
Summary: The clinical trial is a phase1/2a, open-label, dose-escalating, multicentre trial evaluating the safety and immunogenicity of the CD40.Pan.CoV vaccine, adjuvanted or not, as a booster injection in adult participants in France. 48 participants divided into 4 cohorts will be included in the trial.
Primary objectives are the following:
* To determine the safety and reactogenicity of different doses (0.25 mg and 1 mg) of a booster of a CD40.Pan.CoV vaccine, adjuvanted or not, in healthy volunteers between Day 0 and Month1
* To determine the humoral immune response (neutralizing antibody titers) induced by different doses (0.25 mg and 1 mg) of a booster of a CD40.Pan.CoV vaccine, adjuvanted or not, at Month1 after administration
Interventions:
description: SC Injection in deltoid of Low dose (LD; 0.25 mg) CD40.Pan.CoV vaccine non adjuvanted at Day 0.
name: CD40.Pan.CoV Low dose(0.25mg)
type: Biological
description: SC injection in deltoid of LD (0.25 mg) CD40.Pan.CoV vaccine Hiltonol® adjuvanted at Day 0.
name: CD40.Pan.CoV Low dose (0,25mg) adjuvanted with Hiltonol®
type: Biological
description: SC injectionin deltoid of High dose (HD; 1mg) CD40.Pan.CoV vaccine non adjuvanted at Day 0.
name: CD40.Pan.CoV High dose (1mg)
type: Biological
description: SC injection in deltoid of HD (1mg) CD40.Pan.CoV vaccine Hiltonol® adjuvanted at Day 0.
name: CD40.Pan.CoV High dose (1mg) adjuvanted with Hiltonol®
type: Biological
Study arms:
design_group_description: Injection of Low dose CD40.Pan.CoV vaccine non adjuvanted
design_group_title: Cohort 1
design_group_type: Experimental
design_group_description: Injection of LD CD40.Pan.CoV vaccine adjuvanted
design_group_title: Cohort 2
design_group_type: Experimental
design_group_description: Injectionin of High dose CD40.Pan.CoV vaccine non adjuvanted
design_group_title: Cohort 3
design_group_type: Experimental
design_group_description: Injection of HD CD40.Pan.CoV vaccine adjuvanted
design_group_title: Cohort 4
design_group_type: Experimental
Sponsor: ANRS Emerging infectious diseases
Collaborators: Institut National de la Santé et de la Recherche Médicale
Drug name mappings:
name: CD40.Pan.CoV Vaccine
lang: EN
Clinical trial NCT02236000: A Dose-Escalation Study Evaluating the Combination of Trastuzumab Emtansine (T-DM1) With Neratinib in Women With Metastatic HER2-Positive Breast Cancer
Official title: A Phase Ib/II Dose-Escalation Study Evaluating the Combination of Trastuzumab Emtansine (T-DM1) With Neratinib in Women With Metastatic HER2-Positive Breast Cancer
Conditions: Breast Cancer
Summary: This study is being done for the following reasons:
* The study has two parts. The purpose of the first part (Phase I) of the study is to find out the highest dose of neratinib that can be given safely with T-DM1.
* The purpose of the second part of the study (Phase II) is to find out whether the dose of neratinib with T-DM1 determined in Phase I will keep breast cancer from getting worse for a period of time.
* In order to learn more about study therapy levels in blood and discover genetic and protein changes associated with cancer, the study includes special research tests using samples from blood and from breast tumor. Blood samples will be collected before study treatment, once during treatment, and after study treatment stops.
* In the optional part of this study, three biopsies will be performed to obtain fresh tumor samples from an area where your cancer has spread.
Interventions:
description: Dose-Escalation Phase (Part 1) - Neratinib Dose-escalation will proceed on the basis of DLT during Cycle 1 starting at 120 mg/day.<br/>Dose level 1: 120 mg/day; Dose level 2: 160 mg/day; Dose level 3: 200 mg/day; Dose level 4: 240 mg/day<br/>Dose-evaluation Phase (Part 2) - Patients will receive the highest dose of neratinib with T-DM1 found in Phase I as study therapy
name: Neratinib
type: Drug
description: Dose-Escalation Phase (Part 1) - Trastuzumab emtansine (T-DM1) will be given at 3.6 mg/kg IV Day 1 every 21 days.<br/>Dose-evaluation Phase (Part 2) - Trastuzumab emtansine (T-DM1) will be given at 3.6 mg/kg IV Day 1 every 21 days.
name: T-DM1
type: Drug
Study arms:
design_group_title: Neratinib and T-DM1
design_group_type: Experimental
Sponsor: NSABP Foundation, Inc.
Collaborators: Puma Biotechnology, Inc.
Drug name mappings:
name: 恩美曲妥珠单抗
lang: CN
name: ADO-Trastuzumab Emtansine
lang: EN
name: トラスツズマブ エムタンシン（遺伝子組換え）
lang: JP
name: 马来酸奈拉替尼
lang: CN
name: Neratinib maleate
lang: EN