PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT04313400: Topically Applied AMTX-100 CF for Adult Patients With Mild to Moderate Atopic Dermatitis
Official title: A Two Part, Phase I/II, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study of the Safety and Efficacy of Topically Applied AMTX-100 CF in Adult Patients With Mild to Moderate Atopic Dermatitis
Conditions: Atopic Dermatitis
Summary: This study determines the Maximum Tolerable Dose (MTD) by maximum BSA percentage treated and evaluates safety and efficacy of 1.1% w/w AMTX-100 CF versus placebo (vehicle).
The study has two parts:
Phase I (Part 1):
Approximately Twenty-five (25) subjects with various treatable Body Surface Area (BSA) involvement of Mild to Moderate Atopic Dermatitis will be enrolled in the study and treated with 1.1% w/w AMTX-100 CF.
Phase II (Part 2):
Approximately sixty (60) subjects with Mild to Moderate Atopic Dermatitis with various treatable BSA involvement of Mild to Moderate Atopic Dermatitis will be randomized to be treated with 1.1% w/w AMTX-100 CF3 concentration or Vehicle (Placebo) in the study.
Interventions:
description: AMTX-100 CF, topical cream with 1.1% w/w active pharmaceutical ingredient
name: 1.1% w/w AMTX-100 CF-part1
type: Drug
description: Topical cream manufactured to mimic AMTX-100 CF3
name: Placebo
other_name: placebo (vehicle 0% w/w)
type: Drug
description: AMTX-100 CF3, topical cream with 1.1% w/w active pharmaceutical ingredient
name: 1.1% w/w AMTX-100 CF3-part2
other_name: part2
type: Drug
Study arms:
design_group_description: Open-label, five (5) cohorts were sequentially enrolled. AMTX-100 CF 1.1% w/w, topically applied twice a day for 7 consecutive days to all treatable AD affected areas from 3% to 70% of the Body Surface Area (BSA) (3% BSA ≤ AD Affected Area ≤ 70% BSA)
design_group_title: Part 1 Dose Escalation: 3% to 70% of the BSA
design_group_type: Experimental
design_group_description: AMTX-100 CF3 (1.1% w/w), topically applied twice a day for 28 consecutive days to all treatable AD affected areas
design_group_title: Part 2 Group A: 1.1% w/w
design_group_type: Experimental
design_group_description: Placebo (Vehicle) (0% w/w), topically applied twice a day for 28 consecutive days to all treatable AD affected areas
design_group_title: Part 2 Group B: Placebo
design_group_type: Placebo Comparator
Sponsor: Amytrx Therapeutics, Inc.
Collaborators: Amarex Clinical Research LLC
Drug name mappings:
name: AMTX-100
lang: EN
Clinical trial NCT04725331: A Clinical Trial Assessing BT-001 Alone and in Combination With Pembrolizumab in Metastatic or Advanced Solid Tumors
Official title: A Phase I/IIa Study of Intra-tumoral BT-001 (TG6030) Administered Alone and in Combination With Pembrolizumab in Patients With Cutaneous or, Subcutaneous Lesions or Easily Injectable Lymph Nodes of Metastatic/Advanced Solid Tumors.
Conditions: Metastatic Cancer
Soft Tissue Sarcoma
Merkel Cell Carcinoma
Melanoma
Triple Negative Breast Cancer
Non Small Cell Lung Cancer
Summary: This is a Phase I/IIa, multicenter, open-label, consecutive cohorts, dose-escalation study of BT-001 with repeated IT administrations alone and in combination with IV infusions of pembrolizumab.
Interventions:
description: Oncolytic Vaccinia virus containing genes encoding the 4-E03 human recombinant anti-hCTLA4 antibody and human GM-CSF administered at different dose [Phase I, Part A]; one dose lower and at Recommended Dose for Part B [Phase I, Part B] by intra-tumoral (IT) route.
name: BT-001
type: Biological
description: Programmed death receptor (PD-1) blocking antibody administered at 200mg by intravenous (IV) infusions every 3 weeks.
name: Pembrolizumab [KEYTRUDA®]
other_name: KEYTRUDA®
type: Drug
Study arms:
design_group_description: Dose escalation with repeated administrations of BT-001 directly into tumor as a single agent, in patients with metastatic or advanced solid tumors.
design_group_title: Phase I, Part A - Dose escalation and safety of BT-001 alone
design_group_type: Experimental
design_group_description: Repeated administrations of BT-001 directly into tumor in combination with infusions of pembrolizumab in patients with metastatic or advanced soft tissue sarcoma (STS), Merkel cell carcinoma (MCC), melanoma, triple negative breast cancer (TNBC) or non-small cell lung cancer (NSCLC)..
design_group_title: Phase I, Part B - Safety of BT-001 in combination with pembrolizumab
design_group_type: Experimental
design_group_description: Repeated administrations of BT-001 directly into tumor in combination with infusions of pembrolizumab in several cohorts of patients with defined metastatic or advanced solid tumor conditions: soft tissue sarcoma, Merkel cell carcinoma, melanoma, triple negative breast cancer, non-small cell lung cancer.
design_group_title: Phase IIa - Expansion cohorts of BT-001 in combination with pembrolizumab
design_group_type: Experimental
Sponsor: Transgene SA
Collaborators: Merck Sharp & Dohme Corp.
BioInvent International AB
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: BT-001(Transgene)
lang: EN
Clinical trial NCT01037088: Effects of Vaporized Marijuana on Neuropathic Pain
Official title: CCRC: The Analgesic Effect of Vaporized Cannabis on Neuropathic Pain
Conditions: Neuropathic Pain
Reflex Sympathetic Dystrophy
Peripheral Neuropathy
Post-herpetic Neuralgia
Spinal Cord Injury
Multiple Sclerosis
Summary: This study theorized that a low dose of vaporized cannabis could alleviate nerve injury pain.
Interventions:
description: 3.53% THC by weight
name: Mild dose cannabis
other_name: marijuana
type: Drug
description: 1.29% THC by weight
name: Low dose cannabis
other_name: marijuana
type: Drug
description: 0.00% THC by weight
name: Cannabis
other_name: placebo marijuana
type: Drug
Study arms:
design_group_description: 3.53% THC by weight
design_group_title: Mild dose cannabis
design_group_type: Experimental
design_group_description: 1.29% THC by weight
design_group_title: Low dose cannabis
design_group_type: Experimental
design_group_description: placebo marijuana
design_group_title: Placebo cannabis
design_group_type: Placebo Comparator
Sponsor: University of California, Davis
Collaborators: Center for Medicinal Cannabis Research
Drug name mappings:
name: 屈大麻酚
lang: CN
name: Dronabinol
lang: EN
Clinical trial NCT03052933: Copanlisib and Gemcitabine in Relapsed/Refractory PTCL
Official title: Prospective, Multicenter, Open-labeled, Phase I/II Study of the Efficacy and Safety of Copanlisib (BAY 80-6946) and Gemcitabine Combination in Patients With Relapsed/Refractory Peripheral T-cell or NK/T-cell Lymphoma
Conditions: Mature T-Cell and NK-Cell Neoplasm
Summary: COPGEM (Copanlisib and Gemcitabine)chemotherapy regimen is proposed as the salvage treatment for relapsed or refractory peripheral T-cell or NK/T-cell lymphomas in this study protocol, which would be expected to be feasible and effective in this group of patients.
Copanlisib (BAY 80-6946), a highly selective and potent class-1 PI3K inhibitor with sub-nanomolar IC50s against PI3Kα and PI3Kδ, has demonstrated activity in relapsed/refractory, aggressive NHLs, suggesting an ORR of 50% for T-cell lymphomas.
Gemcitabine has demonstrated clinical antitumor activity against PTCLs including NK/T-cell lymphomas both as single-agent (ORR 30-50%) and in combination therapy, with limited extramedullary toxicities.
Considering the evidence of activity for both agents against PTCLs, the investigators propose that targeted therapy with copanlisib in combination with gemcitabine will exhibit early elimination of rapidly growing tumor cells and be a rational therapeutic modality for use in relapsed or refractory PTCLs, if the overlapping toxicities can be managed.
Interventions:
description: For phase I study, participants will receive copanlisib (in combination with gemcitabine) IV infusion at a dose of 45 mg or 60 mg on Days 1, 8, and 15 of each 28-day treatment cycle. During phase I study, participants will be treated at the level of 45 mg/dose (level+0), or 60 mg/dose (level+1) of copanlisib. Maximal tolerated dose will be determined by modified 3+3 design including level-1 dose de-escalation.<br/>For phase II study, copanlisib dose level, determined during phase I study, will be administered on Days 1, 8, and 15.<br/>Maximum 6 cycles of gemcitabine and copanlisib combination and subsequent copanlisib monotherapy in participants with ≥ SD to copanlisib and gemcitabine until maximum 12 cycles will be given for this study.
name: Copanlisib
type: Drug
description: For phase I/II study, participants will receive gemcitabine (in combination with copanlisib) IV infusion at fixed dose of 1,000 mg/m2 on Days 1 and 8 of each 28-day treatment cycle until maximum 6 cycles.
name: Gemcitabine
type: Drug
Study arms:
design_group_title: Copanlisib/gemcitabine
design_group_type: Experimental
Sponsor: Chonnam National University Hospital
Collaborators: Bayer AG
Drug name mappings:
name: 盐酸可泮利塞
lang: CN
name: Copanlisib dihydrochloride
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 NCT00369447: A Study of Nimotuzumab in Combination With External Radiotherapy in Non-Small Cell Lung Cancer
Official title: A Phase I-II Clinical Study of Nimotuzumab (TheraCIM h-R3) in Combination With External Radiotherapy in Stage IIB, III and IV NSCLC
Conditions: Non-small-cell Lung Cancer
Summary: This is a Phase I-II study designed to investigate nimotuzumab (TheraCIM h-R3) in combination with external radiation in patients with non-small cell lung cancer. The purpose of the Phase I portion of the study is to evaluate the safety and feasibility of the administration of nimotuzumab with palliative radiation in patients who are unsuitable for radical therapy and to select the optimal dose for the Phase II component of the study. The primary objective for the Phase II portion of the study is to examine the efficacy of this combination treatment.
The Phase I component of this study has been completed. The Phase II is now closed to recruitment.
Interventions:
description: Radiotherapy for first 2 weeks, 10 daily fractions of 30Gy 2 additional fractions to be added if desirable
name: External radiotherapy
type: Procedure
description: weekly dose until disease progression
name: nimotuzumab
type: Biological
Study arms:
design_group_description: 200 mg dose
design_group_title: 1
design_group_type: Experimental
design_group_title: 2
design_group_type: Placebo Comparator
Sponsor: YM BioSciences, Inc.
Collaborators: CIMYM Biosciences, Inc.
Drug name mappings:
name: 尼妥珠单抗
lang: CN
name: Nimotuzumab
lang: EN
Clinical trial NCT02751255: Daratumumab in Combination With ATRA
Official title: A Phase 1 and Phase 2 Study of Daratumumab in Combination With All-trans Retinoic Acid in Relapsed/Refractory Multiple Myeloma
Conditions: Multiple Myeloma
Summary: Multiple myeloma (MM) patients who develop bortezomib and lenalidomide-resistant disease have a very poor survival of only a median of 9 months, indicating that new agents are urgently needed. Recent studies have shown that daratumumab as a single agent is effective and well tolerated in these heavily pretreated MM patients. However, approximately 60% of patients do not achieve a partial response, and ultimately all patients will develop progressive disease during daratumumab therapy.
The investigators have demonstrated that levels of the target antigen CD38, and expression levels of the complement inhibitory proteins CD55 and CD59 determine the susceptibility of the MM cells towards daratumumab. In addition, MM cells have lower CD38 expression levels and higher levels of CD55/CD59 at the time of progression. Importantly, all-trans retinoic acid (ATRA) upregulates CD38 levels and downregulates CD55/CD59 levels on MM cells, both in daratumumab naïve cells and in cells that are resistant to daratumumab because of previous exposure to this drug. These alterations in expression explain the strong synergy between ATRA and daratumumab, both in MM cells derived from daratumumab naïve patients and from patients with daratumumab-refractory disease.
These data form the preclinical rationale for clinical evaluation of ATRA and daratumumab in MM patients.
Interventions:
description: Phase 1 and 2: daratumumab 16 mg/kg, first 8 infusions are given weekly, then 8 infusions every 3 weeks, then every 4 weeks until progression Phase 1: ATRA 15, 30, or 45 mg/m2/day for 3 days. Phase 2: ATRA will be administered twice daily as an oral formulation at the MTD dose, or if no MTD is reached, at the dose of 45 mg/m2/day for 3 days. The first administration of ATRA will be given in the morning, two days before the scheduled daratumumab infusion. The last administration of ATRA will be given in the evening of the day that daratumumab was administered (days -2, -1, and 0; day 0 is the day of daratumumab infusion).
name: all-trans retinoic acid (ATRA)
other_name: ATRA
type: Drug
Study arms:
design_group_description: In part A of the study patients will be treated with daratumumab as a single agent. In case patients have progressive disease after cycle 1, or in case patients achieve less than minimal response after cycle 2, or patients achieve less than PR after cycle 3, or in case patients experience progression during daratumumab therapy after having obtained a response, then ATRA will be added to daratumumab (part B).
design_group_title: daratumumab--> daratumumab + ATRA
design_group_type: Experimental
Sponsor: Stichting Onderzoek Cancer Center Amsterdam
Collaborators: Vejle Hospital
Erasmus Universitair Medisch Centrum Rotterdam
University Medical Center of Utrecht
University of Turin
Drug name mappings:
name: 维A酸
lang: CN
name: Tretinoin
lang: EN
name: トレチノイン
lang: JP
Clinical trial NCT02602483: Exploratory Study To Assess the Efficacy and Safety of a Triple Combination for Acute Pain Treatment in Patients With Temporomandibular Joint Disorders (TMJD).
Official title: Randomized, Double Blind, Placebo Controlled Exploratory Study To Assess the Efficacy and Safety of a Triple Combination of Ibuprofen+Mg+Ascorbic Acid for Acute Pain Treatment in Temporomandibular Join Disorder (TMJD) Patients
Conditions: Temporomandibular Joint Disorders
Summary: The objetive of this study is to explore the efficacy and safety of a triple combination of ibuprofen, magnesium and ascorbic acid for acute pain treatment in TMJD patients
Interventions:
name: Ibuprofen
type: Drug
name: Magnesium
type: Drug
name: Ascorbic Acid
type: Drug
name: Placebo
type: Drug
Study arms:
design_group_description: Powder for oral administration
design_group_title: Triple combination
design_group_type: Experimental
design_group_description: Powder for oral administration
design_group_title: Ibuprofen
design_group_type: Active Comparator
design_group_description: Powder for oral administration
design_group_title: Magnesium + ascorbic acid
design_group_type: Active Comparator
design_group_description: Powder for oral administration
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: Spherium Biomed SL
Collaborators: Hospital Universitario La Fe
Universitat Internacional de Catalunya
Drug name mappings:
name: 维生素C
lang: CN
name: Ascorbic Acid
lang: EN
name: アスコルビン酸
lang: JP
name: 布洛芬
lang: CN
name: Ibuprofen
lang: EN
name: イブプロフェン
lang: JP
Clinical trial NCT03617328: Vaccination With 6MHP, With or Without Systemic CDX-1127, in Patients With Stage II-IV Melanoma
Official title: Evaluation of Safety and Durable Immunogenicity of Melanoma Vaccination, With or Without Systemic CDX-1127, in Patients With Stage II-IV Melanoma
Conditions: Melanoma
Summary: This study evaluates whether it is safe to administer a peptide vaccine (6MHP) with adjuvants and the CDX-1127 monoclonal antibody, and whether the adjuvants and the CDX-1127 monoclonal antibody boost immune responses to the vaccine. In this study, the adjuvants are Montanide ISA-51 and polyICLC. The investigators will monitor these effects by performing tests in the laboratory on participants' blood and tissue from a vaccine site.
Interventions:
description: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides
name: 6MHP
other_name: 6 melanoma helper peptide vaccine
type: Biological
description: Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant
name: Montanide ISA-51
type: Drug
description: polyICLC, local adjuvant
name: polyICLC
type: Drug
description: CDX-1127, anti-CD27 monoclonal antibody
name: CDX-1127
other_name: Varlilumab
type: Drug
Study arms:
design_group_description: 200 mcg of 6MHP plus 0.9 mg of polyICLC emulsified in Montanide ISA-51 adjuvant will be administered subcutaneously on days 1, 8, 15, and 36. 200 mcg of 6MHP in Montanide ISA-51 adjuvant (without polyICLC) will be administered subcutaneously/intradermally on day 176. CDX-1127 (3mg/kg) will be administered intravenously on days 1, 36, and 78.
design_group_title: Arm A: 6MHP/Montanide ISA-51 + polyICLC + CDX-1127
design_group_type: Experimental
design_group_description: 200 mcg of 6MHP plus 0.9 mg of polyICLC emulsified in Montanide ISA-51 adjuvant will be administered subcutaneously on days 1, 8, 15, and 36. 200 mcg of 6MHP in Montanide ISA-51 adjuvant (without polyICLC) will be administered subcutaneously/intradermally on day 176.
design_group_title: Arm B: 6MHP/Montanide ISA-51 + polyICLC
design_group_type: Experimental
Sponsor: University of Virginia
Collaborators: Celldex Therapeutics, Inc.
Drug name mappings:
name: 聚肌胞
lang: CN
name: Poly ICLC
lang: EN
name: 瓦利鲁单抗
lang: CN
name: Varlilumab
lang: EN
name: 6-melanoma helper peptide vaccine(University of Virginia)
lang: EN
Clinical trial NCT02074046: Safety Study of Cancer Stem Cell Vaccine to Treat Pancreatic Cancer
Official title: Study of Cancer Stem Cell Vaccine That as a Specific Antigen in Metastatic Adenocarcinoma of the Pancreas
Conditions: Neoplasms, Pancreas
Summary: Most studies of cancer stem cells (CSC) involve the inoculation of cells from human tumors into immunosuppressed mice, preventing an assessment on the immunologic interactions and effects of CSCs. In this study, the investigators examined the vaccination effects produced by CSC-enriched populations from histologically distinct murine tumors after their inoculation into different syngeneic immunocompetent hosts. Enriched CSCs were immunogenic and more effective as an antigen source than unselected tumor cells in inducing protective antitumor immunity.Immune sera from CSC-vaccinated hosts contained high levels of IgG which bound to CSCs, resulting in CSC lysis in the presence of complement.CTLs generated from peripheral blood mononuclear cells or splenocytes harvested from CSC-vaccinated hosts were capable of killing CSCs in vitro. Mechanistic investigations established that CSC-primed antibodies and T cells were capable of selective targeting CSCs and conferring antitumor immunity.
Interventions:
name: cancer stem cell vaccine
type: Biological
Study arms:
design_group_description: The using dosage,frequency and duration of cancer stem cell vaccine are still undetermined.
design_group_title: non-cancer stem cell vaccine
design_group_type: Placebo Comparator
design_group_description: The using dosage,frequency and duration of cancer stem cell vaccine are still undetermined.
design_group_title: giving low dose vaccine
design_group_type: Experimental
design_group_description: The using dosage,frequency and duration of cancer stem cell vaccine are still undetermined.
design_group_title: giving middle dose vaccine
design_group_type: Experimental
design_group_description: The using dosage,frequency and duration of cancer stem cell vaccine are still undetermined.
