ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01436656
Conditions: Melanoma and Metastatic Colorectal Cancer
Keywords: BRAF mutant, BRAF mutated, melanoma, metastatic, advanced, RAF kinase inhibitor BRAF V600 mutation
Sponsor: Pfizer
Start date: 2011-09-05; Completion date: 2022-11-07
Enrollment: 107 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
CLGX818X2101 is a first-time in-human, phase I study to establish the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of daily administered LGX818 (daily, twice daily and/or every-other-day), a RAF kinase inhibitor. Patients with locally advanced or metastatic melanoma harboring the BRAF V600 mutation (during dose escalation phase and expansion phase) and patients with metastatic colorectal cancer harboring the BRAF V600 mutation (during the expansion phase) will be enrolled. The study consists of a dose escalation part were cohorts of patients will receive escalating oral doses of LGX818, followed by a safety dose expansion part were patients will be treated with oral dose of LGX818 given at the MTD or RP2D.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: LGX818
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT04229095
Conditions: Alcohol Use Disorder (AUD)
Sponsor: The Scripps Research Institute
Start date: 2021-11-17; Completion date: 2022-11-08
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary hypotheses under test are that alcohol dependent subjects treated with suvorexant will report decreased craving for alcohol following alcohol exposure in the laboratory and report significantly less drinking under naturalistic conditions, than those treated with placebo. Suvorexant (Belsomra®) received approval by the FDA in 2014 for treatment of insomnia. To control for any effect of pre-existing sleep disturbance for which suvorexant may be indicated, subjects will be stratified on the basis of a Pittsburgh Sleep Quality Index total score of \> 5 versus \<5. Subjects were also stratified by sex.

Detailed description:

Arms: arm 1: 20 mg single-dose administration given on an inpatient clinical research unit arm 2: Placebo single-dose administration given on an inpatient clinical research unit
Interventions: intervention 1: Suvorexant 20 mg intervention 2: Placebo oral tablet
Intervention descriptions: intervention 1: Single-dose administration of 20 mg suvorexant given on an inpatient clinical research unit intervention 2: Single-dose administration of placebo given on an inpatient clinical research unit

Protocol documents:
ICF_002.pdf: 





















Prot_000.pdf: 



































































SAP_001.pdf:
Clinical trial NCT04688164
Conditions: Major Depressive Disorder
Keywords: REL-1017
Sponsor: Relmada Therapeutics, Inc.
Start date: 2021-01-08; Completion date: 2022-11-10
Enrollment: 227 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an outpatient, 2-arm, Phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of REL-1017 once daily (QD) as an adjunctive treatment of Major Depressive Disorder. Study participants will continue to take their current antidepressant therapy in addition to the study drug or placebo for the duration of the treatment period.

Detailed description:

Arms: arm 1: A 75 mg REL-1017 loading dose (three 25 mg REL-1017 tablets) will be administered on Day-1 of the 28-day treatment period. From Day-2 to Day-28, participants will take 25 mg REL-1017 in addition to their ongoing antidepressant. arm 2: Three tablets of matching placebo will be administered on Day-1 of the 28-day treatment period. From Day-2 to Day-28, participants will take 1 placebo tablet in addition to their ongoing antidepressant.
Interventions: intervention 1: REL-1017 intervention 2: Placebo
Intervention descriptions: intervention 1: REL-1017 tablet intervention 2: Placebo tablet

Protocol documents:
Prot_SAP_000.pdf: 
CLINICAL STUDY PROTOCOL 
Protocol Title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-
Controlled Study to Assess the Efficacy and Safety of REL-1017 for Treatment 
of Major Depressive Disorder 
(The RELIANCE-I Study) 
Protocol Number: REL-1017-301 
NCT Number: 
NCT04688164 
Name of Investigational Product: 
REL-1017 
Phase of Development: 
3 
Indication: 
Major Depressive Disorder 
Sponsor: 
Relmada Therapeutics Inc. 
Document Date: 
December 01 2022 
Certain information within this protocol has been redacted to protect either personally 
identifiable information or company confidential information. 
This may include, but is not limited to, redaction of the following: 
•
Names, addresses, and other personally identifiable information
•
Proprietary information, such as scales or coding systems, which are considered 
confidential information.
•
Other information as needed to protect the trade secret and/or confidential information of 
Relmada Therapeutics






INVESTIGATOR SIGNATURE PAGE 
Protocol Title: 
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled 
Study to Assess the Efficacy and Safety of REL-1017 for Treatment of 
Major Depressive Disorder (The RELIANCE-I Study) 
Protocol Number: 
REL-1017-301 
Confidentiality and Current Good Clinical Practice (GCP)/E6(R2): 
I agree, as an Investigator conducting this study: 
• 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
 
 
 
 
 
 
 
 
 
 
 
 
<Name> 
<Title> 
Investigator Signature 
Date (DD-Mmm-YYYY) 
Institution
Clinical trial NCT05050149
Conditions: Microcystic Lymphatic Malformation
Sponsor: Palvella Therapeutics, Inc.
Start date: 2022-01-13; Completion date: 2022-12-15
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study evaluates the safety and efficacy of PTX-022 (sirolimus) Topical Gel 3.9% w/w in the treatment of Microcystic Lymphatic Malformations. The participant will receive 3 months of PTX-022 treatment by the end of the study.

Detailed description:

Arms: arm 1: PTX-022 QTORIN
Interventions: intervention 1: PTX-022
Intervention descriptions: intervention 1: Safety and Efficacy of PTX-022 in the Treatment of Microcystic Lymphatic Malformations

Protocol documents:
Prot_SAP_000.pdf: 
PTX-022 
Palvella Therapeutics, Inc. 
Protocol PALV-06
27June2022 
Amendment #4 
Confidential 
A MULTICENTER, PHASE 2, OPEN-LABEL STUDY EVALUATING THE SAFETY 
AND EFFICACY OF SIROLIMUS 3.9% TOPICAL GEL (PTX-022) IN THE 
TREATMENT OF MICROCYSTIC LYMPHATIC MALFORMATIONS  
Protocol Number: PALV-06 
Compound Number 
PTX-022 
Sponsor Name: 
Palvella Therapeutics, Inc. 
Legal Registered Address: 
125 Strafford Ave, Suite 360 
Wayne, PA 19087 
Regulatory Agency Identifying 
Number(s): 
Approval Date 
27June2022
Clinical trial NCT00494234
Conditions: Breast Neoplasms
Keywords: Advanced breast cancer Poly(ADP ribose) polymerases AZD2281,KU-0059436 (olaparib) BRCA1 protein BRCA2 protein
Sponsor: AstraZeneca
Start date: 2007-06-15; Completion date: 2022-12-21
Enrollment: 54 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to see if the drug KU-0059436 (olaparib) is effective and well tolerated in treating participants with measurable breast cancer gene (BRCA)1- or BRCA2-positive advanced breast cancer and for whom no curative therapeutic option exists.

Detailed description:
This is a Phase II, open-label, non-comparative, international, multicenter study to assess the efficacy and safety of olaparib when given orally twice daily (bd) in participants with advanced BRCA1- or BRCA2- associated breast cancer. Two sequential participant cohorts will receive continuous oral olaparib in 28-day cycles. The first cohort will receive 400 mg bd and the second cohort will receive 100 mg bd.

Arms: arm 1: Participants will receive two 50 mg capsules in the morning and two 50 mg capsules in the evening in 28-days cycle until confirmed disease progression, continuous treatment interruption, unacceptable toxicity or any other discontinuation criterion is met. arm 2: Participants will receive eight 50 mg capsules in the morning and eight 50 mg capsules in the evening in 28-days cycle until confirmed disease progression, continuous treatment interruption, unacceptable toxicity or any other discontinuation criterion is met.
Interventions: intervention 1: Olaparib
Intervention descriptions: intervention 1: Participants will receive capsules of olaparib orally as stated in arm description.

Protocol documents:
Clinical trial NCT03890120
Conditions: Primary Sclerosing Cholangitis
Sponsor: Gilead Sciences
Start date: 2019-03-27; Completion date: 2022-12-23
Enrollment: 419 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate whether cilofexor reduces the risk of fibrosis progression among non-cirrhotic adults with primary sclerosing cholangitis (PSC).

Detailed description:

Arms: arm 1: Participants received cilofexor 100 mg tablet, orally, once daily for up to 100.3 weeks. arm 2: Participants received placebo to match cilofexor 100 mg tablet, orally, once daily for up to 98.1 weeks. arm 3: Participants who received cilofexor in blinded phase and had entered the open-label extension (OLE) phase received open-label cilofexor 100 mg tablet, orally, once daily for up to 44.7 weeks. arm 4: Participants who received placebo in blinded phase and had entered the OLE phase received open-label cilofexor 100 mg tablet, orally, once daily for up to 45.0 weeks.
Interventions: intervention 1: Cilofexor intervention 2: Placebo
Intervention descriptions: intervention 1: 100 mg tablet administered orally once daily intervention 2: Tablet administered orally once daily

Protocol documents:
Prot_000.pdf: 























































































































































































































































































SAP_001.pdf:
Clinical trial NCT05005273
Conditions: Non-Small Cell Lung Cancer
Keywords: Non-Small Cell Lung Cancer NSCLC BMS-986207 Nivolumab Opdivo Ipilimumab Yervoy
Sponsor: Bristol-Myers Squibb
Start date: 2022-10-03; Completion date: 2022-12-27
Enrollment: 1 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the safety and efficacy of BMS-986207 in combination with nivolumab and ipilimumab as first-line treatment for participants with stage IV non-small cell lung cancer (NSCLC).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Nivolumab intervention 2: Ipilimumab intervention 3: BMS-986207 intervention 4: Placebo
Intervention descriptions: intervention 1: Specified dose on specified days intervention 2: Specified dose on specified days intervention 3: Specified dose on specified days intervention 4: Specified dose on specified days

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT05627518
Conditions: Safety Bioavailability Pharmacokinetics
Sponsor: Cinclus Pharma Holding AB
Start date: 2022-11-15; Completion date: 2023-01-03
Enrollment: 67 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a single-center, open-label, randomized, single dose, 3-way crossover study in healthy volunteers designed to evaluate the relative bioavailability of a new oral tablet formulation of linaprazan glurate in comparison to a previously studied oral tablet formulation under fasting conditions, and to assess the effect of a high fat, high calorie meal on the pharmacokinetics (PK) of linaprazan glurate and the active substance linaprazan after the administration of the new oral tablet formulation.

Detailed description:

Arms: arm 1: 100 mg linaprazan glurate reference formulation (4x25 mg oral tablets) in fasting conditions arm 2: 100 mg linaprazan glurate test formulation (1x100 mg oral tablet) in fasting conditions arm 3: 100 mg linaprazan glurate test formulation (1x100 mg oral tablet) in fed conditions
Interventions: intervention 1: Linaprazan glurate
Intervention descriptions: intervention 1: 100 mg

Protocol documents:
Prot_000.pdf: 















































































































































SAP_001.pdf:
Clinical trial NCT02163733
Conditions: Advanced Non Small Cell Lung Cancer Advanced (Inoperable) Non Small Cell Lung Cancer
Keywords: oncology, cancer, non small cell lung cancer, anticancer drug, pharmacokinetics, AZD9291, EGFR sensitivity mutation, food effect
Sponsor: AstraZeneca
Start date: 2014-11-14; Completion date: 2023-01-24
Enrollment: 38 participants; Allocation: RANDOMIZED; Intervention model: 

Brief summary:
This is a 2-part study in patients with epidermal growth factor receptor mutation positive (EGFRm+) non-small cell lung cancer (NSCLC) whose disease has progressed on treatment with an epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI): Part A will determine the effect of food on the pharmacokinetics (PK) of AZD9291; Part B will allow patients further access to AZD9291 and will provide for additional safety data collection.

Part A is a randomised, open-label, 2 treatment period crossover study in which patients will each receive a single oral dose of AZD9291 (1 x 80 mg tablet) at breakfast time (approximately 0800) in each of 2 treatment periods (once immediately following a high fat meal \[fed\], and once in the fasted state \[fasted\]), with a washout period of 9 days between doses.

Approximately 38 patients are planned to be enrolled and dosed; at least 30 evaluable patients will be required to complete Part A (ie, the last PK sample in Treatment Period 2 \[TP 2\] has been collected). Additional patients may be enrolled to allow for at least 30 evaluable patients

Detailed description:

Arms: arm 1: AZD9291 tablets following a period of fasting arm 2: AZD9291 tablets following a high-fat meal.
Interventions: intervention 1: AZD9291 tablets intervention 2: Pharmacokinetic sampling - AZD9291 intervention 3: Dietary Fasted intervention 4: Dietary High Fat intervention 5: Pharmacokinetic sampling - AZ5140 and AZ7550
Intervention descriptions: intervention 1: AZD9291 tablets: Part A 80mg od, days 1 and 10 only. Part B 80mg od for 12 months. intervention 2: Blood samples taken pre and post dosing of AZD9291 following either a period of fasting or consumption of a meal. intervention 3: Fasted from 10 hours prior to dosing with 80mg AZD9291 tablet and 4 hours after dosing intervention 4: Allocated breakfast prior to dosing with 80mg AZD9291 tablet intervention 5: Blood samples taken pre and post dosing of AZD9291 following either a period of fasting or consumption of a meal.

Protocol documents:
Clinical trial NCT05065619
Conditions: SARS-CoV-2 Infection
Sponsor: Medicago
Start date: 2021-10-02; Completion date: 2023-01-29
Enrollment: 128 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to evaluate the safety and immunogenicity of MT-2766 in Japanese adults.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: MT-2766 High dose (3.75 µg) intervention 2: Placebo intervention 3: MT-2766 Low dose
Intervention descriptions: intervention 1: Subjects will receive two doses of MT-2766 high dose (3.75 µg) given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once) intervention 2: Subjects will receive two doses of placebo given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once) intervention 3: Subjects will receive two doses of MT-2766 low dose given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once)

Protocol documents:
SAP_002.pdf: 























































































































Prot_000.pdf:
Clinical trial NCT00588523
Conditions: CNS Cancer CNS BRAIN
Keywords: Brain CNS TEMOZOLOMIDE Busulfan Thiotepa
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2002-09-01; Completion date: 2023-02-02
Enrollment: 60 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to see how effective treatment of high doses of chemotherapy is for your tumor. We will also be looking at the side effects and risks of this treatment.

You will receive very high doses of chemotherapy. High doses of chemotherapy can destroy tumor cells, but it can also destroy normal bone marrow cells. These cells produce white blood cells (which fight infection), red blood cells (which carry oxygen) and platelets (which allow your blood to clot). With too few of these cells there is a serious risk of infection and bleeding.

Therefore, before treatment begins, we will collect some of your own blood cells, called peripheral blood progenitor cells (PBPCs). These cells help create new blood cells. The PBPCs are frozen and saved while you are being treated. Then at the end of treatment, your PBPCs are thawed and given back to you. These healthy PBPCs will replace the blood cells that the high dose chemotherapy destroys and allow your bone marrow to recover and produce blood cells. In a prior study we treated 69 patients in a similar way. More than half were able to avoid or delay brain radiation. This new study will use a different high dose chemotherapy regimen.

Detailed description:

Arms: arm 1: temozolomide followed by high dose busulfan and thiotepa
Interventions: intervention 1: temozolomide followed by high dose busulfan and thiotepa
Intervention descriptions: intervention 1: Temozolomide 200mg/m2 PO Days 1-5 recycled every 28 days Day minus -8 thiotepa 250 mg/m2 intravenously Day minus -7 thiotepa 250 mg/m2 intravenously Day minus -6 thiotepa 250 mg/m2 intravenously Day minus -5 busulfan 3.2 mg/kg intravenously over two hours Day minus -4 busulfan 3.2 mg/kg intravenously over two hours Day minus -3 busulfan 3.2 mg/kg intravenously over two hours Day minus -2 rest Day minus -1 rest Day 0 peripheral blood stem cell or bone marrow reinfusion

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT01320085
Conditions: BRAF or NRAS Mutant Metastatic Melanoma
Keywords: Metastatic melanoma, BRAF-mutant, NRAS-mutant
Sponsor: Pfizer
Start date: 2011-03-24; Completion date: 2023-02-06
Enrollment: 183 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will assess the safety and efficacy of single-agent MEK162 in adult patients with locally advanced and unresectable or metastatic malignant cutaneous melanoma, harboring BRAFV600E or NRAS mutations.

Detailed description:

Arms: arm 1: BRAFV600 mutant, 45mg bid MEK162 arm 2: NRAS mutant, 45mg bid MEK162 arm 3: BRAFV600 mutant, 60mg bid MEK162
Interventions: intervention 1: MEK162
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00418886
Conditions: Non Small Cell Lung Cancer Lung Cancer
Keywords: NSCLC Non Small Cell Lung Cancer
Sponsor: Genzyme, a Sanofi Company
Start date: 2007-01-01; Completion date: 2023-02-14
Enrollment: 698 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Non-small cell lung cancer (NSCLC) can be treated with drugs that kill tumour cells, stop them from dividing, or stop the growth of the blood supply that cancers need to grow and spread. Clinical research has shown that drugs that inhibit vascular endothelial growth factor receptor (VEGFR) or epidermal growth factor receptor (EGFR) signalling can increase overall survival in patients with advanced non-small cell lung cancer (NSCLC). Preclinical studies have shown that vandetanib (ZD6474) is an inhibitor of both VEGFR and EGFR signalling. Giving vandetanib may therefore inhibit the growth of cancer cells by blocking their blood supply and by stopping them from dividing. This lung cancer study is to investigate if adding vandetanib to Alimta (pemetrexed) is more effective than Alimta (pemetrexed) alone.

Detailed description:
This randomized phase III non-small cell lung cancer clinical trial is studying the effect of Alimta (pemetrexed) plus vandetanib to see how well the combination works compared to Alimta (pemetrexed) alone in patients who have previously been treated for non-small cell lung cancer (NSCLC).

Arms: arm 1: Placebo Vandetanib + Pemetrexed arm 2: Vandetanib + Pemetrexed
Interventions: intervention 1: Vandetanib intervention 2: Pemetrexed
Intervention descriptions: intervention 1: oral once daily tablet intervention 2: intravenous infusion

Protocol documents:
Clinical trial NCT05716763
Conditions: Healthy
Sponsor: Unither Pharmaceuticals, France
Start date: 2023-02-14; Completion date: 2023-02-27
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study aims to demonstrate the bioequivalence between the formulation of 5 mg/mL Tramadol Hydrochloride Oral Solution (08P1902F0) Relative to the reference product Contramal® (100 mg/mL Oral Solution).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Tramadol Hydrochloride 5 MG/ML Oral Solution intervention 2: Tramadol Hydrochloride 100 MG/ML Oral Solution (Contramal(r))
Intervention descriptions: intervention 1: 50mg (10mL) single dose intervention 2: 50mg (20 drops) single dose

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT02108652
Conditions: Bladder Cancer
Keywords: anti-PD-L1 PD-L1 MPDL3280A PD-1 bladder cancer atezolizumab Tecentriq
Sponsor: Hoffmann-La Roche
Start date: 2014-05-31; Completion date: 2023-02-28
Enrollment: 310 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This Phase II, single-arm study is designed to evaluate the effect of atezolizumab treatment in participants with locally advanced or metastatic urothelial bladder cancer. Participants will be enrolled into 1 of 2 cohorts. Cohort 1 will consist of participants who are treatment-naïve and ineligible for cisplatin-containing chemotherapy. The results of Cohort 1 are reported separately (NCT02951767). Cohort 2 (reported here) will contain participants who have progressed during or following a prior platinum-based chemotherapy regimen. Participants in both cohorts will be given a 1200 milligrams (mg) intravenous (IV) dose of atezolizumab on Day 1 of 21-day cycles. Treatment of participants in Cohort 1 will continue until disease progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or unmanageable toxicity. Treatment of participants in Cohort 2 will continue until loss of clinical benefit or unmanageable toxicity.

Detailed description:

Arms: arm 1: Participants with advanced disease who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting will receive atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
Interventions: intervention 1: Atezolizumab
Intervention descriptions: intervention 1: Atezolizumab 1200 mg given by IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria/loss of clinical benefit or unmanageable toxicity.

Protocol documents: