ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00411151
Conditions: Gastric Adenocarcinoma Barrett Esophagus
Keywords: Adenocarcinoma of esophagogastric junction Adenocarcinoma of lower esophagus (Barrett carcinoma)
Sponsor: Johannes Gutenberg University Mainz
Start date: 2006-12-01; Completion date: 2009-08-01
Enrollment: 52 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This trial will be conducted to evaluate the efficacy, safety, and tolerability of sunitinib (sunitinib-malate) as a second-line palliative therapy in metastatic gastric cancer. Despite the efforts in front-line therapy, second-line protocols have not yet been established in randomized clinical trials for those patients. Although many patients are still in good performance status and present with low tumor burden after failure of first-line chemotherapy, they may clearly benefit from second-line treatment. Increasingly more metachronic metastatic patients are urging for new platinum-free therapeutic options due to the fast-growing use of (neo-) adjuvant platin-based protocols.

So far, only sparse data on chemotherapy are available after failure of platin-based protocols. Nearly only irinotecan-containing combinations have properly been analyzed, and produced excellent response rates and survival times of up to 30% and 7.6 months, respectively. However, irinotecan has not been approved yet for this indication. In addition, as irinotecan-containing regimens have been submitted for approval for first-line therapy, second-line regimens in irinotecan-refractory patients have not been evaluated in any trial. Thus, there is an urgent need to establish new second-line treatment options for both, cisplatinum- or irinotecan-combination refractory patients with advanced or metastatic gastric cancer.

Sunitinib inhibits the receptor tyrosine kinases (RTKs) involved in tumor proliferation and angiogenesis, specifically the VEGFR, PDGFR, KIT, FLT-3, and RET. The VEGF pathway has been shown to be a significant factor in metastatic gastric cancer. In gastric carcinoma cells, VEGF ligands and its receptors are definitely involved in the process of tumor progression. KDR and FLT-1 are expressed widely and VEGF stimulated KDR-positive tumor cell growth directly. The ligand VEGF-C has also been shown to be involved in progression of human gastric carcinoma, particularly via lymphangiogenesis. In addition, peritoneal metastases of some cancers such as gastric cancers were largely dependent on VEGF. Therefore, patients with chemo-refractory metastatic gastric cancer might benefit from VEGFR inhibitory therapy with sunitinib.

Detailed description:

Interventions: intervention 1: Sunitinib-Malate
Intervention descriptions: intervention 1: Capsules of 50, 25 or 12,5 mg. Dosage 50 mg, 37.5 mg or 25 mg once daily until progression of disease or untolerable side effects

Protocol documents:
Clinical trial NCT00426127
Conditions: Pancreatic Cancer
Keywords: Pancreatic Docetaxel Doxorubicin Enoxaparin
Sponsor: University of Iowa
Start date: 2006-11-01; Completion date: 2009-08-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the effects of the treatment combination of the commercially available chemotherapy drugs, docetaxel and liposomal doxorubicin, and a blood thinner Enoxaparin on pancreatic cancer. The main goal of the study is to find out if this combination chemotherapy and enoxaparin increases the number of individuals whose tumors shrink.

Detailed description:
The objective of the study is to determine the safety and efficacy of the combination of docetaxel and liposomal doxorubicin chemotherapy combined with enoxaparin in patients with advanced pancreatic cancer.

Docetaxel (TAXOTERE) belongs to the group of anticancer drugs called mitotic inhibitors. Liposomal doxorubicin (Doxil) is an anthracycline, and is thought to prevent nucleic acid synthesis that is needed to make DNA. Enoxaparin (Lovenox) is an anticoagulant. We are interested in combining chemotherapy with the blood thinner enoxaparin because there is a scientific link between blood clotting and malignancy.

This research is being done to improve on currently available chemotherapy treatments for advanced pancreatic cancer. The main goal of the study is to find out if this combination chemotherapy and enoxaparin increases the number of individuals whose tumors shrink. Another purpose of this study is to find out how this study treatment effects blood clotting levels in individuals. We will also determine the incidence of elevated D-dimer and the effect of this regimen on the level of D-dimer, and collect safety data on this regimen.

Arms: arm 1: Docetaxel 75 mg/m\^2 + Doxil 30 mg/m\^2 + Enoxaparin 1.5 mg/kg
Interventions: intervention 1: Docetaxel intervention 2: Liposomal Doxorubicin intervention 3: Enoxaparin
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00431067
Conditions: Breast Neoplasms
Sponsor: Boehringer Ingelheim
Start date: 2006-09-01; Completion date: 2009-08-01
Enrollment: 41 participants; Allocation: NON_RANDOMIZED; Intervention model: 

Brief summary:
The primary objective of this trial is to explore the efficacy of BIBW 2992 in HER2 positive metastatic breast cancer patients after failure of trastuzumab containing regimens.

Detailed description:

Arms: arm 1: BIBW 2992 (Afatinib) once daily until progression
Interventions: intervention 1: BIBW 2992
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00441558
Conditions: Sexual Dysfunctions, Psychological
Sponsor: Sprout Pharmaceuticals, Inc
Start date: 2007-02-01; Completion date: 2009-08-01
Enrollment: 1723 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To determine if long-term treatment with Flibanserin is safe and to monitor the effectiveness of Flibanserin in Women with HSDD that have already completed a previous study (511.70/71/.74/.75/.105) with Flibanserin.

Detailed description:

Arms: arm 1: flexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily.
Interventions: intervention 1: Flibanserin
Intervention descriptions: intervention 1: flexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily.

Protocol documents:
Clinical trial NCT00445588
Conditions: Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma Recurrent Adult Brain Tumor
Sponsor: National Cancer Institute (NCI)
Start date: 2007-01-01; Completion date: 2009-08-01
Enrollment: 56 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well giving erlotinib together with sorafenib works in treating patients with progressive or recurrent glioblastoma multiforme. Erlotinib and sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving erlotinib together with sorafenib may kill more tumor cells.

Detailed description:
PRIMARY OBJECTIVES:

I. The primary objective of this trial is to estimate the overall survival rate associated with this combined regimen in treating adult patients with recurrent glioblastoma multiforme.

SECONDARY OBJECTIVES:

I. To assess and estimate the toxicities. II. Tumor response rate. III. To estimate 6-month progression free survival. IV. To describe the pharmacokinetics of this route of administration. V. For the Molecular Targeted Combinations Correlative (MTC2) Study Initiative: To determine the relationship between tumor and blood biomarkers and clinical outcome of patients treated with the combination of targeted agents.

OUTLINE: This is a multicenter, open-label, phase II study.

Patients receive oral erlotinib hydrochloride once daily and oral sorafenib tosylate twice daily on days 1-28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.

Tumor tissue and blood samples are collected prior to beginning treatment. Samples are analyzed by immunohistochemistry, gene expression, and DNA mutation and genomic analyses of the epidermal growth factor receptor, ras-raf-ERK, and PI3K-Akt-mTOR pathways to identify markers that correlate with patient outcomes. Blood samples are also collected on day 15 of course 1 for pharmacokinetic studies. Samples are analyzed by reversed-phase isocratic high-performance liquid chromatography with electrospray ionization mass spectrometry to determine the concentration of erlotinib hydrochloride and sorafenib tosylate and its known metabolites.

After completion of study therapy, patients are followed every 2 months.

Arms: arm 1: Patients receive oral erlotinib hydrochloride 150mg once daily and oral sorafenib tosylate 400mg twice daily on days 1-28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.

Other: pharmacological study
Interventions: intervention 1: erlotinib hydrochloride intervention 2: sorafenib tosylate intervention 3: pharmacological study
Intervention descriptions: intervention 1: 150mg Given orally once daily intervention 2: 400mg Given orally twice daily intervention 3: Correlative studies

Protocol documents:
Clinical trial NCT00447005
Conditions: Carcinoma
Keywords: Safety PK Biomarker
Sponsor: Pfizer
Start date: 2007-02-01; Completion date: 2009-08-01
Enrollment: 12 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To evaluate the clinically recommended dose of AG-013736 (Axitinib) in Japanese patients by reviewing the safety of AG-013736 (Axitinib) following single and multiple dosing.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Axitinib (AG-013736)
Intervention descriptions: intervention 1: AG-013736 5mg twice daily \[BID\]

Protocol documents:
Clinical trial NCT00453999
Conditions: Influenza
Keywords: influenza flu
Sponsor: BioCryst Pharmaceuticals
Start date: 2007-07-01; Completion date: 2009-08-01
Enrollment: 137 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study has been designed as a randomized, double-blind, controlled, study to evaluate the efficacy and safety of two once daily intravenous peramivir regimens (200 mg and 400 mg) versus oral oseltamivir phosphate (75 mg twice daily) in hospitalized subjects with acute serious or potentially life threatening influenza. Study treatments will be provided for up to 5 consecutive days.

Detailed description:

Arms: arm 1: Peramivir 200 mg administered intravenously once daily for 5 days (5 doses) arm 2: Peramivir 400 mg administered intravenously once daily for 5 days (5 doses) arm 3: Oseltamivir 75 mg oral suspension administered orally twice daily for 5 days (10 doses)
Interventions: intervention 1: Peramivir 200 mg intervention 2: Peramivir 400 mg intervention 3: Oseltamivir
Intervention descriptions: intervention 1: Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment intervention 2: Peramivir (400 mg in 100 mL of solution ) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 ml) intervention 3: Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL)

Protocol documents:
Clinical trial NCT00461305
Conditions: Dysmenorrhea
Keywords: Dysmenorrhea Intracyclic bleeding Drospirenone (DRSP) Ethinylestradiol
Sponsor: Bayer
Start date: 2007-02-01; Completion date: 2009-08-01
Enrollment: 420 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate efficacy of ethinylestradiol for intracyclic bleeding profile in patients with dysmenorrhea and to investigate the long term safety

Detailed description:
The "drospirenone 3 mg/ethinylestradiol 20 μg (13 cycles)" group is to be treated by oral administration for 52 weeks, 13 cycles. The "drospirenone 3 mg/ethinylestradiol 30 μg (6 cycles)" group is to be treated by oral administration for 24 weeks, 6 cycles.

The trial is sponsored by Bayer Yakuhin, Ltd.

Arms: arm 1: 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles) arm 2: 1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
Interventions: intervention 1: DRSP 3 mg/EE 20 µg (13 cycles) intervention 2: DRSP 3 mg/EE 30 µg (6 cycles)
Intervention descriptions: intervention 1: 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles) intervention 2: 1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)

Protocol documents:
Clinical trial NCT00468104
Conditions: Pleural Effusion Associated With Pulmonary Infection Bacterial Pleural Effusion Other Than Tuberculosis
Keywords: parapneumonic pleural effusion empyema TPA (Activase, Alteplase)
Sponsor: Midwest Pulmonary and Critical Care
Start date: 2004-04-01; Completion date: 2009-08-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to document the efficacy and safety of intrapleural instillation of Activase vs Placebo in the management of complicated pleural effusions and empyemas

Detailed description:
The current treatments available for complicated pleural effusions (CPE) include chest tube placement for drainage and IV antibiotics. If this fails and CPE occurs then in most patients thoracotomy is performed. Patients that are not surgical candidates have image guided catheter placement performed, sometimes multiple times. The American College of Chest Physicians (ACCP) formed a CPE panel and published guidelines for treating CPE. Percutaneous image-guided drainage is the most common approach for CPE. The panel recognizes the cumulative data that supports the use of fibrinolytics, VATS, and thoracotomy. The CPE panel acknowledged the lack of randomized clinical trials to determine efficacy and safety of these modalities in CPE and strongly encourages the research to take place.

Fibrinolytic therapy is a relatively noninvasive, easy to use, and is relatively inexpensive. If successful, it will prevent sepsis and septic shock, decrease hospital stay, morbidity and mortality and prevent any surgical procedures. Multiple doses of fibrinolytics have been used in CPE with no evidence of systemic anti-fibrinolytic activity. Complications with these medications are also very uncommon and only isolated instances are reported. The benefit from successful pleural drainage using these agents will decrease morbidity, mortality, surgical procedures, and hospital stay.

Arms: arm 1: Either 25 mg of Alteplase or Placebo instilled daily. Response to therapy after three days. cross over to the other drug if no response was noted. arm 2: If the first arm fails then the 2nd arm ( cross over to either Placebo or Alteplase not used in the first arm) instilled intrapleurally daily for three days
Interventions: intervention 1: Alteplase intervention 2: Placebo
Intervention descriptions: intervention 1: 25 Mg of Alteplase in 100 cc of normal saline was instilled intrapeurally for daily for three days intervention 2: Placebo in 100 cc of normal saline was instilled intrapleurally daily for three days

Protocol documents:
Clinical trial NCT00471718
Conditions: Prostate Cancer
Keywords: adenocarcinoma of the prostate stage IV prostate cancer recurrent prostate cancer
Sponsor: Vanderbilt-Ingram Cancer Center
Start date: 2004-01-01; Completion date: 2009-08-01
Enrollment: 27 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as ABT-751, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase I/II trial is studying the side effects and best dose of ABT-751 and to see how well it works in treating patients with metastatic prostate cancer that did not respond to hormone therapy.

Detailed description:
OBJECTIVES:

Primary

* Evaluate the safety and efficacy of ABT-751 in patients with androgen-independent, hormone-refractory metastatic prostate cancer and determine the maximum tolerated dose (MTD) and optimal phase II dose of this drug in these patients.

Secondary

* Determine the objective response rate (partial and complete response) in patients with measurable disease treated with this drug.
* Evaluate the effect of this drug on prostate-specific antigen (PSA) response in patients with nonmeasurable disease.
* Determine the time to tumor progression in patients treated with this drug.
* Determine survival of patients treated with this drug.
* Determine the toxicity of this drug in these patients.

OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.

* Phase I: Patients receive oral ABT-751 twice daily on days 1-7 and 15-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of ABT-751 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Up to 50 additional patients may be treated at the recommended phase II dose (RPTD) which is the dose level at the maximally administered dose.

* Phase II: Patients receive ABT-751 at the MTD determined in phase I. After completion of study treatment, patients are followed every 3 months for 2 years.

PROJECTED ACCRUAL: A total of 53 patients will be accrued for this study.

Arms: arm 1: Phase I: Patients receive oral ABT-751 twice daily on days 1-7 and 15-21.

Phase II: Patients receive ABT-751 twice daily
Interventions: intervention 1: ABT-751
Intervention descriptions: intervention 1: Phase I:

Cohort \| Number of Patients \|Dose (mg) ABT-751 (BID)

* -1 \| 3-6 \|100 mg BID
* 1 \| 3-6 \|125 mg BID
* 2 \| 3-6 \|150 mg BID
* 3 \| 3-6 \|175 mg BID
* 4 \| 3-6 \|200 mg BID

Phase II:

Patients receive ABT-751 at 125mg po BID for 7 days on, 7 days off (X2) for a 28 day cycle

Protocol documents:
Clinical trial NCT00478777
Conditions: Relapsed or Refractory Multiple Myeloma
Keywords: CC-5013 Revlimid Lenalidomide Celgene Multiple Myeloma
Sponsor: Celgene Corporation
Start date: 2007-03-01; Completion date: 2009-08-01
Enrollment: 150 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This was a multicenter, open-label, single-arm phase 3B study of the combination lenalidomide plus pulse high-dose dexamethasone.

This study (CC-5013-MM-019) was set up and executed primarily as an expanded access program in Germany.

Screening procedures were to take place within 28 days prior to Cycle 1 Day 1 (baseline) with the exception of hematology assessments that were to be performed within 14 days prior to Cycle 1 Day 1. Randomization, blinding, and stratification were not applied in this open-label single-arm study.

Eligible subjects given open-label treatment and received treatment with lenalidomide plus high-dose dexamethasone in 28-day cycles.

Lenalidomide (hard capsules) was to be administered orally (PO) at a dose of 25 mg daily (QD) for the first 21 days of each 28-day cycle. According to the protocol, accrual of subjects to the study was to be terminated within 2 months of commercial availability of lenalidomide for this indication in Germany.

Upon discontinuation from study, minimal information was collected in order to identify when disease progressed.

Detailed description:

Arms: arm 1: Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), dexamethasone was to be reduced to 40 mg QD for Days 1-4 of each 28 day-cycle.
Interventions: intervention 1: Lenalidomide intervention 2: dexamethasone
Intervention descriptions: intervention 1: Oral lenalidomide at a dose of 25 mg daily for 21 days every 28 days. Treatment as tolerated until disease progression. intervention 2: Oral pulse dexamethasone at a dose of 40 mg daily on days 1-4, 9-12, and 17-20 for each 28-day-cycle for cycles 1 through 4 (approximately months 1-4). Beginning cycle 5 (approximately month 5) dexamethasone is reduced to 40 mg daily for days 1-4 every 28 days.

Protocol documents:
Clinical trial NCT00485693
Conditions: Postoperative Pain
Keywords: pain postoperative total knee arthroplasty analgesia
Sponsor: Pacira Pharmaceuticals, Inc
Start date: 2007-06-01; Completion date: 2009-08-01
Enrollment: 138 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Dose-ranging study for prolonged postoperative analgesia in subjects undergoing total knee arthroplasty

Detailed description:
This is a phase 2, multicenter, parallel-group, active-control, randomized, double-blind, dose-ranging study conducted to evaluate three dose levels of SKY0402 compared with 150 mg of bupivacaine HCl.

Arms: arm 1: Bupivacaine HCl (Marcaine 0.25% with epinephrine 1:200,000) arm 2: SKY0402 at various dosage levels. Single administration.
Interventions: intervention 1: Bupivacaine HCl intervention 2: SKY0402
Intervention descriptions: intervention 1: 150 mg Bupivacaine HCl intervention 2: 600 mg SKY0402 (study drug)

Protocol documents:
Clinical trial NCT00510224
Conditions: Prostate Cancer
Sponsor: University of California, San Francisco
Start date: 2007-07-01; Completion date: 2009-08-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open label, single center Phase II trial of Sandostatin LAR in patients with hormone refractory prostate cancer. Patients will receive Sandostatin LAR 30 mg intramuscularly every 28 days. Patients will be treated until the time of disease progression, unacceptable toxicity or withdrawal of consent. The study will require 27 evaluable patients.

Detailed description:
Primary Objective:

To evaluate changes in prostate specific antigen (PSA) in patients with androgen independent prostate cancer who are treated with Sandostatin LAR.

Secondary Objective:

To evaluate the effects of Sandostatin LAR on circulating levels of Insulin Growth Factor-1 and Insulin Growth Factor Binding Protein 1.

To evaluate the safety of Sandostatin LAR in this patient population. To evaluate the pre versus post treatment mitogenic effects of serum derived from subjects with prostate cancer compared to pretreatment serum.

Patients with androgen independent prostate cancer who do not have bone or visceral metastases are selected for this trial because they are a patient population that is likely to have no symptoms from the disease or rapid progression that would suggest the need for chemotherapy. Additionally, given the preclinical data suggesting that IGF-1 expression and signaling occurs concomitantly with the onset of androgen independent growth, it is felt that testing in the "early" androgen independent state is warranted. This trial is consistent with overall goal to develop IGF-1 targeted therapies in patients with disease progression and a lower disease burden.

Arms: arm 1: None
Interventions: intervention 1: Sandostatin
Intervention descriptions: intervention 1: Sandostatin 30mg intramuscular every 28 days

Protocol documents: