ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01432951
Conditions: Solid Tumor Lymphoma, Malignant
Sponsor: Eli Lilly and Company
Start date: 2011-11-01; Completion date: 2018-01-05
Enrollment: 26 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the pharmacokinetics (PK) of enzastaurin and its metabolites in native Chinese participants with advanced and/or metastatic solid tumors or lymphoma. Information about any side effects that may occur will also be collected. Treatment of disease is not the main purpose of the study.

This is a Phase 1 study of enzastaurin in native Chinese participants with advanced and/or metastatic solid tumors or lymphoma. Participants will receive daily doses of enzastaurin for 14 days, stop dosing for 3 days during PK sampling, and resume dosing on Day 18. Participants may be allowed to receive enzastaurin for approximately 2 to 4 weeks after day 18 to provide an opportunity for a participant's oncologist to assess the potential benefit of the participant continuing to receive enzastaurin in the safety extension phase. There is no planned duration for the extension phase; participants are allowed to continue receiving enzastaurin until disease progression or other reason for discontinuation as per the investigator's assessment.

Detailed description:

Arms: arm 1: Enzastaurin 500 mg, four 125-mg tablets administered orally once daily for 14 days. Dosing is held for 3 days, and resumes on Day 18. Participants may continue receiving optional enzastaurin for an additional 2 to 4 weeks.

Safety Extension: Participants had the option to continue receiving enzastaurin until disease progression or discontinuation criteria are met, as per the investigator's assessment.
Interventions: intervention 1: Enzastaurin
Intervention descriptions: intervention 1: Administered orally

Protocol documents:
Clinical trial NCT02576951
Conditions: Healthy
Sponsor: Eli Lilly and Company
Start date: 2015-10-19; Completion date: 2018-01-08
Enrollment: 178 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purposes of this study are:

* To evaluate tolerability of the Galcanezumab solution injectable formulation (Part A)
* To measure how much of the Galcanezumab lyophilized (freeze dried) injectable formulation is absorbed into the blood stream and how long it takes the body to get rid of it compared to the Galcanezumab solution injectable formulation after a single injection under the skin (subcutaneous \[SC\]) (Part B).

Information about any side effects that may occur will also be collected. Each part of the study will last about six months. Participants may only enroll in one part.

Detailed description:

Arms: arm 1: Galcanezumab solution formulation in a prefilled syringe given SC once. arm 2: Placebo in a prefilled syringe given SC once. arm 3: Galcanezumab lyophilized (freeze dried) formulation given SC once. arm 4: Galcanezumab solution formulation in a prefilled syringe given SC once.
Interventions: intervention 1: Galcanezumab intervention 2: Placebo
Intervention descriptions: intervention 1: Administered SC intervention 2: Administered SC

Protocol documents:
Clinical trial NCT01349049
Conditions: Acute Myeloid Leukemia
Keywords: AML relapsed refractory
Sponsor: Daiichi Sankyo
Start date: 2011-11-21; Completion date: 2018-01-09
Enrollment: 90 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
The purpose of this study is to evaluate the safety of study drug PLX3397 at 3 dose levels (800 mg/day, 1000 mg/day, and 1200 mg/day) and explore the efficacy in patients with relapsed or refractory acute myeloid leukemia (AML). Additional dose levels beyond 1200 mg/day may be considered based on safety and efficacy observations.

Detailed description:
Protocol PLX108-05 is a Phase 1/2 open-label, sequential dose escalation (Part 1) followed by cohort expansion (Part 2) design at the recommended phase 2 dose established in Part 1 (i.e. 3,000 mg/day). Treatment with PLX3397 will consist of continuous oral administration in 28-day cycles until unacceptable or dose-limiting toxicity, disease progression or relapse, patient death, Investigator decision, or voluntary withdrawal.

Arms: arm 1: Subjects will be dosed at the recommended Phase 2 dose (RP2D) arm 2: Level 0 arm 3: Level 1 arm 4: Level 2 arm 5: Level 3 arm 6: Level 4 arm 7: Level 5 arm 8: Level 6 arm 9: Level 7
Interventions: intervention 1: PLX3397 intervention 2: PLX3397
Intervention descriptions: intervention 1: Maximum Tolerated Dose of PLX3397 will be administered orally, twice daily. intervention 2: The drug product is available in capsule form, to be taken orally.

Protocol documents:
Clinical trial NCT00278343
Conditions: Recurrent Fallopian Tube Cancer Recurrent Ovarian Epithelial Cancer Recurrent Primary Peritoneal Cavity Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2006-04-01; Completion date: 2018-01-15
Enrollment: 74 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well cediranib maleate works in treating patients with persistent, recurrent, or refractory advanced ovarian epithelial, peritoneal cavity, or fallopian tube cancer. Cediranib maleate may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. Objective tumor response rate (complete plus partial response plus stable disease \> 16 weeks as defined by the Response Evaluation Criteria in Solid Tumors \[RECIST\] criteria) in women with recurrent or refractory advanced ovarian or primary peritoneal cancer.

SECONDARY OBJECTIVES:

I. Time to disease progression, median survival time, and duration of overall cancer antigen (CA)-125 response.

OUTLINE:

Patients receive cediranib maleate orally (PO) once daily (QD) every 4 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 4 weeks and then every 3 months thereafter.

Arms: arm 1: Patients receive cediranib maleate PO QD every 4 weeks in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: cediranib maleate intervention 2: laboratory biomarker analysis
Intervention descriptions: intervention 1: 30mg given PO, daily intervention 2: Correlative studies

Protocol documents:
Clinical trial NCT02643394
Conditions: Postoperative Pain
Keywords: Acetaminophen Postoperative pain Sinus Surgery
Sponsor: University of Texas Southwestern Medical Center
Start date: 2015-08-17; Completion date: 2018-01-15
Enrollment: 110 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The comparative efficacy of intravenous (IV) to oral (PO-'per os') acetaminophen in the management of postoperative pain is understudied and largely unknown. In this observer blinded randomized clinical trial, investigators aim to determine the comparative efficacy of PO (preoperative) vs. IV (intraoperative) acetaminophen in a sinus surgery population.

Detailed description:
The comparative efficacy of intravenous (IV) to oral (PO-'per os') acetaminophen is understudied and largely unknown. Intravenous acetaminophen has been available since 2010 (http://www.accessdata.fda.gov/drugsatfda\_docs/label/2010/022450lbl.pdf) and has proven superiority over placebo in human clinical trials. It is clearly advantageous in patients who cannot take oral medications. Similarly, oral acetaminophen has proven efficacy in the management of postoperative pain.

However, in patients who can receive either formulation the incremental cost of the IV formulation, both to the Health System and patient, is substantial. This incremental cost would be justifiable if there were clear efficacy or safety data to support the preferential use of IV over PO acetaminophen.

However, there is no evidence of superior safety and there are only two studies to our knowledge investigating the question of comparative efficacy. Fenlon et al. randomized 130 patients undergoing 3rd molar (i.e., wisdom tooth) removal to IV vs. PO acetaminophen and found that PO acetaminophen was non-inferior to IV acetaminophen. The primary endpoint was postoperative pain score 1h after surgery. No safety concerns were identified in either group. Pettersson et al. randomized cardiac surgery patients to IV or PO acetaminophen, starting immediately postoperatively through the following morning, and found a significant opioid sparing effect of IV acetaminophen but no difference in pain scores or nausea.

IV acetaminophen avoids first-pass hepatic metabolism and therefore generates higher serum and cerebrospinal fluid (CSF)/brain levels than does PO acetaminophen (http://ofirmev.com/Pharmacokinetics/). Based on the pharmacokinetic data, one can hypothesize that IV acetaminophen would be superior to PO acetaminophen at time points where serum and/or cerebrospinal fluid drug levels are higher.

Arms: arm 1: Oral Acetaminophen 1-hour before surgery arm 2: Intravenous Acetaminophen within 1-hour prior to anesthetic emergence
Interventions: intervention 1: Oral Acetaminophen intervention 2: Intravenous acetaminophen
Intervention descriptions: intervention 1: 1000mg oral acetaminophen + 400mg oral celecoxib given within one hour of incision intervention 2: 400mg oral celecoxib given within one hour of incision + 1000mg IV acetaminophen within one hour prior to anesthetic emergence.

Protocol documents:
Clinical trial NCT02675998
Conditions: Hyperphosphatemia
Sponsor: Ardelyx
Start date: 2016-01-01; Completion date: 2018-01-17
Enrollment: 219 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This phase 3, 8-week, randomized, double-blind, parallel group, multi-center study with a 4-week, placebo-controlled, randomized withdrawal period will evaluate the efficacy, safety and tolerability of Tenapanor to treat hyperphosphatemia in end-stage renal disease patients on hemodialysis (ESRD-HD). Subjects who qualify are randomized into the study will either receive 3 mg BID, 10 mg BID, or a titration regimen of tenapanor.

Detailed description:
The study consists of a screening visit, a wash out period of up to 3 weeks, when existing phosphate lowering medication is withheld, an 8-week treatment period, in which all groups receive tenapanor, and a 4-week placebo-controlled, randomized withdrawal period, during which patients are re-randomized 1:1 to either remain on their current tenapanor treatment or placebo.

Depending on the increase in serum phosphate levels, subjects can be randomized 1,2, or 3 weeks after being taken off their phosphate lowering medication.

Arms: arm 1: Tenapanor, 3mg BID (6mg total) arm 2: Tenapanor, 10mg BID (20mg total) arm 3: Tenapanor, patients start at 30mg BID and can down titrate weekly to 20, 15, 10, and 3mg BID, sequentially based on a GI tolerability question arm 4: Placebo
Interventions: intervention 1: Tenapanor intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02391116
Conditions: Diffuse, Large B-Cell, Lymphoma
Sponsor: Bayer
Start date: 2015-05-08; Completion date: 2018-01-19
Enrollment: 67 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To assess the potential efficacy (in terms of objective response) of single agent copanlisib in patients with relapsed or refractory Diffuse large B-cell lymphoma (DLBCL) and assess the relationship between efficacy and a potentially predictive biomarker

Detailed description:

Arms: arm 1: Copanlisib (Aliqopa, BAY80-6946) solution for IV infusion (test drug/investigational medicinal product)
Interventions: intervention 1: Copanlisib (Aliqopa, BAY80-6946)
Intervention descriptions: intervention 1: Participants assigned to receive copanlisib intravenous (IV) infusion at a dose of 60 mg as single agent on Days 1, 8, and 15 of 28-day treatment cycle. Copanlisib treatment was to be continued until disease progression (PD), unacceptable toxicity, or until another criterion was met for withdrawal from the study treatment

Protocol documents:
Clinical trial NCT01597193
Conditions: Breast Cancer
Keywords: enzalutamide MDV3100 breast cancer
Sponsor: Pfizer
Start date: 2012-04-30; Completion date: 2018-01-22
Enrollment: 101 participants; Allocation: NON_RANDOMIZED; Intervention model: 

Brief summary:
The purpose of this study is to determine the safety, tolerability and pharmacokinetics of enzalutamide alone and in combination with anastrozole, or exemestane, or fulvestrant in patients with incurable breast cancer.

Detailed description:

Arms: arm 1: enzalutamide be provided as two or four 40-mg capsules by mouth daily arm 2: enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily in combination with anastrozole (1 mg) administered as one 1-mg tablet by mouth once daily. arm 3: enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily in combination with exemestane administered as one 25-mg tablet daily arm 4: enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily in combination with exemestane administered as two 25-mg tablets daily arm 5: enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily in combination with fulvestrant (500 mg) administered as two 250-mg intramuscular injections every 28 days
Interventions: intervention 1: enzalutamide intervention 2: anastrozole intervention 3: exemestane intervention 4: fulvestrant intervention 5: enzalutamide intervention 6: exemestane
Intervention descriptions: intervention 1: 80 mg (2 capsules) or 160 mg (4 capsules) taken orally daily. intervention 2: 1 mg/day intervention 3: The exemestane dose is 25mg daily. intervention 4: 500 mg every 28 days intervention 5: 160 mg (4 capsules) taken orally daily. intervention 6: The exemestane dose is 50 mg daily.

Protocol documents:
Clinical trial NCT01721109
Conditions: Acquired Immunodeficiency Syndrome HIV Infections
Keywords: Adolescents HIV-1 HIV Treatment Naive
Sponsor: Gilead Sciences
Start date: 2012-12-06; Completion date: 2018-01-29
Enrollment: 50 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objectives of this study are to evaluate the steady-state pharmacokinetics (PK) and confirm the dose of the elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF) single-tablet regimen (STR) (Part A) and to evaluate the safety and tolerability of EVG/COBI/FTC/TDF STR through Week 48 (Part B) in HIV-1 infected, antiretroviral (ARV) treatment-naive adolescents.

A total of 50 adolescent participants (12 to \< 18 years of age) will be enrolled to receive EVG/COBI/FTC/TDF as follows:

* Part A: Twelve to 16 eligible participants will be enrolled to evaluate steady-state PK, and confirm the dose, with the intent to enroll at least 4 participants 12 to \< 15 and at least 4 participants 15 to \< 18 years of age.
* Part B: Following confirmation of EVG exposure in at least 12 participants from Part A, 34 to 38 participants in addition to those enrolled in Part A will be enrolled to evaluate the safety, tolerability, and antiviral activity of EVG/COBI/FTC/TDF STR.

Detailed description:

Arms: arm 1: Participants will receive treatment for 48 weeks and then had the option to enter an Extension Phase to receive EVG/COBI/FTC/TDF until 1) the age of 18, 2) EVG/COBI/FTC/TDF becomes commercially available in the country the participant is enrolled, or 3) Gilead elects to terminate the development of EVG/COBI/FTC/TDF in that country.
Interventions: intervention 1: EVG/COBI/FTC/TDF
Intervention descriptions: intervention 1: 150/150/200/300 mg STR administered orally once daily with food

Protocol documents:
Clinical trial NCT00064077
Conditions: Cervical Adenocarcinoma Cervical Adenosquamous Carcinoma Cervical Squamous Cell Carcinoma Recurrent Cervical Carcinoma Stage IVB Cervical Cancer
Sponsor: Gynecologic Oncology Group
Start date: 2003-05-01; Completion date: 2018-01-30
Enrollment: 513 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized phase III trial is studying four combination chemotherapy regimens using cisplatin to compare how well they work in treating women with stage IVB, recurrent, or persistent cancer of the cervix. Drugs used in chemotherapy such as cisplatin, paclitaxel, vinorelbine, gemcitabine, and topotecan, use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen containing cisplatin is most effective in treating cervical cancer.

Detailed description:
PRIMARY OBJECTIVES:

I. Compare the survival and response of patients with stage IVB, recurrent, or persistent carcinoma of the cervix when treated with paclitaxel and cisplatin vs vinorelbine and cisplatin vs gemcitabine and cisplatin vs topotecan and cisplatin.

II. Compare the toxic effects of these regimens in these patients. III. Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 4 treatment arms.

ARM I: Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2.

ARM II: Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1.

ARM III: Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II.

ARM IV: Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II.

In all arms, treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, before courses 2 and 5, and at 9 months after study entry.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Arms: arm 1: Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2. arm 2: Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1. arm 3: Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II. arm 4: Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II.
Interventions: intervention 1: Cisplatin intervention 2: Gemcitabine Hydrochloride intervention 3: Paclitaxel intervention 4: Quality-of-Life Assessment intervention 5: Topotecan Hydrochloride intervention 6: Vinorelbine Tartrate
Intervention descriptions: intervention 1: Given IV intervention 2: None intervention 3: Given IV intervention 4: Ancillary studies intervention 5: Given IV intervention 6: Given IV

Protocol documents:
Clinical trial NCT00300781
Conditions: Breast Neoplasms Neoplasms
Keywords: phase 2 HER2+ breast cancer monotherapy neratinib HKI-272 Neratinib Nerlynx PB-272
Sponsor: Puma Biotechnology, Inc.
Start date: 2006-08-04; Completion date: 2018-01-30
Enrollment: 136 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to learn whether neratinib is safe and effective in treating women with advanced human epidermal growth factor receptor 2 (HER2) positive breast cancer.

Detailed description:
Arm A: HER2 gene amplification and disease progression following at least 6 weeks of standard doses of Herceptin; Arm B: HER2 gene amplification and no prior Herceptin or HER2-targeted treatment.

Arms: arm 1: Neratinib administered with 80 mg capsules and 40 mg coated tablets taken orally in prescribed dose of 240 mg daily, as long as tolerated and disease does not worsen. arm 2: Neratinib administered with 80 mg capsules and 40 mg coated tablets taken orally in prescribed dose of 240 mg daily, as long as tolerated and disease does not worsen.
Interventions: intervention 1: neratinib
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00325416
Conditions: Multiple Myeloma
Keywords: melphalan topotecan topoisomerase bone marrow transplant drug sequence
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Start date: 2001-11-19; Completion date: 2018-01-30
Enrollment: 177 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to determine the safest dose of topotecan when given in a high dose before a stem cell transplant; topotecan will be given with melphalan.

Detailed description:
The stem cells being transplanted are cells found in the bone marrow and blood that are responsible for making red blood cells, white blood cells, and platelets. The stem cells are collected by a process called leukapheresis and will be frozen for later use. After receiving the chemotherapy drugs, the stem cells will be thawed and given like a blood transfusion. This is called autologous stem cell transplant or rescue. The study doctors will be measuring how well the disease responds to the drugs as well as any side effects to the drugs. During the course of this study, blood and bone marrow samples will be obtained to measure levels of the chemotherapy drugs as well as levels of certain enzymes (proteins).

The staff of the Blood and Marrow Transplant program will continue to collect information about the participant's disease and its treatment for the rest of their life.

Arms: arm 1: Participants 18 - 60 years of age. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant. arm 2: Participants 61 years of age or older. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.
Interventions: intervention 1: melphalan intervention 2: topotecan (TPT) intervention 3: Autologous Stem Cell Rescue
Intervention descriptions: intervention 1: (Days -4,-3,-2) 50 mg/m\^2/day IV over 30 minutes (total dose 150 mg/m\^2) intervention 2: Phase I Dose Escalation: Level 1 - 20 mg/m\^2; Level 2 - 30 mg/m\^2; Level 4 - 54 mg/m\^2; Level 5 - 72 mg/m\^2; Level 6 - 96 mg/m\^2; Level 7 - 127.8 mg/m\^2; Level 8 - 170.1 mg/m\^2

Phase II: Treatment at maximum tolerated dose (MTD) intervention 3: Day 0

Protocol documents: