ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT03056638
Conditions: Prostate Cancer
Keywords: Androgen Deprivation Therapy Ultra-Hypofractionated SBRT 16-1686
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2017-03-28; Completion date: 2023-08-16
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Stereotactic body radiation therapy (SBRT) is a very precise form of radiation therapy that allows the physician to deliver more radiation dose in a single session. Because of this, the number of radiation sessions can be reduced from the typical 45-48 sessions, as in conventional daily session radiation, to 5 sessions given every other day over a week and a half. Giving the radiation at a higher dose during each treatment may be more effective in killing the prostate cancer cells than the standard way of using external radiation therapy where a small amount of radiation is given over many sessions.

Androgen Deprivation Therapy (ADT) or hormonal therapy is one of the methods to treat intermediate risk prostate cancer. This therapy works by reducing the level of testosterone and stopping them from affecting your cancer. The ADT used in this study is known as Degarelix. Degarelix is an approved medication that reduces the body's production of testosterone; this medication is usually given to all men with intermediate risk prostate cancer getting external radiation.

This study is a randomized study to find out whether combining stereotactic (also known as precision) radiation to the prostate cancer combined with a short course of Degarelix will result in a greater likelihood of killing the cancer in the prostate compared to stereotactic radiation therapy given alone. It has been shown that the combination of radiation with medications that interfere with testosterone production and its effects makes prostate cancer cells more sensitive to the radiation.

Detailed description:

Arms: arm 1: Degarelix monthly for 6 months SBRT 8 Gy x 5 arm 2: SBRT 8 Gy x 5
Interventions: intervention 1: Degarelix intervention 2: stereotactic body radiosurgery (SBRT)
Intervention descriptions: intervention 1: Degarelix monthly for 6 months intervention 2: SBRT 8 Gy x 5

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT04569084
Conditions: ALS
Sponsor: Mitsubishi Tanabe Pharma America Inc.
Start date: 2020-11-13; Completion date: 2023-09-29
Enrollment: 384 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate and compare the efficacy of two dosing regimens of oral edaravone in subjects with amyotrophic lateral sclerosis (ALS) based on the change in ALS Functional Rating Scale- Revised (ALSFRS-R) score from baseline up to Week 48:

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: MT-1186 intervention 2: Placebo
Intervention descriptions: intervention 1: Oral edaravone intervention 2: Oral

Protocol documents:
Prot_000.pdf: 















































































































































































































SAP_001.pdf:
Clinical trial NCT05151471
Conditions: ALS
Sponsor: Mitsubishi Tanabe Pharma America Inc.
Start date: 2022-01-11; Completion date: 2023-09-29
Enrollment: 202 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate and compare the efficacy of two dosing regimens of oral edaravone in subjects with amyotrophic lateral sclerosis (ALS), based on the time from the randomization date in Study MT-1186-A02 to at least a 12-point decrease in Revised ALS Functional Rating Score (ALSFRS-R) or death, whichever happens first, over the course of the study or until oral edaravone is commercially available in that country

Detailed description:

Arms: arm 1: Oral edaravone administered once daily for up to 48 weeks or until the drug is commercially available in that country. arm 2: Oral edaravone administered for 10 days followed by 18-day placebo (regimen denoted as on/off) for up to 48 weeks or until the drug is commercially available in that country.
Interventions: intervention 1: MT-1186 intervention 2: Placebo
Intervention descriptions: intervention 1: Oral edaravone intervention 2: Oral

Protocol documents:
Prot_000.pdf: 



















































































































































































SAP_001.pdf:
Clinical trial NCT01755975
Conditions: Multiple Myeloma Non-Hodgkin's Lymphoma
Keywords: LENALIDOMIDE (CC-5013) Romidepsin (Istodax) 12-170
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2012-12-01; Completion date: 2023-10-01
Enrollment: 49 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The treatments used to treat lymphoma and multiple myeloma sometimes do not always work well or they may only work for a short period of time. This is why new treatments are being tested.

This study will test a new combination of two drugs that are already approved by the Food and Drug Administration for treatment of certain kinds of blood cancers. These drugs are romidepsin and lenalidomide. Both these drugs by themselves have been used to treat lymphoma or multiple myeloma. However, while these drugs are routinely used alone, this is the first time they will be tested together. The mechanism of action of both drugs is not well understood but both have been shown to to be effective by themselves in lymphoma and multiple myeloma.

Detailed description:

Arms: arm 1: This will be a multicentered, open label, phase Ib/IIa trial of romidepsin and lenalidomide in patients with relapsed or refractory lymphomas or multiple myeloma. Lenalidomide will be provided in accordance with the Celgene Corporation's Revlimid REMS® program. Per standard Revlimid REMS® program requirements, all physicians who prescribe lenalidomide for research subjects enrolled into this trial, and all research subjects enrolled into this trial, must be registered in, and must comply with, all requirements of the Revlimid REMS® program. Only enough lenalidomide for one cycle of therapy will be supplied to the patient each cycle.
Interventions: intervention 1: Romidepsin intervention 2: Lenalidomide
Intervention descriptions: intervention 1: Romidepsin will be administered intravenously on days 1, 8, and 15 of a 28-day cycle. intervention 2: Lenalidomide will be taken orally daily for 21 days of a 28-day cycle.

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT00753545
Conditions: Ovarian Cancer
Keywords: Serous, Ovarian cancer, PARP, BRCA1, BRCA2, Poly(ADP ribose) polymerases, Platinum sensitive, Homologous Recombination Deficiency (HRD)
Sponsor: AstraZeneca
Start date: 2008-08-28; Completion date: 2023-10-12
Enrollment: 265 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study to determine if AZD2281 is effective and well tolerated in maintaining the improvement in your cancer after previous platinum-based chemotherapy

Detailed description:

Arms: arm 1: AZD2281 arm 2: matching placebo
Interventions: intervention 1: AZD2281 intervention 2: matching placebo
Intervention descriptions: intervention 1: Tablets Oral BID intervention 2: matching placebo bid

Protocol documents:
Clinical trial NCT03414034
Conditions: Metastatic Castration-Resistant Prostate Cancer
Keywords: PLK1 PLK Inhibitor Onvansertib
Sponsor: Cardiff Oncology
Start date: 2018-08-14; Completion date: 2023-10-16
Enrollment: 72 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the phase 2 study is to determine whether Onvansertib is safe and tolerable in adult participants with Metastatic Castration-Resistant Prostate Cancer who have disease progression while receiving abiraterone acetate (abiraterone) and prednisone therapy, and to observe the effects of Onvansertib in combination with abiraterone and prednisone on disease control.

Detailed description:

Arms: arm 1: On Day 1 of each cycle, onvansertib will be administered orally (PO) once daily (QD) at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 21-day cycle. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants will also receive abiraterone and prednisone. This arm was discontinued. arm 2: On Day 1 of each cycle, onvansertib will be administered orally (PO) once daily (QD) at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants will also receive abiraterone and prednisone. arm 3: On Day 1 of each cycle, onvansertib will be administered orally (PO) once daily (QD) at a dose of 12 mg/m\^2 for 14 days (Day 1 through Day 14) out of a 21-day cycle. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants will also receive abiraterone and prednisone.
Interventions: intervention 1: Onvansertib intervention 2: Abiraterone intervention 3: Prednisone
Intervention descriptions: intervention 1: Onvansertib orally intervention 2: Abiraterone orally intervention 3: Prednisone orally

Protocol documents:
Prot_000.pdf: 
Protocol Number: TROV-053 
Official Title: A Phase 2 Study of Onvansertib (PCM-075) in Combination with Abiraterone and 
Prednisone in Patients with Metastatic Castration-Resistant Prostate Cancer 
NCT Number: NCT03414034 
Document Date: 16 Nov 2020 

















































































































































SAP_001.pdf: 
Protocol Number: TROV-053 
Official Title: A Phase 2 Study of Onvansertib (PCM-075) in Combination with Abiraterone and 
Prednisone in Patients with Metastatic Castration-Resistant Prostate Cancer 
NCT Number: NCT03414034
Document Date: 23 May 2023
Clinical trial NCT02094261
Conditions: Non Small Cell Lung Cancer
Keywords: Phase II, open label study; safety and efficacy of AZD9291; diagnosis of Epidermal Growth Factor Receptor mutation positive and T790M mutation positive NSCLC
Sponsor: AstraZeneca
Start date: 2014-05-20; Completion date: 2023-11-07
Enrollment: 210 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A Phase II, Open Label, Single-arm Study to Assess the Safety and Efficacy of AZD9291 in Patients with Locally Advanced/Metastatic Non Small Cell Lung Cancer whose Disease has Progressed with Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and whose Tumours are Epidermal Growth Factor Receptor Mutation and T790M Mutation Positive

Detailed description:
This is a phase II, open label, single arm study assessing the safety and efficacy of AZD9291 (80 mg, orally, once daily) in patients with a confirmed diagnosis of Epidermal Growth Factor Receptor mutation positive and T790M mutation positive NSCLC,who have progressed following prior therapy with an approved Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) agent. Patients must agree to provide a biopsy for central confirmation of T790M mutation status following confirmed disease progression on the most recent treatment regimen. The primary objective of the study is to assess the efficacy of AZD9291 by assessment of Objective Response Rate according to RECIST 1.1 by an Independent Central Review.

Arms: arm 1: Once daily tablet 80 mg
Interventions: intervention 1: AZD9291
Intervention descriptions: intervention 1: Once daily tablet 80 mg

Protocol documents:
Clinical trial NCT00676715
Conditions: Multiple Sclerosis, Relapsing-Remitting
Sponsor: Genentech, Inc.
Start date: 2008-07-17; Completion date: 2023-11-08
Enrollment: 220 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex (interferon beta-1a) controlled dose finding study to evaluate the efficacy as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in participants with Relapsing Remitting Multiple Sclerosis (RRMS).

Detailed description:

Arms: arm 1: Participants received two intravenous (IV) infusions of matching placebo separated by 14 days in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of cycles 3 and 4. Each cycle was of 168 days. arm 2: Participants two IV infusions of ocrelizumab 300 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 600 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days. arm 3: Participants received two IV infusions of ocrelizumab 1000 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 1000 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 1000 mg was administered on Day 1 of Cycle 3 and a single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycle 4. Each cycle was of 168 days. arm 4: Participants received weekly intramuscular injections of Avonex 30 microgram (mcg) in Cycle 1, followed by two infusions of OCR 300 mg separated by 14 days in Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
Interventions: intervention 1: Placebo intervention 2: Ocrelizumab intervention 3: Avonex
Intervention descriptions: intervention 1: Placebo matching to ocrelizumab administered as IV infision in Cycle 1 Day 1. intervention 2: Ocrelizumab 300 mg was administered in cycle 1 followed by an infusion of ocrelizumab 600 mg on Day 1. A single infusion of ocrelizumab 600 mg was administered on Day 1 of cycles 3 and 4. intervention 3: Avonex was administered weekly intramuscular injections of 30 mcg in cycle 1 Day 1.

Protocol documents:
Clinical trial NCT01828112
Conditions: Non-Small Cell Lung Cancer
Keywords: Non-Small Cell Lung Cancer ALK LDK378 Non-small cell lung carcinoma (NSCLC) treatment of lung cancer after first metastasis lung cancer lung adenocarcinoma Non small cell lung carcinoma Non small cell lung cancer NSCLC chemotherapy ALK-positive ALK-rearranged advanced non-small cell lung cancer crizotinib
Sponsor: Novartis Pharmaceuticals
Start date: 2013-06-28; Completion date: 2023-11-10
Enrollment: 231 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of the study was to compare the antitumor activity of LDK378 vs. chemotherapy in patients previously treated with chemotherapy (platinum doublet) and crizotinib. Patients in the chemotherapy arm were given the option to switch to LDK378 after confirmed progressive disease (PD), while also had the choice to continue with pemetrexed treatment.

Detailed description:
A total of 231 patients were randomized to one of the two treatment arms in a 1:1 ratio. Randomization was stratified by World Health Organization (WHO) performance status (0 versus 1-2) and whether the patient had brain metastases at screening. The study was planned to be ended once the final overall survival (OS) analysis was performed (at the earliest of approximately 196 deaths observed or statistical significance reached at earlier OS interim analysis).

Following an agreement between Novartis and European Medicines Agency (EMA) in May 2023 to terminate the trial earlier, this study was completed when the total number of deaths was 190. Patients who had Response Evaluation Criteria In Solid Tumors (RECIST)-defined disease progression as confirmed by the Blinded Independent Review Committee (BIRC), but who, in the opinion of the Investigator, had continued clinical benefit from study treatment on either the chemotherapy arm or the ceritinib arm, continued to receive treatment. These patients continued assessments in the treatment phase. In addition, only patients randomized to the chemotherapy arm were allowed to crossover to receive ceritinib therapy (extension treatment \[ET\] phase) after BIRC-confirmed, RECIST-defined disease progression, and provided they met the eligibility requirements.

Arms: arm 1: Ceritinib 750 mg arm 2: Chemotherapy as determined by BIRC
Interventions: intervention 1: Ceritinib intervention 2: Pemetrexed intervention 3: Docetaxel
Intervention descriptions: intervention 1: Ceritinib was the investigational treatment and was provided as 150 mg hard gelatin capsules for oral use. The dose was 750 mg once daily. intervention 2: Pemetrexed was one of the chemotherapy treatments. Pemetrexed, a reconstituted solution, was intravenously administered over 10 minutes at 500 mg/m\^2 every 21 days. intervention 3: Docetaxel was one of the chemotherapy treatments. Docetaxel, a reconstituted solution, was intravenously administered over 1 hour, at 75 mg/m\^2 every 21 days.

Protocol documents:
Clinical trial NCT01084863
Conditions: Metastatic Breast Cancer
Keywords: Herceptin Her 2-positive metastatic breast cancer CT-P6
Sponsor: Celltrion
Start date: 2010-02-01; Completion date: 2023-12-01
Enrollment: 143 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to demonstrate equivalent pharmacokinetics (PK)

Detailed description:
Patients will receive CT-P6 or Herceptin.

Arms: arm 1: CT-P6 was administered at a loading dose of 8 mg/kg body weight by IV infusion over 90 minutes on Day 1, Cycle 1, then at 6 mg/kg repeated at 3-weekly intervals until disease progression, death, or discontinuation.

Paclitaxel was administered at a dose of 175 mg/m2 body surface area (BSA) as a continuous 3-hour IV infusion on the day following the first dose of study drug (CT-P6). If the first dose of study drug was well tolerated, subsequent doses of paclitaxel were given immediately after the next dose of study drug. Paclitaxel cycles were repeated every 3 weeks until disease progression, death, intolerable toxicity, or discontinuation. arm 2: Herceptin was administered at a loading dose of 8 mg/kg body weight by IV infusion over 90 minutes on Day 1, Cycle 1, then at 6 mg/kg repeated at 3-weekly intervals until disease progression, death, or discontinuation.

Paclitaxel was administered at a dose of 175 mg/m2 body surface area (BSA) as a continuous 3-hour IV infusion on the day following the first dose of study drug (Herceptin). If the first dose of study drug was well tolerated, subsequent doses of paclitaxel were given immediately after the next dose of study drug. Paclitaxel cycles were repeated every 3 weeks until disease progression, death, intolerable toxicity, or discontinuation.
Interventions: intervention 1: CT-P6 intervention 2: Herceptin intervention 3: Paclitaxel
Intervention descriptions: intervention 1: CT-P6: administered every 3 weeks intervention 2: Herceptin: administered every 3 weeks intervention 3: Paclitaxel: administered every 3 weeks

Protocol documents:
Clinical trial NCT02811679
Conditions: Non-Hodgkin Lymphoma
Keywords: Lymphoma
Sponsor: Massachusetts General Hospital
Start date: 2016-08-01; Completion date: 2023-12-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This research study is studying Blinatumomab as a possible treatment for Indolent Non-Hodgkin Lymphoma (NHL).

Detailed description:
This research study is a Phase II clinical trial. The overall purpose of this study is to determine if blinatumomab is safe and effective for treating adult subjects with relapsed or refractory indolent B cell NHL.

Blinatumomab will be infused causing T cells to recognize the Cancer and work against them. This approach has been FDA approved for acute lymphocytic leukemia but has not yet been approved for lymphoma.

Arms: arm 1: Blinatumomab will be administered as a continuous IV infusion through a central venous catheter for a 42 day cycle. Blinatumomab will start with a 7 day infusion at 9mcg/d. If no dose limiting toxicity (table 6.1) after 7 days, the dose will be escalated to 28 mcg/d for 7 additional days. If no dose limiting toxicity (table 6.1) after 14 days, blinatumomab will be infused at a target dose of at 112mcg/d for 28 days. Subjects will be restaged after a 6 week treatment free period by PET CT. All subjects without disease progression will receive an additional 4 week cycle starting at the target dose of 112 mcg/d.
Interventions: intervention 1: Blinatumomab
Intervention descriptions: intervention 1: Blinatumomab is a bispecific t cell engaging antibody targeting CD19 and CD3 approved for B cell acute lymphoblastic leukemia

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT01802632
Conditions: Advanced Non Small Cell Lung Cancer Advanced (Inoperable) Non Small Cell Lung Cancer
Keywords: Oncology, Non Small Cell Lung Cancer, Metastatic, EGFR sensitivity mutation, T790M resistance mutation
Sponsor: AstraZeneca
Start date: 2013-03-04; Completion date: 2023-12-13
Enrollment: 603 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will treat patients with advanced NSCLC who have already received at least one course of specific anti-cancer treatment but the tumour has started to re-grow following that treatment. This is the first time this drug has ever been tested in patients, and so it will help to understand what type of side effects may occur with the drug treatment, it will measure the levels of drug in the body, it will also measure the anti-cancer activity. By using these pieces of information together the best dose of this drug to use in further clinical trials will be selected.

Detailed description:
A Phase I/II, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of Ascending Doses of AZD9291 in Patients with Advanced Non Small Cell Lung Cancer who have Progressed Following Prior Therapy with an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Agent (AURA)

Arms: arm 1: Daily oral dose of AZD9291
Interventions: intervention 1: AZD9291
Intervention descriptions: intervention 1: Starting dose 20 mg, administered once daily. If tolerated subsequent cohorts will test increasing doses of AZD9291, until a maximum tolerated dose or maximum feasible dose is defined

Protocol documents: