ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01358721
Conditions: Renal Cell Carcinoma
Sponsor: Bristol-Myers Squibb
Start date: 2011-09-23; Completion date: 2019-05-22
Enrollment: 119 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the pharmacodynamic and biologic properties of BMS-936558 in subjects with metastatic renal cell carcinoma.

Detailed description:
Intervention Model: Parallel Dose Comparison

Arms: arm 1: None arm 2: None arm 3: None arm 4: (treatment naive)
Interventions: intervention 1: BMS-936558 (Anti-PD-1) intervention 2: BMS-936558 (Anti-PD-1) intervention 3: BMS-936558 (Anti-PD-1)
Intervention descriptions: intervention 1: Solution, Intravenous infusion, 0.3 mg/kg, Every 3 weeks, Indefinitely depending on response intervention 2: Solution, Intravenous infusion, 2 mg/kg, Every 3 weeks, Indefinitely depending on response intervention 3: Solution, Intravenous infusion, 10 mg/kg, Every 3 weeks, Indefinitely depending on response

Protocol documents:
Clinical trial NCT01576588
Conditions: B-Cell Chronic Lymphocytic Leukemia
Keywords: Chronic lymphocytic leukemia, relapsed, elderly or unfit patients, methylprednisolone, rituximab
Sponsor: Prof. Dr. Med. Laimonas Griskevicius
Start date: 2011-10-01; Completion date: 2019-06-01
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The study will test the efficacy rituximab in addition to glucocorticoids for the treatment of B-CLL in elderly or unfit patients.

Detailed description:
Patient Population: Pretreated patients with symptomatic B-CLL 18-64 years of age with poor performance status or \>/=65 years of age with any performance status.

Treatment: Up-to 4 cycles of glucocorticoid (Methylprednisolone or Dexamethasone) and Rituximab every 21 day.

Study Duration: The study period for each subject is expected to be 21 months. Subjects will receive up-to 4 cycles of IV infusion of Rituximab and Glucocorticoid. Maximum duration of treatment is expected to be 6 months. Subjects will complete scheduled visits not later than Study Month 21, thereafter they will enter into the long-term follow-up period. Subjects will be followed every 3 months for disease progression, initiation of subsequent leukemia treatment or survival.

Arms: arm 1: Rituximab (Rtx) antibody infusions will be administered on Day 1, 2, 3 (cycle 1) and Day 1 (cycles 2 to 4).

Glucocorticoid (either Dexamethasone or Methyl-prednisolone) infusions will be administered on Days 1 to 3 (cycles 1-4(6)) and should precede the Rituximab infusion.
Interventions: intervention 1: Rituximab intervention 2: Glucocorticoid
Intervention descriptions: intervention 1: Rituximab (Rtx) antibody infusions will be administered on Day 1, 2, 3 (cycle 1) and Day 1 (cycles 2 to 4). intervention 2: Glucocorticoid (either Dexamethasone or Methyl-prednisolone) infusions will be administered on Days 1 to 3 (cycles 1-4(6)) and should precede the Rituximab infusion.

Protocol documents:
Clinical trial NCT01588821
Conditions: Lung Cancer Solid Tumor (Not Breast or Prostate Cancers)
Keywords: Metastatic Refractory Relapsed
Sponsor: Massachusetts General Hospital
Start date: 2012-06-01; Completion date: 2019-06-01
Enrollment: 37 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it-such as the safest dose to use, the side effects it may cause, and if the drug is effective for treating different types of cancer. It also means that the FDA has not approved the drug for this type of cancer, or for any use outside of research studies.

When cancer spreads from the primary tumor, one of the most commons sites it spreads to is bone. When cancer spreads to bone there can be significant symptoms such as pain.

Cabozantinib works by blocking signaling that leads to cancer growth as well as blocking the growth of new blood vessels (angiogenesis) that help to feed a tumor. Cabozantinib has been studied or is being studied in research studies as a possible treatment for various types of cancer, including prostate cancer, brain cancer, thyroid cancer, lung cancer and kidney cancer.

Previous clinical research studies indicate that cabozantinib may also have activity against cancer once it has spread to the bones.

The purpose of this study is to find out if cabozantinib is effective in treating cancer that has spread to the bone.

Detailed description:
Cabozantinib is a tablet that the subject will take by mouth. The subject will take it once per day. The study treatment with cabozantinib will be divided into 28 day cycles. A member of the study staff will give the subject a drug diary and explain to the subject how to use it to record doses of cabozantinib. This diary will also contain specific instructions about how the subject take cabozantinib.

Every 28 days the subject will undergo the following procedures: Physical examination, questions about any side effects the subject may have, blood samples for routine laboratory tests and research tests, urine sample, electrocardiogram (EKG), and questionnaires to measure quality of life and level of pain. Every two months the subject will undergo a CT scan or MRI to evaluate the subjects disease.

The investigators would like the subject to return to the study clinic for follow-up procedures about 4-5 weeks after the last dose of cabozantinib.

The subject can continue to receive the study drug for as long as their disease does not worsen and the subject do not experience unacceptable side effects.

Arms: arm 1: Cabozantinib
Interventions: intervention 1: Cabozantinib
Intervention descriptions: intervention 1: 60 mg daily by mouth

Protocol documents:
Clinical trial NCT01763164
Conditions: Metastatic or Unresectable Cutaneous Melanoma
Keywords: Melanoma Cutaneous melanoma Skin disease Skin cancer Skin Neoplasms Neoplasm Metastasis
Sponsor: Pfizer
Start date: 2013-07-12; Completion date: 2019-06-04
Enrollment: 402 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Two-arm, randomized, prospective, open-label, multi-center, phase III study to compare the efficacy and safety of MEK162 (45 mg BID) versus dacarbazine (1000 mg/m2 IV every 3 weeks) in patients with advanced (Stage IIIC) unresectable or metastatic (Stage IV) NRAS Q61 mutation-positive cutaneous or unknown primary melanoma. The mutation analysis will be performed at a central laboratory. Only those patients with Q61 mutation per central laboratory and meet all eligibility criteria will be randomized. A total of 393 patients will be randomized 2:1 to receive either MEK162 or dacarbazine. Patients will be stratified according to AJCC stage (IIIC, IVM1a, and IVM1b versus IVM1c), ECOG Performance status (0 versus 1) and any prior number of lines of immunotherapy (immunotherapies versus none). This study will use an Interactive Response Technology (IRT). The primary end point of the study is progression-free survival. Key secondary end point is overall survival

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: MEK162 intervention 2: Dacarbazine
Intervention descriptions: intervention 1: MEK162 will be administered as a fixed dose of 45 mg (3 x 15 mg tablets) BID, with a glass of water and taken with or without food. intervention 2: Patients randomized to dacarbazine will receive an IV infusion of dacarbazine 1000 mg/m2 over the course of 1 hour on day 1 and then every three weeks.

Protocol documents:
Clinical trial NCT02443883
Conditions: Gastric Adenocarcinoma Gastroesophageal Junction Adenocarcinoma
Keywords: stomach cancer
Sponsor: Eli Lilly and Company
Start date: 2015-07-07; Completion date: 2019-06-05
Enrollment: 164 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study was to evaluate the safety and pharmacokinetics of administering various dose regimens of ramucirumab in participants with advanced gastric cancer whose disease has progressed during or following prior chemotherapy.

Detailed description:

Arms: arm 1: Standard dose of 8 milligram per kilogram (mg/kg) ramucirumab given intravenously (IV) on day 1 and day 15 of each cycle (28-day cycle) until discontinuation criteria are met. arm 2: Experimental dose of 12 mg/kg ramucirumab given IV on day 1 and day 15 of each cycle (28-day cycle) until discontinuation criteria are met. arm 3: Experimental dose of 6 mg/kg ramucirumab given IV on day 1, 8, 15 and 22 of each cycle (28-day cycle) until discontinuation criteria are met. arm 4: Experimental dose of 8 mg/kg ramucirumab given IV on day 1 and day 8 of each cycle (21-day cycle) until discontinuation criteria are met.
Interventions: intervention 1: Ramucirumab
Intervention descriptions: intervention 1: Administered IV

Protocol documents:
Clinical trial NCT00520767
Conditions: Primary Systemic Amyloidosis Light Chain Deposition Disease
Keywords: primary systemic amyloidosis light chain deposition disease
Sponsor: Barbara Ann Karmanos Cancer Institute
Start date: 2007-09-01; Completion date: 2019-06-06
Enrollment: 35 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Giving bortezomib together with melphalan and dexamethasone may be an effective treatment for primary amyloidosis and light chain deposition disease.

PURPOSE: This phase II trial is studying how well giving bortezomib together with melphalan and dexamethasone works in treating patients with primary amyloidosis or light chain deposition disease.

Detailed description:
OBJECTIVES:

Primary

* Determine the complete hematologic response rate at 12 months.

Secondary

* Determine the overall hematologic response rate.
* Determine the organ response rate.
* Determine time to treatment failure.
* Determine the overall survival.

OUTLINE: This is a multicenter study.

Patients receive oral melphalan on days 1-4, bortezomib IV on days 1, 8, 15, and 22, and dexamethasone orally or IV on days 1, 2, 8, 9, 15, 16, 22, and 23. Treatment repeats every 4-6 weeks for up to 20 courses in the absence of disease progression or unacceptable toxicity.

Blood, urine, and bone marrow aspirates are collected at baseline and periodically after treatment to permit the correlation of clinical results with measured molecular events. A single baseline peripheral blood DNA sample is collected for future association studies linking disease onset, progression, and response to administered therapy with single nucleotide polymorphisms. Blood plasma and urine samples are evaluated for proteomic markers associated with disease progression and therapeutic response. Peripheral blood RNA samples are evaluated for transcriptional response to treatment of peripheral blood lymphocytes. Bone marrow aspirates are collected to extract plasma cells by flow cytometry for gene expression profiling.

Quality of life is assessed at the beginning of each course.

Arms: arm 1: Bortezomib 1.3 mg/m2 days 1, 8, 15, 22; Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23; Melphalan 9 mg/m2/day days 1-4
Interventions: intervention 1: bortezomib intervention 2: dexamethasone intervention 3: melphalan intervention 4: microarray analysis intervention 5: flow cytometry intervention 6: laboratory biomarker analysis intervention 7: quality-of-life assessment
Intervention descriptions: intervention 1: Bortezomib 1.3 mg/m2 days 1, 8, 15, 22 intervention 2: Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23 intervention 3: Melphalan 9 mg/m2/day days 1-4 intervention 4: ≤28 days prior to enrollment intervention 5: Day 1 of cycles 6, 12, 18 and at end of study. intervention 6: ≤28 days prior to enrollment intervention 7: Start of each cycle

Protocol documents:
Clinical trial NCT02402764
Conditions: Breast Cancer
Keywords: Triple Negative Breast Cancer (TNBC) Breast - Female Breast - Male Metastatic Triple Negative Breast Cancer Receptor Tyrosine-protein Kinase erbB-2 (HER2) Negative Erythroblastosis virus oncogene B (erbB)
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Start date: 2015-07-08; Completion date: 2019-06-06
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The main purpose of this study is to see whether the combination of selinexor (KPT-330) can help people with triple negative breast cancer (TNBC). Researchers also want to study the safety and tolerability of Selinexor in TNBC patients.

Detailed description:

Arms: arm 1: Screening period (which may last up to 28 days), followed by Selinexor treatment for qualified participants.

During the treatment period, participants will undergo physical examination every 2 weeks until Cycle 6 Day 1 (C6D1), and then every 4 weeks and assessment of tumor response every 8 weeks.

Participants will be treated until progression of disease or the development of unacceptable toxicities. All participants will then undergo a final visit (end of treatment visit).
Interventions: intervention 1: Selinexor
Intervention descriptions: intervention 1: Participants will receive selinexor twice weekly on Monday/Wednesday, Tuesday/Thursday or Wednesday/Friday of Weeks 1, 2 and 3 of each 4-week cycle. Selinexor will not be taken during Week 4. One cycle is defined as 28 days or 6 doses. The starting dose for this trial is 60 mg (flat dose as long as their dose-based body surface area (BSA) analysis does not exceed 70 mg/m\^2).

Protocol documents:
Clinical trial NCT00598481
Conditions: Immunologic Deficiency Syndromes
Keywords: SCID gene therapy Adenosine deaminase retroviral vector
Sponsor: Fondazione Telethon
Start date: 2002-10-02; Completion date: 2019-06-19
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a phase I/II protocol to evaluate the safety and efficacy of ADA gene transfer into hematopoietic stem/progenitor cells for the treatment of adenosine deaminase (ADA)-deficiency. This condition is an autosomal recessive form of Severe Combined Immunodeficiency (SCID) characterized by impaired immune responses, recurrent infections, failure to thrive and systemic toxicity due to accumulation of purine metabolites. Transplants from an human leukocyte-antigen (HLA)-identical sibling donor is the treatment of choice, but available for a minority of patients. The use of alternative bone marrow donors or enzyme replacement therapy is associated with important drawbacks. The drug product studied in this protocol consists of autologous cluster of differentiation (CD)34+ hematopoietic stem/progenitor cells engineered ex vivo with a retroviral vector encoding the therapeutic gene ADA. The engineered CD34+ cells are infused following a nonmyeloablative conditioning with busulfan to make space in the bone marrow. The study objectives are: a) to evaluate the safety and the clinical efficacy of gene therapy, in the absence of enzyme replacement therapy; b) to evaluate the biological activity (engraftment, ADA expression) of ADA transduced CD34+ cells and their hematopoietic progeny. c) to evaluate the immunological reconstitution and purine metabolism after gene therapy.

Detailed description:
The safety of the study will be evaluated by description of all adverse events and adverse drug reactions.

The study is aimed at reaching the minimum sample size of ten patients.

Arms: arm 1: Infusion of autologous CD34+ cells transduced with retroviral vector encoding ADA after non-myeloablative conditioning with busulfan
Interventions: intervention 1: Gene Therapy intervention 2: Busulfan
Intervention descriptions: intervention 1: Infusion of autologous CD34+ cells transduced with retroviral vector encoding ADA after non-myeloablative conditioning with busulfan intervention 2: Busulfan is used for non-myeloablative conditioning

Protocol documents:
Clinical trial NCT00853372
Conditions: Advanced Renal Cell Carcinoma
Sponsor: Amgen
Start date: 2009-05-28; Completion date: 2019-06-25
Enrollment: 85 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This phase 2 study is an open-label, multi-center study to determine the safety and tolerability of AMG 386 in combination with sunitinib in the treatment of subjects with metastatic renal cell carcinoma.

Detailed description:

Arms: arm 1: Trebananib 10 mg/kg intravenously (IV) once weekly (QW) plus sunitinib 50 mg orally (PO) once daily (QD) 4 weeks on/2 weeks off arm 2: Trebananib 15 mg/kg IV QW plus sunitinib 50 mg PO QD 4 weeks on/2 weeks off
Interventions: intervention 1: Sunitinib intervention 2: Trebananib
Intervention descriptions: intervention 1: Sunitinib will be administered 50 mg QD and is considered to be the background therapy as it is licensed for treatment of reneal cell cancer (RCC) and will be administered to all participants. intervention 2: Administered until a participant develops disease progression, clinical progression, unacceptable toxicity, withdraws consent, or death.

Protocol documents:
Clinical trial NCT03544242
Conditions: Diabetes
Keywords: Diabetes Insulin Resistance Nitrite Pancreatic islet cells Autotransplantation Ischemia reperfusion injury Mitigation Cure Nitric oxide Sodium nitrite Islet cell Survival Pancreas Liver
Sponsor: University of Alabama at Birmingham
Start date: 2017-05-07; Completion date: 2019-06-27
Enrollment: 4 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study seeks to investigate the effects of administering nitrite to pancreatic islet cells that have been removed from a patient for autotransplantation.

Detailed description:
Patients diagnosed with chronic pancreatitis or recurrent acute pancreatitis may acquire insulin-dependent diabetes due to islet cell destruction. Therefore, islet cell autotransplantation is the optimal therapeutic approach for many of these patients. Islet cell autotransplantation is typically done by excision of the pancreas, followed by isolation of the islet cells and then infusion of these cells into the sinusoids of the liver. Isolation of the islet cells occurs in an ischemic and hypoxic environment, resulting in ischemia reperfusion (IR) injury and destruction of islet cells following infusion into the sinusoids. Hence, strategies to prevent IR injury and subsequent islet cell destruction, such as the administration of inhaled nitric oxide (NO) or sodium nitrite (NaNO2) could enhance islet cell survival following reperfusion, also decreasing long-term insulin requirement. The purpose of this study is to determine if NO administered by infusion in patients undergoing islet cell auto transplantation, will inhibit islet cell destruction, increase diabetes cure rate (decrease the amount of and/or the need for long-term insulin requirement), decrease the ischemic injury (reduces the injury to the islet cells from a decrease in oxygen levels during procurement of the islet cells) during islet cell procurement, and decrease IR injury following islet cell infusion. The primary endpoints of the study are exogenous insulin use, HgbA1c levels post-operatively, and blood glucose levels.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Control intervention 2: Pre-Isolation Infusion intervention 3: Post-Isolation Infusion
Intervention descriptions: intervention 1: A saline infusion will be administered during the pre-isolation and post-isolation phases. intervention 2: A nitrite infusion will be administered during the pre-isolation phase and a saline infusion will be administered during the post-isolation phase. intervention 3: A saline infusion will be administered during the pre-isolation phase and a nitrite infusion will be administered during the reperfusion phase.

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT00137839
Conditions: Adenocarcinoma Non-small Cell Lung Cancer
Keywords: Tarceva Erlotinib OSI-774 Adenocarcinoma Advanced Lung Cancer
Sponsor: Pasi A. Janne, MD, PhD
Start date: 2004-11-01; Completion date: 2019-07-01
Enrollment: 84 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this trial is to figure out what effects (good or bad) the investigational drug agent called Tarceva (erlotinib; OSI-774) has on women with previously untreated adenocarcinoma.

Detailed description:
Patients will start taking Tarceva daily by mouth on Day 1 and will continue taking this medication daily at home, until participation in the study ends.

Arms: arm 1: Erlotinib: 150 mg orally once daily without interruption Cycle duration considered 4 weeks and treatment duration indefinite until disease progression, unacceptable toxicity or withdrawal for other reasons.
Interventions: intervention 1: Erlotinib
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01251536
Conditions: Colorectal Cancer
Keywords: colorectal cancer K-Ras wildtype first line metastatic standard cetuximab + FOLFIRI dose escalation cetuximab
Sponsor: Universitaire Ziekenhuizen KU Leuven
Start date: 2010-12-01; Completion date: 2019-07-01
Enrollment: 108 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purposes of this study are to determine whether administering escalating doses of cetuximab in patients with no early skin toxicity could delay the progression of disease in a significant proportion of patients and to study the molecular signatures of response.

Detailed description:
Colorectal carcinoma (CRC) is the third most common form of cancer worldwide and remains a leading malignancy both in incidence and mortality.

In the light of existing knowledge, the investigators propose a phase II open label, two arm study in patients presenting with K-Ras wild-type metastatic colorectal tumours in the first line setting. The standard combination of irinotecan plus infusional 5-FU/LV (FOLFIRI) and cetuximab will be given to all patients entering the study. As the investigators hypothesize that increasing the dose of cetuximab might increase the intensity of skin reactions that directly correlates with outcome, in patients experiencing no skin toxicity, the dose of cetuximab will be escalated from 250 mg/m2 to 350 mg/m2 and then up to 500 mg/m2, in order to better define the effect of dose escalation in the first-line setting in a K-Ras wild type tumour population and in an attempt to increase efficacy.

Pharmacokinetic studies will be performed to document PK parameters of cetuximab in patients from both arms in selected centers.

Translational research studies are planned for all patients. Some more in depth molecular testing will be performed in a subset of patients from whom three serial tissue samples from accessible metastases by biopsy are available.

Arms: arm 1: Patients with skin toxicity grade 1-4 or other significant toxicity who are not eligible for dose escalation will continue on the standard dose of cetuximab 250 mg/m2 weekly. No comparison between arms was planned. arm 2: Patients with skin toxicity grade 0 will follow an increasing dose schedule: on days 22 and 29 they will receive 350 mg/m2 and from day 36 onwards, 500 mg/m2 weekly.
Interventions: intervention 1: Dose escalation of cetuximab intervention 2: Standard first line treatment with cetuximab + Folfiri
Intervention descriptions: intervention 1: Dose, frequency \& treatment mode: 400 mg/m2 (loading at day 1) followed by 250 mg/m2 weekly (at day 8 and 15)

Arm allocation at day 22:

Patients with skin toxicity grade 0 will follow an increasing dose schedule: on days 22 and 29 they will receive 350 mg/m2 and from day 36 onwards, 500 mg/m2 weekly intervention 2: Dose, frequency \& treatment mode: 400 mg/m2 (loading at day 1) followed by 250 mg/m2 weekly (at day 8 and 15)

Arm allocation at day 22:

Patients with skin toxicity grade 1-4 or other significant toxicity who are not eligible for dose escalation will continue on the standard dose of cetuximab: 250 mg/m2 weekly.

Protocol documents: