Neoplasms

Nervous System Diseases

Immune System Diseases

All Conditions

Musculoskeletal Diseases

Symptoms and General Pathology

Rare Diseases

Myasthenia Gravis

Muscle Weakness

Paresis

Asthenia

Muscular Diseases

Neuromuscular Manifestations

Neurologic Manifestations

Syndrome

Paraneoplastic Syndromes

Paraneoplastic Syndromes, Nervous System

Nervous System Neoplasms

Autoimmune Diseases

Autoimmune Diseases of the Nervous System

Neurodegenerative Diseases

Neuromuscular Junction Diseases

Neuromuscular Diseases

Participants will receive inebilizumab administered intravenously (IV) on Days 1, 15, and 183 of the RCP.

Participants who elect to enter the open label phase (OLP) will receive inebilizumab administered IV on OLP Days 1, IV placebo on OLP Day 15 (to avoid potential unblinding), and inebilizumab IV on OLP Days 183, 365, 547, 729, and 911.

Participants will receive placebo administered IV on Days 1, 15, and 183 of the RCP.

Participants who elect to enter the OLP will receive inebilizumab administered IV on OLP Days 1,15, 183, 365, 547, 729, and 911.

Participants will receive inebilizumab administered IV on Days 1 and 15 of the RCP.

Participants who elect to enter the OLP will receive inebilizumab administered IV on OLP Day 1, IV placebo on OLP Day 15 (to avoid potential unblinding), and inebilizumab IV on OLP Days 183, 365, 547, 729, and 911.

Participants will receive placebo administered IV on Days 1 and 15 of the RCP. Participants who elect to enter the OLP will receive inebilizumab administered IV on OLP Days 1,15, 183, 365, 547, 729, and 911.

Participants will receive IV inebilizumab

inebilizumab

Participants will receive IV placebo matched to inebilizumab

IV Placebo

Randomized, double-blind, placebo-controlled, Phase 3, parallel-group study with optional open-label extension.

This study is a phase 3, randomized, double-blind, placebo-controlled study, to be conducted at approximately 120 study sites. Approximately 230 participants (188 acetylcholine receptor antibody positive \[AChR-Ab+\] and 42 muscle-specific tyrosine kinase antibody positive \[MuSK-Ab+\]) will be enrolled. Participants with Myasthenia Gravis (MG) who are positive for anti-AChR or anti-MuSK antibodies will be enrolled and analyzed. Patients who do not have anti-AChR or anti-MuSK antibodies will not be enrolled. Patients with Myasthenia Gravis Foundation of America (MGFA) classification II, III, or IV disease, Myasthenia Gravis Activities of Daily Living (MG-ADL) score at screening and randomization between 6 and 10 with \> 50% of this score attributed to non-ocular items, or an MG-ADL score \>=11, Quantitative Myasthenia Gravis (QMG) score \>= 11 at the time of screening and randomization, and use of a corticosteroid and/or non-steroidal immunosuppressant will be included in the study.

All subjects who complete the randomized controlled period (RCP) will have the option to enroll in a 3-year (156 weeks) open-label period.

Study acquired from Horizon in 2024.

A Randomized, Double-blind, Multicenter, Placebo-controlled Phase 3 Study with Open-label Period

This is a double-blind study in which the IV inebilizumab and the IV placebo are matching in appearance.

Myasthenia Gravis Inebilizumab Trial

A Randomized, Double-blind, Multicenter, Placebo-controlled Phase 3 Study With Open-label Period to Evaluate the Efficacy and Safety of Inebilizumab in Adults With Myasthenia Gravis

Amgen

Gland and Hormone Related Diseases

Pituitary Diseases

Pain

Pituitary Neoplasms

Hypothalamic Diseases

Brain Diseases

Central Nervous System Diseases

Endocrine System Diseases

Endocrine Gland Neoplasms

Hypothalamic Neoplasms

Supratentorial Neoplasms

Brain Neoplasms

Central Nervous System Neoplasms

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Antipyretics

Anti-Inflammatory Agents

Antirheumatic Agents

Oxycodone

Acetaminophen

Ibuprofen

Morphine

Hydromorphone

Analgesics, Opioid

Narcotics

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Intravenous (IV) Caldolor (ibuprofen) (800mg every 8 hours) initiated during surgery and oral acetaminophen 1000mg every 6 hours initiated post-operatively and continued for the duration of the hospital stay (an expected average stay of 2 days) or 48 hours, whichever comes first. Breakthrough pain will be treated with rescue narcotics (IV morphine 2-4mg every 2 hours and oral oxycodone 5-15mg every 4 hours immediately post-operatively through discharge, an expected average stay of 2 days). Hydromorphone (IV 0.5-2mg every 2 hours and oral 2-4mg every 4 hours) will be used in patients with morphine or oxycodone allergy or intolerance.

IV placebo will be initiated during surgery and oral acetaminophen 1000mg every 6 hours will be initiated post-operatively and continued for the duration of the hospital stay (an expected average stay of 2 days) or 48 hours, whichever comes first. Breakthrough pain will be treated with rescue narcotics (IV morphine 2-4mg every 2 hours and oral oxycodone 5-15mg every 4 hours immediately post-operatively through discharge, an expected average stay of 2 days). Hydromorphone (IV 0.5-2mg every 2 hours and oral 2-4mg every 4 hours) will be used in patients with morphine or oxycodone allergy or intolerance.

IV Caldolor (IV ibuprofen) intraoperatively and postoperatively

IV Caldolor

IV Placebo intraoperatively and postoperatively

Andrew S Little, MD

A randomized, double-blind, placebo-controlled intervention trial involving 100 treated subjects undergoing endonasal trans-sphenoidal (ENTS) resection of pituitary lesion. Subjects will be randomized into two groups: 50 treated in the opioid-sparing arm and 50 treated in the standard post-operative medication arm.

Post-operative pain control is a common concern patients have when they consider undergoing a surgical procedure. Although effective for treating acute pain, opioid analgesics are also associated with dose-dependent adverse effects, including constipation, nausea and vomiting, altered mental status, and respiratory depression, all of which have been shown to increase patient length of stay. The use of non-opioid analgesics with different mechanisms of actions for acute pain control via a multi-modal approach is efficacious in reducing opioid consumption, decreasing the incidence of adverse effects, improving patient satisfaction and recovery time, and decreasing hospital costs.Certain minimally invasive procedures may afford many patients the opportunity to achieve adequate post-operative pain control with minimal to no requirement of opioid analgesics, thereby sparing the patient known adverse effects that can increase length of stay and costs. The ENTS approach for resection of pituitary tumors is the standard surgical procedure for these lesions, and is associated with pain that is more easily managed post-operatively, making it an ideal procedure for an opioid-sparing post-operative pain regimen. Anecdotally, the investigators note that in the investigator's post-operative pituitary patient population that post-operative pain can frequently be adequately managed with scheduled non-opioid analgesics, often without requiring breakthrough opioid doses. Another safe and effective non-opioid analgesic that is widely used in multi-modal pain management for moderate pain is IV Caldolor (ibuprofen). After literature review, the investigators were unable to find a study that had attempted to use an opioid-sparing analgesic regimen for post-operative pain control following ENTS approach for resection of pituitary tumors.

Analgesia Regimens Following Trans-sphenoidal Surgery for Pituitary Tumors

Randomized, Double-Blind, Placebo-Controlled Trial Comparing Opioid-Sparing and Opioid-Containing Analgesia Regimens Following Trans-sphenoidal Surgery for Pituitary Tumors

Total hospital costs for patients in IV ibuprofen arm compared to IV placebo arm

patients with one or more bowel movement(s) in the first 48 hours after surgery

Length of hospital stay from time of surgery to time of discharge.

Use of antiemetics in first 48 hours after surgery

Comparison of pain scores between two arms using Visual Analog Scale (VAS) for Pain. Units of measure are 0=No Pain, 1=Annoying, 2=Mild Pain, 3=Troublesome, 4=Nagging Pain, Uncomfortable, 5=Distressing, 6=Miserable, 7=Horrible, 8=Intense, Dreadful, 9=Unbearable, 10=Worst Possible Pain. Higher values represent a worse outcome. There are no subscales.

Rescue narcotic in both groups will be recorded and compared using a standard equianalgesic oral morphine equivalent (OME) calculation

Epistaxis, potentially related to IV ibuprofen, will be compared between two groups

St. Joseph's Hospital and Medical Center, Phoenix

Intravenous (IV) Caldolor (ibuprofen) (800mg every 8 hours) initiated during surgery and oral acetaminophen 1000mg every 6 hours initiated post-operatively and continued for the duration of the hospital stay (an expected average stay of 2 days) or 48 hours, whichever comes first. Breakthrough pain will be treated with rescue narcotics (IV morphine 2-4 mg every 2 hours and oral oxycodone 5-15mg every 4 hours immediately post-operatively through discharge, an expected average stay of 2 days). Hydromorphone (IV 0.5-2 mg every 2 hours and oral 2-4 mg every 4 hours) will be used in patients with morphine or oxycodone allergy or intolerance.

IV Caldolor (Ibuprofen): Compare addition of IV Caldolor (ibuprofen) intraoperatively and postoperatively against IV placebo added intraoperatively and postoperatively.

Opioid-sparing Group

IV placebo will be initiated during surgery and oral acetaminophen 1000mg every 6 hours will be initiated post-operatively and continued for the duration of the hospital stay (an expected average stay of 2 days) or 48 hours, whichever comes first. Breakthrough pain will be treated with rescue narcotics (IV morphine 2-4mg every 2 hours and oral oxycodone 5-15mg every 4 hours immediately post-operatively through discharge, an expected average stay of 2 days). Hydromorphone (IV 0.5-2 mg every 2 hours and oral 2-4mg every 4 hours) will be used in patients with morphine or oxycodone allergy or intolerance.

IV placebo: Compare addition of IV placebo intraoperatively and postoperatively against IV Caldolor (ibuprofen) added intraoperatively and postoperatively.

Standard Treatment Group

Intravenous (IV) Caldolor (ibuprofen) (800mg every 8 hours) initiated during surgery and oral acetaminophen 1000mg every 6 hours initiated post-operatively and continued for the duration of the hospital stay (an expected average stay of 2 days) or 48 hours, whichever comes first. Breakthrough pain will be treated with rescue narcotics (IV morphine 2-4mg every 2 hours and oral oxycodone 5-15mg every 4 hours immediately post-operatively through discharge, an expected average stay of 2 days). Hydromorphone (IV 0.5-2mg every 2 hours and oral 2-4mg every 4 hours) will be used in patients with morphine or oxycodone allergy or intolerance.

IV Caldolor (IV Ibuprofen): Compare addition of IV Caldolor (IV ibuprofen) intraoperatively and postoperatively against IV ibuprofen placebo added intraoperatively and postoperatively.

IV Caldolor placebo will be initiated during surgery and oral acetaminophen 1000mg every 6 hours will be initiated post-operatively and continued for the duration of the hospital stay (an expected average stay of 2 days) or 48 hours, whichever comes first. Breakthrough pain will be treated with rescue narcotics (IV morphine 2-4mg every 2 hours and oral oxycodone 5-15mg every 4 hours immediately post-operatively through discharge, an expected average stay of 2 days). Hydromorphone (IV 0.5-2mg every 2 hours and oral 2-4mg every 4 hours) will be used in patients with morphine or oxycodone allergy or intolerance.

IV Ibuprofen placebo: Compare addition of IV ibuprofen placebo intraoperatively and postoperatively against IV Caldolor (IV ibuprofen) added intraoperatively and postoperatively.

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Patients age \>18 years and \<80 years undergoing endonasal transsphenoidal surgery for pituitary adenoma.

Groups were not balanced re:patient age, so pain scores were analyzed, including age as a covariate, to account for this difference. A second limitation is that analysis was not powered to detect rare bleeding complications or sellar hematoma.

Andrew S. Little, MD

All participants enrolled with the intent to treat.

Comparison of Mean Pain Scores Between Two Arms (Measured Every 4 Hours Over 48 Hour)

Breakthrough Narcotic Requirement

IV Caldolor (ibuprofen) 800 mg every 8 hours initiated during surgery and oral acetaminophen 1000 mg every 6 hours plus rescue opiates as needed

Opioid Sparing Group

IV placebo every 8 hours initiated during surgery and oral acetaminophen 1000 mg every 6 hours plus rescue opiates as needed

Other Adverse Events

Total Cost of Hospital Charges Compared Between Two Arms

all patients enrolled with intent to treat

The Number of Participants Who Have a Bowel Movement During Hospitalization in Both Groups

all participants enrolled with the intent to treat

Length of Stay in Hospital Compared Between Two Arms

Total Number of Doses of Any Anti-emetic Required Post-operatively in Both Groups

Overall Study

Digestive System Diseases

Death

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Antineoplastic Agents

Amino Acids

Pembrolizumab

Lenvatinib

Chlorotrianisene

Tyrosine Kinase Inhibitors

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Protein Kinase Inhibitors

Tyrosine

Participants will receive a combination of lenvatinib, pembrolizumab, and TACE. Lenvatinib will be administered at a dose of 12 mg (for participants with screening body weight ≥60 kg) or 8 mg (for participants with screening body weight \<60 kg) orally once a day during each 21-day cycle until progressive disease or unacceptable toxicity (up to 2 years \[\~35 cycles\] or longer with Sponsor approval). Pembrolizumab will be administered via IV infusion at a dose of 400 mg once every 6 weeks (Q6W) for up to 2 years (\~17 doses). Participants will undergo TACE as a background procedure of chemotherapeutic and embolic agent(s).

Participants will receive a combination of lenvatinib-matching oral placebo, pembrolizumab-matching IV placebo, and TACE. Lenvatinib-matching oral placebo will be administered once a day during each 21-day cycle for up to 2 years (\~35 cycles) or longer with Sponsor approval and pembrolizumab-matching IV placebo will be administered once every 6 weeks (Q6W) for up to 2 years (\~17 doses). Participants will undergo TACE as a background procedure of chemotherapeutic and embolic agent(s).

Administered at a dose of 12 mg (for participants with screening body weight ≥60 kg) or 8 mg (for participants with screening body weight \<60 kg) via oral capsules once a day during each 21-day cycle.

Administered via IV infusion at a dose of 400 mg once every 6 weeks (Q6W).

Lenvatinib-matching placebo administered via oral capsules once a day during each 21-day cycle.

Oral Placebo

Pembrolizumab-matching placebo administered via IV infusion once every 6 weeks (Q6W).

Conducted as a background procedure of chemotherapeutic and embolic agent(s).

TACE

Medical Director

The purpose of this study is to evaluate the efficacy and safety of lenvatinib and pembrolizumab in combination with TACE versus TACE plus oral and intravenous (IV) placebos in participants with incurable, non-metastatic hepatocellular carcinoma (HCC). The primary hypotheses are that pembrolizumab plus lenvatinib in combination with TACE is superior to placebo plus TACE with respect to progression-free survival (PFS) and overall survival (OS).

Safety and Efficacy of Lenvatinib (E7080/MK-7902) With Pembrolizumab (MK-3475) in Combination With Transarterial Chemoembolization (TACE) in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma (MK-7902-012/E7080-G000-318/LEAP-012)

A Phase 3 Multicenter, Randomized, Double-blinded, Active-controlled, Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) With Pembrolizumab (MK-3475) in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma (LEAP-012)

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

PFS is defined as the time from randomization to the first documented progressive disease or death due to any cause, whichever occurs first. Responses are according to RECIST 1.1 as assessed by blinded independent central review (BICR).

OS is defined as the time from randomization to death due to any cause.

PFS is defined as the time from randomization to the first documented progressive disease or death due to any cause, whichever occurs first. Responses are according to mRECIST as assessed by BICR.

ORR is defined as the percentage of participants who have a confirmed complete response (CR: disappearance of any intratumoral arterial enhancement in all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of viable \[enhancement in the arterial phase\] target lesions, taking as reference the baseline sum of the diameters of target lesions). Responses are according to mRECIST as assessed by BICR.

DCR is defined as the percentage of participants who have a best overall response of CR (disappearance of any intratumoral arterial enhancement in all target lesions), PR (at least a 30% decrease in the sum of diameters of viable \[enhancement in the arterial phase\] target lesions, taking as reference the baseline sum of the diameters of target lesions), or stable disease (SD). Responses are according to mRECIST as assessed by BICR.

DOR is determined by disease assessment and is defined as the time from the first documented evidence of a response of CR (disappearance of any intratumoral arterial enhancement in all target lesions) or PR (at least a 30% decrease in the sum of diameters of viable \[enhancement in the arterial phase\] target lesions, taking as reference the baseline sum of the diameters of target lesions) until the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to mRECIST as assessed by BICR.

TTP is defined as the time from randomization to the first documented disease progression. Responses are according to mRECIST as assessed by BICR.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experience at least one AE will be reported.

An SAE is an AE that results in death, is life threatening, requires or prolongs a hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is a cancer, is associated with an overdose, or is another important medical event. The percentage of participants who experience at least one SAE will be reported.

Percentage of participants with Hepatic ECIs not due to disease progression or TACE as assessed by the investigator will be reported.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinue study drug due to an AE will be reported.

ORR is defined as the percentage of participants who have a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters). Responses are according to RECIST 1.1 as assessed by BICR.

DCR is defined as the percentage of participants who have a best overall response of CR (disappearance of all target lesions), PR (at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters), or SD. Responses are according to RECIST 1.1 as assessed by BICR.

DOR is determined by disease assessment and is defined as the time from the first documented evidence of a response of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters) until the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to RECIST 1.1 as assessed by BICR.

TTP is defined as the time from randomization to the first documented disease progression. Responses are according to RECIST 1.1 as assessed by BICR.

Eisai Inc.

Merck Sharp & Dohme LLC

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Nausea

Vomiting

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Uterine Neoplasms

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Signs and Symptoms, Digestive

Uterine Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Antiemetics

Gastrointestinal Agents

Fosaprepitant

Aprepitant

Neurokinin-1 Receptor Antagonists

Substance P

Neurokinin A

Neurotransmitter Agents

Fosaprepitant for Injection 150 mg is administered intravenously on Day 1 only as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy. Oral Placebo given on days 1-3

Aprepitant 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) and 80 mg orally once daily in the morning on Days 2 and 3. 100 cc of IV placebo administered on day 1

Fosaprepitant for Injection 150 mg is administered intravenously on Day 1 only as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy. Patient will receive standard pre-medications

fosaprepitant

Aprepitant 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) and 80 mg orally once daily in the morning on Days 2 and 3. patient will receive standard pre-medications

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Myasthenia Gravis Inebilizumab Trial	NCT04524273	Myasthenia Grav...	inebilizumab IV Placebo	18 Years -	Amgen
Analgesia Regimens Following Trans-sphenoidal Surgery for Pituitary Tumors	NCT02351700	Pituitary Tumor Pain	IV Caldolor IV Placebo	18 Years - 79 Years	St. Joseph's Hospital and Medical Center, Phoenix
Safety and Efficacy of Lenvatinib (E7080/MK-7902) With Pembrolizumab (MK-3475) in Combination With Transarterial Chemoembolization (TACE) in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma (MK-7902-012/E7080-G000-318/LEAP-012)	NCT04246177	Carcinoma, Hepa...	Lenvatinib Pembrolizumab Oral Placebo IV Placebo TACE	18 Years -	Merck Sharp & Dohme LLC
Fosaprepitant Versus Aprepitant in the Prevention of Chemotherapy Induced Nausea and Vomiting	NCT01432015	Ovarian Cancer Uterine Cancer	fosaprepitant aprepitant Oral Placebo IV placebo	18 Years -	Gynecologic Oncology Associates

Spots Global Cancer Trial Database for iv placebo

Every month we try and update this database with for iv placebo cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for iv placebo

Every month we try and update this database with for iv placebo cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for iv placebo cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.