ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT03003676
Conditions: Advanced or Unresectable Melanoma Progressing After PD1 Blockade
Sponsor: Targovax Oy
Start date: 2016-12-01; Completion date: 2020-10-01
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a multi center, phase I pilot study of sequential ONCOS-102 and pembrolizumab in patients with advanced or unresectable melanoma progressing after PD1 blockade. The primary objective of the study is to determine the safety of sequential treatment with ONCOS-102 followed by pembrolizumab. The protocol aims to enroll patients into two cohorts: Part I: up to 12 patients will receive sequential treatment with ONCOS-102 followed by pembrolizumab. Part II: up to 12 patients will receive an initial treatment phase with ONCOS-102 followed by a treatment phase with ONCOS-102 in combination with pembrolizumab.

Detailed description:

Arms: arm 1: Part I: Patients will receive 3 doses of intratumoral (i.t.) injection of ONCOS-102 (days 1, 4, and 8) at 3x10\^11 viral particles (VP), preceded by intravenous (i.v.) cyclophosphamide priming 1-3 days prior to day 1. They will then receive pembrolizumab i.v., 2mg/kg or 200mg flat dose, on day 22 (Week 3) and every 3 weeks thereafter until the end of treatment visit on day 169 (Week 24).

Part II: Patients will receive 4 doses of intratumoral (i.t.) injection of ONCOS-102 (days 1, 4, 8 and 15) at 3x10\^11 viral particles (VP), preceded by intravenous (i.v.) cyclophosphamide priming 1-3 days prior to day 1. ONCOS-102 will be given in combination with Pembrolizumab starting on Day 22/Week 3 and every three weeks thereafter until Day 169/Week 24 or until unacceptable toxicity or clinically relevant disease progression, whichever occurs first. Pembrolizumab will be given according to institutional practice (2mg/kg or 200mg flat dose).
Interventions: intervention 1: ONCOS-102 intervention 2: Cyclophosphamide intervention 3: Pembrolizumab
Intervention descriptions: intervention 1: Engineered oncolytic adenovirus expressing Granulocyte-macrophage colony stimulating factor (GM-CSF) intervention 2: Pre-treatment intervention 3: PD1 blockade

Protocol documents:
Prot_000.pdf: 























































































































































SAP_001.pdf:
Clinical trial NCT04555525
Conditions: Acne Rosacea
Sponsor: Derm Research, PLLC
Start date: 2019-04-15; Completion date: 2020-10-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a prospective, parallel group, randomized, investigator-blinded pilot study. Approximately 100 subjects will be randomized at a 3:1 ratio to Seysara (sarecycline) at a weight-based dose per label or Centrum Adult Multivitamin to take by mouth daily. The study is comprised of 5 visits: screening, baseline, week 4, week 8, and week 12. Investigators will perform rosacea IGA (Investigator Global Assessment,) inflammatory lesion count, record adverse events and con meds, and ask each subject to complete a DLQI (Dermatology Life Quality Index.)

Detailed description:

Arms: arm 1: weight-based dose per label by mouth once daily for 12 weeks arm 2: one tablet by mouth daily for 12 weeks
Interventions: intervention 1: sarecycline intervention 2: Centrum Adult Multivitamin
Intervention descriptions: intervention 1: sarecycline tablet intervention 2: Centrum Adult Mulltivitamin tablet

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT01298570
Conditions: Colorectal Cancer Metastatic
Keywords: Metastatic Colorectal Cancer K-RAS mutation BRAF mutation Regorafenib BAY 73-4506 FOLFIRI Irinotecan 5-FU Leucovorin Placebo Phase II Multi-Center Randomized Lineberger North Carolina Cancer Hospital UNC
Sponsor: UNC Lineberger Comprehensive Cancer Center
Start date: 2011-04-07; Completion date: 2020-10-02
Enrollment: 181 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized (2:1), multi-center, placebo-controlled, phase II efficacy study is designed to compare PFS between regorafenib + FOLFIRI chemotherapy (ARM A) versus placebo + FOLFIRI (ARM B) in patients with mCRC previously treated with a FOLFOX regimen.

Detailed description:
This randomized (2:1 ratio), multi-center, placebo-controlled, phase II efficacy study is designed to compare progression-free survival (PFS) between regorafenib + FOLFIRI (5-fluorouracil + leucovorin + irinotecan \[ARM A\] versus placebo + FOLFIRI \[ARM B\]) in patients with metastatic colorectal carcinoma (mCRC) previously treated with a FOLFOX (5-fluorouracil + leucovorin + oxaliplatin) regimen. Secondary objectives include objective response (OR) rates, disease control (DC) rates, and overall survival (OS). A pharmacokinetic (PK) evaluation of irinotecan will be conducted in a subset of patients at selected sites. This trial also incorporates a number of exploratory analyses designed to evaluate potential correlations between blood and tissue biomarkers and clinical benefit.

Arms: arm 1: regorafenib 160 mg + FOLFIRI arm 2: Placebo + FOLFIRI
Interventions: intervention 1: Regorafenib (BAY 73-4506) intervention 2: FOLFIRI intervention 3: Placebo intervention 4: FOLFIRI
Intervention descriptions: intervention 1: Regorafenib, 160 mg, PO, Days 4-10 and Days 18-24 of 28 day cycle intervention 2: FOLFIRI (Irinotecan,180 mg/m2 IV over 90 minutes; 5-Fluorouracil l400 mg/m2 IV bolus followed by 2400 mg/m2 IV over 46 hours; Leucovorin 200-400c mg/m2 IV over 2 hours) Day 1 and Day 15 of each 28 day cycle. intervention 3: Placebo, 160 mg, PO, Days 4-10 and Days 18-24 of 28 day cycle intervention 4: FOLFIRI (Irinotecan,180 mg/m2 IV over 90 minutes; 5-Fluorouracil l400 mg/m2 IV bolus followed by 2400 mg/m2 IV over 46 hours; Leucovorin 200-400c mg/m2 IV over 2 hours) Day 1 and Day 15 of each 28 day cycle.

Protocol documents:
Clinical trial NCT04057118
Conditions: Rheumatoid Arthritis
Sponsor: Oscotec Inc.
Start date: 2019-03-20; Completion date: 2020-10-13
Enrollment: 163 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of SKI-O-703 compared with placebo, in patients with active rheumatoid arthritis (RA) who have had an inadequate response to conventional synthetic disease-modifying agents. Patients will be randomly assigned to one of 4 groups and will receive one of three doses of SKI-O-703 or placebo, administered orally twice daily for 12 weeks.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: SKI-O-703 intervention 2: Placebo
Intervention descriptions: intervention 1: Oral administration, twice per day intervention 2: Oral administration, twice per day

Protocol documents:
Prot_002.pdf: 




Oscotec Inc 
Protocol: OSCO-P220 I Version 5.0 Amendment 4 
Protocol Approval - Sponsor Signatory 
SKl-O-703 
19 Oct 2020 
Study Title 
A Phase 2, Multicenter, Randomized, Double-Blind, 
Placebo-Controlled, Parallel Dose Study to Evaluate the Efficacy and 
Safety of Oral SKI-O-703 in Patients With Active Rheumatoid Arthritis 
Despite Treatment With Conventional Therapies 
Protocol Number 
OSCO-P2201 
Protocol Date 
19 Oct 2020 
Protocol accepted and approved by: 
Page 3268


Oscotec Inc 
Protocol: OSCO-P2201 Version 5.0 Amendment 4 
Protocol Approval - Principal/Coordinating Investigator 
SKl-O-703 
19 Oct 2020 
Study Title 
A Phase 2, Multicenter, Randomized, Double-Blind, 
Placebo-Controlled, Parallel Dose Study to Evaluate the Efficacy and 
Safety of Oral SKI-O-703 in Patients With Active Rheumatoid Arthritis 
Despite Treatment With Conventional Therapies 
Protocol N um her
OSCO-P2201 
Protocol Date 
19 Oct 2020 
Protocol accepted and approved by: 
Page 3269



























































































































































































































SAP_001.pdf:
Clinical trial NCT03267030
Conditions: Acute Lymphoblastic Leukemia
Keywords: Hypersensitivity to PEG-asparaginase
Sponsor: Birgitte Klug Albertsen
Start date: 2017-08-23; Completion date: 2020-10-22
Enrollment: 55 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Pegylated-asparaginase (PEG-ASP) is an important part of the treatment of childhood acute lymphoblastic leukaemia (ALL). Unfortunately 13% of patients develops allergy and further treatment is impossible. Furthermore, 6% of patients have developed antibodies (silent inactivation) and have no effect of the PEG-ASP treatment. Truncated asparaginase therapy is associated with inferior event-free survival outcomes, in particular relapse in central nervous system (CNS).

Eryaspase is a new formulation of asparaginase encapsulated in erythrocytes. The erythrocyte membrane protects asparaginase against fast degradation and elimination processes. The encapsulation eliminates the direct somatic contact, and it is hypothesized that this provides the potential to prolong the activity of the enzyme and reduce toxicities.

Detailed description:

Arms: arm 1: GRASPA will replace remaining PEG-asparaginase doses in case of hypersensitivity.
Interventions: intervention 1: GRASPA
Intervention descriptions: intervention 1: Administration of 1-7 doses of 150 IU/kg IV infusion. (every 2 weeks for a maximum of 4 doses and every 6 weeks for maximum 3 doses).

Protocol documents:
Prot_000.pdf: 































































































































SAP_001.pdf:
Clinical trial NCT04236635
Conditions: Characteristics of Subcutaneous Tissue
Sponsor: Endo Pharmaceuticals
Start date: 2019-12-20; Completion date: 2020-10-26
Enrollment: 10 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the histopathology of subcutaneous tissue isolated after single or multiple Collagenase Clostridium Histolyticum (CCH) injection techniques in adult female participants undergoing abdominoplasty.

Detailed description:

Arms: arm 1: Participants were administered 0.07 milligrams (mg) CCH subcutaneously using a single injection technique.

Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -43 and -22. Area 2 was administered CCH on Day -14. arm 2: Participants were administered 0.07 mg CCH subcutaneously using a single injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -24 and -3. Area 2 was administered CCH on Day -3. arm 3: Participants were administered 0.07 mg CCH subcutaneously using a single injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -22 and -1. Area 2 was administered CCH on Day -1. arm 4: Participants were administered 0.0653 mg CCH subcutaneously using a multiple injection technique.

Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -43 and -22. Area 2 was administered CCH on Day -14. arm 5: Participants were administered 0.0653 mg CCH subcutaneously using a multiple injection technique.

Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -24 and -3. Area 2 was administered CCH on Day -3. arm 6: Participants were administered 0.0653 mg CCH subcutaneously using a multiple injection technique.

Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -22 and -1. Area 2 was administered CCH on Day -1.
Interventions: intervention 1: Collagenase Clostridium Histolyticum Single Injection Technique intervention 2: Collagenase Clostridium Histolyticum Multiple Injection Technique
Intervention descriptions: intervention 1: CCH was injected subcutaneously using a single injection technique. Dose per each administration was 0.07 mg. intervention 2: CCH was injected subcutaneously using a multiple injection technique. Dose per each administration was 0.0653 mg.

Protocol documents:
Prot_000.pdf: 















































































































SAP_001.pdf:
Clinical trial NCT03047980
Conditions: Sturge-Weber Syndrome
Keywords: SWS Cognitive impairment sirolimus
Sponsor: Anne Comi, MD
Start date: 2017-01-01; Completion date: 2020-10-27
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to gain a preliminary understanding of the safety of sirolimus in Sturge-Weber syndrome (SWS) and determine best outcomes to be used to assess the utility of sirolimus for the treatment of cognitive impairments related to Sturge-Weber syndrome.

Detailed description:
Sirolimus will be administered as an adjunct to all current medications. The impact of sirolimus upon cognitive functioning in Sturge-Weber syndrome is the primary outcome measure. This outcome will be assessed using a panel of testing selected based upon extensive experience in testing cognitive function in adults and children with SWS at the Kennedy Krieger Sturge-Weber Center. Changes in a quantitative EEG before and after the trial, Sturge-Weber syndrome clinical neuroscore, port-wine birthmark score, and the impact of sirolimus upon seizures will be assessed.

Arms: arm 1: All subjects will receive the sirolimus oral solution to be taken at home twice daily and will be treated on an outpatient basis. The drug will be taken for six months.
Interventions: intervention 1: Sirolimus
Intervention descriptions: intervention 1: Low dose oral sirolimus

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT02790736
Conditions: Social Anxiety Disorder
Keywords: propranolol public speaking anxiety
Sponsor: New York State Psychiatric Institute
Start date: 2016-06-01; Completion date: 2020-10-30
Enrollment: 6 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will test the efficacy of propranolol or placebo, administered after retrieval of a previously acquired public speaking fear, in reducing fear and avoidance of public speaking.

Detailed description:
Twenty subjects with Performance-Only type of Social Anxiety Disorder will be enrolled in the study. Participants will complete baseline assessments of fear and avoidance of public speaking. Participants will be randomly assigned to a single dose of propranolol 40mg or placebo, administered immediately after a fear activation procedure. Primary outcome assessment will be self-reported fear of public speaking and avoidance behavior in a behavioral avoidance task 2 weeks after the intervention.

Arms: arm 1: Propranolol 40 mg capsule, given once after fear activation procedure arm 2: Placebo capsule, given once after fear activation procedure
Interventions: intervention 1: propranolol intervention 2: Placebo
Intervention descriptions: intervention 1: active treatment intervention 2: inactive pill

Protocol documents:
Prot_SAP_ICF_000.pdf:
Clinical trial NCT00948675
Conditions: Advanced Non-Small Cell Lung Cancer
Keywords: Advanced Non-Small Cell Lung Cancer of Nonsquamous Histology Advanced Lung Cancer Non-Small Cell Lung Cancer Lung Cancer
Sponsor: Eli Lilly and Company
Start date: 2009-09-01; Completion date: 2020-11-06
Enrollment: 361 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the regimens of pemetrexed, carboplatin with pemetrexed maintenance and paclitaxel, carboplatin, bevacizumab with bevacizumab maintenance in participants with Stage IV nonsquamous non-small cell lung cancer.

Detailed description:
This is a multicenter, randomized, open-label, Phase III trial. Eligible participants will be randomized in a 1:1 ratio to receive pemetrexed and carboplatin followed by pemetrexed or paclitaxel, carboplatin, and bevacizumab followed by bevacizumab as their study treatment. Participants randomized to Pemetrexed + Carboplatin + Pemetrexed will receive folic acid, vitamin B12, and dexamethasone as stated in the pemetrexed label. Before administration of paclitaxel, participants randomized to Paclitaxel + Carboplatin + Bevacizumab will receive premedication (dexamethasone, diphenhydramine, and cimetidine or ranitidine) as recommended in the paclitaxel label.

Arms: arm 1: Pemetrexed and Carboplatin followed by Pemetrexed arm 2: Paclitaxel, Carboplatin, and Bevacizumab followed by Bevacizumab
Interventions: intervention 1: Pemetrexed intervention 2: Carboplatin intervention 3: Paclitaxel intervention 4: Bevacizumab
Intervention descriptions: intervention 1: Induction therapy: 500 milligrams/square meter (mg/m²) given intravenously every 21 days for 4 cycles. Maintenance therapy: 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation. intervention 2: Induction Therapy (every 21 days for 4 cycles): Area Under the Curve (AUC) 6 \[maximum possible dose of 900 milligrams (mg)\] intravenously infused over 30 minutes. intervention 3: Induction Therapy (every 21 days for 4 cycles): 200 mg/m² intravenously infused over 3 hours intervention 4: Induction therapy: 15 milligrams/kilogram (mg/kg) given intravenously every 21 days for 4 cycles. Maintenance therapy: 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation.

Protocol documents:
Clinical trial NCT04035200
Conditions: Insomnia
Sponsor: Imbrium Therapeutics
Start date: 2019-09-23; Completion date: 2020-11-06
Enrollment: 114 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety, tolerability and efficacy of V117957 in subjects with alcohol use disorder (AUD) who experience insomnia associated with alcohol cessation, compared to placebo.

Detailed description:

Arms: arm 1: V117957 tablets taken orally at bedtime arm 2: V117957 tablets taken orally at bedtime arm 3: Placebo to match V117957 tablets taken orally at bedtime
Interventions: intervention 1: V117957 tablets intervention 2: Placebo
Intervention descriptions: intervention 1: V117957 tablets taken orally at bedtime intervention 2: Tablets to match V117957

Protocol documents:
Prot_SAP_000.pdf: 
Official Title:  A Phase 2, Randomized, Double-Blind, Multi-Center, Placebo-
Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of 
V117957 in Subjects with an Alcohol Use Disorder who are Experiencing Insomnia 
Associated with Alcohol Cessation
NCT #: NCT04035200
Date of Document: September 27, 2019
Clinical trial NCT00551070
Conditions: Borderline Ovarian Serous Tumor Low Grade Ovarian Serous Adenocarcinoma Micropapillary Serous Carcinoma Primary Peritoneal Carcinoma Primary Peritoneal Low Grade Serous Adenocarcinoma Recurrent Borderline Ovarian Surface Epithelial-Stromal Tumor
Sponsor: National Cancer Institute (NCI)
Start date: 2007-12-17; Completion date: 2020-11-13
Enrollment: 52 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies the side effects and how well selumetinib sulfate works in treating patients with low-grade ovarian cancer that has come back (recurrent). Selumetinib sulfate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. To examine the tumor response rate of patients on AZD6244 (selumetinib sulfate) (NSC #748727).

II. To examine the acute toxicity of AZD6244 (NSC #748727) during the first course of treatment using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

III. To define the pharmacokinetic profile for AZD6244, 100 mg administered orally twice daily.

SECONDARY OBJECTIVES:

I. To examine the toxicity of AZD6244 (NSC #748727) using the 21 major categories of the CTCAE version 3.0.

II. To examine the dose and number of courses of AZD6244 (NSC #748727) given. III. To estimate the progression free survival, and overall survival of women receiving AZD6244 (NSC #748727).

TRANSLATIONAL RESEARCH OBJECTIVES:

I. To examine deoxyribonucleic acid (DNA) isolation with sequencing of braf, and ras mutation analysis and to explore their relationship with tumor response with AZD6244 (NSC #748727).

II. To examine protein levels of phosphorylated (p)-ERK/ERKERK) and explore their relationship with tumor response in patients treated with AZD6244 (NSC #748727).

OUTLINE:

Patients receive selumetinib sulfate orally (PO) twice a day (BID) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients undergo blood sample collection periodically for correlative and pharmacokinetic studies and to analyze selumetinib sulfate peak concentrations and the corresponding peak time values. Previously collected archived tumor tissue samples are obtained to determine protein levels of p-ERK/ERKERK, DNA isolation and sequencing of BRAF and ras mutation analysis by immunohistochemistry (IHC).

After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then once a year for 5 years.

Arms: arm 1: Patients receive selumetinib sulfate PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Laboratory Biomarker Analysis intervention 2: Pharmacological Study intervention 3: Selumetinib intervention 4: Selumetinib Sulfate
Intervention descriptions: intervention 1: Correlative studies intervention 2: Correlative studies intervention 3: Given PO intervention 4: Given PO

Protocol documents: