ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01816594
Conditions: HER2-positive Newly Diagnosed, Primary Breast Cancer
Keywords: HER2 breast cancer neoadjuvant PI3K inhibitor first line chemotherapy trastuzumab GBG SOLTI BIG
Sponsor: Novartis Pharmaceuticals
Start date: 2013-09-03; Completion date: 2015-02-18
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized, parallel cohort, two stage, double-blind, placebo-controlled study evaluated the oral PI3K inhibitor BKM120 in combination with trastuzumab and paclitaxel in HER2-positive, PIK3CA wild-type and PIK3CA mutant primary breast cancer prior to surgery (neo-adjuvant setting).

Detailed description:
NeoPHOEBE evaluated the efficacy (as defined by pCR) of BKM120 (an oral PI3K inhibitor) in combination with trastuzumab and paclitaxel in a randomized, placebo-controlled, neo-adjuvant study in women diagnosed with primary breast cancer \>1.5 cm (by US or MRI) with centrally confirmed HER2 overexpression or amplification, who have not previously undergone treatment for invasive breast cancer.

Prior to the initiation of paclitaxel, there was a 6-week "biologic window" with trastuzumab plus BKM120 or placebo only. The study was conducted separately in two cohorts (PIK3CA mutated and PI3K3CA wild-type) using a two-stage approach. Within each cohort patients were randomized into one of the following treatment arms:

Arm 1: BKM120 plus trastuzumab for 6 weeks followed by BKM120 and trastuzumab plus weekly paclitaxel for an additional 12 weeks.

Arm 2: BKM120 placebo plus trastuzumab for 6 weeks followed by BKM120 placebo plus trastuzumab plus weekly paclitaxel for an additional 12 weeks.

After completion of study treatment, patients were to have undergone definitive surgery.

Arms: arm 1: BKM120 (oral, pan-class I PI3K inhibitor) in combination with trastuzumab and paclitaxel. arm 2: BKM120 placebo in combination with trastuzumab and paclitaxel
Interventions: intervention 1: BKM120 intervention 2: Trastuzumab intervention 3: Paclitaxel intervention 4: BKM120 Placebo
Intervention descriptions: intervention 1: Neo-adjuvant BKM120 (oral pan-class I PI3K inhibitor, continuous daily dosing). BKM120 was administered orally 100 mg/day. intervention 2: Trastuzumab is a humanized monoclonal antibody directed against the extracellular juxtamembrane domain of the HER2 receptor. Administered 4mg/kg i.v. load followed by 2mg/kg i.v. weekly. intervention 3: Paclitaxel is a cytotoxic agent with proven antitumor activity in a variety of solid tumors. The antitumor activity of paclitaxel is based on tubulin-binding and stabilization of non-functional microtubule bundles, thereby blocking normal mitotic spindle development and subsequent cell division. Administered weekly 80mg/m2 i.v. intervention 4: Neoadjuvant BKM120 placebo Administered orally 100 mg/day.

Protocol documents:
Clinical trial NCT02004041
Conditions: Treatment-resistant Pruritus Associated With Atopic Dermatitis
Keywords: pruritus atopic dermatitis VLY-686
Sponsor: Vanda Pharmaceuticals
Start date: 2013-12-10; Completion date: 2015-02-19
Enrollment: 69 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is randomized, double-blind, placebo-controlled study to test whether VLY-686 can reduce chronic pruritus in subjects with treatment-resistant pruritus associated with atopic dermatitis in comparison with placebo.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: VLY-686 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00093470
Conditions: Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome Adult Acute Megakaryoblastic Leukemia Adult Acute Monocytic Leukemia Adult Acute Myeloid Leukemia in Remission Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11 Adult Acute Myeloid Leukemia With Maturation Adult Acute Myeloid Leukemia With Minimal Differentiation Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11 Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1 Adult Acute Myeloid Leukemia With t(9;11)(p22.3;q23.3); MLLT3-KMT2A Adult Acute Myeloid Leukemia Without Maturation Adult Acute Myelomonocytic Leukemia Adult Erythroleukemia Adult Pure Erythroid Leukemia Alkylating Agent-Related Acute Myeloid Leukemia Myelodysplastic Syndrome With Excess Blasts Recurrent Adult Acute Myeloid Leukemia
Sponsor: National Cancer Institute (NCI)
Start date: 2004-08-18; Completion date: 2015-02-20
Enrollment: 144 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized phase III trial studies tipifarnib in treating patients with acute myeloid leukemia (AML) in remission. Tipifarnib may stop the growth of cancer cells by blocking the enzymes necessary for their growth. It is not yet known whether tipifarnib is more effective than observation alone in preventing the recurrence of AML.

Detailed description:
PRIMARY OBJECTIVES:

I. To compare R115777 (tipifarnib) maintenance therapy to observation only with respect to disease-free survival (DFS) in patients with AML in second or subsequent complete remission or in complete response (CR) following primary induction failure.

SECONDARY OBJECTIVES:

I. To compare overall survival of patients in both arms. II. To evaluate the long-term safety and toxicity of extended administration of R115777 in AML patients in remission.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM A: Patients receive tipifarnib orally (PO) twice daily (BID) on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ARM B: Patients undergo observation only.

After completion of study treatment, patients are followed up for 5 years.

Arms: arm 1: Patients receive tipifarnib PO BID on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. arm 2: Patients undergo observation only.
Interventions: intervention 1: Clinical Observation intervention 2: Tipifarnib
Intervention descriptions: intervention 1: Undergo observation intervention 2: Given PO

Protocol documents:
Clinical trial NCT01075048
Conditions: Metastatic Colorectal Cancer
Keywords: Colorectal cancer wild-type KRAS irinotecan cetuximab second-line therapy
Sponsor: Daiichi Sankyo
Start date: 2010-01-26; Completion date: 2015-02-20
Enrollment: 131 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
ARQ 197 or placebo in combination with irinotecan and cetuximab in participants with metastatic colorectal cancer (CRC), in participants with wild-type KRAS alleles who have failed front-line systemic therapy, to evaluate the safety, tolerability, and efficacy of ARQ 197, define the recommended dose for Phase 2.

After the recommended dose is determined for Phase 2, participants receive study drug or placebo with irinotecan and cetuximab.

Detailed description:
Phase 1/2 Multicenter study:

* Phase 1 portion is open-label to evaluate the safety of ARQ 197 administered in combination with irinotecan and cetuximab.
* Phase 2 portion is designed as a randomized, double-blind placebo-controlled study to assess the efficacy and safety of ARQ 197 or matching placebo administered in combination with irinotecan and cetuximab.

Arms: arm 1: Tivantinib in combination with irinotecan and cetuximab. arm 2: Placebo in combination with irinotecan and cetuximab arm 3: Tivantinib in combination with irinotecan and cetuximab.
Interventions: intervention 1: Tivantinib intervention 2: Placebo intervention 3: Cetuximab intervention 4: Irinotecan
Intervention descriptions: intervention 1: ARQ 197 is supplied as a 120-mg capsule, administered twice daily at the dose determined in the Phase 1 portion of the study. Administered until disease progression, unacceptable toxicity or other discontinuation criteria is met. intervention 2: Placebo to match ARQ 197, administered twice daily. Administered until disease progression, unacceptable toxicity or other discontinuation criteria is met. intervention 3: Cetuximab 500 mg/ m\^2 intravenous infusion over 120 minutes at the first cycle, then over 60-minutes at subsequent cycles. Administered on Day 1 and Day 15 of each 28 day cycle. Administered until disease progression, unacceptable toxicity or other discontinuation criteria is met. intervention 4: 60 minutes after cetuximab, Irinotecan 180 mg/m\^2 intravenous infusion over 30 - 90 minutes. Administered on Day 1 and Day 15 of each 28 day cycle. Administered until disease progression, unacceptable toxicity or other discontinuation criteria is met.

Protocol documents:
Clinical trial NCT01992874
Conditions: Neoplasms
Keywords: Neoplasms Pimasertib Cancer
Sponsor: EMD Serono
Start date: 2013-11-30; Completion date: 2015-02-28
Enrollment: 38 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a Phase 1, multi-center, open-label, single-dose, 2 period, 2 sequence cross-over trial to investigate the relative bioavailability of 2 solid oral pimasertib formulations in cancer subjects (Part A), followed by open-label pimasertib administration (Part B and trial extension phase).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Pimasertib Capsule (Part A) intervention 2: Pimasertib Tablet (Part A) intervention 3: Pimasertib Tablet (Part A) intervention 4: Pimasertib Capsule (Part A) intervention 5: Pimasertib Capsule (Part B and trial extension phase)
Intervention descriptions: intervention 1: Pimasertib capsule administration at a single dose of 60 milligram (mg) orally on Day 1 in Part A. intervention 2: Pimasertib tablet administration at a single dose of 60 mg orally on Day 3 in Part A. intervention 3: Pimasertib tablet administration at a single dose of 60 mg orally on Day 1 in Part A. intervention 4: Pimasertib capsule administration at a single dose of 60 mg orally on Day 3 in Part A. intervention 5: Subjects completing Part A to receive pimasertib capsule at a dose of 60 mg orally twice daily in cycles of 21 days each in Part B and trial extension phase until disease progression, intolerable toxicity, subject withdrawal, loss to follow-up or death.

Protocol documents:
Clinical trial NCT01253811
Conditions: Congenital Bleeding Disorder Congenital FXIII Deficiency
Sponsor: Novo Nordisk A/S
Start date: 2011-01-01; Completion date: 2015-03-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This trial will be conducted in Asia, Europe and the United States of America (USA).

The aim of this clinical trial is to investigate long-term safety of rFXIII when administered for prevention of bleeding episodes in children aged between 1 and 6 years with congenital FXIII A-subunit deficiency. This trial is an extension to trial F13CD-3760 (mentor™4, NCT01230021). If applicable the trial will be extended up to maximum 3 years dependent on when recombinant factor XIII will be commercially available in subject's respective country for use in children of 1-6 years of age.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: catridecacog
Intervention descriptions: intervention 1: Intravenous injection of a single dose of recombinant factor XIII, 35 IU/kg body weight every 4th week

Protocol documents:
Clinical trial NCT01395017
Conditions: Pancreatic Cancer
Keywords: Pancreatic cancer Dasatinib chemotherapy Locally advanced
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2011-06-01; Completion date: 2015-03-01
Enrollment: 202 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether patients with locally advanced pancreatic cancer who receive dasatinib added to standard of care (gemcitabine) live longer, compared to patients who receive standard of care (gemcitabine) plus placebo; i.e. gemcitabine alone.

Detailed description:

Arms: arm 1: One arm will receive standard of care treatment (ie, GEM 1000 mg/m2 by intravenous \[IV\] infusion weekly for 3 weeks of a 4-week cycle) plus dasatinib 100 mg by mouth once daily (QD). arm 2: The other arm will receive standard of care treatment (ie, GEM 1000 mg/m2 by intravenous \[IV\] infusion weekly for 3 weeks of a 4-week cycle) plus matched placebo by mouth once daily (QD).
Interventions: intervention 1: dasatinib intervention 2: Placebo
Intervention descriptions: intervention 1: GEM 1000 mg/m2 by intravenous \[IV\] infusion weekly for 3 weeks of a 4-week cycle plus dasatinib 100 mg (or matched placebo) by mouth once daily (QD). Subjects will continue to receive study treatment until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. intervention 2: Matching Placebo

Protocol documents:
Clinical trial NCT01565668
Conditions: Leukemia, Myeloid, Acute
Keywords: FLT3-ITD positive Acute Myeloid Leukemia (AML) AC220 Relapse Refractory
Sponsor: Daiichi Sankyo
Start date: 2012-04-01; Completion date: 2015-03-01
Enrollment: 76 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate two doses of Quizartinib in patients with relapsed or refractory acute myeloid leukemia who are also FMS-like tyrosine kinase - internal tandem duplication ( FLT3-ITD) positive. Patient will be randomly assigned in a 1:1 ratio to one of two treatment arms. Both treatment arms will receive Quizartinib but at different doses. The study treatment is taken orally in 28 day cycles until either disease progression occurs or an unacceptable toxicity occurs. In addition to the study assessments to evaluate the disease, blood will be drawn to measure drug levels and biomarkers. Patients will be followed for survival at three month intervals after the end of treatment.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: AC220
Intervention descriptions: intervention 1: oral

Protocol documents:
Clinical trial NCT01605227
Conditions: Prostate Cancer Castration Resistant Prostate Cancer Pain Prostatic Neoplasms
Keywords: prostate cancer castration resistant prostate cancer bone pain CRPC
Sponsor: Exelixis
Start date: 2012-07-01; Completion date: 2015-03-01
Enrollment: 1028 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the effect of cabozantinib compared to prednisone on overall survival in men with previously treated metastatic castration-resistant prostate cancer with bone-dominant disease who have experienced disease progression on docetaxel-containing chemotherapy and abiraterone or MDV3100.

Detailed description:

Arms: arm 1: Subjects randomized to the cabozantinib arm will also receive placebo-matched prednisone capsules. arm 2: Subjects randomized to the prednisone arm will also receive placebo-matched cabozantinib.
Interventions: intervention 1: cabozantinib intervention 2: prednisone
Intervention descriptions: intervention 1: Tablets taken orally once-daily intervention 2: Taken twice a day orally. Commercially-obtained prednisone tablets will be over-encapsulated in order to blind identity.

Protocol documents:
Clinical trial NCT01625377
Conditions: Liver Transplantation
Keywords: Everolimus, liver transplantation, early introduction, renal function
Sponsor: Novartis Pharmaceuticals
Start date: 2012-12-01; Completion date: 2015-03-01
Enrollment: 188 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aims of the study was to evaluate the safety and efficacy of early introduction one month post-transplantation of everolimus associated to EC-MPS with tacrolimus discontinuation in de novo liver transplant recipients and to evaluate if it leads to a better renal function 6 month post-transplantation compared to standard treatment associating tacrolimus and EC-MPS.

The renal function was estimated by glomerular filtration rate.

Detailed description:

Arms: arm 1: From transplantation to randomization: Basiliximab (40mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids arm 2: From transplantation to randomization: Basiliximab (40mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.

From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest).
Interventions: intervention 1: tacrolimus intervention 2: everolimus intervention 3: Basiliximab intervention 4: Mycophenolic Acid intervention 5: Corticosteroids
Intervention descriptions: intervention 1: Arm 1 : tacrolimus (C0 6-10 ng/ml) from D3-D5 post-transplantation to month 6 post-transplantation. Arm 2 : tacolimus (C0 6-10 ng/ml) from D3-D5 post-transplantation to 16 weeks post-transplantation at the latest. intervention 2: Arm 1: no everolimus Arm 2: everolimus (C0 6-10 ng/ml) from randomization to month 6 post-transplantation intervention 3: Basiliximab was supplied to the participating centers as marketed, i.e. in packs containing one vial of 20-mg powder, and water for injection (WFI). 20 mg at D0 and D4 intervention 4: Dose of 1440 mg/day from transplantation to month 6 post- transplantation intervention 5: Administration of oral corticosteroid therapy was at the discretion of the centers according to their usual practice

Protocol documents:
Clinical trial NCT01688882
Conditions: Bullous Pemphigoid
Keywords: bullous pemphigoid QGE031
Sponsor: Novartis Pharmaceuticals
Start date: 2013-01-01; Completion date: 2015-03-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the safety and efficacy of QGE031 versus placebo in patients with bullous pemphigoid. Efficacy will be assessed as a reduction of disease activity. How QGE031 is broken down by the body and the impact it has on different blood and tissue markers will also be explored.

Detailed description:
This study was planned to be divided into 2 distinct parts. Part 1 was a multicenter, randomized, placebo-controlled study evaluating the efficacy, safety, PK and PD of multiple, subcutaneous doses of QGE031 in the treatment of patients with BP with disease refractory to oral steroid treatment. Patients were treated with QGE031 or placebo in a 2:1 ratio.

Part 2 of this study was planned to be a multi-center, open label, dose range finding study evaluating the efficacy, safety, PK and PD of multiple, subcutaneous doses of QGE031 in the treatment of patients with BP with disease refractory to oral steroid treatment.

This study was stopped after Part 1 completed and was terminated because the predefined criteria of efficacy was not reached ( \>50% better then placebo)

Arms: arm 1: QGE031 240 mg Q2W s.c. arm 2: Placebo to Match Q2W s.c. arm 3: Open Label QGE031 Q2W s.c.
Interventions: intervention 1: QGE031 intervention 2: Placebo
Intervention descriptions: intervention 1: QGE031 will be evaluated at various dose levels and regimens, based on the impact on disease of the next highest dose level and regimen. intervention 2: Placebo will be used to control for normal variability in disease severity.

Protocol documents:
Clinical trial NCT01693029
Conditions: Anemia Chronic Kidney Disease (CKD)
Keywords: erythropoietin alfa CKD 5d
Sponsor: Sandoz
Start date: 2012-09-01; Completion date: 2015-03-01
Enrollment: 435 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to show biosimilarity of HX575 epoetin alfa with the US licensed reference product Epogen®/Procrit® when applied subcutaneously. This study is intended to generate data supporting that the efficacy and safety under treatment with HX575 and Epogen®/Procrit® are comparable.

Detailed description:
This is a randomized, double-blind, parallel-group, multicenter study to evaluate the efficacy and safety of HX575 epoetin alfa vs. US-licensed epoetin alfa (Epogen®/Procrit®) in the treatment of anemia associated with chronic kidney disease (CKD).

Arms: arm 1: HX575, recombinant human epoetin alfa arm 2: US-licensed recombinant human epoetin alfa
Interventions: intervention 1: HX575 epoetin alfa intervention 2: US-licensed epoetin alfa
Intervention descriptions: intervention 1: Solution for subcutaneous injection. The drug is administered subcutaneously at least once per week over 52 weeks. The dose will be individually titrated to maintain hemoglobin levels between 10 to 11 g/dL. intervention 2: Solution for subcutaneous injection.

Protocol documents:
Clinical trial NCT01970878
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Sponsor: Pearl Therapeutics, Inc.
Start date: 2013-11-01; Completion date: 2015-03-01
Enrollment: 892 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multi-center, randomized, double-blind, parallel group, chronic dosing, active-controlled, 28-week safety extension study of the two pivotal 24-week safety and efficacy studies (Studies PT003006 and PT003007). This study is designed to assess the long-term safety and tolerability of Glycopyrrolate (GP) and Formoterol Fumarate (FF) combination (GFF) metered dose inhaler (MDI), GP MDI, and FF MDI in subjects with moderate to very severe COPD over a total observation period of 52 weeks. Open-label Spiriva is included as an active control. To be eligible for this study, a subject must complete participation in Study PT003006 (NCT01854645) or Study PT003007 (NCT01854658).

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: Open-label tiotropium bromide inhalation powder (Spiriva® Handihaler®)
Interventions: intervention 1: GFF MDI (PT 003) intervention 2: GP MDI (PT001) intervention 3: FF MDI (PT005) intervention 4: Open-label tiotropium bromide inhalation (Spiriva® Handihaler®)
Intervention descriptions: intervention 1: GFF MDI administered as two puffs BID intervention 2: GP MDI administered as two puffs BID intervention 3: FF MDI administered as two puffs BID intervention 4: Taken as 1 capsule daily containing 18 μg of open-label tiotropium via the Handihaler dry powder inhaler (DPI)

Protocol documents: