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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

To evaluate the safety and tolerability of MEDI1873 in adult subjects with selected advanced solid tumors.

A Study in Adult Subjects With Select Advanced Solid Tumors

This is a first-time-in-human, Phase 1, multicenter, open-label, single-arm dose-escalation study of MEDI1873 to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics and anti-tumor activity in adult subjects with advanced solid tumor malignancies

NCT ID

Patient Level Data

Therapeutic Area

Subjects will receive MEDI1873 by intravenous administration

Research Site

A Phase 1 Study of MEDI1873 (GITR Agonist) in Adult Subjects With Select Advanced Solid Tumors

The DLT was defined as any Grade 3 or higher treatment-related toxicity that occurred during the DLT evaluation period including: liver transaminase elevation >= 5 × but <= 8 × upper limit of normal (ULN) that does not downgrade to Grade 2 within 5 days after onset of systemic corticosteroids, or transaminase elevation > 8 × ULN or total bilirubin > 5 × ULN, or concurrent elevation of 3 × ULN for aspartate transaminase (AST)/alanine transaminase (ALT) and total bilirubin > 2 × ULN (ie, Hy’s Law).

An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.

Number of participants with abnormal clinical laboratory parameters reported as TEAEs are reported. Clinical laboratory abnormalities are defined as any abnormal findings in analysis of serum chemistry, hematology, coagulation, and urinalysis.

Number of participants with abnormal vital signs reported as TEAEs are reported. Abnormal vital signs are defined as any abnormal findings in the vital signs parameters (body temperature, blood pressure, pulse rate, and respiratory rate).

Number of participants with abnormal electrocardiograms (ECGs) reported as TEAEs are reported. Abnormal ECGs are defined as any abnormal findings in heart rate, RR interval, PR interval, QRS, axis, and QT intervals from the primary lead of the digital 12-lead ECG.

Age Continuous

Sex: Female, Male

Race (NIH/OMB)

Ethnicity (NIH/OMB)

As-treated population included all the participants who received any dose of study drug.

DLT population included all participants in the dose-escalation phase who received study drug per protocol and completed safety follow-up through DLT-evaluable period or experience any DLT during the DLT-evaluation period (Days 1 to 15 of first cycle for single-participant dose levels; Days 1 to 28 of first cycle for other dose levels).

Number of Participants With Dose-limiting Toxicities (DLTs)

TEAEs

TESAEs

As-treated population included all participants who received any dose of study drug.

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

Anemia

Lymphocyte count decreased

Platelet count decreased

Alanine aminotransferase increased

Alkaline phosphatase increased

Aspartate aminotransferase increased

Blood bilirubin increased

Creatinine increased

Hypocalcemia

Hypercalcemia

Hyperglycemia

Hypokalemia

Hyperkalemia

Hyponatremia

Lipase increased

Amylase increased

Haematuria

Hyperuricaemia

Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs

Hypertension

Hypotension

Dyspnoea

Weight decreased

Weight increased

Pyrexia

Number of Participants With Abnormal Vital Signs Reported as TEAEs

Acute myocardial infarction

Pericarditis

Ventricular fibrillation

Palpitations

Angina pectoris

Number of Participants With Abnormal Electrocardiogram (ECG) Results Reported as TEAEs

The OR is defined as confirmed complete response (CR) or confirmed partial response (PR) based on Response Evaluation Criteria in Solid Tumours (RECIST v1.1). The confirmed CR is defined as disappearance of all target and non-target lesions and no new lesions. The confirmed PR is defined as >= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new non-target lesion.

Percentage of Participants With Objective Response (OR)

Disease control is defined as complete response (disappearance of all target and non-target lesions and no new lesions), partial response (>= 30% decrease in the sum of diameters of target lesions compared to baseline and no new lesions), or stable disease (neither sufficient shrinkage to qualify as a response nor sufficient growth to qualify as progression). Participants achieving stable disease were included in the DC rate if they maintain stable disease for >= 8 weeks

Percentage of Participants With Disease Control

The DoR is defined as the duration from the first documentation of OR to the first documented disease progression or death due to any cause, whichever occurred first. The confirmed CR is defined as disappearance of all target and non-target lesions and no new lesions. The confirmed PR is defined as >= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new non-target lesion.

Participants who received any dose of study drug and achieved OR(confirmed CR or confirmed PR) were analyzed for this outcome measure.

Duration of Response (DoR)

The TTR was measured from treatment start to the first documentation of disease response and was evaluated only in participants who achieved OR (confirmed CR or confirmed PR). The confirmed CR is defined as disappearance of all target and non-target lesions and no new lesions. The confirmed PR is defined as >= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new non-target lesion.

Time to Response (TTR)

The PFS is defined as the time from the start of study drug until the first documentation of disease progression or death due to any cause, whichever occurred first. The PFS was assessed using Kaplan Meier method.

Progression-free Survival (PFS)

The OS is defined measured from the start of study treatment until death due to any cause.

Overall Survival (OS)

Cmax of MEDI1873 during first cycle is reported.

Maximum Observed Serum Concentration (Cmax) of MEDI1873 During First Cycle

The AUC0-t of MEDI1873 during first cycle is reported.

Area Under the Serum Concentration-time Curve From Time Zero to the Last Measurable Concentration (Auc0-t) of MEDI1873 During First Cycle

The AUC0-inf of MEDI1873 during first cycle is reported.

Area Under the Serum Concentration-time Curve From Time Zero to Infinity (Auc0-inf) of MEDI1873 During First Cycle

The t1/2 of MEDI1873 during first cycle is reported.

Terminal Half-life (t1/2) of MEDI1873 During First Cycle

The CL of MEDI1873 during first cycle is reported.

Systemic Clearance (CL) of MEDI1873 During First Cycle

ADA prevalence positive

ADA Persistent Positive

ADA Transient Positive

Number of participants with positive ADA titer to MEDI1873 are reported as: ADA prevalence positive (participants with positive ADA result at any time, baseline or post baseline), ADA persistent positive (participants positive at >=2 post baseline assessments [with >=16 weeks between first and last positive] or positive at last post baseline assessment) and ADA transient positive (participants with at least one post baseline ADA positive assessment and not fulfilled the conditions of persistent positive).

ADA evaluable population included all the participants who had baseline ADA and at least one post baseline ADA results.

Number of Participants With Positive Anti-drug Antibodies (ADAs)

The CD8+ effector means 2-fold increase in densities of CD8+ cells.

Participants who received any dose of study drug and had pre- and post-treatment tumor biopsy samples were analyzed for this outcome measure.

Number of Participants With CD8+ Effector Within Tumor Biopsies

The FoxP3+ Tregs effectors means modest reduction in FoxP3+ cells.

A Study in Adult Subjects With Select Advanced Solid Tumors

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

Trial Results Summaries

Contacts

Contact

Contact Backup

Investigators

Principal Investigator