ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01774344
Conditions: Carcinoma, Hepatocellular
Keywords: Regorafenib BAY73-4506
Sponsor: Bayer
Start date: 2013-05-14; Completion date: 2019-07-05
Enrollment: 573 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study was to evaluate efficacy and safety of regorafenib in patients with advanced liver cancer who had progressed after sorafenib treatment. Patients were treated with regorafenib or placebo using a 2:1 randomization scheme.

Detailed description:

Arms: arm 1: 160 mg orally (p.o.) every day (qd) for 3 weeks of every 4 week cycle (i.e. 3 weeks on, 1 week off) plus BSC (Best Supportive Care) arm 2: 4 matching placebo tablets for 3 weeks of every 4 week cycle (i.e. 3 weeks on, 1 week off) plus BSC
Interventions: intervention 1: Regorafenib (Stivarga, BAY73-4506) intervention 2: Placebo
Intervention descriptions: intervention 1: Regorafenib, 40 mg tablets intervention 2: Placebo tablets matching in appearance

Protocol documents:
Clinical trial NCT02787083
Conditions: Cystitis, Interstitial
Keywords: Interstitial Cystitis
Sponsor: Philadelphia Urosurgical Associates
Start date: 2016-08-01; Completion date: 2019-07-05
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Bladder pain syndrome/interstitial cystitis (BPS/IC) is a difficult disease to both diagnose and treat. It is defined as an unpleasant sensation (pain, pressure, or discomfort) perceived to be related to the urinary bladder and associated with lower urinary tract symptoms for at least 6 weeks duration, in the absence of infection or other identifiable causes. Pain is the universal symptom, but many also experience symptoms of overactive bladder, possibly directly related to the mechanism of pain. Treating pain may influence the symptom of urgency, if the urge arises from a need to alleviate pain. In some patients whose pain improves with treatment, troubling overactive bladder symptoms still remain. Beta-3 adrenergic agonists have been found to decrease signaling of C-fibers in animal models. So, the investigators hypothesize that mirabegron, which is FDA-approved for treatment of overactive bladder, would also improve symptoms in patients with BPS/IC. As a selective beta-3 agonist, mirabegron acts on the beta-3 receptors found in the bladder which mediate relaxation of the detrusor muscle. It has been shown to significantly decrease the number or micturition episodes, urgency episodes, and increased mean volume of urine voided per micturition. It also has a favorable tolerability profile.

Detailed description:

Arms: arm 1: These patients will receive mirabegron 50mg tablets daily for 12 weeks. arm 2: These patients will receive placebo tablets daily for 12 weeks.
Interventions: intervention 1: Mirabegron intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Prot_SAP_ICF_000.pdf:
Clinical trial NCT01106157
Conditions: Diabetes Mellitus, Type 1
Keywords: Autoimmune, Diabetes Mellitus, Glucose Metabolism
Sponsor: University of Florida
Start date: 2010-04-01; Completion date: 2019-07-16
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to determine if giving the combination therapy consisting of Thymoglobulin® (ATG) and Neulasta® (GCSF) to patients with established Type 1 Diabetes (T1D) is safe and secondarily, if the ATG and GCSF will preserve insulin production.

Detailed description:
This is a randomized, placebo controlled, phase I/II trial. Potential subjects will be screened via a 4 hour mixed meal tolerance test to assess residual beta cell (C-peptide) function. If the C-peptide level at any time is ≥ 0.1 pmol/ml, and the subject meets the additional inclusion and exclusion criteria, they will be eligible for randomization and enrollment. The study will be randomized 2:1 such that 17 subjects will receive active therapy and 8 will receive placebo. Subjects must receive Thymoglobulin®/ Neulasta® or placebo within 8 weeks of randomization. Thymoglobulin® (2.5mg/kg)/placebo will be given as 0.5 mg/kg IV on day 1 and 2 mg/kg on day 2. Six doses of Neulasta® (6mg/dose)/placebo will be given as standard of care every 2 weeks, with the first dose given prior to discharge after the Thymoglobulin® infusion. Complete metabolic panel (CMP) and complete blood count (CBC) will be done at the screening visit, just prior to study drug initiation, daily during the Thymoglobulin® infusion admission, and at follow up visits. Following discharge, daily phone calls will be made to the subjects during the first 5 days of therapy and weekly thereafter. In addition, weekly phone calls for the month following completion of therapy will be used to document adverse reactions. Thereafter calls will be made every two weeks.

Arms: arm 1: Subjects will receive an infusion of Anti-Thymocyte Globin (ATG) followed by 6 doses of pegylated GCSF every 2 weeks for 10 weeks. arm 2: Saline infusion will be given on both Day 1 and Day 2 followed by placebo injection given in identical volumes in identical syringes in the identical subcutaneous manner
Interventions: intervention 1: Anti-Thymocyte Globin (ATG) intervention 2: Placebo intervention 3: Pegylated GCSF
Intervention descriptions: intervention 1: Anti-Thymocyte Globin (ATG) will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2. intervention 2: Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes intervention 3: 6 doses of pegylated GCSF (6mg/dose) will be given subcutaneously every 2 weeks beginning after the ATG infusion.

Protocol documents:
Clinical trial NCT03439137
Conditions: Anemia; Hemodialysis Dependent Chronic Kidney Disease
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2018-02-14; Completion date: 2019-07-16
Enrollment: 323 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
For hemodialysis subjects currently receiving ESAs with anemia associated with chronic kidney disease, demonstrate non-inferiority of MT-6548 compared to darbepoetin alfa using Hb value and evaluate long-term safety of MT-6548.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: MT-6548 intervention 2: Darbepoetin alfa intervention 3: MT-6548-matching placebo intervention 4: Darbepoetin alfa-matching placebo
Intervention descriptions: intervention 1: Oral tablet intervention 2: Intravenous administration intervention 3: Oral tablet intervention 4: Intravenous administration

Protocol documents:
Prot_000.pdf: 





























































































































































































































SAP_001.pdf:
Clinical trial NCT03262116
Conditions: Type 1 Diabetes Mellitus
Keywords: bionic pancreas insulin continuous glucose monitor type 1 diabetes insulin pharmacokinetics
Sponsor: Massachusetts General Hospital
Start date: 2019-03-19; Completion date: 2019-07-23
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Subjects will participate in three weeks of the bionic pancreas in the insulin-only configuration. Each week, subjects will use a different rapid acting insulin analog -- Humalog, Novolog, or BC222 insulin lispro -- in a randomized cross-over order.

Detailed description:
The investigators hypothesize that differences in the PK characteristics of insulin analogs will lead to differences in glycemic outcomes when delivered by the insulin-only configuration of the bionic pancreas. Specifically, the investigators predict that insulin analogs that have faster absorption (numerically lower Tmax and/or T½max) and insulin analogs that have faster clearance (numerically lower terminal half-life) will result in lower mean glucose and/or a lower percentage of time in the hypoglycemic range.

Up to 30 subjects will participate in three 7-day study arms using insulin lispro, insulin aspart, and BC222 lispro in the bionic pancreas in random order. The co-primary outcomes will be mean CGMG and fraction of time spent with CGMG \<54 mg/dl with comparisons made between arms for individual participants. Secondary analyses will include time in glycemic ranges (\<50, \<60, \<70, 70-120, 70-180, \>180, \>250 mg/dl), coefficient of variation, mean postprandial excursion (difference in CGMG from the time of meal announcement to the peak CGMG in the first 4 hours after the meal announcement) for both mixed meal challenges, number of symptomatic hypoglycemic events, grams of carbohydrate consumed to treat hypoglycemia, and TDD of insulin, between arms for individual subjects.

Arms: arm 1: Subjects will participate in one week of wearing the insulin only bionic pancreas using humalog as the rapid acting insulin. arm 2: Subjects will participate in one week of wearing the insulin only bionic pancreas using novolog as the rapid acting insulin. arm 3: Subjects will participate in one week of wearing the insulin only bionic pancreas using BC222 insulin lispro as the rapid acting insulin.
Interventions: intervention 1: Humalog intervention 2: Novolog intervention 3: BC222 insulin lispro intervention 4: Bionic Pancreas
Intervention descriptions: intervention 1: Subjects will participate in one week of wearing the insulin only bionic pancreas using humalog as the rapid acting insulin. intervention 2: Subjects will participate in one week of wearing the insulin only bionic pancreas using novolog as the rapid acting insulin. intervention 3: Subjects will participate in one week of wearing the insulin only bionic pancreas using BC222 insulin lispro as the rapid acting insulin. intervention 4: The insulin-only bionic pancreas will be used in all three arms of the study

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT05342597
Conditions: Healthy Adult Subjects
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2019-06-10; Completion date: 2019-07-24
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To evaluate the effect of food on the pharmacokinetics of oral edaravone in healthy adult subjects. In this study, we determined 5 different dietary conditions including 4 different meal contents and fasting condition.

Detailed description:

Arms: arm 1: A single oral dose of MT-1186 with fasted condition in period 1, meal 1 condition in period 2, meal 2 condition in period 3, meal 3 condition in period 4, and meal 4 condition in period 5. arm 2: A single oral dose of MT-1186 with meal 1 condition in period 1, meal 2 condition in period 2, meal 3 condition in period 3, fasted condition in period 4, and meal 4 condition in period 5. arm 3: A single oral dose of MT-1186 with meal 2 condition in period 1, meal 3 condition in period 2, fasted condition in period 3, meal 1 condition in period 4, and meal 4 condition in period 5. arm 4: A single oral dose of MT-1186 with meal 3 condition in period 1, fasted condition in period 2, meal 1 condition in period 3, meal 2 in period 4, and meal 4 condition in period 5.
Interventions: intervention 1: MT-1186
Intervention descriptions: intervention 1: A crossover study in which Japanese healthy subjects receive a single dose of MT-1186 under several dosing condition on Day 1, 3, 5, 7 and 24 according to their treatment sequence.

Protocol documents:
Prot_000.pdf: 



































































































































SAP_001.pdf:
Clinical trial NCT00438802
Conditions: Lymphoma
Keywords: recurrent cutaneous T-cell non-Hodgkin lymphoma angioimmunoblastic T-cell lymphoma anaplastic large cell lymphoma adult nasal type extranodal NK/T-cell lymphoma recurrent mycosis fungoides/Sezary syndrome
Sponsor: Mayo Clinic
Start date: 2006-03-01; Completion date: 2019-07-25
Enrollment: 23 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Combinations of biological substances in alefacept may be able to carry cancer-killing substances directly to cancer cells.

PURPOSE: This phase I trial is studying the side effects and best dose of alefacept in treating patients with relapsed or refractory cutaneous T-cell lymphoma or peripheral T-cell non-Hodgkin's lymphoma.

Detailed description:
OBJECTIVES:

Primary

* Determine the maximum tolerated dose or the optimal immunologic dose of alefacept in patients with relapsed or refractory cutaneous T-cell lymphoma or peripheral T-cell non-Hodgkin's lymphoma.

Secondary

* Determine if antitumor activity of this drug exists in these patients.

OUTLINE: This is a multicenter, dose-escalation study.

* Induction therapy: Patients receive alefacept IV over 2-5 minutes once weekly for up to 8 weeks in the absence of disease progression or unacceptable toxicity. Patients with stable disease or complete or partial response after induction therapy proceed to maintenance therapy.

Cohorts of 6 patients receive escalating doses of alefacept until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. The optimal immunologic dose is defined as the dose that does not exceed the MTD, has the highest alefacept level, and achieves saturation of CD2 receptors.

* Maintenance therapy: Patients receive alefacept IV on day 1. Treatment repeats every 4 weeks for 10-12 courses in the absence of disease progression or unacceptable toxicity.

Patients who experience disease progression during maintenance therapy may receive reinduction therapy\* comprising 4 weekly doses of alefacept. The patient then proceeds to a second maintenance phase in the absence of disease progression.

NOTE: \*Only 1 reinduction allowed.

Patients undergo blood and tissue collection periodically for pharmacological studies. Blood serum is analyzed for alefacept concentration, cytokine concentration, CD16 polymorphisms, and CD2 saturation via flow cytometry.

After completion of study treatment, patients are followed every 3 months for up to 3 years and then periodically thereafter.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.

Arms: arm 1: Determine both the maximum tolerated dose level as well as the optimal immunologic dose and toxicity.
Interventions: intervention 1: Alefacept
Intervention descriptions: intervention 1: Dose escalation theme. 0.075mg/kg by IV Weekly x 8 to 0.30mg/kg IV Weekly x 8

Protocol documents:
Clinical trial NCT02439216
Conditions: Muscular Dystrophy, Duchenne
Keywords: Muscular Dystrophies Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Duchenne muscular dystrophy DMD dystrophin dystrophy Duchenne
Sponsor: Catabasis Pharmaceuticals
Start date: 2016-04-01; Completion date: 2019-08-01
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The MoveDMD study is a 3-part, Phase 1/2, multi-site study to evaluate the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of edasalonexent (also known as CAT-1004) in pediatric patients with a genetically confirmed diagnosis of DMD. Male patients from ≥4 to \<8 years of age will be enrolled.

Edasalonexent is an orally administered small molecule targeted to inhibit activated NF-κB, a molecule that is activated from infancy in DMD and which is central to causing muscle damage and preventing muscle regeneration. Data on magnetic resonance imaging of the lower and upper leg muscles, physical function (including timed function tests) and muscle strength will be studied.

Detailed description:
Part A was a 1-week, open-label study to assess safety, tolerability, pharmacokinetics and biomarkers for three dose levels of edasalonexent and is now complete.

Part B was a randomized, double-blind, placebo-controlled, multiple dose study to evaluate the safety, efficacy, PK, and PD of edasalonexent over 12 weeks. Patients who participated in Part A also participated in Part B, along with newly enrolled patients. Patients received either edasalonexent 67 mg/kg/day, edasalonexent 100 mg/kg/day, or placebo in Part B. Part B is now complete.

Following completion of Part B, patients receive edasalonexent for 138 weeks in Part C, the open-label portion of the MoveDMD study. Patients on the 67 mg/kg/day treatment moved to the 100 mg/kg/day treatment. Patients on the 100 mg/kg/day treatment remained on the 100 mg/kg/day treatment. If clinically indicated, concomitant treatment with eteplirsen (Exondys 51™) may be acceptable in patients with amenable gene mutations during Part C after the patient has been exposed to edasalonexent for 6 months.

\*\*Following completion of MoveDMD Part C, access to edasalonexent for trial participants will continue through the open-label extension study, GalaxyDMD.\*\*

Arms: arm 1: Edasalonexent 67 mg/kg/day. Capsules taken by mouth two times per day arm 2: Edasalonexent 100 mg/kg/day. Capsules taken by mouth three times per day arm 3: Matching placebo
Interventions: intervention 1: Edasalonexent intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT03329196
Conditions: Anemia; Non-dialysis Dependent Chronic Kidney Disease
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2017-10-30; Completion date: 2019-08-09
Enrollment: 304 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
For Non-dialysis subjects with anemia associated with chronic kidney disease, demonstrate non-inferiority of MT-6548 compared to darbepoetin alfa using Hb value and evaluate long-term safety of MT-6548.

For subjects not currently receiving ESAs, evaluate Hb correction and maintenance effect of MT-6548 and for subjects currently receiving ESAs, evaluate Hb conversion and maintenance effect of MT-6548

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: MT-6548 intervention 2: Darbepoetin alfa
Intervention descriptions: intervention 1: Oral tablet intervention 2: Subcutaneous

Protocol documents:
Prot_000.pdf: 







































































































































































































SAP_001.pdf:
Clinical trial NCT01484275
Conditions: High-risk Smoldering Multiple Myeloma
Keywords: High-risk smoldering multiple myeloma Multiple myeloma Siltuximab
Sponsor: Janssen Research & Development, LLC
Start date: 2012-03-01; Completion date: 2019-08-21
Enrollment: 85 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of siltuximab compared with placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial) in patients with high-risk smoldering multiple myeloma (SMM).

Detailed description:
This is a randomized (treatment assigned by chance), double-blind (neither patient nor investigator know which treatment is given), multicenter study to evaluate the safety and efficacy of siltuximab compared with placebo in patients with high-risk SMM (defined as bone marrow plasma cells \>=10% and either serum monoclonal protein \>=3 g/dL, or abnormal free light chain ratio \<0.126 or \>8 and serum M-protein \<3 g/dL but \>=1 g/dL). Approximately 74 patients will receive either siltuximab or placebo by intravenous (IV, injection into a vein) infusion every 4 weeks until progression to symptomatic multiple myeloma, unacceptable toxicity, withdrawal of consent, or the end of the study (approximately 4 years after randomization of the last patient). Efficacy, pharmacokinetics, immunogenicity, and potential biomarkers will be assessed at time points defined in the protocol. Patient reported outcomes (European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire-Core 30, Brief Pain Inventory \[worst pain\], Non-Chemotherapy Anemia Symptom Scale) will be administered before any procedure or treatment at each visit. Patient safety will be monitored throughout the study.

Arms: arm 1: Type=exact, unit=mg/kg, number=15, form=intravenous infusion, route=intravenous use, every 4 weeks until progression to symptomatic multiple myeloma, unacceptable toxicity, withdrawal of consent, or the end of the study. arm 2: Form=intravenous infusion, route=intravenous use route=intravenous, use every 4 weeks until progression to symptomatic multiple myeloma, unacceptable toxicity, withdrawal of consent, or the end of the study.
Interventions: intervention 1: Siltuximab intervention 2: Placebo
Intervention descriptions: intervention 1: Type=exact, unit=mg/kg, number=15, form=intravenous infusion, route=intravenous use, every 4 weeks until progression to symptomatic multiple myeloma, unacceptable toxicity, withdrawal of consent, or the end of the study. intervention 2: Form=intravenous infusion, route=intravenous use route=intravenous, use every 4 weeks until progression to symptomatic multiple myeloma, unacceptable toxicity, withdrawal of consent, or the end of the study.

Protocol documents:
Clinical trial NCT02014129
Conditions: Neoplasm Metastasis Lymphoma
Sponsor: Eli Lilly and Company
Start date: 2013-12-18; Completion date: 2019-08-21
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study is to evaluate safety and side effects of LY2835219 in Japanese participants with advanced cancer.

Detailed description:

Arms: arm 1: 100 milligram (mg) abemaciclib administered orally every 12 hours (Q12H) in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met. arm 2: 150 mg abemaciclib administered orally Q12H in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met. arm 3: 200 mg abemaciclib administered orally Q12H in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met.
Interventions: intervention 1: LY2835219
Intervention descriptions: intervention 1: Administered orally

Protocol documents:
Clinical trial NCT02162719
Conditions: Breast Neoplasms
Sponsor: Genentech, Inc.
Start date: 2014-08-19; Completion date: 2019-08-31
Enrollment: 124 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This multicenter, randomized, double-blind study will estimate the efficacy, safety and tolerability of ipatasertib combined with paclitaxel compared with placebo combined with paclitaxel in participants with inoperable locally advanced or metastatic triple-negative breast cancer (mTNBC), as measured by progression-free survival (PFS) in all participants and in participants with phosphatase and tensin homolog (PTEN)-low tumors.

Detailed description:

Arms: arm 1: Participants randomised to receive paclitaxel 80 mg/m\^2, intravenously on Days 1, 8, and 15 along with ipatasertib 400 mg, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination. arm 2: Participants randomised to receive paclitaxel 80 mg/m\^2, intravenously on Days 1, 8, and 15 along with placebo matching ipatasertib, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
Interventions: intervention 1: Ipatasertib intervention 2: Paclitaxel intervention 3: Placebo
Intervention descriptions: intervention 1: Participants received ipatasertib orally 400 milligrams (mg) daily on Days 1-21 of each 28-day cycle. intervention 2: Participants received paclitaxel 80 milligrams per square meter (mg/m\^2) intravenously (IV) on Days 1, 8, and 15 of each cycle. intervention 3: Participants received oral placebo matched to ipatasertib, daily on Days 1-21 of each 28-day cycle.

Protocol documents: