ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01684215
Conditions: Neoplasms Breast Neoplasms
Keywords: Phase 1/2 PD-0332991 palbociclib Cyclin Dependent Kinase 4/6 inhibitor Japanese solid tumors breast cancer A5481010
Sponsor: Pfizer
Start date: 2012-10-19; Completion date: 2018-10-25
Enrollment: 61 participants; Allocation: NON_RANDOMIZED; Intervention model: 

Brief summary:
This study is comprised of two portions: a Phase 1 portion and a Phase 2 portion. The Phase 1 portion is a single-country, non-randomized, open label, clinical trial which will evaluate the safety, tolerability, preliminary efficacy, and PK profile of PD-0332991 as a single agent in Japanese patients with advanced solid tumors, and PD-0332991 in combination with letrozole in the first-line treatment of Japanese patients with ER(+) HER2(-) ABC. The Phase 2 portion is a single-country, non-randomized, open-label, single-cohort, multi-center clinical trial to evaluate the efficacy and safety of PD-0332991 in combination with letrozole for the first-line treatment of postmenopausal Japanese patients with ER(+) HER2(-) ABC.

Detailed description:

Arms: arm 1: Phase 1 Part 1 arm 2: Phase 1 Part 2 arm 3: Phase 2
Interventions: intervention 1: PD-0332991 intervention 2: PD-0332991 intervention 3: letrozole intervention 4: PD-0332991 intervention 5: letrozole
Intervention descriptions: intervention 1: PD-0332991 (100 mg or 125 mg) will be orally administered once a day for 3 weeks followed by 1 week off treatment, in the morning on an empty stomach. Dose reduction of PD-0332991 by one (100 mg) or two (75 mg) dose level is permitted depending on treatment related toxicity. intervention 2: PD-0332991, 125 mg, will be orally administered with food once a day for 3 weeks followed by 1 week off treatment. PD-0332991 will be administered once a day together with letrozole. Dose reduction of PD-0332991 by one (100 mg) or two (75 mg) dose level is permitted depending on treatment related toxicity. intervention 3: Letrozole, 2.5 mg, will be orally administered once a day in continuous daily dosing together with PD-0332991. Dose reduction of letrozole is not permitted, but dosing interruptions for letrozole-related toxicity are allowed as per investigator's medical judgement. intervention 4: PD-0332991, 125 mg, will be orally administered with food once a day for 3 weeks followed by 1 week off treatment. PD-0332991 will be administered once a day together with letrozole. Dose reduction of PD-0332991 by one (100 mg) or two (75 mg) dose level is permitted depending on treatment related toxicity. intervention 5: Letrozole, 2.5 mg, will be orally administered once a day in continuous daily dosing together with PD-0332991. Dose reduction of letrozole is not permitted, but dosing interruptions for letrozole-related toxicity are allowed as per investigator's medical judgement.

Protocol documents:
Clinical trial NCT01700036
Conditions: Graft vs Host Disease
Sponsor: University of Michigan Rogel Cancer Center
Start date: 2013-07-01; Completion date: 2018-10-26
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This clinical trial will study the safety and efficacy of using the drug Zemaira, an Alpha 1-Antitrypsin (AAT) medication (also known as an Alpha1-Proteinase Inhibitor \[Human\]) for the treatment of steroid refractory GVHD.

For bone marrow transplant patients, the most common, serious complication is Graft vs Host Disease (GVHD), which at its most severe is a life-threatening, complication and a significant cause of treatment related death, following stem cell transplantation. GVHD is a major obstacle to the overall success of transplant treatment, a strategy that would otherwise provide the possibility of a cure for patients with blood cancers or severe blood disorders. GVHD primarily affects the skin, gut, and liver of the recipient, and involves the interaction of the recipient's (the host's) cells and tissues with the donor's immune system cells that see the host tissues as foreign, and attack the host's cells resulting in tissue and organ damage.

The severity of acute GvHD ranges from mild to severe, and for patients who don't respond to steroid therapy, the complication is nearly always fatal, either from organ damage or opportunistic infection as a consequence of high dose, steroid treatments.

There is currently no known effective therapy for patients with acute graft vs host disease that's refractory (nonresponsive) to steroid therapy. As stated earlier,the overwhelming majority of these patients may ultimately die from infection. The incidence of acute GvHD that requires intervention, is higher for unrelated donor transplants, the most common treatment option available, and therefore, these patients are at higher risk for treatment related complications from GVHD. Approximately 20,000 unrelated donor transplants are performed each year. The magnitude of this problem then is significant for patients who otherwise might be cured of their blood cancer or disease.

Detailed description:

Arms: arm 1: Alpha-1-Antitrypsin (AAT) for the treatment of Steroid Refractory Acute Graft vs Host Disease.
Interventions: intervention 1: Alpha-1-Antitrypsin (AAT)
Intervention descriptions: intervention 1: AAT (Zemaira) will be administered at a dose of 60mg/kg (actual weight) on D1, 4, 8, 12, 16, 20, 24, and 28. A second course of treatment will not be given.

Protocol documents:
Clinical trial NCT01677858
Conditions: Multiple Myeloma
Sponsor: Amgen
Start date: 2012-07-04; Completion date: 2018-10-31
Enrollment: 116 participants; Allocation: NA; Intervention model: SEQUENTIAL

Brief summary:
The study had the following primary objectives:

* Phase 1: to determine the maximum tolerated dose (MTD) of once-weekly (QW) carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior therapies
* Phase 2: to estimate the overall response rate (ORR) for patients with relapsed or refractory multiple myeloma who received 1 to 3 prior therapies treated with carfilzomib and dexamethasone QW at the MTD established in phase 1.

Detailed description:
This is a Phase 1/2, multicenter, single-arm, nonrandomized, open-label and dose-escalation study of weekly carfilzomib and dexamethasone for patients with progressive multiple myeloma. The Phase 1 dose escalation portion will enroll patients into sequential dose-escalating cohorts consisting of 3 patients each to establish the maximum tolerated dose (MTD) of carfilzomib administered weekly as a 30 minute intravenous (IV) infusion with dexamethasone. The Phase 2 portion will enroll patients using the MTD established for carfilzomib from the Phase 1 portion of the study. Dexamethasone will be administered IV or orally at the same dose and schedule as used in the Phase 1 portion of the study.

Arms: arm 1: In phase 1 participants were assigned to one of four sequential dose-escalating cohorts to receive 45, 56, 70 or 88 mg/m² carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.

In phase 2 participants received carfilzomib at the maximum tolerated dose (MTD) established in the Phase 1 portion of the study on days 1, 8 and 15 plus 40 mg dexamethasone IV or orally at the same schedule as used in the Phase 1 portion of the study.

Participants were treated until confirmed progressive disease, unacceptable toxicity, withdrew consent for further treatment, were lost to follow-up, died, or the sponsor closed the study.
Interventions: intervention 1: Carfilzomib intervention 2: Dexamethasone
Intervention descriptions: intervention 1: Carfilzomib was administered as a 30-minute IV infusion on days 1, 8, and 15 of each 28-day treatment cycle. intervention 2: Dexamethasone was administered at a dose of 40 mg IV or orally (PO) on days 1, 8, 15, and 22 for the first 8 cycles; starting with cycle 9 dexamethasone was administered on days 1, 8, and 15.

Protocol documents:
Clinical trial NCT02326025
Conditions: Sarcoma, Soft Tissue
Sponsor: Eli Lilly and Company
Start date: 2015-01-22; Completion date: 2018-11-02
Enrollment: 49 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
The purpose of this study is to assess how the body handles olaratumab when it is given with another drug called doxorubicin.

The safety and tolerability of these drugs will be studied. Each participant will complete two 21-day cycles in a fixed order. Participants who complete Cycle 2 may continue to receive olaratumab + doxorubicin for an additional six 21-day cycles and then may receive olaratumab alone until discontinuation criteria are met.

Screening is required within 21 days prior to first dose.

Part B was added in October, 2015 to assess how the body handles a higher dose of olaratumab when given with doxorubicin.

Participants may only enroll in one part.

Detailed description:

Arms: arm 1: Doxorubicin Alone: On Cycle 1, Day 1, participants received 75 milligram/square meter (mg/m2) of doxorubicin intravenously (IV).

Olaratumab Alone: On Cycle 1, Day 10, participants received 15 milligram/kilogram (mg/kg) of olaratumab IV.

Olaratumab + Doxorubicin: For Cycles 2 to 8, participants received 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, IV and 75 mg/m2 of doxorubicin IV immediately following the completion of the olaratumab infusion.

Participants continued to receive olaratumab monotherapy (on days 1 and 8 of each cycle) for Cycle 9 onward, until discontinuation criteria are met. arm 2: Doxorubicin Alone: On Cycle 1, Day 1, participants received doxorubicin 75 mg/m2 IV

Olaratumab Alone: On Cycle 1, Day 10, participants received 20 mg/kg of olaratumab IV.

Olaratumab + Doxorubicin:

For Cycle 2, participants received 20 mg of olaratumab on Days 1 and 8 of each 21-day cycle, IV. On Day 1 of Cycle 2, doxorubicin 75 mg/m2 was administered IV immediately following the completion of the olaratumab infusion.

For Cycles 3 - 8, Day 1 and 8, olaratumab 15 mg/kg was administered and on Day 1 doxorubicin 75 mg/m2 was administered IV immediately following the completion of the olaratumab infusion.

Participants continued to receive olaratumab monotherapy (on days 1 and 8 of each cycle) for Cycle 9 onwards, until discontinuation criteria are met.
Interventions: intervention 1: Olaratumab intervention 2: Doxorubicin
Intervention descriptions: intervention 1: Administered IV intervention 2: Administered IV

Protocol documents:
Clinical trial NCT02273596
Conditions: Wilson Disease
Sponsor: Alexion Pharmaceuticals, Inc.
Start date: 2014-11-24; Completion date: 2018-11-07
Enrollment: 29 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The main purpose of the study was to evaluate the efficacy of ALXN1840 (formerly WTX101) for 24 weeks on non-ceruloplasmin-bound copper (NCC) concentrations adjusted for molybdenum plasma concentration in participants newly diagnosed with Wilson Disease (WD) who were aged 18 and older and who had NCC concentrations within or above the reference range at the time of enrollment in the study. The study consisted of a 24-week Treatment Period, followed by a planned 36-month Extension Period.

Detailed description:

Arms: arm 1: Treatment Period: ALXN1840 at individualized doses ranging from 15 to 60 milligram (mg) per day. Dose increases or dose reductions were dependent on the individual NCC concentrations adjusted for Mo plasma concentration. ALXN1840 may have been administered every other day, once daily, or twice daily, depending on individualized dosing regimen, for 24 weeks.

Extension Period: Participants continued the same ALXN1840 daily dose maintained at Week 24 of the Treatment Period and the same dosing regimen. During the Extension Period, no up-titration was made unless NCC concentrations adjusted for Mo plasma concentration did not remain stable within (or below) the reference range. ALXN1840 could have been received for up to 36 months in the Extension Period.
Interventions: intervention 1: ALXN1840
Intervention descriptions: intervention 1: Individualized oral doses of ALXN1840.

Protocol documents:
Clinical trial NCT02613871
Conditions: Hepatitis C Virus Infection
Sponsor: Gilead Sciences
Start date: 2015-12-22; Completion date: 2018-11-07
Enrollment: 111 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objectives of this study are to determine the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults with chronic genotype 1 or 2 HCV infection who are coinfected with HBV in Taiwan.

Detailed description:

Arms: arm 1: LDV/SOF FDC for 12 weeks
Interventions: intervention 1: LDV/SOF
Intervention descriptions: intervention 1: 90/400 mg FDC tablet administered orally once daily

Protocol documents:
Clinical trial NCT03291067
Conditions: Menopause Hot Flashes
Sponsor: Mitsubishi Tanabe Pharma America Inc.
Start date: 2017-10-09; Completion date: 2018-11-09
Enrollment: 375 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the efficacy and safety of MT-8554 for treatment of vasomotor symptoms (VMS) associated with menopause.

Detailed description:
This is a Phase II randomized, double-blind, placebo-controlled study for dose selection in postmenopausal women with moderate to severe VMS, defined as follows:

* Moderate: sensation of heat with sweating, able to continue activity
* Severe: sensation of heat with sweating, causing cessation of activity This study is comprised of a screening period, a run-in period and a 12-week double-blind treatment period.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: MT-8554 1mg intervention 2: MT-8554 5mg intervention 3: MT-8554 10mg intervention 4: Placebo
Intervention descriptions: intervention 1: MT-8554 1mg QD, oral, 12 weeks intervention 2: MT-8554 5mg QD, oral, 12 weeks intervention 3: MT-8554 10mg QD, oral, 12 weeks intervention 4: Placebo QD, oral, 12 weeks

Protocol documents:
Prot_000.pdf: 





















































































































































SAP_001.pdf:
Clinical trial NCT01524289
Conditions: Hyperlipoproteinemia Type II Hypercholesterolemia, Familial
Sponsor: Merck Sharp & Dohme LLC
Start date: 2012-02-03; Completion date: 2018-11-13
Enrollment: 306 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to evaluate the efficacy and tolerability of adding anacetrapib to ongoing statin therapy in participants with heterozygous familial hypercholesterolemia (HeFH).

Detailed description:

Arms: arm 1: Participants were administered one tablet of 100 mg anacetrapib orally once daily with a meal for 52 weeks during the treatment period. arm 2: Participants were administered one matching placebo tablet orally once daily with a meal for 52 weeks during the treatment period.
Interventions: intervention 1: Anacetrapib intervention 2: Placebo
Intervention descriptions: intervention 1: One oral tablet, orally once daily for 52 weeks intervention 2: One oral tablet once daily for 52 weeks

Protocol documents:
Clinical trial NCT03463031
Conditions: Seasonal Allergic Rhinitis (SAR)
Keywords: GSP 301 nasal spray for the treatment of Seasonal Allergic Rhinitis
Sponsor: Glenmark Specialty S.A.
Start date: 2018-03-16; Completion date: 2018-11-14
Enrollment: 446 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study to evaluate the efficacy, safety and tolerability of GSP 301 nasal spray (NS) compared with placebo NS in pediatric subjects (aged 6 to under 12 years) with Seasonal Allergic Rhinitis (SAR).

Detailed description:

Arms: arm 1: Fixed dose combination of olopatadine hydrochloride 665 μg and mometasone furoate 25 μg NS arm 2: GSP 301 Placebo nasal spray
Interventions: intervention 1: GSP 301 NS intervention 2: GSP 301 Placebo NS
Intervention descriptions: intervention 1: 1 spray in each nostril twice daily for 14 days intervention 2: 1 spray in each nostril twice daily for 14 days

Protocol documents:
Prot_000.pdf: 
 
   
 
Confidential 
 
 
Page 1 of 1 
 
 
A Double-Blind, Randomized, Parallel-Group Study to Evaluate the Efficacy, Safety and 
Tolerability of Fixed Dose Combination GSP 301 Nasal Spray Compared With Placebo 
Nasal Spray in Pediatric Subjects (Aged 6 to Under 12 Years) With Seasonal Allergic 
Rhinitis (SAR)  
 
Identifiers                   NCT03463031 
Date of Document     18 July 2018 





















































































































































































SAP_001.pdf:
Clinical trial NCT02224729
Conditions: Stage I Multiple Myeloma Stage II Multiple Myeloma Stage III Multiple Myeloma
Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
Start date: 2014-08-25; Completion date: 2018-11-17
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies side effects and how well bendamustine hydrochloride, bortezomib, and dexamethasone work in treating patients with newly diagnosed multiple myeloma. Drugs used in chemotherapy, such as bendamustine hydrochloride and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving bendamustine hydrochloride with bortezomib and dexamethasone may kill more cancer cells.

Detailed description:
PRIMARY OBJECTIVES:

I. Establish the response rate of induction therapy following 4 cycles of the combination regimen bendamustine (bendamustine hydrochloride), bortezomib and dexamethasone (BBd) in patients with newly diagnosed multiple myeloma.

II. Describe the tolerability and toxicities of this regimen. III. Provide one-year progression-free survival and one-year overall survival data following this therapeutic strategy.

OUTLINE:

Patients receive bendamustine hydrochloride intravenously (IV) over 30 minutes on days 1 and 2; bortezomib subcutaneously (SC) on days 1, 8, 15, and 22; and dexamethasone orally (PO) on days 1, 8, 15, and 22. Treatment repeats every 35 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than a very good partial response (VGPR) or with more than 10% bone marrow plasmacytosis may receive 2 additional courses.

NOTE: Patients requiring immediate reduction in paraprotein during course 1 only receive bendamustine hydrochloride IV over 30 minutes on days 1 and 2; bortezomib IV on days 1, 4, 8, and 11; and dexamethasone PO on days 1-4.

After completion of study treatment, patients are followed up for 1 year.

Arms: arm 1: Patients receive bendamustine hydrochloride IV over 30 minutes on days 1 and 2; bortezomib SC on days 1, 8, 15, and 22; and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 35 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than a VGPR or with more than 10% bone marrow plasmacytosis may receive 2 additional courses.
Interventions: intervention 1: Bendamustine hydrochloride intervention 2: Bortezomib intervention 3: Dexamethasone
Intervention descriptions: intervention 1: Given IV intervention 2: Given SC intervention 3: Given PO

Protocol documents:
Clinical trial NCT00636168
Conditions: High Risk Stage III Melanoma
Sponsor: Bristol-Myers Squibb
Start date: 2008-06-30; Completion date: 2018-11-26
Enrollment: 1211 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine if ipilimumab is effective in preventing or delaying recurrence and prolongs survival after complete resection of high risk stage III melanoma

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: ipilimumab intervention 2: Placebo
Intervention descriptions: intervention 1: IV solution, IV, 10 mg/kg, 4x every 21 days, then starting from Week 24 every 12 weeks until Week 156 (3 years), disease recurrence, unacceptable toxicity or patient withdrawal intervention 2: IV solution, IV, 10 mg/kg, 4x every 21 days then starting from Week 24 every 12 weeks until Week 156 (3 years), disease recurrence, unacceptable toxicity or patient withdrawal

Protocol documents:
Clinical trial NCT02090725
Conditions: Muscle Weakness
Keywords: fluctuating muscle weakness hyporeflexia autonomic Dysfunction
Sponsor: Jeffrey A. Cohen, MD
Start date: 2004-02-01; Completion date: 2018-11-28
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The main purpose for this study is to provide access to 3,4 DAP, a drug which has demonstrated to be effective in treating weakness associated with Lambert-Eaton Myasthenic Syndrome. LEMS is a rare autoimmune cause of a defect in neuromuscular transmission. The disorder is clinically characterized by fluctuating muscle weakness, hyporeflexia and autonomic dysfunction.

Detailed description:
More than half of LEMS cases are associated with malignancy, usually small cell lung cancer. These paraneoplastic cases progress more quickly than primary autoimmune LEMS. An overlap syndrome with other autoimmune diseases is often detected in LEMS patients.

3,4 DAP is effective in LEMS because it increases calcium influx into the nerve terminal by blocking potassium efflux and thereby prolonging the presynaptic action potential. 3,4 DAP is less likely to provoke epileptic seizures than its precursor, 4-aminopyridine, because it is less able to cross the blood-brain barrier. 3,4 DAP is effective in increasing strength and improving autonomic symptoms in LEMS patients of both the primary autoimmune and paraneoplastic etiologies.

Arms: arm 1: None
Interventions: intervention 1: 3-4 Diaminopyridine
Intervention descriptions: intervention 1: None

Protocol documents:
Prot_000.pdf:
Clinical trial NCT01059630
Conditions: Non-Hodgkin's Lymphoma
Keywords: follicular follicular lymphoma
Sponsor: Genentech, Inc.
Start date: 2010-04-30; Completion date: 2018-11-30
Enrollment: 413 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This open-label, multicenter, randomized Phase III study will investigate the efficacy, safety, pharmacokinetics and pharmacoeconomics of obinutuzumab (RO5072759, GA101) combined with bendamustine followed by continued obinutuzumab treatment (maintenance monotherapy) compared with bendamustine alone treatment in participants with rituximab-refractory indolent Non-Hodgkin's lymphoma (iNHL). The end of study was defined to when safety follow-up for all patients had been completed (2 years' safety follow-up from last dose).

Detailed description:

Arms: arm 1: Participants will receive bendamustine 120 milligrams per meter square (mg/m\^2) Intravenous (IV) infusion on Days 1 and 2 of each 28-day cycle for up to six cycles. arm 2: Induction phase: Participants will receive bendamustine 90 mg/m\^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants will also receive obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.

Maintenance phase: Participants with complete response (CR), partial response (PR) or stable response (SD) then will receive obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurs first).
Interventions: intervention 1: Obinutuzumab intervention 2: Bendamustine
Intervention descriptions: intervention 1: IV infusion. intervention 2: IV infusion.

Protocol documents: