ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01901146
Conditions: Breast Cancer
Keywords: Human Epidermal Growth Factor Receptor 2 (HER2) Positive Early Breast Cancer
Sponsor: Amgen
Start date: 2013-04-29; Completion date: 2017-01-27
Enrollment: 725 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to compare the effectiveness and safety of ABP 980 against trastuzumab in women with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer.

Detailed description:

Arms: arm 1: Participants received ABP 980 at an initial dose of 8 mg/kg by intravenous (IV) infusion, then 6 mg/kg IV infusion every 3 weeks (Q3W) for 3 additional cycles plus 175 mg/m² paclitaxel Q3W for 4 cycles during the neoadjuvant phase.

Surgery (lumpectomy or mastectomy with sentinel lymph node dissection or axillary lymph node dissection) was completed 3 to 7 weeks after the last dose of study drug in the neoadjuvant phase.

After surgery (adjuvant phase) participants continued receiving 6 mg/kg ABP 980 IV Q3W for up to 1 year from the first day of study drug administration in the neoadjuvant phase. arm 2: Participants received trastuzumab at an initial dose of 8 mg/kg IV infusion, then 6 mg/kg IV infusion Q3W for 3 additional cycles plus 175 mg/m² paclitaxel Q3W for 4 cycles during the neoadjuvant phase.

Surgery (lumpectomy or mastectomy with sentinel lymph node dissection or axillary lymph node dissection) was completed 3 to 7 weeks after the last dose of study drug in the neoadjuvant phase.

After surgery (adjuvant phase) participants were re-randomized to either continue receiving 6 mg/kg trastuzumab IV Q3W or transition to 6 mg/kg ABP 980 IV Q3W for up to 1 year from the first day of study drug administration in the neoadjuvant phase.
Interventions: intervention 1: ABP 980 intervention 2: Trastuzumab intervention 3: Paclitaxel intervention 4: Lumpectomy or Mastectomy with Sentinel Node or Axillary Node Dissection
Intervention descriptions: intervention 1: ABP 980 was administered at an initial dose of 8 mg/kg over a 90-minute intravenous (IV) infusion, then 6 mg/kg IV infusion Q3W for all subsequent cycles. intervention 2: Trastuzumab was administered at an initial dose of 8 mg/kg over a 90-minute IV infusion, then 6 mg/kg IV infusion Q3W for all subsequent cycles. intervention 3: Paclitaxel, 175 mg/m² Q3W for 4 cycles (or 80 mg/m² QW for 12 cycles, if local standard of care). intervention 4: None

Protocol documents:
Clinical trial NCT01971476
Conditions: Leukemia Neoplasms
Sponsor: Boehringer Ingelheim
Start date: 2013-10-22; Completion date: 2017-01-27
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The present trial will be performed according to an open design to determine the maximum tolerable dose (MTD) by evaluation of dose-limiting toxicity (DLT) of volasertib in paediatric leukaemia and solid tumours in the age group 2 to less than 12 and 12 to less than 18 years. A further objective is to collect data on safety, tolerability, toxicity, efficacy (preliminary activity), pharmacokinetics and pharmacodynamics of volasertib in paediatric cancer patients

Detailed description:

Arms: arm 1: Volasertib will be administered as intravenous infusion
Interventions: intervention 1: volasertib
Intervention descriptions: intervention 1: intravenous administration on day 1of a treatment course

Protocol documents:
Clinical trial NCT01286987
Conditions: Advanced or Recurrent Solid Tumors Breast Neoplasms Ovarian Cancer, Epithelial Ewing Sarcoma Small Cell Lung Carcinoma Prostate Cancer Pancreas Cancer
Keywords: BRCA1 Protein BRCA2 Protein
Sponsor: Pfizer
Start date: 2011-01-03; Completion date: 2017-01-30
Enrollment: 113 participants; Allocation: ; Intervention model: 

Brief summary:
This is a single-arm, open-label study to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of talazoparib in patients with advanced tumors with DNA-repair pathway deficiencies. There will be 2 parts to the study: a dose escalation phase in which the maximum tolerated dose will be defined, and a dose expansion phase.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Talazoparib
Intervention descriptions: intervention 1: Oral capsule with multiple dosage forms given once daily

Protocol documents:
Clinical trial NCT02683109
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Start date: 2016-03-08; Completion date: 2017-01-30
Enrollment: 221 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 4-week, multicenter, randomized, double-blind, parallel group and active controlled study.

Patients will be randomized (1 to 1 ratio) to a 4-week double-blind treatment period of either FDC (fixed-dose combination) of tiotropium + olodaterol (5/5 µg) plus placebo or the free combination of tiotropium 5 µg and olodaterol 5 µg; all administered via the Respimat® inhaler. The purpose is to show non-inferiority between the FDC and the free combination of tiotropium and olodaterol in patients with COPD.

Detailed description:

Arms: arm 1: Fixed Dose Combination of tiotropium + olodaterol arm 2: None
Interventions: intervention 1: FDC of tiotropium + olodaterol intervention 2: Placebo intervention 3: Tiotropium intervention 4: Olodaterol
Intervention descriptions: intervention 1: Fixed Dose Combination of tiotropium + olodaterol intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT01378962
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Sponsor: Hoffmann-La Roche
Start date: 2011-03-31; Completion date: 2017-01-31
Enrollment: 50 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single-arm, open-label study evaluated the efficacy and safety of Tarceva (erlotinib) in participants with locally advanced or metastatic non-small cell lung cancer. Participants received daily oral doses of 150 mg Tarceva. The anticipated time on study treatment was 12 months.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: erlotinib
Intervention descriptions: intervention 1: 150 mg orally once a day for 12 months

Protocol documents:
Clinical trial NCT02546609
Conditions: NAFLD
Sponsor: NuSirt Biopharma
Start date: 2015-11-19; Completion date: 2017-01-31
Enrollment: 91 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goal of this study is to determine if NS-0200 can reduce the amount of liver fat in patients diagnosed with non-alcoholic fatty liver disease (NAFLD). This study will compare two doses of NS-0200 to placebo in NAFLD patients.

Detailed description:
This is a randomized, 16-week, placebo-controlled, double-blind study to evaluate the effect of two fixed-dose combinations of leucine, metformin and sildenafil, NS-0200 compared to placebo, on the reduction of liver fat in patients diagnosed with non-alcoholic fatty liver disease (NAFLD). Subjects meeting all the inclusion criteria and no exclusion criteria will be randomized to one of three study arms.

The primary objective of this study is to evaluate the change in hepatic fat content assessed by proton-density-fat-fraction (PDFF) employing magnetic resonance imaging (MRI) in subjects from : Screening/Visit 2 (Day-7/Week-1) to Study Termination/Visit 8 (Day 112/Week 16) receiving two fixed-dose combinations of leucine, metformin and sildenafil compared to placebo. Secondary objectives will also assess changes in serum alanine aminotransferase (ALT) activity, change in circulating cytokeratin 18, a surrogate marker of necro-inflammation, change in HbA1c, change in fasting glucose, insulin and insulin sensitivity, change in blood lipids such as cholesterol, LDL, HDL, triglycerides, and changes in in C-reactive protein. In addition this study will evaluate the safety and tolerability of NS-0200.

Patients will have two screening visits, the first to determine their eligibility based on lab tests and the second based on the percentage of hepatic fat assessed by MRI imaging. Once qualified, patients will be randomly assigned to either one of the treatment groups or the placebo control group and monitored for a total of 16 weeks. Patients will return to the clinic each month for lab tests, and routine examinations. At the conclusion of the treatment period patients will again undergo an MRI scan to examine the percentage of hepatic fat.

Arms: arm 1: Leu-Met-Sil 0.5: 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 500 mg metformin and 0.5 mg of sildenafil. arm 2: Leu-Met-Sil 1.0: 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 500 mg metformin and 1.0 mg of sildenafil. arm 3: Placebo: 3 capsules BID containing 99% Avicel PH302 and 1% magnesium stearate (w/w)
Interventions: intervention 1: Leu-Met-Sil 0.5 intervention 2: Leu-Met-Sil 1.0 intervention 3: Placebo
Intervention descriptions: intervention 1: NS-0200 low dose intervention 2: NS-200 high dose intervention 3: Placebo

Protocol documents:
Clinical trial NCT02577523
Conditions: Parkinson's Disease
Sponsor: NeuroDerm Ltd.
Start date: 2015-12-29; Completion date: 2017-01-31
Enrollment: 38 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multicenter, parallel-group, rater-blinded, randomized clinical study in subjects with advanced PD investigating the efficacy, PK, safety and tolerability of continuous SC infusion of 2 dosing regimens of ND0612H, a solution of LD/CD delivered via a pump system as a continuous SC infusion, compared to standard oral LD/CD. After screening, subjects will undergo 1 day of standard oral LD/CD inpatient dosing followed by 2 days of inpatient treatment with 1 of 2 randomly allocated (1:1 randomization ratio) dosing regimens of ND0612H continuous SC infusion. Subjects will then continue on a maintenance dose of the assigned ND0612H dosing regimen for the next 25 days. A safety visit will be performed 4 weeks after the last SC administration of the study drug for a total of about 2.5 months of participation for each subject enrolled into the trial.

Detailed description:
This phase IIa randomized, controlled, parallel-group study will be conducted in 36 subjects with advanced PD who are treated with oral LD/CD at a stable dose and have predictable morning "OFF" periods and at least 2.5 hrs of daily "OFF" periods. The study will investigate the efficacy, PK, safety and tolerability of continuous SC infusion of 2 dosing regimens of ND0612H. Regimen 1 will employ continuous infusion for 24 hrs using a low infusion rate at night and a higher rate at daytime with supplemental administration of oral immediate release (IR) LD/CD in the mornings. During the inpatient period of about 3 days, the site staff will manage the administration and replacement of the infusions. On Day 4 subjects will be discharged home after they and their study partners have received training on the administration of the infusion. Subjects will then continue on a maintenance dose of the assigned ND0612 dosing regimen for the next 25 days. A safety visit will be performed 4 weeks after the last SC administration of the study drug.

Arms: arm 1: Dosing Regimen 1 of ND0612 (Levodopa/Carbidopa solution) continuous SC infusion over 24 hours. arm 2: Dosing Regimen 2 of ND0612 (Levodopa/Carbidopa solution) continuous SC infusion over 14 hours. Infusion started at wake-up time supplemented with an oral IR LD/CD tablet.
Interventions: intervention 1: ND0612 (Levodopa/Carbidopa solution) intervention 2: ND0612 (Levodopa/Carbidopa solution) + morning oral IR-LD/CD
Intervention descriptions: intervention 1: The total daily dose of levodopa/carbidopa 720/90 mg. Device: CRONO TWIN pump system. intervention 2: The total daily dose levodopa/carbidopa from ND0612 538/67 mg. Morning dose of oral IR-LD/CD 150/15 mg. Device: CRONO TWIN pump system.

Protocol documents:
Clinical trial NCT02579603
Conditions: Idiopathic Pulmonary Fibrosis
Sponsor: Boehringer Ingelheim
Start date: 2015-10-16; Completion date: 2017-01-31
Enrollment: 105 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a phase IV, twelve week, open label, randomized, parallel group study to assess safety and tolerability of combined treatment with nintedanib and pirfenidone.

A secondary objective is to assess the exposure based on PK trough concentration values to nintedanib either given alone or in combination with pirfenidone and to assess the exposure of pirfenidone when combined with nintedanib.

Detailed description:

Arms: arm 1: Nintedanib 150 mg bid arm 2: Nintedanib 150 mg bid combined with pirfenidone up to 801 mg tid
Interventions: intervention 1: Nintedanib intervention 2: Pirfenidone
Intervention descriptions: intervention 1: Nintedanib 150mg bid intervention 2: None

Protocol documents:
Clinical trial NCT00529373
Conditions: Postmenopausal Osteoporosis
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-09-13; Completion date: 2017-02-01
Enrollment: 16071 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the event-driven base study is to determine the safety and efficacy, especially fracture risk reduction, of odanacatib in postmenopausal women diagnosed with osteoporosis. In a placebo-controlled extension of the base study, participants continued to receive the same blinded study medication for a total of up to 5 years of blinded study medication combined between the base study and the extension. After participants received 5 years of blinded study medication, they received open-label odanacatib through the end of the first extension. Participants were then invited to enroll in a second extension study in which they received open-label odanacatib for an additional 5 years. Two imaging substudies (PN032-Base/Extension and PN035) were conducted for participants in the MK-0822-018 Study. Additional safety information was collected for participants who discontinued from the base study or the blinded first extension in an observational follow-up study, MK-0822-083 (EudraCT number: 2007-002693-66) .

Detailed description:

Arms: arm 1: Participants receive 50 mg of blinded odanacatib weekly over the course of the base study and first extension study (5 years total), followed by 50 mg of open-label odanacatib weekly for 5 years. Participants also receive Vitamin D3 and open-label supplemental calcium so that total daily calcium intake (from both dietary and supplemental sources) is approximately 1200 mg. arm 2: Participants receive blinded placebo to 50 mg of odanacatib weekly over the course of the base study and first extension study (5 years total), followed by 50 mg of open-label odanacatib weekly for 5 years. Participants also receive Vitamin D3 and open-label supplemental calcium so that total daily calcium intake (from both dietary and supplemental sources) is approximately 1200 mg.
Interventions: intervention 1: Odanacatib intervention 2: Placebo for Odanacatib intervention 3: Vitamin D3 intervention 4: Calcium carbonate
Intervention descriptions: intervention 1: 50 mg tablet orally once weekly (OW) intervention 2: 50 mg tablet orally OW intervention 3: 5600 IU orally OW intervention 4: If needed. Total daily calcium intake (from both dietary and supplemental sources) will be approximately 1200 mg but not to exceed 1600 mg

Protocol documents:
Clinical trial NCT01920555
Conditions: Treatment Resistant Depression
Keywords: Depression Treatment Resistant Depression Ketamine Antidepressant MDD Major Depression
Sponsor: Massachusetts General Hospital
Start date: 2014-12-01; Completion date: 2017-02-01
Enrollment: 99 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is looking at the efficacy, durability, safety, and tolerability of multiple single doses of Ketamine vs. active placebo for treating patients with treatment resistant depression who are taking an antidepressant that is not working for them.

Detailed description:
The primary objective is to investigate whether all doses (0.1 mg/kg, 0.2 mg/kg, 0.5 mg/kg, and 1.0 mg/kg) of ketamine are superior to active placebo (midazolam 0.045 mg/kg) therapy in the acute treatment of patients with treatment resistant depression within 72 hours (Day 3), when added to ongoing and stable antidepressant therapy.

Arms: arm 1: Patients in this arm will receive 0.1 mg/kg of Ketamine - one single infusion arm 2: Patients in this arm will receive 0.2 mg/kg of Ketamine - one single infusion arm 3: Patients in this arm will receive 0.5 mg/kg of Ketamine - one single infusion arm 4: Patients in this arm will receive 1.0 mg/kg of Ketamine - one single infusion arm 5: Patients in this arm will receive 0.045 mg/kg of midazolam - one single infusion
Interventions: intervention 1: Ketamine intervention 2: Ketamine intervention 3: Ketamine intervention 4: Ketamine intervention 5: Placebo Midazolam
Intervention descriptions: intervention 1: Dose of Ketamine will be 0.1 mg/kg - one single infusion intervention 2: Dose of Ketamine will be 0.2 mg/kg - one single infusion intervention 3: Dose of Ketamine will be 0.5 mg/kg - one single infusion intervention 4: Dose of Ketamine will be 1.0 mg/kg - one single infusion intervention 5: Dose of Midazolam (active placebo) will be 0.045 mg/kg - one single infusion

Protocol documents:
Clinical trial NCT02640157
Conditions: Chronic Hepatitis C Hepatitis C Virus Genotype 3 Hepatitis C Virus
Keywords: interferon free Hepatitis C daclatasvir Sovaldi HCV Hepatitis C Virus Hepatitis C Genotype 3 Hep C sofosbuvir Chronic Hepatitis C Daklinza
Sponsor: AbbVie
Start date: 2015-12-01; Completion date: 2017-02-01
Enrollment: 506 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to compare the safety and efficacy of ABT-493/ABT-530 to the combination of sofosbuvir (SOF) and daclatasvir (DCV) in adults with genotype 3 (GT3) chronic hepatitis C virus (HCV) infection.

Detailed description:
This study was a Phase 3, randomized, open-label, active-controlled multicenter study to compare efficacy and safety of ABT-493/ABT-530 to SOF and DCV in treatment-naïve chronic HCV GT3-infected participants without cirrhosis. The study consisted of 2 periods, a treatment period (participants received 8 or 12 weeks of ABT-493/ABT-530 or 12 weeks of SOF with DCV) and a post-treatment period (participants who completed or prematurely discontinued the treatment period were followed for 24 weeks after their last dose of study drug to evaluate efficacy and to monitor HCV RNA and the emergence and persistence of viral variants).

Arms: arm 1: ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks. arm 2: Sofosbuvir 400 mg once daily (QD) co-administered with daclatasvir 60 mg QD for 12 weeks. arm 3: ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
Interventions: intervention 1: ABT-493/ABT-530 intervention 2: Sofosbuvir intervention 3: Daclatasvir
Intervention descriptions: intervention 1: Tablet; ABT-493 coformulated with ABT-530 intervention 2: Tablet intervention 3: Tablet

Protocol documents:
Clinical trial NCT00227721
Conditions: Ovarian Cancer Peritoneal Cavity Cancer
Keywords: recurrent ovarian epithelial cancer peritoneal cavity cancer
Sponsor: Robert Morris
Start date: 2004-02-01; Completion date: 2017-02-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with docetaxel works in treating patients with relapsed or refractory ovarian epithelial or peritoneal cancer.

Detailed description:
OBJECTIVES:

Primary

* Determine the response rate in patients with platinum-sensitive or -resistant relapsed or refractory ovarian epithelial or peritoneal cavity cancer treated with gemcitabine and docetaxel.

Secondary

* Determine the toxicity of this regimen in these patients.
* Determine the overall survival of patients treated with this regimen.
* Determine the time to treatment failure and progression-free survival of patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients are stratified according to response to prior treatment with a platinum-containing regimen (platinum-resistant disease vs platinum-sensitive disease).

Patients receive gemcitabine IV over 30 minutes and docetaxel IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 3 additional courses beyond CR (≥ 6 total courses of treatment).

PROJECTED ACCRUAL: Approximately 36-62 patients (19-29 for stratum I \[platinum-resistant disease\] and 17-33 for stratum II \[platinum-sensitive disease\]) will be accrued for this study.

Arms: arm 1: Docetaxel, 40 mg/m2, 30 min IV infusion on Days 1 and 8, of a 21 day cycle Gemcitabine hydrochloride, 800mg/m2 30 min IV infusion on Days1 and 8, of a 21 day cycle
Interventions: intervention 1: Docetaxel intervention 2: Gemcitabine hydrochloride
Intervention descriptions: intervention 1: 40 mg/m2, 30 minute IV infusion, Days 1 and 8, Every 21 days intervention 2: 800mg/m2, 30 minute IV infusion, Days 1 and 8, every 21 days

Protocol documents:
Clinical trial NCT00509899
Conditions: Myelofibrosis Polycythemia Vera Thrombocytosis
Sponsor: Incyte Corporation
Start date: 2007-06-01; Completion date: 2017-02-01
Enrollment: 154 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To determine the safety, tolerability and effectiveness of ruxolitinib (INCB018424), administered orally to patients with Primary Myelofibrosis (PMF), Post Polycythemia Vera Myelofibrosis (PPV-MF) and Essential Thrombocythemia Myelofibrosis (PET-MF).

Detailed description:
This is a multicenter, open-label, non-randomized, dose escalation study of ruxolitinib, a small molecule Janus kinase (JAK) inhibitor, administered orally to patients with PMF, PPEV-MF or PET-MF. The study is comprised of 3 parts:

Part 1: Dose escalation and determination of maximum tolerated dose (complete).

Part 2: Exploration of alternative dosing schedules (complete).

Part 3: Further evaluation of selected dose regimens, including additional response measures to explore effect of ruxolitinib on symptoms and other parameters including daily physical activity and long-term survival (ongoing).

Arms: arm 1: All participants received oral ruxolitinib. Patients began treatment with either 10 mg twice a day (bid), 15 mg bid, 25 mg bid, 50 mg bid, 25 mg once a day (qd), 50 mg qd, 100 mg qd, or 200 mg qd, depending on the time period when they entered the study. The doses were titrated based on efficacy and safety to a maximum of 25 mg bid for patients who entered the study after sufficient dosing information had been obtained to define the maximum dose for patients in the study. Patients could continue receiving treatment indefinitely if receiving benefit at a dose that continues to maintain benefit but does not exceed a maximum dose of 25 mg BID.
Interventions: intervention 1: Ruxolitinib
Intervention descriptions: intervention 1: 5 and 25 mg tablets with a daily dosing range from 10 to 200 mg qd or bid.

Protocol documents: