ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00703326
Conditions: Breast Cancer
Keywords: Metastatic breast cancer HER2 negative breast cancer locally recurrent breast cancer
Sponsor: Eli Lilly and Company
Start date: 2008-08-06; Completion date: 2020-11-19
Enrollment: 1144 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to compare the progression-free survival (PFS) of the drug combination ramucirumab plus docetaxel to placebo plus docetaxel in previously untreated participants with human epidermal growth factor receptor 2 (HER2)-negative, unresectable, locally-recurrent or metastatic breast cancer.

Detailed description:
Female participants at least 18 years of age with histologically or cytologically confirmed, human epidermal growth factor receptor 2 (HER2) negative breast adenocarcinoma that is metastatic or locally-recurrent and inoperable with curative intent will be randomized. Participants may not have received chemotherapy for metastatic or locally-recurrent, inoperable breast cancer.

It is anticipated that 1113 participants will be randomized with 371 participants in the docetaxel plus placebo arm and 742 participants in the docetaxel plus ramucirumab (IMC-1121B) arm. There will be approximately 250 centers in North and South America, Europe, Asia, Middle East, Africa, Australia, and New Zealand.

On Day 1 of each 21-day cycle, participants will receive docetaxel 75 mg/m² as a one-hour I.V. infusion followed by either ramucirumab (IMC-1121B) 10 mg/kg or placebo 10 mg/kg as a one-hour I.V. infusion. Each cycle is repeated every 21 days.

Treatment will continue until there is evidence of progressive disease, unacceptable toxicity, or other withdrawal criteria are met. Participants who discontinue study treatment with either ramucirumab (IMC-1121B) or placebo may continue to receive docetaxel.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: ramucirumab (IMC-1121B) intervention 2: docetaxel intervention 3: Placebo
Intervention descriptions: intervention 1: Ramucirumab (IMC-1121B) is administered at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle. intervention 2: Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle. intervention 3: Placebo comparator for ramucirumab (IMC-1121B) administered at a dose of 10 mg/kg as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.

Protocol documents:
Clinical trial NCT01969409
Conditions: Ambulatory IPF
Keywords: Lung Fibrosis
Sponsor: University of Alabama at Birmingham
Start date: 2014-01-01; Completion date: 2020-11-30
Enrollment: 58 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Recent research studies have suggested that proteins called antibodies that are produced by the immune system might be involved in the lung damage of idiopathic pulmonary fibrosis (IPF). Antibodies produced by the immune system normal help to fight infections by attacking bacteria and viruses without harming our own tissues. In patients with IPF, there is evidence that certain antibodies (called autoantibodies) attack the lung and contributes to the injury and scarring that occurs in IPF. Our recent studies have found that many IPF patients appear to have excessive autoantibody levels in blood and lungs that might make their disease worse.

Rituximab is a medication approved by the Food and Drug Administration (FDA) for the treatment of autoantibody diseases such as rheumatoid arthritis. Rituximab works by destroying B cells, a type of white blood cell, called a B-lymphocyte, which produce autoantibodies. In this research study, rituximab will be given into a vein to reduce the autoantibody levels that we believe might be contributing to the lung damage in IPF.

This study is being conducted to determine if rituximab provides beneficial effects for IPF patients by decreasing further lung injury.

Detailed description:
This is a double-blinded, Phase II trial in which 58 ambulatory IPF patients at any of four medical centers (University of Pittsburgh, University of Chicago, Geisinger Medical Center, and Temple University) will be randomized equally to 1. placebo or 2. two doses of rituximab 1 gm i.v., with a 14 day interval inbetween doses.

Subjects will be followed for 9 months.

Arms: arm 1: These subjects will receive i.v. placebo (5% dextrose in water) administered identically to the rituximab. arm 2: Rituximab i.v. given on two occasions, with 14 days between doses.
Interventions: intervention 1: Rituximab intervention 2: Placebo
Intervention descriptions: intervention 1: i.v. rituximab given on two occasions 14 days apart. intervention 2: Subjects randomized to placebo will receive two i.v. doses of 5% dextrose in water (D5W) in the same schedule as the rituximab subjects. The D5W and rituximab preparations will be indistinguishable.

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT01824823
Conditions: Head and Neck Squamous Cell Carcinoma
Keywords: afatinib head and neck squamous cell carcinoma
Sponsor: ECOG-ACRIN Cancer Research Group
Start date: 2014-06-30; Completion date: 2020-12-01
Enrollment: 3 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized phase II trial studies how well giving afatinib after chemoradiation and surgery works in treating patients with stage III-IV squamous cell carcinoma of the head and neck at high-risk of recurrence. Afatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. Examine disease-free survival (DFS) given afatinib/placebo adjuvant therapy in patients with viable tumors in lymph nodes after neck dissection for suspected residual disease after concurrent chemoradiation.

SECONDARY OBJECTIVES:

I. Evaluate the recurrence rate, recurrence patterns, development of second primary malignancies, overall survival (OS) and toxicity of afatinib/placebo.

II. Evaluate on-target inhibition by afatinib, and determine circulating deoxyribonucleic acid (DNA) as a biomarker of afatinib resistance.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM A: Patients receive afatinib orally (PO) once daily (QD) on days 1-28.

ARM B: Patients receive placebo PO QD on days 1-28.

In both Arms, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 1 year and then every 12 months for 2 years.

Arms: arm 1: Patients receive afatinib PO QD on days 1-28. arm 2: Patients receive placebo PO QD on days 1-28.
Interventions: intervention 1: afatinib intervention 2: placebo
Intervention descriptions: intervention 1: Given PO intervention 2: Given PO

Protocol documents:
Clinical trial NCT02465437
Conditions: Diffuse Cutaneous Systemic Sclerosis
Keywords: JBT-101, Lenabasum, Systemic Sclerosis
Sponsor: Corbus Pharmaceuticals Inc.
Start date: 2015-08-01; Completion date: 2020-12-11
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of JBT-101 in adult subjects with diffuse cutaneous systemic sclerosis.

Detailed description:
Part A of the study is an interventional, double-blind, randomized, placebo-control design will be used to test safety, tolerability, pharmacokinetics, and efficacy of JBT-101 in subjects ≥ 18 and ≤ 70 years of age with active diffuse cutaneous systemic sclerosis. The screening period is up to 28 days, with 84 days treatment period and 28 days follow-up off active treatment.

Part B of the study is an interventional, open-label design will be used. All subjects who complete dosing in Part A without permanent discontinuation of study drug and who pass repeat safety screening will be eligible for enrollment. The screening period is up to 28 days, with a 364 day treatment period and 28 day follow up after last dose of JBT-101.

Arms: arm 1: JBT-101 5 mg q am and placebo q pm on Days 1-28, then JBT-101 20 mg twice a day (bid) on Days 29-84. arm 2: JBT-101 20 mg q am and placebo q pm on Days 1-28, then JBT-101 20 mg bid on Days 29-84. arm 3: JBT-101 20 mg bid on Days 1-84. arm 4: Placebo bid on Days 1-84. arm 5: JBT-101 20 mg bid on Days 1-364
Interventions: intervention 1: JBT-101 intervention 2: Placebo intervention 3: Part B Open-Label Extension
Intervention descriptions: intervention 1: JBT-101 5 mg q am, 20 mg q am, or 20 mg bid on Days 1-28. JBT-101 20 mg bid on Days 29-84. intervention 2: Placebo q pm (with JBT-101 5 or 20 mg q AM) or placebo bid on Days 1-28. Placebo bid on Days 29-84. intervention 3: JBT-101 20mg bid on Days 1-364

Protocol documents:
Clinical trial NCT00700882
Conditions: Melanoma (Skin)
Keywords: stage IV melanoma acral melanoma mucosal melanoma vulvovaginal melanoma stage III melanoma
Sponsor: Eastern Cooperative Oncology Group
Start date: 2009-07-02; Completion date: 2020-12-28
Enrollment: 81 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well dasatinib works in treating patients with locally advanced or metastatic mucosal melanoma or acral melanoma.

Detailed description:
OBJECTIVES:

Primary

* To estimate the objective tumor response rate in patients with KIT-positive, unresectable, locally advanced or metastatic acral or mucosal melanoma treated with dasatinib monotherapy.

Secondary

* To estimate the response duration in patients treated with this drug.
* To estimate the progression-free survival of patients treated with this drug.
* To evaluate the safety profile of this drug in these patients.
* To evaluate the PDGFR expression and activation of Src family kinases in tumor samples and correlate these parameters with response to treatment.

OUTLINE: This is a multicenter study.

Patients receive oral dasatinib twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Tissue samples may be collected from some patients for correlative studies.

After completion of study therapy, patients are followed up periodically for up to 5 years.

Arms: arm 1: Patients receive oral dasatinib at 70 mg twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: dasatinib
Intervention descriptions: intervention 1: Patients receive oral dasatinib at 70 mg twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Protocol documents:
Clinical trial NCT01721746
Conditions: Unresectable or Metastatic Melanoma
Sponsor: Bristol-Myers Squibb
Start date: 2012-12-21; Completion date: 2020-12-29
Enrollment: 405 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to estimate the response rate and compare overall survival of patients taking BMS-936558 to those taking study physician's choice of either Dacarbazine or Carboplatin and Paclitaxel

Detailed description:

Arms: arm 1: BMS-936558 3 mg/kg solution for injection by intravenous (IV), every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends arm 2: Dacarbazine: 1000mg/m2, Powder for IV solution, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

Carboplatin: Area under the concentration-time curve (AUC) 6, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

Paclitaxel: 175 mg/ m2, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Interventions: intervention 1: BMS-936558 intervention 2: Dacarbazine intervention 3: Carboplatin intervention 4: Paclitaxel
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT03451071
Conditions: HPV-Related Malignancy
Sponsor: University of Alabama at Birmingham
Start date: 2019-04-29; Completion date: 2020-12-30
Enrollment: 195 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Human papillomavirus (HPV)-related cancers are on the rise in the United States. Furthermore, greater than 90% of cervical cancer cases are attributable to HPV, and cervical cancer disproportionately affects women of color in both incidence and mortality. Due to low HPV vaccine uptake in the US, innovative approaches to vaccinating vulnerable populations are necessary in order to maximize the cancer prevention potential of this vaccine. The puerperium is a time period when women are engaged in the healthcare system and have almost universal access to affordable health care. Two prior studies have shown that postpartum HPV vaccination is acceptable to patients, and high rates of vaccination were achieved in these primarily Hispanic populations. However, data show that the immune response in young women is less robust than in adolescents, and no studies have examined immunogenicity in postpartum women specifically. We propose an HPV vaccination pilot study in women who receive postpartum care at University of Alabama at Birmingham (UAB) hospital. We will examine the acceptability, uptake and immunogenicity of the vaccine in the postpartum setting.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Gardasil9
Intervention descriptions: intervention 1: Gardasil 9

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT03753763
Conditions: Multiple System Atrophy
Keywords: MSA, safinamide
Sponsor: Zambon SpA
Start date: 2019-10-29; Completion date: 2021-01-05
Enrollment: 49 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is a placebo controlled study, with two parallel arms, in which participants will be randomly assigned in a 2:1 ratio to receive either active (200 mg safinamide) or placebo in a double blind manner. Study population is patients diagnosed, with possible or probable parkinsonian variant of Multiple System Atrophy who are on a stable treatment of levodopa

Detailed description:
The overall design is a parallel group, placebo controlled, double blind study. The target population are participants diagnosed with possible or probable parkinsonian variant of Multiple System Atrophy who are on stable doses of levodopa.

Trial participation will be up to a maximum duration of 14 weeks and will comprise a screening period (up to 2 weeks), a 2-week run in period during which subjects will receive 1 tablet (either 100 mg safinamide or matching placebo), followed by a 10-week period, during which study participants will take 2 tablets of study medication (200 mg safinamide or placebo) once daily, taken in the morning in addition to their morning levodopa dose. A telephone follow-up call will be performed 2 weeks after the end of treatment.

Arms: arm 1: Safinamide methanesulfonate film-coated tablets once daily arm 2: Safinamide Methanesulfonate matching placebo film-coated tablets once daily
Interventions: intervention 1: Safinamide Methanesulfonate intervention 2: Safinamide Methanesulfonate matching placebo
Intervention descriptions: intervention 1: 100 mg (free base) intervention 2: 100 mg placebo

Protocol documents:
Prot_000.pdf: 
 
 
 
16. 
APPENDICES 
APPENDIX 16.1: 
STUDY INFORMATION 
APPENDIX 16.1.1: PROTOCOL AND PROTOCOL AMENDMENTS 
Summary of Changes for Protocol Amendment 01, 13 July 2020 ................................................. 2 
Protocol Amendment 01, Version 2.0, 13 July 2020 .................................................................... 10 
Protocol Administrative Letter #1, 09 August 2019 ..................................................................... 71 
Original Protocol, Version 1.0, 21 February 2019 ........................................................................ 75 
 































































































































































































































































SAP_001.pdf: 
APPENDIX 16.1.9: DOCUMENTATION OF STATISTICAL METHODS 
Statistical Analysis Plan, Version 2.0, 20 January 2021 ................................................................. 2 
Statistical Analysis Plan, Version 1.0, 13 November 2020 .......................................................... 22
Clinical trial NCT03303469
Conditions: Hepatocellular Carcinoma
Sponsor: University of Alabama at Birmingham
Start date: 2017-10-30; Completion date: 2021-01-06
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
\[18F\] FMISO Positron Emission Tomography (PET) to determine hypoxia in patients with HCC treated with TACE.

Detailed description:
This Phase II study will investigate the utility of \[18F\] FMISO in patients with hepatocellular carcinoma (HCC). This trial is designed to test the hypothesis that PET determined \[18F\]FMISO uptake will indicate tumor hypoxia in patients with HCC treated with trans-arterial chemo-embolization (TACE). We anticipate that \[18F\] FMISO PET/CT will advance our understanding of the role of hypoxia in HCC prior to treatment and that this knowledge will help design newer combination therapeutic trials for better treatment outcomes. \[18F\] FMISO PET/CT provides three parameters, tissue hypoxic volume (HV), maximum tissue to blood uptake ratio (T:Bmax) and tumor blood flow. Both pre-and post-therapy images will be examined to investigate changes in these parameters during the course of TACE treatment.

Arms: arm 1: FMISO imaging at baseline, post-TACE and post-SBRT
Interventions: intervention 1: FMISO intervention 2: FMISO intervention 3: FMISO
Intervention descriptions: intervention 1: FMISO PET/CT imaging at baseline intervention 2: FMISO PET/CT post TACE intervention 3: FMISO PET/CT post SBRT

Protocol documents:
Prot_SAP_001.pdf: 
Hypoxic Changes in Hepatocellular Carcinoma (HCC) 
Following Trans Arterial Chemo Embolization and 
Stereotactic Radiation: [18F]Fluoromisonidazole (FMISO) 
Imaging 
Study Protocol & Statistical Analysis Plan 
NCT03303469
July 30, 2020 
Janis O'Malley, M.D., Principal Investigator 
University of Alabama at Birmingham 
Birmingham, AL 35294
Clinical trial NCT01865747
Conditions: Renal Cell Carcinoma
Keywords: renal cell cancer kidney vascular endothelial growth factor receptor 2 (VEGFR2) tyrosine kinase inhibitor hepatocyte growth factor receptor protein (MET) von Hippel-Lindau gene
Sponsor: Exelixis
Start date: 2013-06-01; Completion date: 2021-01-15
Enrollment: 658 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effect of Cabozantinib (XL184) compared with Everolimus (Afinitor) on progression-free survival (PFS) and overall survival (OS) in subjects with advanced renal cell cancer that has progressed after prior VEGFR tyrosine kinase inhibitor therapy.

Detailed description:

Arms: arm 1: Cabozantinib (XL184) 60 mg tablet once daily. arm 2: Everolimus (Afinitor) 10 mg tablet once daily.
Interventions: intervention 1: Cabozantinib tablets intervention 2: Everolimus (Afinitor) tablets
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT04177680
Conditions: Hypertriglyceridemia
Sponsor: Matinas BioPharma Nanotechnologies, Inc.
Start date: 2020-06-03; Completion date: 2021-01-18
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Pharmacodynamic effects of MAT9001 compared to Vascepa in adults with hypertriglyceridemia

Detailed description:
An open-label, randomized, crossover study to assess the pharmacodynamic effects of MAT-9001, an omega-3 free fatty acid compared to Vascepa (icosapent ethyl) on triglycerides and other lipoprotein lipids in men and women with elevated triglycerides.

Arms: arm 1: 2g MAT9001 capsules twice daily with meals arm 2: 2g Vascepa capsules twice daily with meals
Interventions: intervention 1: Omega 3 pentaenoic acid intervention 2: icosapent ethyl
Intervention descriptions: intervention 1: Encapsulated omega-3 pentaenoic acid intervention 2: Encapsulated omega-3 acid ethyl esters

Protocol documents:
Prot_000.pdf: 

















































































































SAP_001.pdf:
Clinical trial NCT03436693
Conditions: Diabetic Nephropathy
Keywords: Diabetic Nephropathy Canagliflozin Canaglu Diabetes Mellitus, Type 2
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2018-02-15; Completion date: 2021-01-21
Enrollment: 308 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of Canagliflozin (TA-7284) in Japanese patients with Diabetic Nephropathy, compared with placebo

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Canagliflozin intervention 2: Placebo
Intervention descriptions: intervention 1: Canagliflozin 100mg orally once daily intervention 2: Placebo orally once daily

Protocol documents:
Prot_000.pdf: 































































































































































SAP_001.pdf:
Clinical trial NCT01896531
Conditions: Gastric Cancer
Sponsor: Genentech, Inc.
Start date: 2013-08-14; Completion date: 2021-01-26
Enrollment: 153 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy of ipatasertib in combination with oxaliplatin, 5-fluorouracil, and leucovorin (modified FOLFOX6 \[mFOLFOX6\]) chemotherapy in participants with advanced or metastatic gastric or gastroesophageal junction (GEJ) cancer. Participants will be randomized to receive either ipatasertib or placebo orally daily on Days 1 to 7 of each 14-day cycle in combination with mFOLFOX6 on Day 1 of each cycle.

Detailed description:

Arms: arm 1: Participants will receive oral ipatasertib on Days 1 to 7 of each 14-day cycle in combination with mFOLFOX6, administered on Day 1 of each cycle. arm 2: Participants will receive the placebo equivalent to ipatasertib on Days 1 to 7 of each 14-day cycle in combination with mFOLFOX6, administered on Day 1 of each cycle.
Interventions: intervention 1: 5-Fluorouracil intervention 2: Ipatasertib intervention 3: Leucovorin intervention 4: Oxaliplatin intervention 5: Placebo
Intervention descriptions: intervention 1: Participants will receive bolus and infusional 5-fluorouracil on Day 1 of each 14-day cycle (as a part of mFOLFOX6 therapy), until disease progression or unacceptable toxicity. The infusion times for infusional 5-fluorouracil may be determined per local and/or institutional standards and product labeling. intervention 2: Participants will receive ipatasertib, 600 milligrams (mg) orally once daily on Days 1 to 7 of each 14-day cycle until disease progression or unacceptable toxicity. intervention 3: Participants will receive leucovorin or equivalent substitute orally, on Day 1 of each 14-day cycle (as a part of mFOLFOX6 therapy), until disease progression or unacceptable toxicity. intervention 4: Participants will receive oxaliplatin via intravenous (IV) infusion on Day 1 of each 14-day cycle (part of mFOLFOX6 therapy). Oxaliplatin will be discontinued after completion of 8 cycles intervention 5: Participants will receive matching oral placebo capsules once daily on Days 1 to 7 of each 14-day cycle until disease progression or unacceptable toxicity.

Protocol documents: