PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT05672342: Phytocannabinoids for the Treatment of Chronic Chemotherapy-Induced Peripheral Neuropathy in Breast and Colon Cancer Survivors
Official title: A Pilot Study to Evaluate the Benefits of Phytocannabinoids for the Treatment of Chronic Chemotherapy-Induced Peripheral Neuropathy
Conditions: Breast Carcinoma
Chemotherapy-Induced Peripheral Neuropathy
Colon Carcinoma
Summary: This clinical trial tests how well phytocannabinoids (cannabidiol [CBD] and tetrahydrocannbinol [THC]) work in reducing chronic chemotherapy-induced peripheral neuropathy (CIPN) in breast and colon cancer survivors. Neuropathy is the most common neurological symptom reported by cancer patients due to treatment. A variety of pharmacologic treatments have been evaluated to alleviate CIPN symptoms; however, no definitive treatment has been found to successfully treat all the symptoms of CIPN. Therefore, investigators continue to seek other possible treatment options including cannabis. Phytocannabinoids may be a particularly useful intervention for cancer patients given the limited effective treatments for CIPN. In addition, cannabis-based medicines have become tremendously popular as both cancer patients and clinicians are seeking therapies with fewer potential risks of dependency and other side effects. This trial is being done to provide cancer patients and clinicians with reliable information to help guide their use of phytocannabinoids to manage the tremendous distress and pain experienced by many cancer patients, which impacts their long-term quality of life.
Interventions:
description: Given PO
name: Cannabidiol
other_name: CBD
CBD Oil
Epidiolex
GWP42003-P
type: Drug
description: Given PO
name: Delta-8-Tetrahydrocannabinol
other_name: .DELTA.8-TETRAHYDROCANNABINOL
delta-8-THC
type: Drug
description: Given PO
name: Placebo Administration
type: Drug
description: Ancillary studies
name: Questionnaire Administration
type: Other
Study arms:
design_group_description: Patients receive CBD PO on study.
design_group_title: Arm I (CBD)
design_group_type: Experimental
design_group_description: Patients receive CBD PO + THC PO on study.
design_group_title: Arm II (CBD + THC)
design_group_type: Experimental
design_group_description: Patients receive placebo PO on study.
design_group_title: Arm III (placebo)
design_group_type: Placebo Comparator
Sponsor: City of Hope National Medical Center
Collaborators: National Cancer Institute
Drug name mappings:
name: 大麻二酚
lang: CN
name: Cannabidiol
lang: EN
name: Delta-8-THC
lang: EN
Clinical trial NCT05076513: Trial of Niraparib in Participants With Newly-diagnosed Glioblastoma and Recurrent Glioma
Official title: A Phase 0 'Trigger' Trial of Niraparib in Newly-diagnosed Glioblastoma and Recurrent IDH1/2(+) ATRX Mutant Glioma
Conditions: Glioblastoma
Glioblastoma Multiforme
Glioma
GBM
Glioma, Malignant
Glioblastoma Multiforme of Brain
Summary: This is an open-label, multi-center Phase 0 study with an expansion phase that will enroll up to 24 participants with newly-diagnosed glioblastoma and up to 18 recurrent glioma participants with IDH mutation and ATRX loss. The trial will be composed of a Phase 0 component (subdivided into Arm A and B) and a therapeutic expansion phase. Patients with tumors demonstrating a positive PK Response (in Arm A) or a positive PD Response (in Arm B) of the Phase 0 component of the study will graduate to a therapeutic expansion phase that combines therapeutic dosing of niraparib plus standard-of-care fractionated radiotherapy (in Arm A) or niraparib monotherapy (in Arm B) until progression of disease.
Interventions:
description: In Phase 0, 300mg administered orally QD for 4 days prior to resection.<br/>In the Expansion cohort/Maintenance phase, niraparib will be administered as described below:<br/>* For patients weighing <77 kg (<170 lbs) OR with a platelet count <150,000/mcL, the recommended dosage is 200 mg taken orally once daily.<br/>* For patients weighing ≥77 kg (≥170 lbs) AND a platelet count ≥150,000/ mcL, the recommended dosage is 300 mg taken orally once daily.
name: Niraparib
other_name: Zejula
type: Drug
description: Participants in Arm A who move onto the Expansion cohort will receive 6-7 weeks of radiation therapy per standard of care.
name: Radiation therapy
type: Radiation
Study arms:
design_group_description: Participants undergoing resection for a presumed newly-diagnosed glioblastoma (WHO grade 4) will be treated with niraparib for 4 days prior to surgical resection. Participants who proceed to the therapeutic expansion phase of this study will receive niraparib in combination with radiation (60 Gy over 6-7 weeks, as per standard of care). Following radiotherapy, eligible study participants may receive niraparib maintenance treatment.
design_group_title: Arm A: Presumed Newly-Diagnosed glioblastoma
design_group_type: Experimental
design_group_description: Participants undergoing resection of a recurrent WHO Grade II, III, or IV glioma with IDH1 or IDH2 mutation and ATRX loss will be treated with niraparib for 4 days prior to a planned surgical resection. Participants who proceed to the Expansion cohort will receive niraparib in 28d cycles after surgery.
design_group_title: Arm B: Recurrent Glioma (Grades II-IV)
design_group_type: Experimental
Sponsor: St. Joseph's Medical Center, Inc.
Collaborators: The University of California, San Francisco
Barrow Neurological Institute
GSK Plc
Drug name mappings:
name: 甲苯磺酸尼拉帕利
lang: CN
name: Niraparib Tosylate
lang: EN
name: ニラパリブトシル酸塩水和物
lang: JP
Clinical trial NCT05280782: Development and Translation of Generator-Produced PET Tracer for Myocardial Perfusion Imaging-Dosimetry Group
Official title: Development and Translation of Generator-Produced PET Tracer for Myocardial Perfusion Imaging
Conditions: Coronary Artery Disease
Summary: This study is a single center, early phase 1 clinical imaging study designed to assess the dosimetry of 68Ga-Galmydar for PET/CT imaging.
Interventions:
description: Single intravenous injection of the PET radiotracer 68Ga-Galmydar.
name: Ga-68 Galmydar
other_name: IND 157468
type: Drug
Study arms:
design_group_description: Normal Volunteers will receive a single intravenous injection of 8 mCi ± 20% (6.4-9.6 mCi) of the PET radiotracer 68Ga-Galmydar. They will undergo whole-body PET/CT imaging at three-time points, immediately post [68Ga]Galmydar injection, and at 2 hours and 4 hours after injection. Serum chemistries, complete blood count, EKG, vital signs, and physical examination will performed before injection and at the completion of the examinations.
design_group_title: Dosimetry Group
design_group_type: Experimental
Sponsor: Washington University School of Medicine
Collaborators: National Heart, Lung & Blood Institute
National Institutes of Health
Drug name mappings:
name: Ga-68 Galmydar
lang: EN
Clinical trial NCT04231435: Influence of Fedratinib on the Pharmacokinetics of the Transporter Probe Substrates Digoxin, Rosuvastatin, and Metformin
Official title: A Phase 1, Open-label Study to Evaluate the Influence of Fedratinib on the Pharmacokinetics of Transporter Probe Substrates (Digoxin, Rosuvastatin, and Metformin) in Healthy Adult Subjects
Conditions: Healthy Volunteers
Summary: This is a nonrandomized, fixed-sequence, open-label study to evaluate the effect of a single dose of fedratinib on the PK, safety, and tolerability of single doses of digoxin, rosuvastatin, and metformin in healthy subjects. The subjects will participate as follows:
* Screening phase
* Treatment phase (includes baseline)
* Follow-up telephone call Subjects will be screened for eligibility during the screening phase. Subjects who meet all inclusion criteria and none of the exclusion criteria will return to the clinical site on Day -1 for protocol-specified assessments, and will be domiciled at the clinical site from Day -1 through the morning of Day 22.
During the study, blood samples will be collected at prespecified times for PK and PD. Urine samples will be collected at prespecified times for urinary PK evaluation of metformin. Subject safety will be monitored throughout the study.
Interventions:
description: Oral
name: Fedratinib
type: Drug
description: Oral
name: Digoxin
type: Drug
description: Oral
name: Rosuvastatin
type: Drug
description: Oral
name: Metformin
type: Drug
Study arms:
design_group_description: All subjects will receive the following oral doses of IP following an overnight fast in the fixed-sequence below:<br/>* Day 1 (Period 1): 1 × 0.25-mg digoxin tablet, 1 × 10-mg rosuvastatin tablet, and 1 × 1000-mg metformin tablet.<br/>* Day 7 (Period 2): 6 × 100-mg fedratinib capsules PLUS (after approximately 1 hour from the time of fedratinib administration) 1 × 0.25 mg digoxin tablet, 1 × 10-mg rosuvastatin tablet, and 1 × 1000-mg metformin tablet.
design_group_title: Treatment Administration
design_group_type: Experimental
Sponsor: Celgene Corp.
Collaborators: Impact Biomedicines, Inc.
Drug name mappings:
name: 瑞舒伐他汀钙
lang: CN
name: Rosuvastatin Calcium
lang: EN
name: ロスバスタチンカルシウム
lang: JP
name: 菲卓替尼
lang: CN
name: Fedratinib Hydrochloride
lang: EN
name: フェドラチニブ塩酸塩水和物
lang: JP
name: 地高辛
lang: CN
name: Digoxin
lang: EN
name: ジゴキシン
lang: JP
name: 盐酸二甲双胍
lang: CN
name: Metformin Hydrochloride
lang: EN
name: メトホルミン塩酸塩
lang: JP
Clinical trial NCT05497778: A Phase 1b Study of Gemcitabine and Nab-paclitaxel in Combination With IM156 in Patients With Advanced Pancreatic Cancer.
Official title: A Phase 1b Study of Gemcitabine and Nab-paclitaxel in Combination With IM156 in Patients With Advanced Pancreatic Cancer.
Conditions: Pancreas Cancer
Summary: To learn if adding a new medication, IM156, to treatment with gemcitabine and nab-paclitaxel is safe and tolerable. The ability of this combination to improve the success of this treatment for these patients will also be studied.
Interventions:
description: Given by IV (vein)
name: Gemcitabine
other_name: Gemcitabine Hydrochloride
GemzarÂ®
type: Drug
description: Given by IV (vein)
name: Nab paclitaxel
other_name: Abraxane, ABI-007
Paclitaxel (protein-bound)
type: Drug
description: Given by PO
name: IM156
type: Drug
Study arms:
design_group_description: In the Dose Escalation Phase of the study, we will identify the RPD2 of IM156. Subsequently, we will evaluate IM156 at the RP2D (established in the Dose Expansion Phase) and gemcitabine + nab-paclitaxel in the Dose Expansion Phase.
design_group_title: Dose Escalation Phase followed by a Dose Expansion Phase
design_group_type: Experimental
Sponsor: The University of Texas MD Anderson Cancer Center
Collaborators: National Cancer Institute
Drug name mappings:
name: 白蛋白结合型紫杉醇
lang: CN
name: Albumin-Bound Paclitaxel
lang: EN
name: パクリタキセル(JAN)
lang: JP
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
name: Lixumistat
lang: EN
Clinical trial NCT02876510: ACTolog in Patients With Solid Cancers
Official title: Phase I Adoptive Cellular Therapy Trial With Endogenous CD8+ T Cells (ACTolog® IMA101) Alone or in Combination With Atezolizumab in Patients With Relapsed and/or Refractory Solid Cancers
Conditions: Cancer
Solid Tumor
Summary: The study purpose is to learn about the safety and tolerability of IMA101 alone (Cohort 1) or in combination with atezolizumab (Cohort 2) in patients with advanced solid cancers that express pre-defined Immatics tumor targets.
Interventions:
description: Fludarabine infusion
name: Fludarabine
other_name: Fludarabine monophosphate
type: Drug
description: Cyclophosphamide infusion
name: Cyclophosphamide
other_name: Cytoxan
type: Drug
description: i.v. infusion of IMA101 product(s).
name: IMA101 product
type: Biological
description: Low dose IL-2 Infusion for two weeks
name: Recombinant human interleukin-2
other_name: Aldesleukin
Proleukin
type: Biological
description: IMADetect is a laboratory test that is part of screening used to determine the mRNA expression of ACTolog target source genes in tumor biopsies from solid tumors. IMADetect is intended for investigational use only.
name: IMADetect
type: Diagnostic Test
description: Atezolizumab infusion will be given no earlier than 3 weeks post IMA101 infusion and after hematologic recovery is achieved, thereafter every 3 weeks until 1 year after IMA101 infusion.
name: Atezolizumab
other_name: Tecentriq
type: Drug
Study arms:
design_group_description: * Pre-conditioning by non-myeloablative chemotherapy with Fludarabine and Cyclophosphamide<br/>* Infusion of the IMA101 T-cell product(s)<br/>* Post-infusion administration of low-dose recombinant human interleukin-2
design_group_title: IMA101 product only (Cohort 1)
design_group_type: Experimental
design_group_description: * Pre-conditioning by non-myeloablative chemotherapy with Fludarabine and Cyclophosphamide<br/>* Infusion of the IMA101 T-cell product(s)<br/>* Post-infusion administration of low-dose recombinant human interleukin-2<br/>* Treatment with atezolizumab every 3 weeks after IMA101 product infusion, for 1 year
design_group_title: IMA101 product + atezolizumab (Cohort 2)
design_group_type: Experimental
Sponsor: Immatics US, Inc.
Collaborators: The University of Texas MD Anderson Cancer Center
Drug name mappings:
name: 磷酸氟达拉滨
lang: CN
name: Fludarabine Phosphate
lang: EN
name: フルダラビンリン酸エステル
lang: JP
name: 环磷酰胺
lang: CN
name: Cyclophosphamide
lang: EN
name: シクロホスファミド水和物
lang: JP
name: 阿替利珠单抗
lang: CN
name: Atezolizumab
lang: EN
name: アテゾリズマブ（遺伝子組換え）
lang: JP
name: IMA-101
lang: EN
Clinical trial NCT01032148: Study of LBH589, A Deacetylase Inhibitor in Patients With Recurrent or Refractory Hodgkin or Non-Hodgkin's Lymphoma
Official title: Phase I Study of LBH589, A Novel Oral Deacetylase Inhibitor in Patients With Recurrent or Refractory Hodgkin or Non-Hodgkin's Lymphoma
Conditions: Hodgkin's Lymphoma
Non-Hodgkin's Lymphoma
Summary: The purpose of this study is to find out the effects of a drug called LBH589 when given to people with recurrent or refractory Hodgkin or Non-Hodgkin's lymphoma. The safety of this drug will also be studied. The participants' physical state, changes in the size of the tumor, or state of Hodgkin or non-Hodgkin's Lymphoma, and laboratory findings taken while on-study will help the researchers decide if LBH589 is safe and effective.
Interventions:
description: LBH589 will be administered orally as once daily dose of 20 mg po q M, W, F on a q28 day cycle.
name: LBH589
type: Drug
Study arms:
design_group_description: LBH589 administered orally as once daily dose of 20 mg po q M, W, F on a q 28 day cycle, escalating to a maximum dase of 60 mg
design_group_title: LBH589
design_group_type: Experimental
Sponsor: Roswell Park Comprehensive Cancer Center
Collaborators: Novartis AG
Drug name mappings:
name: 乳酸帕比司他
lang: CN
name: Panobinostat lactate
lang: EN
name: パノビノスタット乳酸塩
lang: JP
Clinical trial NCT06329206: A Phase Ia/Ib Study of GH2616 Tablet in Subjects With Advanced Solid Tumors
Official title: A Phase Ia/Ib Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Antitumor Activity of GH2616 Tablet in Subjects With Advanced Solid Tumors
Conditions: Advanced Solid Tumors
Summary: This is a Phase Ia/Ib, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, pharmacodynamics (PD) and preliminary efficacy of GH2616 Tablet in subjects with advanced solid tumors. It includes two parts: the dose escalation study (Phase Ia) and the dose expansion study (Phase Ib).
Interventions:
description: GH2616 tablets will be given orally
name: GH2616 Tablets
type: Drug
Study arms:
design_group_description: Dose Escalation: Dose Escalation Cohorts Subjects will be enrolled at various doses of GH2616. These Dose Escalation Cohorts will be utilized to To determine the maximum tolerated dose (MTD) and/or recommended dose for expansion(s) (RDEs) for Dose Expansion. Dose Escalation: Backfill Cohorts 2 <br/> 3 dose cohorts are allowed to be backfilled.These Backfill Cohorts will be utilized to build additional data to support selection of doses and/or tumor types for further study in Dose Expansion.<br/>Dose Expansion: Expansion Cohorts 2 <br/> 3 dose cohorts are planned.Subjects with advanced solid tumors harboring TP53 mutation and whole genome duplication (WGD+) will be enrolled.These Cohorts will be utilized to to determine the recommended Phase II dose (RP2D) of GH2616 Tablet.
design_group_title: GH2616 GROUP
design_group_type: Experimental
Sponsor: Suzhou Genhouse Bio Co., Ltd.
Collaborators: The First Affiliated Hospital of Zhengzhou University
Zhejiang Cancer Hospital
Henan Cancer Hospital
Hubei Cancer Hospital
Drug name mappings:
name: GH-2616
lang: EN
Clinical trial NCT04405167: Tasquinimod for the Treatment of Relapsed or Refractory Myeloma
Official title: Phase 1 Study of Tasquinimod Alone and in Combination With Standard Therapy for Relapsed or Refractory Myeloma
Conditions: Multiple Myeloma
Summary: This study is the first study of tasquinimod, an inhibitor of S100A9, in patients with multiple myeloma.
Interventions:
description: Tasquinimod will be supplied as oral capsules.
name: Tasquinimod
type: Drug
description: IRd chemotherapy with ixazomib, lenalidomide, and dexamethasone
name: IRd chemotherapy
other_name: Ixazomib, Lenalidomide, Dexamethasone
type: Drug
Study arms:
design_group_description: There are up to 5 planned dose levels, with 3 de-escalation dose levels available in case dose level 1 is determined to exceed the MTD. This arm will enroll 15-30 subjects if all dose levels are explored.
design_group_title: A1: Tasquinimod single agent dose escalation
design_group_type: Experimental
design_group_description: Additional subjects will enroll in arm A2 at the MTD and optimal schedule, so that 12 subjects total who are evaluable for response will have received the MTD/optimal schedule of single agent tasquinimod. Enrollment in arm A2 will not begin until enrollment in arm A1 has been completed and a single agent MTD/optimal schedule has been established.
design_group_title: A2: Tasquinimod single agent expansion
design_group_type: Experimental
design_group_description: Dose levels will be defined according to the same tasquinimod doses as in the single agent (Arm A1) dose escalation. Enrollment in arm B1 will not begin until enrollment in arm A1 has been completed and an MTD/optimal schedule has been established for single agent tasquinimod. Initial subjects in arm B1 will be enrolled at the lower of dose level 1 or one dose level below the single agent MTD . If this initial dose level is determined to exceed the combination MTD, further subjects will be enrolled at one dose level lower. Enrollment is not planned in arm B1 at doses higher than the single agent MTD. There are 9-12 planned subjects if all dose levels are explored.
design_group_title: B1: Tasquinimod+IRd dose escalation
design_group_type: Experimental
design_group_description: Additional subjects will enroll in arm B2 at the MTD and optimal schedule, so that 12 subjects total who are both evaluable for response and previously refractory to their most recent Imid/PI combination will have received the MTD/optimal schedule of tasquinimod in combination with ixazomib, lenalidomide, and dexamethasone. To facilitate rapid enrollment and gain more experience with the combination therapy, up to 12 additional subjects with triple-class refractory myeloma (who are not previously refractory to their most recent Imid/PI combination) may be enrolled in cohort B2. Enrollment in arm B2 will not begin until enrollment in arm B1 has been completed and a combination MTD/optimal schedule has been established.
design_group_title: B2: Tasquinimod+IRd expansion
design_group_type: Experimental
Sponsor: University of Pennsylvania
Collaborators: Active Biotech AB
Drug name mappings:
name: 他喹莫德
lang: CN
name: Tasquinimod
lang: EN
Clinical trial NCT00539617: Chemotherapy & Erlotinib in Treating Patients w/ Esophageal or Gastroesophageal Cancer That Cannot Be Removed by Surgery
Official title: A Single-Arm, Phase II Study of Tarceva Plus FOLFOX6 in Patients With Unresectable or Metastatic Cancer of Esophagus or Gastroesophageal Junction
Conditions: Esophageal Cancer
Summary: The purpose of this study is to test the safety and effectiveness of erlotinib and FOLFOX in patients with esophageal or gastro-esophageal cancer that cannot be removed by surgery.
Interventions:
description: Tarceva single agent therapy: 150 mg/day PO
name: Erlotinib
other_name: Tarceva
type: Drug
description: 5-FU bolus: 400 mg/m2 IV once every 2 weeks for 16 weeks 5-FU infusion: 2400 mg/m2 IV over 46-48 hours, once every 2 weeks for 16 weeks
name: 5-fluorouracil
other_name: 5-FU
Adrucil
type: Drug
description: 400 mg/m2 IV once every 2 weeks for 16 weeks
name: Leucovorin
other_name: Folinic acid
type: Drug
description: 85 mg/m2 IV once every 2 weeks for 16 weeks
name: Oxaliplatin
other_name: Eloxatin
type: Drug
Study arms:
design_group_description: COMBINATION THERAPY PHASE: Patients receive erlotinib hydrochloride orally (PO) once daily (QD) on days 1-56. Patients also receive FOLFOX6 therapy comprising oxaliplatin intravenously (IV) over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46-48 hours on days 1, 15, 29, and 43. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity. Patients with stable disease or no evidence of disease after course 2 or subsequent courses continue on to maintenance phase.<br/>MAINTENANCE PHASE: Patients receive erlotinib hydrochloride PO QD on days 1-42. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
design_group_title: Tarceva and FOLFOX
design_group_type: Experimental
Sponsor: The University of California, San Francisco
Collaborators: Genentech, Inc.
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: 亚叶酸钙
lang: CN
name: Leucovorin Calcium
lang: EN
name: ホリナートカルシウム
lang: JP
name: 奥沙利铂
lang: CN
name: Oxaliplatin
lang: EN
name: オキサリプラチン
lang: JP
name: 氟尿嘧啶
lang: CN
name: Fluorouracil
lang: EN
name: フルオロウラシル
lang: JP
Clinical trial NCT01822210: Botulinum Toxin for Stomach Cancer Treatment
Official title: Botulinum Toxin (BOTOX) for Stomach Cancer Treatment
Conditions: Stomach Neoplasms
Summary: Preclinical studies at our institution, using a genetic mouse model of gastric cancer, strongly suggest that innervation of the stomach wall is required not only for the development, but also for the progression of gastric cancer, and that denervation of the stomach either by vagotomy or by injection of botulinum toxin (Botox®) in the stomach wall may represent an effective therapeutic intervention. New treatment options for inoperable cancer in the stomach are urgently needed, and local treatment with botulinum toxin seems to be an attractive possibility. In this pilot study Botox injections will be given by gastroscopy in both the tumor and the surrounding stomach wall. The purpose of the study is to obtain data needed to calculate sample size in a larger controlled trial.
Interventions:
description: injection by gastroscopy (100 Allergen units)
name: Botox
other_name: Botulinum toxin
type: Drug
Study arms:
design_group_description: Injection of Botox in the tumor and surrounding stomach wall.
design_group_title: Botox
design_group_type: Experimental
Sponsor: St. Olavs Hospital HF
Collaborators: Norwegian University of Science & Technology
Drug name mappings:
name: A型肉毒毒素
lang: CN
name: Onabotulinumtoxin A
lang: EN
name: A 型ボツリヌス毒素
lang: JP