midazolam and Lung Neoplasms

midazolam has been researched along with Lung Neoplasms in 21 studies

Midazolam: A short-acting hypnotic-sedative drug with anxiolytic and amnestic properties. It is used in dentistry, cardiac surgery, endoscopic procedures, as preanesthetic medication, and as an adjunct to local anesthesia. The short duration and cardiorespiratory stability makes it useful in poor-risk, elderly, and cardiac patients. It is water-soluble at pH less than 4 and lipid-soluble at physiological pH.
midazolam : An imidazobenzodiazepine that is 4H-imidazo[1,5-a][1,4]benzodiazepine which is substituted by a methyl, 2-fluorophenyl and chloro groups at positions 1, 6 and 8, respectively.

Lung Neoplasms: Tumors or cancer of the LUNG.

Research

Studies (21)

Authors

Clinical Trials (2)

Trial Overview

Trial Outcomes

Assess the Dose Limiting Toxicities (DLTs) of G1T28/Trilaciclib Administered With Topotecan in Part 1

"The percentage of patients experiencing DLTs in Part 1 of the study in each cohort, including:~Absolute neutrophil count (ANC) < 0.5 × 10^9/L lasting for ≥ 7 days~≥ Grade 3 neutropenic infection/febrile neutropenia~Grade 4 thrombocytopenia or ≥ Grade 3 thrombocytopenia with bleeding~Unable to start next cycle of chemotherapy due to lack of recovery to an ANC ≥ 1.5 × 10^9/L and platelet count ≥ 100 × 10^9/L; a delay of up to 1 week from the scheduled start of Cycle 2 is allowed for recovery of ANC and platelet count, and is not considered a DLT~≥ Grade 3 nonhematologic toxicity (nausea, vomiting, and diarrhea failing maximal medical management; fatigue lasting for > 72 hours)" (NCT02514447)
Timeframe: Evaluated for Cycle 1 (i.e., from date of first dose of study drug (Part 1) to the end of Cycle 1, each cycle = 21 days)

Assess the Hematologic Profile of G1T28/Trilaciclib Administered With Topotecan

The weekly event rate of Major Adverse Hematologic Events (MAHE) events (NCT02514447)
Timeframe: During the treatment period. From date of first dose (Part 1)/randomization (Part 2), 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator (assessed up to 1090 days).

Chemotherapy Exposure

Average duration of exposure to chemotherapy (topotecan) in days. (NCT02514447)
Timeframe: During the treatment period. From date of first dose, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator (assessed up to a maximum of 1335 days).

Dose Reductions in Chemotherapy (Topotecan)

Overall event rate of dose reductions in chemotherapy (topotecan) (NCT02514447)
Timeframe: During the treatment period. From date of first dose (Part 1)/randomization (Part 2), 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator (assessed up to 1090 days).

Duration of Response (DOR)

The median months and 95% CIs of duration of response. (NCT02514447)
Timeframe: From date of first dose of study drug (Part 1)/randomization (Part 2) until the occurrence of progressive disease, withdrawal of consent, or initiation of subsequent anti-cancer therapy, (assessed up to a maximum of 1335 days).

Duration of Severe (Grade 4) Neutropenia in Cycle 1

Duration of severe neutropenia (DSN; days) was defined as the number of days from the date of the first ANC value of <0.5 × 10^9/L observed between start of cycle and end of cycle to the date of the first ANC value ≥0.5 × 10^9/L that met the following criteria: (1) occurred after the ANC value of <0.5 × 10^9/L and (2) no other ANC values <0.5 × 10^9/L occurred between this day and end of cycle. DSN is set to 0 for patients who did not experience SN in a cycle, including those who were randomized but never treated. Data from unscheduled visits and the actual assessment date (rather than visit date) were included in the derivation. (NCT02514447)
Timeframe: Evaluated for Cycle 1 (i.e., from date of first dose of study drug (Part 1)/randomization (Part 2) to the end of Cycle 1, each cycle = 21 days)

Need for Treatment With Hematopoietic Growth Factors

Percentage of patients requiring G-CSF administration. (NCT02514447)
Timeframe: During the treatment period. From date of first dose (Part 1)/randomization (Part 2), 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator (assessed up to 1090 days).

Occurrence of Erythropoietin-stimulating Agent (ESA) Administrations

The count of patients who received any ESA administration. (NCT02514447)
Timeframe: During the treatment period. From date of first dose (Part 1)/randomization (Part 2), 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator (assessed up to 1090 days).

Occurrence of Febrile Neutropenia Adverse Events

Percentage of patients who experience febrile neutropenia adverse events (NCT02514447)
Timeframe: During the treatment period. From date of first dose (Part 1)/randomization (Part 2), 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator (assessed up to 1090 days).

Occurrence of Grade 3 and 4 Hematologic Toxicities

The count of patients with any hematologic lab value that meets the CTCAE toxicity grade criteria for ≥ Grade 3 and the value is treatment emergent (occurs after first dose of study drug). Labs include: Hemoglobin (HGB), hematocrit, white blood cell (WBC), platelet counts, ANC, ALC, Monocyte Absolute, Basophil Absolute, and Eosinophil Absolute. (NCT02514447)
Timeframe: During the treatment period. From date of first dose (Part 1)/randomization (Part 2), 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator (assessed up to 1090 days).

Occurrence of Infection Serious Adverse Events (SAEs)

Percentage of patients experiencing an SAE that codes to the Medical Dictionary for Regulatory Activities (MedDRA) system organ class (SOC) of Infections and Infestations (NCT02514447)
Timeframe: During the treatment period. From date of first dose (Part 1)/randomization (Part 2), 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator (assessed up to 1090 days).

Occurrence of Intravenous (IV) Antibiotic Use

Percentage of patients requiring systemic/IV antibiotics (NCT02514447)
Timeframe: During the treatment period. From date of first dose (Part 1)/randomization (Part 2), 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator (assessed up to 1090 days).

Occurrence of Platelet Transfusions

Percentage of patients requiring a platelet transfusion (NCT02514447)
Timeframe: During the treatment period. From date of first dose (Part 1)/randomization (Part 2), 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator (assessed up to 1090 days).

Occurrence of Pulmonary Infection Serious Adverse Events (SAEs)

Percentage of patients experiencing an SAE that codes to the Medical Dictionary for Regulatory Activities (MedDRA) system organ class (SOC) of Infections and Infestations and falls into a preferred term (PT) categorized as a pulmonary infection custom MedDRA query (CMQ) (NCT02514447)
Timeframe: During the treatment period. From date of first dose (Part 1)/randomization (Part 2), 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator (assessed up to 1090 days).

Occurrence of RBC Transfusions

Percentage of patients requiring a RBC transfusion on/after week 5 (NCT02514447)
Timeframe: During the treatment period. From date of first dose (Part 1)/randomization (Part 2), 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator (assessed up to 1056 days).

Occurrence of Severe (Grade 4) Neutropenia

Number of Participants with severe (Grade 4) neutropenia (SN) was a binary variable. If a patient had at least 1 absolute neutrophil count value <0.5 × 10^9/L during the Treatment Period, the patient was assigned as Yes to the occurrence of SN; otherwise, it was No. (NCT02514447)
Timeframe: During the treatment period. From date of first dose (Part 1)/randomization (Part 2), 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator (assessed up to 1090 days).

Overall Survival (OS)

Median time (months) and 95% CI from date of first dose date of study drug/randomization until date of death. Patients who do not die during the study will be censored at the date last known to be alive. (NCT02514447)
Timeframe: From date of first dose of study drug (Part 1)/randomization (Part 2) until the date of death due to any cause (evaluated up to a maximum of 2220 days).

Pharmacokinetic Profile for Topotecan When Administered With Trilaciclib (G1T28)

Maximum concentration (Cmax) of topotecan when administered with trilaciclib (G1T28) (NCT02514447)
Timeframe: Part 1 of the study during Cycle 1 Day 4 : predose, 0.5, 1, 1.5, 2, 2.5, 3, 4.5, 6.5, 8.5 (optional), and 24.5 hours post dose. Part 2 of the study during Cycle 1 Day 4 : predose, 0.5, 1, between 3 to 4 hours and between 5.5 to 6.5 hours post dose.

Pharmacokinetic Profile for Trilaciclib (G1T28) When Administered With Topotecan

Maximum concentration (Cmax) of trilaciclib (G1T28) when administered with topotecan (NCT02514447)
Timeframe: Part 1 of the study during Cycle 1 Day 4 : predose, 0.5, 1, 1.5, 2, 2.5, 3, 4.5, 6.5, 8.5 (optional), and 24.5 hours post dose. Part 2 of the study during Cycle 1 Day 4 : predose, 0.5, 1, between 3 to 4 hours and between 5.5 to 6.5 hours post dose.

Progression Free Survival (PFS)

"Median time (months) and 95% CI from date of first dose of study drug/randomization until date of documented disease progression or death due to any cause.~Investigators followed the Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 guidelines for tumor assessments to determine progression. Progressive Disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression)." (NCT02514447)
Timeframe: From date of first dose of study drug (Part 1)/randomization (Part 2), until date of documented disease progression or death due to any cause (evaluated up to a maximum of 1335 days).

Chemotherapy Cycles and Modifications Overall

Average exposure and cycle modifications in chemotherapy (topotecan) (NCT02514447)
Timeframe: During the treatment period. From date of first dose, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator (assessed up to a maximum of 1335 days).

Occurrence of Grade 4 and Grade 3/4 Decreased Platelet Count Laboratory Values (Thrombocytopenia)

The count of patients with any platelet lab value that meets the CTCAE toxicity grade criteria for ≥ Grade 3 and the value is treatment emergent (occurs after first dose of study drug). (NCT02514447)
Timeframe: During the treatment period. From date of first dose (Part 1)/randomization (Part 2), 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator (assessed up to 1090 days).

Tumor Response Based on RECIST, Version 1.1

"The percentage of patients who fall into each category of Best overall response (BOR) as defined by RECIST, Version 1.1.~Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions.~Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions.~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.~When no imaging/measurement is done, the patient is not evaluable (NE); and if only a subset of lesion measurements are made, usually the case is also considered NE." (NCT02514447)
Timeframe: From date of first dose of study drug (Part 1)/randomization (Part 2) until the occurrence of progressive disease, withdrawal of consent, or initiation of subsequent anti-cancer therapy, (assessed up to a maximum of 1335 days).

Trials

5 trials available for midazolam and Lung Neoplasms

Other Studies

16 other studies available for midazolam and Lung Neoplasms