ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01206465
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Sponsor: University of Nebraska
Start date: 2010-09-14; Completion date: 2017-06-01
Enrollment: 29 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Pralatrexate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving pralatrexate together with fluorouracil may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of pralatrexate when given together with fluorouracil in treating patients with recurrent solid tumors

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the recommended dose of PDX (pralatrexate) given in combination with a fixed dose of 5-FU (fluorouracil) administered as a 48-hour infusion given every other week.

SECONDARY OBJECTIVES:

I. To assess clinical response to therapy in subjects with measurable disease and time to disease progression in all subjects.

II. To assess the toxicity profile of the combination of PDX and 5-FU. III. To determine the pharmacokinetics of PDX and 5-FU and correlate with clinical toxicity.

IV. To analyze polymorphisms in methylenetetrahydrofolate reductase and thymidylate synthase (TS) and correlate with clinical toxicity.

OUTLINE: This is a dose-escalation study of pralatrexate.

Patients receive pralatrexate intravenously (IV) over 5 minutes on day 1 and fluorouracil IV continuously over 48 hours on days 2 and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 30 days.

Arms: arm 1: Patients receive pralatrexate IV over 5 minutes on day 1 and fluorouracil IV continuously over 48 hours on days 2 and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: pralatrexate intervention 2: fluorouracil intervention 3: laboratory biomarker analysis intervention 4: DNA analysis intervention 5: high performance liquid chromatography intervention 6: polymerase chain reaction intervention 7: nucleic acid sequencing intervention 8: pharmacological study intervention 9: pharmacogenomic studies intervention 10: polymorphism analysis
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV intervention 3: Correlative studies intervention 4: Correlative studies intervention 5: Correlative studies intervention 6: Correlative studies intervention 7: Correlative studies intervention 8: Correlative studies intervention 9: Correlative studies intervention 10: Correlative studies

Protocol documents:
Clinical trial NCT01708161
Conditions: PIK3CA Mutated Advanced Solid Tumors PIK3CA Amplified Advanced Solid Tumors
Keywords: PIK3CA mutation advanced solid tumor breast cancer ovarian cancer cancers with a mass bulky tumor nodule lump advanced cancer advanced solid malignancies
Sponsor: Novartis Pharmaceuticals
Start date: 2012-11-27; Completion date: 2017-06-01
Enrollment: 47 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This was a multi-center, open-label, phase Ib/II study. The aim of the phase Ib part was to estimate the MTD(s) and/or identify the recommended phase II dose(s) (RP2Ds) for the combination of BYL719 and AMG 479 (ganitumab), followed by the phase II part to assess the clinical efficacy and to further assess the safety of the combination in selected patient populations. Patients were to be treated until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. All patients were to be followed up. At a minimum, patients must have completed the safety follow-up assessments 30 days after the last dose of the study treatment.

Detailed description:
This was a multi-center, open-label, phase Ib/II study. The aim of the phase Ib part was to estimate the MTD(s) and/or identify the recommended phase II dose(s) (RP2Ds) for the combination of BYL719 and AMG 479 (ganitumab), followed by the phase II part to assess the clinical efficacy and to further assess the safety of the combination in selected patient populations. The dose escalation part of the study were to be guided by a Bayesian Logistic Regression Model (BLRM).

Once MTD/RP2D had been determined, patients were to be enrolled in two Phase II arms. Patients with PIK3CA mutated or amplified hormone receptor positive breast carcinoma were to be enrolled in Arm 1; patients with PIK3CA mutated or amplified ovarian carcinoma were to be enrolled in Arm 2. Patients were to be treated until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. All patients were to be followed up. At a minimum, patients must have completed the safety follow-up assessments 30 days after the last dose of the study treatment.

Arms: arm 1: For: Dose escalation phase/Phase II Expansion Phase. Cohorts of 3-6 patients were to be enrolled sequentially until an MTD or a recommended Phase II dose were defined. All patients were to receive the combination treatment. Sequential cohorts may receive different doses of the combination. In the Phase II expansion, all patients were to receive the same combination treatment.
Interventions: intervention 1: BYL719 intervention 2: AMG 479
Intervention descriptions: intervention 1: BYL719 is a small molecule inhibiting PI3-Kinase. intervention 2: AMG 479 is a monoclonal antibody directed against IGF1-R.

Protocol documents:
Clinical trial NCT02069704
Conditions: Metastatic Colorectal Cancer (mCRC)
Keywords: colorectal cancer metastatic first-line treatment comparability
Sponsor: mAbxience Research S.L.
Start date: 2014-10-29; Completion date: 2017-06-01
Enrollment: 142 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multicenter, open label, randomized bioequivalence study of BEVZ92 (bevacizumab biosimilar) and Avastin® with 2 parallel arms to compare the pharmacokinetic (PK) profile of BEVZ92 and Avastin® in combination with FOLFOX (any) or FOLFIRI chemotherapy.

FOLFOX (any) or FOLFIRI will be chosen as per investigator criteria based on the hospital standard of care.

Detailed description:
Planned enrolment duration: 12 months. Pre-treatment period (included in enrolment period): 1 month. Treatment period: Patients will continue treatment until disease progression or unacceptable toxicity, or withdrawal of consent.

Arms: arm 1: Bevacizumab 25 mg/mL (strength: 100 mg/4 mL). arm 2: Bevacizumab 25mg/ml (strength: 100mg/4ml)
Interventions: intervention 1: Bevacizumab biosimilar (BEVZ92) intervention 2: Avastin® (bevacizumab, reference product)
Intervention descriptions: intervention 1: Active ingredient Bevacizumab 25 mg/mL (strength = 100 mg/4 mL). 30-minute\* IV infusion (5 mg/kg) every 2 weeks, prior to chemotherapy (Folfox any or Folfiri).

FOLFIRI = Folinic Acid + Fluorouracil + Irinotecan FOLFOX = Folinic Acid + Fluorouracil + Oxaliplatin Treatment will continue until disease progression, unacceptable toxicity, patient withdraws consent or death (whichever occurs first).

\*The first infusion will be given over 90 minutes. If it is well tolerated, the second infusion can be given over 60 minutes. If it is well tolerated, subsequent infusions can be given over 30 minutes.

The FOLFOX (any) or FOLFIRI regimen will be chosen as per investigator's criteria based on the hospital standard of care. intervention 2: Active ingredient: Bevacizumab 25 mg/mL (strength: 100 mg/4 mL). 30-minute\* IV infusion (5 mg/kg) every 2 weeks, prior to administration of chemotherapy. Treatment will continue until disease progression, unacceptable toxicity, patient withdraws consent or death (whichever occurs first).

\*The first infusion will be given over 90 minutes. If the first infusion is well tolerated, the second infusion can be given over 60 minutes. If this infusion is well tolerated, subsequent infusions can be given over 30 minutes.

The FOLFOX (any) or FOLFIRI regimen will be chosen as per investigator's criteria based on the hospital standard of care.

Protocol documents:
Clinical trial NCT02194088
Conditions: Pain
Sponsor: Brigham and Women's Hospital
Start date: 2014-04-01; Completion date: 2017-06-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This research study is being done to assess if a combination of medications can enhance the relief of superficial pain (pain at the surface of the skin, such as sunburn pain). The investigators also want to find out if certain genes may be linked to individual differences in experienced efficacy of pain killers. The combination of medications under investigation is diclofenac and atropine. Diclofenac has been approved by the U.S. Food and Drug Administration (FDA) to treat pain. Atropine has been approved by the FDA to treat certain types of poisoning, heartbeat problems, and other diseases but atropine is not approved to treat pain. However, atropine has been used for many years in different European countries to treat painful conditions such as stomach cramps.This research study will compare diclofenac and atropine to placebo.

Detailed description:

Arms: arm 1: Diclofenac and Atropine combination drug Provided PO. This is a novel combination. Diclofenac 100mg + Atropine 1.2 mg in one single dose arm 2: Placebo capsules will be delivered in same number as the medication
Interventions: intervention 1: Diclofenac and Atropine combination drug intervention 2: Placebo
Intervention descriptions: intervention 1: Diclofenac will be associated with a small dose of atropine 1.2mg intervention 2: For each capsule of active medication, a capsule of placebo will be provided, identical looking.

Protocol documents:
Clinical trial NCT02231762
Conditions: Gastroenteropancreatic Neuroendocrine Tumors
Sponsor: Ipsen
Start date: 2014-10-01; Completion date: 2017-06-01
Enrollment: 57 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to evaluate the efficacy and tolerability of the combination of Lanreotide Autogel 120 mg and Temozolomide in patients with progressive gastro-entero-pancreatic neuroendocrine tumours (GEP-NET) graded as G1 or G2 (G1/G2). All progressive tumours classified according to Response Evaluation Criteria In Solid Tumours (RECIST, 1.1).

Detailed description:

Arms: arm 1: Combination phase for first 6 months: Lanreotide Autogel 120 mg and Temozolomide.

Followed by either 6 months Lanreotide Autogel 120 mg maintenance or 6 months of no treatment.
Interventions: intervention 1: Lanreotide Autogel 120 mg intervention 2: Temozolomide (TMZ)
Intervention descriptions: intervention 1: Lanreotide Autogel 120 mg subcutaneous (s.c) - injection, every 28 days (+/-2 days). intervention 2: Temozolomide capsule (variable dose). 150 mg/m2 per day for 5 days in the first month. 200 mg/m2 per day for 5 days in months 2, 3, 4, 5 and 6.

Protocol documents:
Clinical trial NCT02261532
Conditions: Advanced or Metastatic Solid Tumors
Sponsor: Taiho Pharmaceutical Co., Ltd.
Start date: 2014-09-01; Completion date: 2017-06-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to evaluate the pharmacokinetics of TAS-102 after single and multiple dose in Chinese patients with solid tumor.

Detailed description:
This is an open-label, non-randomized, single group Phase 1 study of TAS-102, evaluating the pharmacokinetics, safety, and antitumor activity. Blood sampling will be performed during the first cycle (Day1 and Day 12) of therapy in all consenting patients.

Arms: arm 1: None
Interventions: intervention 1: TAS-102
Intervention descriptions: intervention 1: TAS-102 (35 mg/m2/dose) orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria is met.

Protocol documents:
Clinical trial NCT02475070
Conditions: Type 2 Diabetes
Sponsor: Lund University
Start date: 2016-01-01; Completion date: 2017-06-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The aim of the study is to assess if vildagliptin and dapagliflozin have dissociated effects on glucagon secretion after a mixed meal ingestion in metformin-treated subjects with type 2 diabetes and whether this is associated with effects on glucose homeostasis.

Detailed description:
The aim of the study is to assess if vildagliptin and dapagliflozin have dissociated effects on glucagon secretion after a mixed meal ingestion in metformin-treated subjects with type 2 diabetes and whether this is associated with effects on glucose homeostasis. Subjects will therefore be treated with vildagliptin or dapagliflozin as add-on to metformin for two weeks followed by a meal test in which glucagon levels will be determined.

Arms: arm 1: Treatment with vildagliptin 50mg twice daily for two weeks followed by four weeks washout and then treatment with dapagliflozin 10mg once daily for two weeks arm 2: Treatment with dapagliflozin 10 mg once daily for two weeks followed by four weeks washout and then treatment with vildagliptin 50 mg twice daily for two weeks
Interventions: intervention 1: Vildagliptin intervention 2: Dapagliflozin
Intervention descriptions: intervention 1: Vildagliptin added at 50 mg twice daily for two weeks followed by four weeks washout and then dapagliflozin 10mg once daily for two weeks intervention 2: Dapagliflozin added at 10 mg once daily for two weeks followed by four weeks washout and then vildagliptin 50 mg twice daily for two weeks

Protocol documents:
Prot_000.pdf: 































SAP_001.pdf:
Clinical trial NCT02517515
Conditions: Hepatitis C Virus (HCV)
Keywords: HCV Infection Chronic Hepatitis C Virus Hepatitis C Virus (HCV) Genotype 1b
Sponsor: AbbVie
Start date: 2015-07-01; Completion date: 2017-06-01
Enrollment: 650 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study to evaluate ABT 450/r/ABT-267 and ABT-333 in treatment-naïve and treatment-experienced Asian adults with subgenotype 1b chronic HCV without cirrhosis.

Detailed description:

Arms: arm 1: Double-blind 3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\] and dasabuvir \[250 mg twice daily\]) for 12 weeks. arm 2: Double-blind placebo for 12 weeks, followed by open-label 3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\] and dasabuvir \[250 mg twice daily\]) for 12 weeks.
Interventions: intervention 1: ombitasvir/paritaprevir/ritonavir and dasabuvir intervention 2: Placebo for ombitasvir/paritaprevir/ritonavir and dasabuvir
Intervention descriptions: intervention 1: Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet intervention 2: Placebo for ombitasvir/paritaprevir/ritonavir and dasabuvir

Protocol documents:
Clinical trial NCT02499900
Conditions: Multiple Sclerosis
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2015-08-10; Completion date: 2017-06-02
Enrollment: 861 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to compare patient medication satisfaction as measured by the Medication Satisfaction Questionnaire (MSQ) scores between the Copaxone 40 mg/mL three time a week (TIW) group and the Copaxone 20 mg/mL once daily (QD) group over 6 months of treatment.

Detailed description:

Arms: arm 1: Subcutaneous Injections 40 mg/mL Three Times a Week for the core period which last 6 months. In the extension period patient are administered Copaxone® 40 mg/mL for months 7 - 12. arm 2: Subcutaneous Injections 20 mg/mL Daily for the core period which last 6 months. In the extension period patient are administered Copaxone® 40 mg/mL for months 7 - 12.
Interventions: intervention 1: Copaxone®
Intervention descriptions: intervention 1: Subcutaneous Injections

Protocol documents:
Clinical trial NCT01553916
Conditions: Small Cell Lung Carcinoma
Sponsor: Washington University School of Medicine
Start date: 2012-04-26; Completion date: 2017-06-05
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase I/II trial studies the effects and safety of giving lithium carbonate (lithium) to patients with small cell lung cancer (SCLC) undergoing radiation therapy to the brain (PCI; prophylactic cranial irradiation). PCI is used to prevent cancer metastases from returning in the brain. This treatment can cause short-term memory problems by damaging the hippocampus. Lithium may help prevent or lessen memory problems caused by PCI by protecting the hippocampus.

Detailed description:

Arms: arm 1: Lithium carbonate 300 mg PO BID for 7 days prior to the start of prophylactic cranial irradiation (PCI) and will be continued during PCI.

PCI will be given at 2.5 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 25 Gy, starting on Day 8 after 7 days of lithium.
Interventions: intervention 1: Lithium Carbonate intervention 2: Prophylactic cranial irradiation
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02460991
Conditions: Hepatocellular Carcinoma Hepatoma Liver Cell Carcinoma
Sponsor: Boston Scientific Corporation
Start date: 2015-11-01; Completion date: 2017-06-05
Enrollment: 2 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a prospective, multicenter study that will be conducted at up to 40 centers in the United States and Outside United States (OUS). Participants in the study will be randomly assigned to receive either ONCO-DOX or sorafenib treatment. This study will evaluate the study participants' outcomes (medical condition) after being treated with ONCO-DOX and compare it to those treated with sorafenib alone.

Detailed description:
This is a prospective, two-arm, stratified then randomized (1:1), open label, controlled, multicenter Phase III trial to evaluate the safety and efficacy of ONCOZENE™ Microspheres loaded with doxorubicin (ONCO-DOX) in comparison with orally administered sorafenib in patients with unresectable, locally-advanced hepatocellular carcinoma (HCC).

Patients will be stratified by ECOG Performance Status 0 versus 1, portal vein invasion (yes vs. no), and alpha feto protein \<400 versus ≥400. They will then be randomized at each site within each stratum.

The study will be conducted at up to 40 centers in the United States, Europe \& Asia. Enrolled patients will be randomized with equal allocation by study site.

Patients will be followed for two years after the onset of treatment.

The study will assess prospectively the efficacy and safety of DEB-TACE (ONCO-DOX) in patients with unresectable, locally-advanced HCC. The primary objective of this study is to compare the overall survival between DEB-TACE (ONCO-DOX) and sorafenib treatment groups.

Arms: arm 1: ONCO-DOX (Doxorubicin loaded Microspheres) up to 150 mg per treatment; treatments can be repeated every 4-8 weeks until complete tumor response is achieved. arm 2: 200 mg Sorafenib twice daily; continue until unacceptable toxicity or unequivocal tumor progression
Interventions: intervention 1: DEB-TACE intervention 2: Sorafenib
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Prot_SAP_ICF_000.pdf:
Clinical trial NCT02006121
Conditions: Parkinson's Disease
Keywords: Parkinson's disease motor fluctuations not well controlled medical treatment apomorphine
Sponsor: Britannia Pharmaceuticals Ltd.
Start date: 2014-03-03; Completion date: 2017-06-08
Enrollment: 107 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the trial was to investigate the efficacy of apomorphine continuous subcutaneous infusion compared to placebo in Parkinson's Disease patients with motor fluctuations not well controlled on medical treatment.

The secondary objective of the study was to investigate the safety and tolerability of apomorphine continuous subcutaneous therapy.

Detailed description:
The primary efficacy variable is the mean change in time spent "OFF" from baseline (start of blinded treatment) to the end of a 12 weeks' double-blind treatment period based on patient diaries. Patients recorded their motor symptoms in half-hour blocks as OFF, ON without dyskinesia, ON without troublesome dyskinesia, or sleeping using the Hauser Parkinson's Disease home diary.

Key secondary Endpoints (tested hierarchically):

* Change in time spent "ON without troublesome dyskinesia"
* Patient Global Impression of Change

Other Endpoints:

* Percentage of patients with response to therapy, defined as a mean OFF time reduction of at least 2 hours
* Change in oral levodopa and levodopa equivalent dose

Arms: arm 1: Apo-go® Apomorphine hydrochloride 5 mg/ml solution for infusion in pre-filled syringe arm 2: Placebo: saline infusion
Interventions: intervention 1: Apomorphine hydrochloride intervention 2: Placebo
Intervention descriptions: intervention 1: Apomorphine hydrochloride 5 mg/ml solution for infusion in pre-filled syringe intervention 2: Sodium chloride 9 mg/ml

Protocol documents:
Clinical trial NCT00313729
Conditions: CNS Tumor, Adult
Keywords: adult oligodendroglioma adult mixed glioma adult diffuse astrocytoma adult pilocytic astrocytoma adult pineal gland astrocytoma
Sponsor: University of California, San Francisco
Start date: 1999-05-01; Completion date: 2017-06-12
Enrollment: 120 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with supratentorial low-grade glioma.

Detailed description:
OBJECTIVES:

Primary

* Determine the efficacy of temozolomide, defined as response rate (complete and partial response), in patients with supratentorial mixed low-grade glioma.

Secondary

* Assess the safety profile of temozolomide in patients with supratentorial low-grade glioma.
* Assess the time to tumor progression in patients treated with temozolomide.

OUTLINE: Patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.

Arms: arm 1: Temozolomide
Interventions: intervention 1: temozolomide
Intervention descriptions: intervention 1: Chemotherapy

Protocol documents: