ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT03593226
Conditions: Superficial, Palpable, Unresectable/Metastatic Solid Tumour
Sponsor: Agalimmune Ltd.
Start date: 2018-11-30; Completion date: 2023-12-31
Enrollment: 38 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate if AGI-134 given alone is safe and tolerate in treating patients with unresectable/metastatic solid tumours.

Detailed description:
Study AGI-134.FIM.101 was a Phase I/IIa, first in man (FIM), multi-center, single-arm, open-label study, designed to evaluate the safety and tolerability of escalating doses of AGI-134 as a monotherapy in unresectable/metastatic solid tumors.

The study comprised of 2 parts:

Part 1 was an accelerated escalation of the AGI-134 dose, designed to assess the safety and tolerability of AGI-134, as well as to determine the MTD (maximum tolerated dose) and recommended dose for Part 2 of the study (RP2D).

Part 2 was designed to assess the safety, tolerability and biological activity of AGI-134 at the RP2D in subjects with either deep or superficial unresectable/metastatic solid tumors.

Arms: arm 1: 25 mg AGI-134 (1 mL) via intratumor injection. The proposed treatment is one dose of AGI-134 monotherapy per cycle; each cycle consists in three weeks, dosing will be given for 4 cycles. arm 2: 50 mg AGI-134 (2 mL) via intratumor injection. The proposed treatment is one dose of AGI-134 monotherapy per cycle; each cycle consists in three weeks, dosing will be given for 4 cycles. arm 3: 100 mg AGI-134 (4 mL) via intratumor injection. The proposed treatment is one dose of AGI-134 monotherapy per cycle; each cycle consists in three weeks, dosing will be given for 4 cycles. arm 4: 200 mg AGI-134 (8 mL) via intratumor injection. The proposed treatment is one dose of AGI-134 monotherapy per cycle; each cycle consists in three weeks, dosing will be given for 4 cycles.
Interventions: intervention 1: AGI-134
Intervention descriptions: intervention 1: AGI-134 via IT injection. The proposed treatment is one dose of AGI-134 monotherapy per cycle; each cycle consists in three weeks, dosing will be given for 4 cycles.

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT01889238
Conditions: Advanced, Androgen Receptor Positive Triple Negative Breast Cancer
Keywords: breast cancer triple negative androgen receptor positive
Sponsor: Pfizer
Start date: 2013-06-12; Completion date: 2024-01-10
Enrollment: 118 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if enzalutamide is safe and effective in the treatment of patients with advanced breast cancer that express the androgen receptor but do not express the estrogen or progesterone receptor and are not Her2 amplified.

Detailed description:

Arms: arm 1: 160 mg administered as four 40 mg soft gelatin capsules orally once daily
Interventions: intervention 1: Enzalutamide
Intervention descriptions: intervention 1: 160 mg administered as four soft gelatin capsules orally once daily

Protocol documents:
Clinical trial NCT02136134
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma Plasmacytoma Refractory Multiple Myeloma Relapsed Multiple Myeloma Daratumumab VELCADE
Sponsor: Janssen Research & Development, LLC
Start date: 2014-08-15; Completion date: 2024-01-10
Enrollment: 498 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the effects of administration of daratumumab when combined with VELCADE (bortezomib) and dexamethasone compared with bortezomib and dexamethasone alone, for participants with relapsed or refractory multiple myeloma.

Detailed description:
This is an open-label (physicians and participants know the identity of the assigned treatment), randomized (the study medication is assigned by chance), multicenter, active-controlled study comparing daratumumab, VELCADE, and dexamethasone (DVd) with VELCADE and dexamethasone (Vd) in participants with relapsed or refractory multiple myeloma. Approximately 480 participants will be randomly assigned in a 1:1 ratio to receive either DVd or Vd. Randomization will be stratified by International Staging System (ISS), number of prior treatment programs (1 vs. 2 or 3 vs. \>3), and prior VELCADE treatment ("no" vs. "yes"). Within each stratum, participants will be randomized to one of the treatment groups.The study will consist of a Screening Phase, a Treatment Phase, and a Follow-up Phase. Participants will be treated until disease progression, unacceptable toxicity, or other reasons to discontinue the study.

Arms: arm 1: Daratumumab, VELCADE and dexamethasone arm 2: VELCADE and dexamethasone.
Interventions: intervention 1: Daratumumab intervention 2: VELCADE (Bortezomib) intervention 3: Dexamethasone
Intervention descriptions: intervention 1: Daratumumab will be administered as an IV infusion or 16 mg/kg weekly for the first 3 cycles, on Day 1 of Cycles 4-9, and then every 4 weeks thereafter. As per protocol amendment-6 participants receiving treatment with daratumumab IV will have the option to switch to daratumumab SC 1800 mg on Day 1 of any cycle, at the discretion of the investigator. intervention 2: VELCADE will be administered at a dose of 1.3 mg/m2 subcutaneously (SC) on Days 1, 4, 8 and 11 of each 21-day cycle. Eight VELCADE treatment cycles are to be administered. intervention 3: Dexamethasone will be administered orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11 and 12 of the first 8 VELCADE treatment cycles.

Protocol documents:
Clinical trial NCT04380337
Conditions: Rectal Cancer
Sponsor: Stanford University
Start date: 2020-05-21; Completion date: 2024-01-17
Enrollment: 38 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the research is to evaluate whether both chemotherapy and radiotherapy can lead to higher rates of clinical complete response leading to organ preservation in human subjects with cancer. The objective is to learn if this treatment approach may safely be used as an alternative to the standard treatment for rectal cancer and to know the quality-of-life in these patients.

Detailed description:
Primary Objective: To assess clinical complete response of an organ preservation approach using short course radiation followed by intensified chemotherapy.

Secondary Objective: To assess safety in all enrolled patients, local regrowth rate and other cancer specific outcomes (metastasis-free survival, colostomy-free survival and overall survival), longitudinal health-related quality of life of this organ preservation approach

Arms: arm 1: Treatment will comprise 6 daily fractions of radiotherapy at 5 Gy per fraction followed by 4 months of FOLFOXIRI. Patients who have performance status or conditions that may preclude use of FOLFOXIRI may be treated with FOLFOX or XELOX. Those who achieve a clinical complete response will be considered for organ preservation approach. All other patients will receive standard of care total mesorectal excision (TME).
Interventions: intervention 1: FOLFOXIRI intervention 2: FOLFOX regimen intervention 3: XELOX intervention 4: IMRT
Intervention descriptions: intervention 1: Chemotherapy regimen of Oxaliplatin 85mg/m2 , Leucovorin 400 mg/m2 , Irinotecan 165mg/m2 , 5-Fluorouracil intervention 2: Chemotherapy regimen of Oxaliplatin 85mg/m2, Leucovorin 400 mg/m2, 5-Fluorouracil 2400mg/m2 intervention 3: Chemotherapy regimen of Oxaliplatin 130 mg/m2, Capecitabine 1000mg/m2 intervention 4: Radiotherapy (5 Gy x 5 fractions) with an additional boost fraction (5 Gy x 1 fraction) delivered sequentially

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT04105010
Conditions: Relapsed or Refractory Peripheral T Cell Lymphoma
Sponsor: Dizal Pharmaceuticals
Start date: 2019-09-10; Completion date: 2024-02-22
Enrollment: 171 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
This is a multinational, non-randomized, open-label, Phase 1/2 clinical study to evaluate the safety, tolerability and anti-tumor efficacy of AZD4205 as monotherapy in patients with peripheral T cell lymphoma (PTCL), who have relapsed from or are refractory/intolerant to standard systemic treatment.

Phase 1 part:

Around 20\~40 patients will be subsequently enrolled into 2 different dose ascending cohorts. Additional 10\~20 patients may be enrolled to further explore a selected dose defined by dose escalation cohorts.

Phase 2 part:

After the recommended phase 2 dose (RP2D) is defined, a phase 2 single-arm open-label pivotal study will be conducted to assess anti-tumor efficacy and safety of AZD4205 at RP2D in patients with refractory or relapsed PTCL.

Detailed description:

Arms: arm 1: Group A: Open label golidocitinib at dose A, once daily (Phase 1) arm 2: Group B: Open label golidocitinib at dose B, once daily (Phase 1) arm 3: Group C: Open label golidocitinib at a selected dose, once daily (Phase 1) arm 4: Group D: Open label golidocitinib at the RP2D, once daily (Phase 2)
Interventions: intervention 1: golidocitinib
Intervention descriptions: intervention 1: golidocitinib will be administered orally as capsules. golidocitinib treatment will be continued until disease progression or intolerant adverse reactions

Protocol documents:
Prot_000.pdf: 

























































































































































































































































































SAP_001.pdf:
Clinical trial NCT04054999
Conditions: Vasoplegic Syndrome Liver Transplant; Complications
Keywords: hydroxocobalamin methylene blue
Sponsor: Mayo Clinic
Start date: 2019-11-30; Completion date: 2024-02-27
Enrollment: 19 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate if Hydroxocobalamin may be a new and possibly superior treatment for refractory vasoplegic syndrome during liver transplant surgery.

Detailed description:

Arms: arm 1: Single dose intraoperatively of Hydroxocobalamin (Cyanokit): 5g IV infusion over 15 minutes arm 2: Single dose intraoperatively of Methylene blue (PROVAYBLUETM), 2 mg/kg IV bolus administered over 15 minutes
Interventions: intervention 1: Hydroxocobalamin intervention 2: Methylene Blue
Intervention descriptions: intervention 1: Hydroxocobalamin (Cyanokit): 5g IV infusion over 15 minutes intervention 2: Methylene blue (PROVAYBLUETM), 2 mg/kg IV bolus administered over 15 minutes

Protocol documents:
Prot_SAP_000.pdf: 
 
 
The Efficacy of Intravenous Hydroxocobalamin 
Versus Methylene Blue as Treatment for 
Intraoperative Vasoplegic Syndrome in Liver 
Transplant Patients 
 
NCT04054999 
 
11DEC2019
Clinical trial NCT05536440
Conditions: Healthy
Keywords: Healthy volunteer Healthy IBD Inflammatory bowel disease
Sponsor: Pfizer
Start date: 2022-10-17; Completion date: 2024-02-29
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
The purpose of this clinical trial is to learn about the safety and effects of the study medicine PF-07261271 for the potential treatment of Inflammatory Bowel Disease.

Detailed description:

Arms: arm 1: Dose A arm 2: Dose A arm 3: Dose B arm 4: Dose B arm 5: Dose C arm 6: Dose C arm 7: Dose D arm 8: Dose D arm 9: Dose E arm 10: Dose E arm 11: Dose F arm 12: Dose F arm 13: Dose G arm 14: Dose G arm 15: Dose H arm 16: Dose H
Interventions: intervention 1: PF-07261271 intervention 2: Placebo
Intervention descriptions: intervention 1: IV or SC intervention 2: IV or SC

Protocol documents:
Prot_000.pdf: 































































































































































































































































SAP_001.pdf:
Clinical trial NCT02496585
Conditions: Lung Cancer Lung Metastases
Keywords: Nintedanib (BIBF 1120) Prednisone Radiation Pneumonitis
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2015-07-08; Completion date: 2024-04-12
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to find out what effects, good and/or bad, the drug nintedanib in combination with steroids, has on the lungs. Furthermore, such treatments' side effects will be studied together with quality of life. In addition, the investigators would like to determine whether they can find markers in the blood which predict worsening lung injury.

Detailed description:

Arms: arm 1: The initial dose of nintedanib will be 150mg two times per day orally according to study protocol. Nintedanib will be taken for 12 weeks. Patients will be given a prednisone taper (40mg prednisone daily for 2 weeks, followed by a strict dose taper of 10mg every 2 weeks for 4 weeks, followed by 10mg for one week and 5mg for one week, for a total duration on prednisone of 8 weeks). arm 2: Placebo will be taken for 12 weeks. Patients will be given a prednisone taper (40mg prednisone daily for 2 weeks, followed by a strict dose taper of 10mg every 2 weeks for 4 weeks, followed by 10mg for one week and 5mg for one week, for a total duration on prednisone of 8 weeks).
Interventions: intervention 1: Nintedanib intervention 2: Prednisone intervention 3: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT03523351
Conditions: Metastatic Solid Tumors of Metastatic Disease
Keywords: Palliative Radiation 18-196
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2018-05-01; Completion date: 2024-04-18
Enrollment: 78 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to compare the outcome of patients who receive standard treatment versus those who receive preventative radiation and then standard treatment.

Detailed description:

Arms: arm 1: Patients randomized to Arm 1 will undergo appropriate therapy as determined by their oncologist. These patients will either continue their current therapy or be transitioned to a new standard of care therapy at the discretion of the treating oncologist. If randomized to Arm 1, these patients may undergo palliative RT for progressive, painful lesions (a skeletal related event) at time of symptom development (not upfront palliative RT). arm 2: Patients on Arm 2 of the study will undergo selective RT to ≤ 5 high risk bone metastases defined as 1. bulkiest sites of osseous disease ≥ 2cm, 2. disease involving the hip (acetabulum, femoral head, femoral neck), shoulder (acromion, glenoid, humeral head), or sacroiliac joints 3. disease in long bones with1/3-2/3 cortical thickness (humerus, radius, ulna, clavicle, femur, tibia, fibula, metacarpus, phalanges) 4. disease in junctional spine (C7-T1, T12-L1, L5-S1) \&/or disease with posterior element involvement.
Interventions: intervention 1: Radiation Therapy intervention 2: Systemic Therapy
Intervention descriptions: intervention 1: Radiation therapy will be delivered according to department standards. For this protocol, total dose and dose fractionation may be delivered at the discretion of the treating radiation oncologist according to department standards. All techniques including conventional, 3D-CRT, or IMRT technique may be used. Image guidance at the time of treatment delivery to verify patient positioning may be chosen at the discretion of the treating radiation oncologist according to department standards. intervention 2: Standard of care systemic therapy, including chemotherapeutics, targeted therapies, immunomodulatory agents, and hormonal therapies will be delivered at the discretion of the treating medical oncologist. Patients may receive systemic therapy concurrently and there are no restrictions on initiation of systemic agents after radiotherapy including immunotherapy and hormonal therapy, the timing of which will be determined by a consensus between the treating medical and radiation oncologists.

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT06024642
Conditions: Overactive Bladder Syndrome
Sponsor: Imbrium Therapeutics
Start date: 2022-06-30; Completion date: 2024-05-21
Enrollment: 51 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to evaluate the safety, tolerability and efficacy of V117957 in subjects with overactive bladder syndrome, compared to placebo.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: V117957 intervention 2: Placebo
Intervention descriptions: intervention 1: V117957 1 mg - 1 tablet taken orally at bedtime. intervention 2: Placebo to match V117957 tablets - 1 tablet taken orally at bedtime.

Protocol documents:
Prot_SAP_000.pdf: 
Official Title: Multicenter, Randomized, Double-blind Placebo-controlled, Crossover Study to 
Investigate Effects of V117957 in Female Subjects with Overactive Bladder Syndrome
NCT #: NCT06024642  
Date of Document: 25-Aug-2023 


Purdue Pharma L.P. 
Confidential 
Protocol: OAG1030 
Amendment 2: 25-Aug-2023 
1
Protocol Number: 
OAG1030 
Protocol Title:  
Multicenter, Randomized, Double-blind Placebo-controlled, 
Crossover Study to Investigate Effects of V117957 in Female 
Subjects with Overactive Bladder Syndrome 
Brief Title:  
Study of V117957 in Overactive Bladder Syndrome 
Compound: 
V117957 Tosylate 
Phase:  
Phase 1b 
Sponsor: 
Purdue Pharma L.P. 
One Stamford Forum 
Stamford, CT 06901-3431  
USA 
Protocol Approval Date: 
11-Oct-2021
Amendment Number  
2 
GCP Statement: 
This study is to be performed in compliance with International 
Conference on Harmonisation (ICH) and applicable Good Clinical 
Practices (GCPs) and federal and local regulations. 
Confidentiality: 
This document is confidential. It contains proprietary information 
of Purdue Pharma. Any viewing or disclosure of such information 
that is not authorized in writing by the Sponsor (or designee) is 
strictly prohibited. Such information may be used solely for the 
purpose of reviewing or performing this study. 










Purdue Pharma 
Confidential 
Protocol: OAG1030 
Amendment 2: 25-Aug-2023 
6 
AEs will be categorized into Preferred Term (PT) and associated System Organ Class (SOC) 
using the Medical Dictionary for Regulatory Activities (MedDRA). Treatment-emergent adverse 
events (TEAEs) will be defined as AEs that start after or increase in intensity after the first dose 
of study drug. TEAEs will be summarized by presenting the incidence of AEs for each treatment 
group by the MedDRA PT, nested within SOC for the safety population. Medical history will be 
coded to MedDRA terms. Coded medical history terms will be summarized for all subjects in the 
randomized safety population. 
Laboratory evaluations and vital signs will be summarized by treatment and time point for the 
randomized safety population. Concomitant and prior medications will be coded using the latest 
version of the World Health Organization Drug Dictionary (WHO-DD) and presented in tables 
and listings.
Clinical trial NCT02197234
Conditions: Non Small Cell Lung Cancer
Keywords: oncology, cancer, non small cell lung cancer, anticancer drug, pharmacokinetics, AZD9291, simvastatin, EGFR genes
Sponsor: AstraZeneca
Start date: 2014-12-22; Completion date: 2024-06-03
Enrollment: 52 participants; Allocation: NA; Intervention model: 

Brief summary:
This is a Phase I, open-label, 2-part study in patients with a confirmed diagnosis of epidermal growth factor receptor (EGFR) mutation positive (EGFRm+) non-small cell lung cancer (NSCLC), who have progressed following prior therapy with an approved EGFR tyrosine kinase inhibitor (TKI) agent.

Part A will assess the effect of AZD9291 on the pharmacokinetic (PK) parameters of simvastatin and simvastatin acid, following multiple oral dosing of AZD9291 in a fasted state.

Part B will allow patients further access to AZD9291 after the PK phase (Part A) and will provide for additional safety data collection. All patients from Part A who completed treatment may continue to receive AZD9291 80 mg once daily until: disease progression; they are no longer deriving clinical benefit; or any other reason.

Detailed description:

Arms: arm 1: Sequential treatments of simvastatin alone followed by AZD9291 alone, followed by simvastatin + AZD9291.
Interventions: intervention 1: Pharmacokinetic sampling - AZD9291 intervention 2: Simvastatin intervention 3: AZD9291 tablet dosing intervention 4: Pharmacokinetic sampling - simvastatin intervention 5: Pharmacokinetic sampling - AZ5140 and AZ7550
Intervention descriptions: intervention 1: Blood sampling to measure AZD9291 intervention 2: Simvastatin (CYP substrate) 40mg taken once daily on Days 1 and 31 (Part A) intervention 3: AZD9291 80mg tablet taken from Days 3 to 32. (Part B) AZD9291 80mg tablet taken daily for 12 months. intervention 4: Blood sampling to measure simvastatin levels intervention 5: Blood samples to measure levels of AZ5140 and AZ7550

Protocol documents:
Clinical trial NCT01496313
Conditions: Thyroid Cancer
Keywords: medullary thyroid cancer metastatic thyroid cancer carcinoma of the thyroid receptor tyrosine kinase inhibitor VEGFR Unresectable locally advanced thyroid cancer
Sponsor: Sanofi
Start date: 2012-08-28; Completion date: 2024-07-11
Enrollment: 81 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to give patients with medullary thyroid cancer either 300mg/day or 150mg/day vandetanib and compare how well each dose affects how their cancer responds. It will also help the investigators understand the side effects of different doses in these patients.

Detailed description:
An International, Randomised, Double-Blind, Two-Arm Study To Evaluate The Safety And Efficacy Of Vandetanib 150 And 300mg/Day In Patients With Unresectable Locally Advanced Or Metastatic Medullary Thyroid Carcinoma With Progressive Or Symptomatic Disease

Arms: arm 1: None arm 2: None
Interventions: intervention 1: 300mg vandetanib intervention 2: 150mg vandetanib
Intervention descriptions: intervention 1: Oral blinded tablets taken once daily.

At objective disease progression or 14 months (whichever is earlier), patient may be unblinded to treatment

Dosing with unblinded study treatment can continue until 24 months after patient was randomised.

At any time dosing may be interrupted for up to 6 weeks due to toxicity. Dosing may restart at a reduced dose (200mg/day). Once reduced, dose increases are not permitted and dosing must stop if further toxicities occur. intervention 2: Oral blinded tablets taken once daily.

At objective disease progression or 14 months (whichever is earlier), patient may be unblinded to treatment. Patients who have not dose reduced at the time of unblinding may have their dose increased to 300mg

Dosing with unblinded study treatment can continue until 24 months after patient was randomised

At any time dosing may be interrupted for up to 6 weeks due to toxicity. Dosing may restart at a reduced dose (100mg/day) \[OR 300 reduced to 200mg/day if dose was increased at unblinding.\] Once reduced, dose increases are not permitted and dosing must stop if further toxicities occur.

Protocol documents:
Clinical trial NCT00410761
Conditions: Thyroid Cancer
Keywords: ZD6474 MTC Hereditary Medullary Thyroid Cancer Sporadic Medullary Thyroid Cancer Medullary Thyroid Cancer
Sponsor: Genzyme, a Sanofi Company
Start date: 2006-11-30; Completion date: 2024-07-26
Enrollment: 437 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to learn how hereditary or sporadic medullary thyroid cancer patients, treated with ZD6474, react to the drug, what happens to ZD6474 in the human body, about the side effects of ZD6474, and if ZD6474 can decrease or prevent the growth of tumors.

Detailed description:

Arms: arm 1: Placebo vandetanib arm 2: Vandetanib
Interventions: intervention 1: ZD6474 (Vandetanib)
Intervention descriptions: intervention 1: once daily oral tablet

Protocol documents: