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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

Participants will receive MEDI9090 (fixed dose durvalumab Dose 1 and tremelimumab Dose 1) every 4 weeks 
(Q4W) via a single IV infusion for 4 months (up to 4 doses), followed by monotherapy with durvalumab Q4W via IV infusion until disease progression, treatment discontinuation due to unrelated or treatment-related toxicities, clinical deterioration with durvalumab monotherapy, or treatment
discontinuation due to other reasons,
whichever occurs first.

This is an open-label, study of MEDI9090 to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of MEDI9090 in adult participants with advanced solid tumors.

Study to Evaluate the Safety and Pharmacokinetics (PK) of MEDI9090 in Participants With Advanced Solid Tumors

NCT ID

Patient Level Data

Therapeutic Area

MEDI9090 will be administered Q4W via a single IV infusion for 4 months (up to 4 doses).

Durvalumab as a single agent will be administered by IV infusion after participants have completed the prescribed doses of MEDI9090.

Research Site

A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of MEDI9090 in Subjects with Advanced Solid Tumors

Number of participants with ADA-positive (baseline [pre-dose on Day 1] or post baseline) to durvalumab within 30 days of first dose of MEDI9090 are reported.

Number of participants with ADA positive (baseline [pre-dose on Day 1] or post baseline) to tremelimumab within 30 Days of first dose of MEDI9090 are reported.

Age Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

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

Evaluable population for IRR included participants who received at least one dose of MEDI9090 per protocol and had at least 30 days of follow up after the initiation of MEDI9090 or experienced any IRR.

Number of Participants With Infusion-related Reactions (IRRs) With MEDI9090

ADA evaluable population included all participants who received at least one dose of MEDI9090, and had non-missing baseline ADA and at least one non-missing post-baseline ADA results.

Number of Participants With Positive Anti-Drug Antibodies (ADA) to Durvalumab Within 30 Days of First Dose of MEDI9090

Number of Participants With Positive ADA to Tremelimumab Within 30 Days of First Dose of MEDI9090

Tmax of durvalumab

Tmax of tremelimumab

The Tmax of durvalumab and tremelimumab after first dose are reported.

Pharmacokinetic (PK) evaluable population included all participants who received at least one dose of MEDI9090 and had any post-dose PK data.

Time to Reach Maximum Observed Concentration (Tmax) of Durvalumab and Tremelimumab  After First Dose

Cmax of durvalumab

Cmax of tremelimumab

The Cmax of durvalumab and tremelimumab after first dose are reported.

The PK evaluable population included all participants who received at least one dose of MEDI9090 and had any post-dose PK data.

Maximum Observed Concentration (Cmax) of Durvalumab and Tremelimumab After First Dose

Ctrough of durvalumab

Ctrough of tremelimumab

The Ctrough of durvalumab and tremelimumab after first dose are reported.

Trough Concentration (Ctrough) of Durvalumab and Tremelimumab  After First Dose

AUClast of durvalumab

AUClast of tremelimumab

The AUClast of durvalumab and tremelimumab after first dose are reported.

Area Under the Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUClast) of Durvalumab and Tremelimumab After First Dose

AUCinf of durvalumab

AUCinf of tremelimumab

The AUCinf of durvalumab and tremelimumab after first dose are reported.

Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) of Durvalumab and Tremelimumab  After First Dose

Cmax,ss of durvalumab

Cmax,ss of tremelimumab

The Cmax,ss of durvalumab and tremelimumab after first dose are reported.

Cmax at Steady State (Cmax,ss) of Durvalumab and Tremelimumab

Ctrough,ss  of durvalumab

Ctrough,ss of tremelimumab

The Ctrough,ss of durvalumab and tremelimumab after first dose are reported.

Ctrough at Steady State (Ctrough,ss) of Durvalumab and Tremelimumab

Cmax.AR of durvalumab

Cmax.AR of tremelimumab

The Cmax.AR of durvalumab and tremelimumab after first dose are reported.

Cmax Accumulation Ratio (Cmax.AR) of Durvalumab and Tremelimumab

Ctrough.AR of durvalumab

Ctrough.AR of tremelimumab

The Ctrough.AR of durvalumab and tremelimumab after first dose are reported.

Ctrough Accumulation Ratio (Ctrough.AR) of Durvalumab and Tremelimumab

Any TEAEs

Any TESAEs

An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An 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. The 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 Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

Anaemia

Lymphopenia

International normalised ratio increased

Lymphocyte count decreased

Neutropenia

Neutrophil count decreased

Thrombocytopenia

Alanine aminotransferase increased

Aspartate aminotransferase increased

Gamma-glutamyltransferase increased

Blood alkaline phosphatase increased

Blood bilirubin increased

Drug-induced liver injury

Transaminases increased

Haematuria

Blood creatinine increased

Proteinuria

Hypothyroidism

Blood thyroid stimulating hormone decreased

Blood thyroid stimulating hormone increased

Hyperthyroidism

Lipase increased

Amylase increased

Hypokalaemia

Blood potassium decreased

Blood magnesium decreased

Hypercalcaemia

Hypomagnesaemia

Hyponatraemia

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

Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs

Weight decreased

Bradycardia

Hypertension

Hypotension

Orthostatic hypotension

Tachycardia

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

Number of Participants With Abnormal Vital Signs and Physical Examinations Reported as TEAEs

Myocardial infarction

Number of participants with abnormal ECG parameters reported as TEAEs are reported.

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

Number of participants with ADA positive (baseline [pre-dose on Day 1] or post baseline) to durvalumab throughout the study are reported.

The ADA evaluable population included all participants who received at least one dose of MEDI9090, and had non-missing baseline ADA and at least one non-missing post-baseline ADA results.

Number of Participants With Positive ADA to Durvalumab Throughout the Study

Number of participants with ADA positive (baseline [pre-dose on Day 1] or post baseline) to tremelimumab throughout the study are reported.

Study to Evaluate the Safety and Pharmacokinetics (PK) of MEDI9090 in Participants With 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

Investigators

Principal Investigator