design_group_title: giving high dose vaccine
design_group_type: Experimental
Sponsor: Fudan University Cancer Hospital
Collaborators: University of Michigan
Drug name mappings:
name: Cancer stem cell vaccine(Fuda Cancer Hospital)
lang: EN
Clinical trial NCT00385047: A Study to Determine Whether 2 Investigational Malaria Vaccines Are Safe, Protective Against Malaria in Adults
Official title: Phase I/IIa Study of the Safety, Immunogenicity and Preliminary Efficacy After Sporozoite Challenge of FMP2.1/AS01B and FMP2.1/AS02A Candidate Malaria Vaccines Administered Intramuscularly at Months 0, 1, and 2 in Malaria-naive Adults Living in the United States
Conditions: Malaria
Summary: The purpose of this study is to determine whether 2 investigational malaria vaccines are safe as well as protective against malaria in adults living in the United States
Interventions:
name: Group A FMP2.1/AS01B
other_name: FMP 2.1 50 μg FMP2.1/AS01B
type: Biological
name: Group B FMP2.1/AS02A
other_name: FMP 2.1 50 μg FMP2.1/AS02A
type: Biological
Study arms:
design_group_description: FMP 2.1 50 μg FMP2.1/AS01B
design_group_title: Group A
design_group_type: Experimental
design_group_description: FMP 2.1 50 μg FMP2.1/AS02A
design_group_title: Group B
design_group_type: Experimental
Sponsor: U S Army Medical Research & Development Command
Collaborators: Path Malaria Vaccine Initiative
GSK Plc
Drug name mappings:
name: FMP2.1/AS01B
lang: EN
name: FMP 2.1 malaria vaccine(Walter Reed Army Institute of Research)
lang: EN
Clinical trial NCT00681252: Histocompatibility Leukocyte Antigen (HLA)-A*0201 Restricted Peptide Vaccine Therapy in Patients With Gastric Cancer
Official title: Phase I/II Study of Multiple-Vaccine Therapy Using Epitope Peptide Restricted to HLA-A*0201 in Treating Patients With Refractory Gastric Cancer
Conditions: Gastric Cancer
Summary: The purpose of this study is to evaluate the safety and time to progression of HLA-A*0201 restricted epitope peptides URLC10, VEGFR1 and VEGFR2 emulsified with Montanide ISA 51.
Interventions:
description: Patients will be vaccinated twice a week for 8 weeks. On each vaccination day, the URLC10 peptide (1mg), VEGFR1 peptide (1mg) and VEGFR2 peptide (1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection in combination with S-1 chemotherapy.
name: URLC10, VEGFR1 and VEGFR2
type: Biological
Study arms:
design_group_title: A
design_group_type: Experimental
Sponsor: University of Tokyo
Collaborators: University of Tokyo
Drug name mappings:
name: HLA-A*0201 Restricted Peptide Vaccine(University of Tokyo)
lang: EN
Clinical trial NCT00630396: Study of a Neuroprotective Drug to Limit the Extent of Damage From an Ischemic Stroke
Official title: Minocycline to Improve Neurologic Outcome in Stroke (MINOS)
Conditions: Stroke, Acute
Summary: The primary aim of this study is to find out which of 4 different doses of minocycline are safe and well tolerated so that we will know the optimal dose to test in future patients.
Interventions:
description: Dose level 1 = 3mg/kg intravenous (IV) initial dose, followed by 1.5mg/kg every 12 hours times 5 more doses.<br/>Dose level 2 = 4.5mg/kg intravenous (IV) initial dose, followed by 2.25mg/kg every 12 hours times 5 more doses.<br/>Dose level 3 = 6 mg/kg intravenous (IV) initial dose, followed by 3 mg/kg every 12 hours times 5 more doses.<br/>Dose level 4 = 10 mg/kg intravenous (IV) initial dose, followed by 5 mg/kg every 12 hours times 5 more doses
name: Minocycline
other_name: Minomycin
Minocycline hydrochloride
Minocycline hydrochloride injection
Minomycin Intravenous (for drip use)
Minomycin Intravenous
MINO
type: Drug
Study arms:
Sponsor: Augusta University
Collaborators: National Institute of Neurological Disorders & Stroke
University of Kentucky
Oregon Health & Science University
Drug name mappings:
name: 盐酸米诺环素
lang: CN
name: Minocycline Hydrochloride
lang: EN
name: ミノサイクリン塩酸塩
lang: JP