ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01313689
Conditions: Leukaemia
Keywords: OMB157 Lymphocytic Chronic Safety Refractory Chronic Lymphocytic Leukemia Oncology Ofatumumab Efficacy Physicians' Choice Bulky Fludarabine Refractory Chronic Lymphocytic Leukemia CLL
Sponsor: Novartis Pharmaceuticals
Start date: 2011-04-14; Completion date: 2017-04-24
Enrollment: 122 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to confirm the clinical benefit observed in the pivotal registration study, Hx-CD20-406. The Committee for Medicinal Products for Human Use (CHMP) required that a randomized study be conducted in CLL patients with bulky fludarabine-refractory disease as a specific obligation for grant of conditional approval for ARZERRA™ in the European Union (EU). This study compared ofatumumab with the physicians' choice of therapy.

Detailed description:
Patients with CLL that is refractory to fludarabine have few treatment options and a poor prognosis. There is a continued need for new therapies for these CLL patients, as demonstrated by the limited responses and substantial toxicities with existing therapies. This is supported by the lack of a consensus around standard of care treatment for CLL patients with bulky fludarabine-refractory disease. The objective of this study was to confirm the response rate and disease control in the refractory setting through a controlled trial comparing ofatumumab with the physicians' choice of therapy in fludarabine-refractory, bulky lymphadenopathy patients. After 24 weeks of treatment with ofatumumab, patients were further randomized to either extended ofatumumab treatment or observation. Patients on the physicians' choice arm had the option of receiving ofatumumab if they experience progressive disease.

Arms: arm 1: Biological arm 2: Physicians' choice of treatment
Interventions: intervention 1: Ofatumumab intervention 2: Physicians' Choice
Intervention descriptions: intervention 1: Ofatumumab IV, initial dose 300 mg, followed 1 week later with 2000 mg once weekly for 7 weeks, followed 4 weeks later by one infusion of 2000 mg every 4 weeks for 4 infusions, for a total of 12 infusions over 24 weeks. After 24 weeks of ofatumumab treatment, patients who have achieved at least stable disease or better, and whom the investigator would deem appropriate for the therapy to continue, would undergo a second randomisation (2:1) to either 1) an additional ofatumumab dose regimen of 2000 mg once every 4 weeks for up to an additional 24 weeks, or 2) no further therapy (i.e. observation only). intervention 2: Non-ofatumumab containing regimen as per physicians' choice for up to 6 months. Permitted therapies include treatments approved for CLL, and well established standards of care for CLL.

Protocol documents:
Clinical trial NCT00445692
Conditions: DS Stage I Plasma Cell Myeloma DS Stage II Plasma Cell Myeloma DS Stage III Plasma Cell Myeloma Refractory Plasma Cell Myeloma
Sponsor: Fred Hutchinson Cancer Center
Start date: 2007-01-10; Completion date: 2017-04-24
Enrollment: 32 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies lenalidomide, dexamethasone, and clarithromycin in treating patients who have undergone stem cell transplant for multiple myeloma. Biological therapies, such as lenalidomide and clarithromycin, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with dexamethasone and clarithromycin may be an effective treatment for multiple myeloma.

Detailed description:
PRIMARY OBJECTIVES:

I. Evaluate the toxicity of the use of lenalidomide/biaxin (clarithromycin)/dexamethasone as maintenance therapy after autologous/syngeneic transplant.

II. Evaluate the median time to disease progression. III. Evaluate survival.

OUTLINE:

Patients receive clarithromycin orally (PO) twice daily (BID) and dexamethasone PO once a week. Treatment with clarithromycin and dexamethasone continues for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also receive lenalidomide PO once daily (QD) on days 1-14. Courses with lenalidomide repeat every 21 days in the absence of disease progression or unacceptable toxicity.

NOTE: \*After one year of treatment, dexamethasone is tapered for an additional 4 weeks.

After completion of study treatment, patients are followed up periodically.

Arms: arm 1: Patients receive clarithromycin orally (PO) twice daily and dexamethasone PO once a week. Treatment with clarithromycin and dexamethasone continues for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also receive lenalidomide PO once daily on days 1-14. Courses with lenalidomide repeat every 21 days in the absence of disease progression or unacceptable toxicity. Lenalidomide is taken 4 hours or more after last dose of daily clarithromycin.

NOTE: \*After one year of treatment, dexamethasone is tapered for an additional 4 weeks.
Interventions: intervention 1: Clarithromycin intervention 2: Dexamethasone intervention 3: Lenalidomide
Intervention descriptions: intervention 1: Given Orally (PO) intervention 2: Given PO intervention 3: Given Orally (PO)

Protocol documents:
Prot_SAP_000.pdf: 
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Clinical trial NCT01596621
Conditions: Non-Hodgkin Lymphoma
Keywords: Bendamustine hydrochloride CEP-18083 Treanda® Non-Hodgkin Lymphoma
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2012-08-06; Completion date: 2017-04-24
Enrollment: 102 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of the study is to determine the overall response rate (ORR), which includes complete response (CR) and partial response (PR), to bendamustine treatment in participants with indolent non-Hodgkin lymphoma (NHL) that has progressed after rituximab or a rituximab-containing therapy.

Detailed description:
This is a multicenter, nonrandomized, open-label, single-agent clinical study conducted in China, and is designed to investigate the use of bendamustine in the treatment of Chinese participants with relapsed, rituximab-refractory indolent NHL. The study consists of a screening period of up to 4 weeks, a treatment period of approximately 24 weeks (up to eight 21-day cycles), and a long-term follow-up period for up to 2 years after the last dose of study drug. Participants are expected to participate in this study for approximately 2.5 years.

Arms: arm 1: Participants will receive bendamustine hydrochloride administered at 120 milligrams (mg)/square meter (m\^2) intravenously (IV) as a 60-minute infusion, and not more than 120 minutes, on Days 1 and 2 in each 21-day treatment cycle for 6 planned cycles and up to 8 total cycles.
Interventions: intervention 1: Bendamustine hydrochloride
Intervention descriptions: intervention 1: Bendamustine will be be administered per dose and schedule specified in the arm description.

Protocol documents:
Clinical trial NCT02083653
Conditions: Metastatic Colorectal Cancer
Keywords: Metastatic Colorectal Cancer Best Supportive Care Capecitabine Fluorouracil (5-FU) Sym004
Sponsor: Symphogen A/S
Start date: 2014-03-06; Completion date: 2017-04-26
Enrollment: 254 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 2, open-label, randomized, 3-arm trial investigating the efficacy of two Sym004 doses (Arm A and Arm B) compared with a control group (Arm C) in subjects with metastatic colorectal cancer (mCRC) and acquired resistance to anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (mAbs).

Detailed description:
This trial assesses the efficacy of two different weekly dosing regimens of Sym004 (Arm A: 12 mg/kg/week versus Arm B: 9 mg/kg loading dose followed by 6 mg/kg/week) compared with investigator's choice in terms of overall survival time in subjects with mCRC. Subjects assigned to Arm C will receive best supportive care (BSC), Fluorouracil (5-FU), or Capecitabine, per local standard of care.

Subjects will receive treatment until unacceptable toxicity, disease progression, withdrawal of consent, or until the subject meets any of the criteria for treatment discontinuation or trial discontinuation. Therefore, the duration of treatment will differ among individuals and cannot be fixed in advance.

Arms: arm 1: Sym004 will be administered as an intravenous infusion at a dose of 12 milligrams per kilogram (mg/kg) weekly until unacceptable toxicity, disease progression, or consent withdrawal. arm 2: Sym004 will be administered as an intravenous infusion at a loading dose of 9 mg/kg followed by 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal. arm 3: Best supportive care (BSC) or Fluorouracil (5-FU) or Capecitabine will be given as per Investigator's discretion.
Interventions: intervention 1: Sym004 (12 mg/kg) intervention 2: Sym004 (9/6 mg/kg) intervention 3: Best Supportive Care (BSC) intervention 4: Fluorouracil (5-FU) intervention 5: Capecitabine
Intervention descriptions: intervention 1: Sym004 is a 1:1 mixture of two mAbs (futuximab and modotuximab) which bind to two non-overlapping epitopes of the EGFR. intervention 2: Sym004 is a 1:1 mixture of two mAbs (futuximab and modotuximab) which bind to two non-overlapping epitopes of the EGFR. intervention 3: BSC is the best palliative care as per Investigator's discretion, excluding antineoplastic agents. BSC may include, but is not limited to, antibiotics, analgesics, antiemetics, blood transfusions, and nutritional support. intervention 4: 5-FU will be administered at doses and schedules as per Investigator's discretion and in line with the local package insert. intervention 5: Capecitabine will be administered at doses and schedules as per Investigator's discretion and in line with the local package insert.

Protocol documents:
Clinical trial NCT01302041
Conditions: Prostate Cancer
Keywords: bone turnover hormone-naïve prostate specific antigen Prostate Cancer
Sponsor: Astellas Pharma Inc
Start date: 2011-05-06; Completion date: 2017-04-27
Enrollment: 67 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To evaluate the effect of enzalutamide on prostate specific antigen (PSA) level in men with prostate cancer.

Detailed description:

Arms: arm 1: Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
Interventions: intervention 1: Enzalutamide
Intervention descriptions: intervention 1: Oral

Protocol documents:
Clinical trial NCT02430311
Conditions: Advanced Solid Tumours
Keywords: Chinese Patients
Sponsor: AstraZeneca
Start date: 2015-06-10; Completion date: 2017-04-28
Enrollment: 36 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 2 parts phase I, open label trial of olaparib monotherapy and olaparib in combination with paclitaxel in patients with solid tumours. Part A will assess the single and multiple dose pharmacokinetics of olaparib monotherapy and multiple dose pharmacokinetics of olaparib in combination with paclitaxel. Part B will assess the safety of multiple doses of olaparib in Cohort 1 and of olaparib when co-administered with paclitaxel in Cohort 2

Detailed description:
Part A will access the pharmacokinetics of olaparib: Cohort 1 will investigate the single and multiple dose pharmacokinetics of olaparib following 300mg bd monotherapy dose(s); Cohort 2 will investigate the single and multiple dose pharmacokinetics of olaparib following 100mg bd monotherapy dose(s) and the multiple dose pharmacokinetics in the presence of co-administered paclitaxel (80mg/m2 weekly on days 1, 8 and 15 of a single 28-day cycle).

In Part B: Safety profile of olaparib 300mg bd as monotherapy and olaparib 100mg bd in combination with weekly paclitaxel will also be investigated in Chinese patients.

Arms: arm 1: Treat 15 patients, single dose olaparib 300mg followed by multiple dose olaparib 300mg twice a day arm 2: Treat 15 patients, single dose olaparib 100mg followed by multiple dose olaparib 100 mg twice a day and then in combination with paclitaxel (80mg/m2 weekly on days 1, 8 and 15 of a single 28-day cycle)
Interventions: intervention 1: Olaparib intervention 2: Paclitaxel intervention 3: Olaparib
Intervention descriptions: intervention 1: Tablet-150mg, Oral intervention 2: Injection intervention 3: Tablet-100mg, Oral

Protocol documents:
Clinical trial NCT00572468
Conditions: Cancer Prostate Cancer
Keywords: cancer pre-operative surgery prostate prostatectomy radiation
Sponsor: VA Office of Research and Development
Start date: 2007-12-01; Completion date: 2017-04-30
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized trial comparing the effect of oral simvastatin versus placebo on targets of the mevalonate pathway in men undergoing a prostatectomy as planned management for prostate cancer. Observed tissue effects will be correlated with changes in serum cholesterol and low-density lipoprotein.

Detailed description:
Prostate cancer patients that have chosen to undergo a prostatectomy as their primary treatment option will be recruited to this trial. Forty-four subjects will be randomized to either placebo or simvastatin (40 mg po/day) for 4 weeks prior to surgery. Serum samples will be obtained at baseline and immediately prior to prostatectomy. At prostatectomy, cancerous and benign prostate tissue will be microdissected and cryopreserved. Archival prostatectomy tissues will be used to construct tissue microarrays containing matched benign and malignant sections. The effect of HMG-CoA reductase inhibition on lipid raft cholesterol content and targets of prenylation will be determined. The incidence of apoptosis will be determined along with protein levels of mediators of apoptosis. Lastly the effect of statin therapy on cellular markers of proliferation will be determined.

Previously, we studied the effect of statin use on the risk of prostate cancer detection in a case-control study at the Portland VA Medical Center. Statin use was associated with a 62% reduction in cancer odds-risk (OR = 0.38, 95% CI 0.21-0.69). Although these epidemiologic and laboratory findings have generated enthusiasm for the study of statins in prostate cancer, no studies have examined the biologic effects of statins on prostate cancer in humans.

Hypothesis: Statin therapy prior to prostatectomy will successfully target the mevalonate pathway in the human prostate and this intervention will favorably alter tumor biomarker status.

Arms: arm 1: Twenty-two men will be on the Statin arm and take 40 mg of simvastatin. arm 2: Twenty-two men will be on the placebo arm.
Interventions: intervention 1: Simvastatin intervention 2: Placebo
Intervention descriptions: intervention 1: 40 mg of simvastatin intervention 2: placebo

Protocol documents:
Clinical trial NCT01231659
Conditions: Postmenopausal Women Locally Advanced Metastatic Breast Cancer Metastatic Breast Cancer
Keywords: RAD001 (Everolimus) Letrozole Breast cancer Metastatic Breast cancer Estrogen receptor positive Failure of Tamoxifen Anastrozole or Examestane
Sponsor: Novartis Pharmaceuticals
Start date: 2011-08-09; Completion date: 2017-04-30
Enrollment: 72 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This was a multi-center, Israeli phase II open label study evaluating treatment with RAD001 (10 mg daily) combined with letrozole (2.5 mg daily) in postmenopausal women after recurrence or progression on Tamoxifen, Anastrozole or Examestane.

There were no treatments specifically approved after recurrence or progression on AIs. Available options, based on common clinical practice and several treatment guidelines (e.g. NCCN treatment guidelines 2008), included fulvestrant.

Combining RAD001 with letrazole was a rational approach to the treatment of advanced Brest Cancer, offering the potential for inhibition of tumor cell growth\\ proliferation and anti angiogenesis while at the same time potentially preventing the development of letrazole resistance.

Detailed description:
Screening Period:

Postmenopausal women with estrogen receptor positive, locally advanced or metastatic breast cancer whose disease was refractory to hormonal therapy and had a documented recurrence or progression on last therapy for their breast cancer with either tamoxifen, anastrozole, letrozole, fulvestrant or exemestan were screened for eligibility within 28 days prior to treatment Day 1.

Treatment Period:

Patients started receiving everolimus (10 mg daily oral dose) combined with letrozole (2.5 mg daily oral dose) tablets from treatment Day 1. Study treatment continued until disease progression, intolerable toxicity or consent withdrawal. Dose adjustment (reduction, interruption or possible dose re-escalation to starting dose) could be done based on the safety findings. Tumor assessments were performed every 12 weeks until disease progression. In order to confirm response at least four weeks after first observation, additional scans to determine a complete response (CR) or partial response (PR) or stable disease (SD) were performed. Patients were followed for safety until 28 days after study treatment discontinuation.

Post Treatment Follow up for Survival:

Patients were followed for survival every 3 months for up to 3 years. Survival information could be obtained via phone and information was documented in the source documents.

Arms: arm 1: All patients received 2 tablets (5 mg each) of Everolimus (a total of 10 mg) + 1 tablet of Letrozole (2.5 mg) daily until disease progression or as described in the protocol.
Interventions: intervention 1: Everolimus intervention 2: Letrozole
Intervention descriptions: intervention 1: Everolimus 10 mg (2 tablets of 5 mg) once daily intervention 2: Letrozole 2.5 mg once daily

Protocol documents:
Clinical trial NCT01356147
Conditions: Pulmonary Infections
Keywords: ventilator associated pulmonary infections
Sponsor: Georgetown University
Start date: 2011-05-01; Completion date: 2017-04-30
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the effect of Dornase alfa on preterm and late preterm neonates with ventilator associated pulmonary infections. Dornase alfa has been effective in the treatment of pulmonary infections in patients with cystic fibrosis by aiding mucus clearance. The bacteria causing pulmonary infections in cystic fibrosis patients is similar to those infecting preterm infants. The investigators expect that dornase alfa therapy will improve recovery from ventilator associated pulmonary infections in preterm infants.

Detailed description:

Arms: arm 1: No therapy will be given to placebo arm. Respiratory therapist will shield infant from view and nebulize saline solution into incubator rather than into ventilator circuit. arm 2: Dornase alfa 2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation
Interventions: intervention 1: Dornase alfa intervention 2: Placebo
Intervention descriptions: intervention 1: 2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation intervention 2: No therapy will be given to placebo arm

Protocol documents:
Clinical trial NCT00464620
Conditions: Rhabdomyosarcoma Malignant Peripheral Nerve Sheath Tumors Chondrosarcoma Sarcoma, Ewing's Sarcoma, Alveolar Soft Part Chordoma Epithelioid Sarcoma Giant Cell Tumor of Bone Hemangiopericytoma Gastrointestinal Stromal Tumor (GIST)
Keywords: Dasatinib Rhabdomyosarcoma Malignant peripheral nerve sheath tumor Chondrosarcoma Ewing's Alveolar soft part sarcoma (ASPS) Chordoma Epithelioid sarcoma Giant cell tumor of bone Hemangiopericytoma/solitary fibrous tumor Gastrointestinal Stromal Tumor (GIST)
Sponsor: Sarcoma Alliance for Research through Collaboration
Start date: 2007-05-01; Completion date: 2017-05-01
Enrollment: 366 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will examine the response rate and the 6-month progression-free survival rates of subjects with advanced sarcoma treated with dasatinib.

Detailed description:
Further details provided by SARC (Sarcoma Alliance for Research through Collaboration):

Treatment: Subjects take Dasatinib twice daily by mouth for 28 days per 28 day cycle.

Subjects will be seen for interim medical history, physical exam and laboratory studies prior to each cycle. Subjects will undergo tumor imaging every 2 months (8 weeks) for the first 6 months and approximately every 3 months thereafter while on treatment.

A blood sample for collection of specimens with which to later study serum level of Dasatinib and effects on biomarkers of drug activity will be obtained approximately 2 to 4 weeks after the start of treatment.

Central collection of archival tumor with which to later study the frequency of expression and/or mutation of kinases inhibited by dasatinib will occur.

Subjects will be followed for approximately every 3 months until 2 years from registration and then approximately yearly until 5 years from registration.

Arms: arm 1: Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles
Interventions: intervention 1: Dasatinib
Intervention descriptions: intervention 1: oral agent, continuous dosing, Cycles = 28 days

Protocol documents:
Clinical trial NCT01471353
Conditions: Colorectal Cancer Metastatic
Keywords: Metastatic Colon Cancer Rectal Cancer
Sponsor: University of Florida
Start date: 2011-11-01; Completion date: 2017-05-01
Enrollment: 43 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Combining Sorafenib with standard cytotoxic fluoropyrimidine therapy for advanced colorectal cancer may provide clinical benefit when no other treatment remains.

Detailed description:
The Raf/MEK/ERK pathway is an important mediator of responses to growth factors, and a strong inducer of genes involved in tumorigenesis, angiogenesis, apoptosis, and tumorigenesis in metastatic colorectal cancer (mCRC). Inhibition of this pathway has been previously proven to be highly clinically beneficial for patients with this disease. It has also been clearly demonstrated that the inhibition of VEGF, when coupled with cytotoxic therapy and/or continued beyond initial response, can improve clinical outcomes and survival in this same cohort of patients. Safety and pharmacokinetic data have already been established for this novel doublet oral chemotherapy. This study is intended to determine the activity of a combination of oral fluoropyrimidine plus sorafenib in an advanced mCRC patient population for whom limited treatment options remain.

Arms: arm 1: Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days. Single arm study.
Interventions: intervention 1: Sorafenib Plus Capecitabine (SorCape)
Intervention descriptions: intervention 1: Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days

Protocol documents: