ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00073528
Conditions: Breast Neoplasms
Keywords: Lapatinib Letrozole breast carcinoma breast cancer breast lump HER2 positive metastatic breast cancer breast cancer positive for human epidermal growth factor receptor 2 HER2 breast cancer progression estrogen-receptor positive breast cancer ER
Sponsor: Novartis Pharmaceuticals
Start date: 2003-12-09; Completion date: 2018-03-22
Enrollment: 1286 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study evaluated and compared the efficacy and tolerability of lapatinib and letrozole, with letrozole and placebo in post-menopausal women with hormone receptor positive (ER positive and/or PgR positive) advanced or metastatic breast cancer, who had not received prior therapy for advanced or metastatic disease.

Detailed description:
Subjects were randomly assigned to receive either lapatinib (1500 mg once daily orally) with letrozole (2.5 mg once daily orally), or letrozole (2.5 mg once daily orally) with placebo (which matched with lapatinib tablet). Randomization was stratified by site of disease (i.e., soft tissue/visceral disease versus bone only disease) and time since prior adjuvant endocrine therapy (\<6 months or ≥ 6 months from discontinuation of adjuvant anti-estrogen therapy (e.g. tamoxifen or raloxifene) or no prior adjuvant antiestrogen therapy). Study therapy was administered daily until disease progression (objective or symptomatic) or withdrawal from therapy (e.g., due to unacceptable toxicity, withdrawal of consent, or other reason). All subjects were to be followed for survival information until death.

On 13 Apr 2015, after the introduction of the Long Term Follow UP (LTFU) phase (per protocol amendment 07), subjects receiving study treatment with lapatinib plus letrozole, or letrozole plus placebo had continued access to this study treatment until the occurrence of one of the following criteria:

* Disease progression (as determined by the Investigator),
* Intercurrent illness that prevented further administration of study treatment
* Drug related AE which was considered by the investigator to warrant permanent discontinuation of study treatment
* The subject decided to withdraw from the study. Investigators collected AEs and/or SAEs related to study participation, until 30 days following study treatment discontinuation. Subjects who were being followed-up for OS but were not taking study medication, were withdrawn from the study.

The study was terminated on 22-Mar-2018 (last subject last visit).

Arms: arm 1: Letrozole (2.5 mg once daily orally) with Placebo (which matched with Lapatinib tablet) arm 2: Lapatinib (1500 mg once daily orally) with Letrozole (2.5 mg once daily orally)
Interventions: intervention 1: Lapatinib intervention 2: Letrozole intervention 3: Placebo
Intervention descriptions: intervention 1: 1500 mg orally once a day intervention 2: 2.5 mg orally once a day intervention 3: Placebo (which matched with lapatinib tablet)

Protocol documents:
Clinical trial NCT00820222
Conditions: Metastases, Brain
Keywords: ErbB2 HERCEPTIN XELODA ErbB1 TYKERB metastatic breast cancer trastuzumab breast cancer capecitabine lapatinib brain metastases HER2 positive TYVERB
Sponsor: Novartis Pharmaceuticals
Start date: 2009-04-14; Completion date: 2018-03-22
Enrollment: 540 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This open label study was designed to evaluate Lapatinib effect on incidence of brain metastases in ErbB2 (HER2) positive metastatic breast cancer patients exposed to prior taxanes or anthracyclines.

Detailed description:
The study was terminated based on the IDMC recommendation in 2012, collection of efficacy outcome measures was discontinued and all primary and secondary outcome measures were reported in 2012.

An amendment protocol allowed subjects who were on study treatment to enroll in a Long Term Follow Up (LTFU) phase if they had evidence of clinical benefit but no local access to standard of care treatments. Subjects received study treatment until disease progression, unacceptable toxicity, or subject withdrawal. In LTFU only Adverse Events data were collected. For the LTFU the Outcome Measure "Number of participants with the indicated Grade 3 or Grade 4 Adverse Events (AEs) occurring in \>=2% of participants in either treatment arm" and "Adverse Events" were updated.

Arms: arm 1: Lapatinib 1250 mg once daily and capecitabine 2000mg/m2/day, days 1-14, every 21 days arm 2: trastuzumab loading dose of 8mg/kg followed by 6mg/kg q3weekly infusions, and capecitabine 2500mg/m2/day, days 1-14, every 21 days
Interventions: intervention 1: capecitabine intervention 2: lapatinib intervention 3: trastuzumab
Intervention descriptions: intervention 1: oral medication; daily dose divided into morning and evening dose and taken for 14 days of 21 day cycle intervention 2: oral medication; daily dose taken once a day intervention 3: infusion therapy; loading dose of 8mg/kg, followed by 6mg/kg given every 3 weeks

Protocol documents:
Clinical trial NCT02115308
Conditions: Coronary Artery Disease
Sponsor: Timothy M. Bateman
Start date: 2014-09-03; Completion date: 2018-03-23
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to measure the changes in cardiac function during a Lexiscan pharmacologic stress test using cardiac magnetic resonance imaging test.

Detailed description:

Arms: arm 1: Regadenoson is a single-use, pre-filled syringe containing 0.4 mg/5 mL of regadenoson.
Interventions: intervention 1: Regadenoson
Intervention descriptions: intervention 1: Regadenoson injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging.

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT01310231
Conditions: Metastatic Breast Cancer
Keywords: Metastatic Breast Cancer Metformin
Sponsor: Ozmosis Research Inc.
Start date: 2011-08-22; Completion date: 2018-03-26
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if the addition of metformin to standard chemotherapy improves progression free survival in women with metastatic breast cancer.

Detailed description:
A double blind Phase II randomized study of metformin versus (vs) placebo in non-diabetic women on first to fourth line chemotherapy with anthracycline, taxane, platinum, capecitabine or vinorelbine based regimens for metastatic or unresectable locally advanced breast cancer (BC). Patients were randomized to receive metformin 850 mg tablets or placebo once daily for two days as ramp-up, followed by one tablet twice a day for the duration of the study. Randomization was stratified by line of chemotherapy (1st, 2nd, 3rd and 4th line) and hormone receptor status (ER and/or PgR positive versus both negative). All patients were required to have measureable or non-measureable, but evaluable metastases at study entry. Metformin or placebo was to be continued until disease progression, even if chemotherapy was changed or stopped prior to disease progression. Recruitment took place at five sites in Ontario, Canada: Mount Sinai Hospital, Princess Margaret Cancer Centre, St. Michael's Hospital, Toronto and London Regional Cancer Centre, London.

Arms: arm 1: Metformin plus standard chemotherapy (containing anthracyclines, platinum, taxanes or capecitabine; first or second line). arm 2: Placebo and standard chemotherapy (containing anthracyclines, platinum, taxanes or capecitabine; first or second line).
Interventions: intervention 1: Metformin intervention 2: Placebo
Intervention descriptions: intervention 1: metformin 850 mg bid in addition to standard chemotherapy (containing anthracyclines, platinum, taxanes or capecitabine; first or second line).

Number of cycles: Until progression or unacceptable toxicity develops. intervention 2: Placebo bid in addition to standard chemotherapy (containing anthracyclines, platinum, taxanes or capecitabine; first or second line).

Number of cycles: until progression or unacceptable toxicity develops.

Protocol documents:
Clinical trial NCT00968968
Conditions: Cancer
Keywords: carcinoma, breast lump, Pagets disease, breast cancer positive for human epidermal growth factor receptor 2, breast cancer progression, estrogen-receptor
Sponsor: Novartis Pharmaceuticals
Start date: 2010-01-20; Completion date: 2018-03-30
Enrollment: 37 participants; Allocation: RANDOMIZED; Intervention model: 

Brief summary:
This was a randomized, open-label, multi-center Phase III study evaluating the efficacy and safety of lapatinib in combination with trastuzumab versus trastuzumab alone as continued HER2 suppression therapy in women with HER2-positive metastatic breast cancer (MBC). Eligible subjects should have completed 12 to 24 weeks of first- or second-line treatment with trastuzumab plus chemotherapy, experienced either complete disappearance of all metastatic lesions, or persistence of metastatic disease (stable disease) without unequivocal progression or the occurrence of new lesions, and been indicated to continue to receive trastuzumab alone as maintenance therapy. Eligible subjects who entered the LPT112515 study on first-line treatment should not have known history of central nervous system (CNS) metastases; subjects who entered the study on second-line treatment should not have known history of CNS metastases or have stable (asymptomatic and off steroids ≥3 months) CNS metastases. The primary objective of this study was to compare progression-free survival (PFS) in subjects with HER2-positive MBC randomized to receive treatment with lapatinib plus trastuzumab versus those randomized to receive trastuzumab alone. The secondary objectives included overall survival, clinical benefit response rate (CR, PR or SD ≥24 weeks) and the qualitative and quantitative adverse event profile of the 2 treatment arms. It was estimated that 280 subjects (140 per group) would be required to observe 193 PFS events.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Lapatinib intervention 2: Trastuzumab
Intervention descriptions: intervention 1: Oral Lapatinib 1000 mg once daily. Lapatinib was a small molecule, reversible inhibitor targeting HER2 tyrosine kinase receptor. intervention 2: IV Trastuzumab 6 mg/kg every three weeks. Trastuzumab was a humanized, monoclonal antibody directed against the extracellular domain of the HER2 tyrosine kinase receptor.

Protocol documents:
Clinical trial NCT02457520
Conditions: Acne
Sponsor: Sun Pharmaceutical Industries Limited
Start date: 2015-01-21; Completion date: 2018-04-01
Enrollment: 201 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an uncontrolled, open-label study being conducted in approximately 200 healthy males, non-pregnant, non-nursing females, age 12 to 45 years, with severe recalcitrant nodular acne.

ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day will be administered for 4 weeks followed by 1.0 mg/kg/day for 16 weeks. Female subjects consenting to use two forms of birth control or abstinence are included.

Detailed description:
This study is designed to collect efficacy, safety, and quality of life (QOL) data from subjects who receive Absorica® without food. The study will investigate the treatment efficacy, frequency of relapse once the treatment has been discontinued, quality of life during the active treatment and during a 2-year post treatment period and the overall safety of treatment with Absorica®.

This is a single-arm, open-label study consisting of 2 phases: a 20-week (5-month) open-label Active Treatment Period (ATP) and a 104-week (2-year) post treatment period (PTP). The total study duration is to be 124 weeks, excluding a screening period. During the ATP, after week 2 visit, visits will be scheduled at 4-week intervals for a total of 8 visits (1 screening visit, 1 baseline visit, and 6 on-study visits). During the PTP, the first visit will be 4 weeks after End of Treatment (EOT), the second visit will be 12 weeks after EOT, and subsequent visits will be scheduled at 26-week (± 2 weeks) intervals for a total of 6 visits.

Arms: arm 1: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.
Interventions: intervention 1: Isotretinoin
Intervention descriptions: intervention 1: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks

Protocol documents:
Prot_SAP_000.pdf: 
An Open-label Study Evaluating the Long-term Efficacy, Quality of
Life, and Safety of ABSORICA® (isotretinoin) Capsules Administered
Without Food in Patients with Severe Recalcitrant Nodular Acne
NCT number: NCT02457520
Date: 19 December 2014
Clinical trial NCT02740972
Conditions: Duchenne Muscular Dystrophy
Sponsor: NS Pharma, Inc.
Start date: 2016-12-01; Completion date: 2018-04-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main objective of this study is to evaluate the safety of a high (80mg/kg) and low (40mg/kg) dose of NS-065/NCNP-01 delivered as an intravenous infusion in patients with Duchenne Muscular Dystrophy (DMD) amendable to exon 53 skipping. Additional objectives include tolerability, muscle function and strength, pharmacokinetics and pharmacodynamics.

Detailed description:
This is a Phase II, multiple center, 2-period, randomized, placebo-controlled, dose finding study of NS-065/NCNP-01 administered by infusion once weekly for 24 weeks to ambulant boys ages 4-\<10 years with DMD. Two dose level cohorts will be enrolled. Period 1 of this study will be conducted in a double-blind fashion. Randomized patients will receive weekly IV infusions of NS-065/NCNP-01 or placebo for the first 4 weeks of their participation (Period 1) and NS-065/NCNP-01 by IV infusion for weeks 5-24 (20 weeks of active treatment - Period 2). Analysis of safety data from Period 1 of the 40mg/kg dose cohort will be completed prior to enrolling patients in the 80mg/kg dose cohort.

Patients completing the 24-week study will be eligible for an open-label extension study.

Clinical efficacy will be assessed at regularly scheduled study visits, including functional tests such as the six-minute walk test (6MWT), time to stand (TTSTAND), time to run/walk 10 meters (TTRW), time to climb 4 stairs (TTCLIMB) and quantitative muscle testing (QMT). All patients will undergo a muscle biopsy of the bicep at baseline and a second muscle biopsy at Week 24.

Safety will be assessed through the collection of adverse events (AEs), blood and urine laboratory tests, electrocardiograms (ECGs), vital signs, and physical examinations throughout the study.

Serial blood samples will be taken at four of the study visits to assess the pharmacokinetics of the study drug.

Arms: arm 1: Six patients with confirmed DMD with genetic deletions amenable to exon 53 skipping will be administered an intravenous infusion of NS-065/NCNP-01 40mg/kg dose once a week for 24 weeks arm 2: Six patients with confirmed DMD with genetic deletions amenable to exon 53 skipping will be administered an intravenous infusion of NS-065/NCNP-01 80mg/kg once a week for 24 weeks arm 3: Two patients in each of the dose groups will be administered placebo as an intravenous infusion once a week for 4 weeks followed by 20 weeks of open label treatment
Interventions: intervention 1: NS-065/NCNP-01 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Prot_SAP_000.pdf: 
NCT02740972
Clinical trial NCT00510718
Conditions: Prostate Cancer Hormone Refractory Prostate Cancer
Keywords: Prostate Cancer Hormone Refractory Castration
Sponsor: Pfizer
Start date: 2007-07-23; Completion date: 2018-04-02
Enrollment: 140 participants; Allocation: ; Intervention model: 

Brief summary:
This is a multi-center open-label dose-escalation study of a novel compound (MDV3100) to treat patients with castration-resistant (hormone-refractory) prostate cancer. Additional patients will be enrolled in expanded cohorts at doses determined to be tolerable. Patients who tolerate the drug and do not progress will be allowed to continue to look for PSA response.

Detailed description:
This is a Phase 1, open-label, uncontrolled, dose-escalation study with dose-expansion at doses determined to be tolerated. Patients who tolerate the drug and do not progress will be allowed to continue treatment. The study endpoints are safety and tolerability and pharmacokinetics. PSA values will also be collected to look for PSA response.

Arms: arm 1: MDV3100
Interventions: intervention 1: MDV3100
Intervention descriptions: intervention 1: MDV3100 daily until progression or dose-limiting toxicity

Protocol documents:
Clinical trial NCT01814826
Conditions: Acute Myelogenous Leukemia
Keywords: Drug Therapy
Sponsor: Millennium Pharmaceuticals, Inc.
Start date: 2013-04-10; Completion date: 2018-04-08
Enrollment: 64 participants; Allocation: ; Intervention model: SEQUENTIAL

Brief summary:
The purpose of this study is to establish the maximum tolerated dose (MTD), and to assess the safety and tolerability of MLN4924 (pevonedistat) in combination with azacitidine in treatment naive participants with AML who were 60 years of age or older.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: MLN4924 intervention 2: Azacitidine
Intervention descriptions: intervention 1: MLN4924 intravenously (IV) in AML participants in a 28-day cycle:

* MLN4924 on Days 1, 3, and 5 for Cycle 1 and all subsequent cycles intervention 2: Azacitidine (IV) or subcutaneously in AML participants in a 28-day cycle:

\- Azacitidine Days 1, 2, 3, 4, 5, 8, 9 in Cycle 1 and for all subsequent cycles

Protocol documents:
Clinical trial NCT01959165
Conditions: Ulcerative Colitis
Keywords: Ulcerative Colitis, Japanese, subcutaneously
Sponsor: AstraZeneca
Start date: 2013-11-21; Completion date: 2018-04-10
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multi-centre, randomised, double-blind, placebo controlled, parallel group, Phase II study to evaluate efficacy and safety of 3 doses of MEDI7183, in Japanese subjects with moderate to severe UC

Detailed description:

Arms: arm 1: Double blinded arm 2: Double blinded arm 3: Double blinded arm 4: Double blinded
Interventions: intervention 1: MEDI7183 low dose intervention 2: MEDI7183 medium dose intervention 3: MEDI7183 high dose intervention 4: Matching Placebo
Intervention descriptions: intervention 1: MEDI7183 will be administered by SC on Day 1, Week 2, 4, and 8 intervention 2: MEDI7183 will be administered by SC on Day 1, Week 2, 4, and 8 intervention 3: MEDI7183 will be administered by SC on Day 1, and placebo for MEDI7183 at Week 2, 4, and 8 intervention 4: Placebo will be administered by SC on Day 1, Week 2,4, and 8

Protocol documents:
Clinical trial NCT01992016
Conditions: Adenocarcinoma of the Prostate Bone Metastases Soft Tissue Metastases Stage IIA Prostate Cancer Stage IIB Prostate Cancer Stage III Prostate Cancer Stage IV Prostate Cancer
Keywords: Prostate cancer F18 FDG-PET Imaging Ranolazine Bone metastases Soft tissue metastases
Sponsor: University of Colorado, Denver
Start date: 2014-04-07; Completion date: 2018-04-11
Enrollment: 11 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This pilot clinical trial studies fludeoxyglucose F18 (FDG)-positron emission tomography (PET) in imaging patients with prostate cancer treated with ranolazine. Diagnostic procedures, such as FDG-PET, may help find prostate cancer and find out how far the disease has spread. Giving ranolazine may enhance FDG-PET imaging by increasing the amount of glucose available for uptake by the scan.

Detailed description:
PET scans have traditionally not been very good at detecting prostate cancers. This is because prostate cancer cells do not take up glucose well so the signals are very weak. The ability of PET imaging to detect cancers requires that the cancer cells take up glucose into the cells. Different methods are being tested to see if we can improve the detection of prostate cancers using PET scans.

Ranolazine is a drug that is already approved by the FDA for treatment of chronic chest pain in people with heart disease. Ranolazine has been studied in the laboratories at the University of Colorado Denver, Anschutz Medical Campus. Ranolazine has been added to prostate cancer cells and grown in petri dishes and in animals in the laboratory. It has been shown to increase the glucose uptake of prostate cancer cells. The goal of this study is to see if patients taking ranolazine will have better PET imaging of their prostate cancers.

Arms: arm 1: Patients receive ranolazine PO BID for 1 day. Patients undergo FDG-PET/CT scan at baseline and after ranolazine treatment. Patients may then undergo robotic or open radical prostatectomy. arm 2: Patients receive ranolazine PO BID for 1 day. Patients undergo FDG-PET/CT scan at baseline and after ranolazine treatment.
Interventions: intervention 1: Ranolazine
Intervention descriptions: intervention 1: 1000mg given orally twice daily for 1 day (2 doses).

Protocol documents:
Clinical trial NCT02547441
Conditions: Rosacea
Sponsor: Maruho Co., Ltd.
Start date: 2015-12-01; Completion date: 2018-04-13
Enrollment: 463 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study evaluates the safety and efficacy of once-daily application of CLS001 topical gel compared to vehicle gel in subjects with severe papulopustular rosacea.

Detailed description:

Arms: arm 1: CLS001 (Omiganan) gel applied once daily arm 2: Vehicle gel applied once daily
Interventions: intervention 1: CLS001 (Omiganan) intervention 2: Vehicle
Intervention descriptions: intervention 1: Topical gel intervention 2: Vehicle Gel

Protocol documents:
Prot_000.pdf: 











































































































SAP_001.pdf: