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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-002040-78 | EudraCT Number |
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The proposed study is designed to examine the effects of AZD0171 and durvalumab in combination with standard-of-care chemotherapy in patients with pancreatic ductal adenocarcinoma (PDAC).
This is a Phase II, open-label, single arm, multicentre study to assess the safety, preliminary antitumour activity, immunogenicity, pharmacodynamics (PD), and pharmacokinetics (PK) of AZD0171 in combination with durvalumab and standard-of-care chemotherapy (gemcitabine and nab-paclitaxel) in participants with first line (1L) metastatic pancreatic ductal adenocarcinoma (mPDAC).
All participants will be treated until progressive disease or unacceptable toxicity or withdrawal of consent or another discontinuation criterion is met.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD0171 + Durvalumab + chemotherapy | Experimental | Participants will receive AZD0171 (intravenous [IV]) along with durvalumab (IV) in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD0171 | Drug | AZD0171 |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) | The safety and tolerability of study intervention (AZD0171, durvalumab, and standard-of-care chemotherapy) was assessed. The grading scales found in the revised National Cancer Institute CTCAE latest version was utilized for all events with an assigned CTCAE grading. Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living (ADL); Grade 4: Life-threatening, urgent intervention required; Grade 5: Death related to AE. | From Cycle 1 Day 1 (each cycle was 28 days in length) until Day 90 (post last dose of study intervention), up to 34 months |
| Overall Survival at 12 Months (OS-12) | Percentage of participants alive at 12 months after initiation of study intervention per Kaplan- Meier estimate of OS at 12 months. | At 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | The ORR is defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) that occurred prior to the initiation of subsequent anti-cancer treatment and prior to progression. The ORR was assessed per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1. | From Cycle 1 Day 1 (each cycle was 28 days in length) until initiation of subsequent anti-cancer treatment and prior to progression (up to 35 months). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | La Jolla | California | 92037 | United States | ||
| Research Site |
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| Label | URL |
|---|---|
| Redacted CSP | View source |
| Redacted CSR Synopsis | View source |
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Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.
All request will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Participants who met the inclusion criteria and none of the exclusion criteria were enrolled to the study. All the study assessments were performed as per the schedule of assessment.
The study enrolled participants across 39 sites in 4 countries. The enrollment period began on December 10, 2021, and the analyses presented in this form are based on clinical data lock date of November 16, 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | AZD0171 + Durvalumab + Chemotherapy | Participants received AZD0171 (intravenous [IV]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 3, 2024 | Oct 6, 2025 |
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| Durvalumab | Drug | Durvalumab |
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| Gemcitabine | Drug | Chemotherapy (Standard-of-Care) |
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| Nab-paclitaxel | Drug | Chemotherapy (Standard-of-Care) |
|
| Disease Control Rate (DCR) | The DCR is defined as the percentage of participants with a best overall response of confirmed CR or PR, or who had stable disease (SD) maintained for 16 weeks from first dose. DCR was assessed per RECIST v1.1 criteria. | Up to 16 weeks |
| Duration of Response (DoR) | The DoR is defined as the time from first documented objective response (confirmed CR or confirmed PR) until date of first documented disease progression or death (by any cause in the absence of disease progression). The DoR was assessed per RECIST v1.1 criteria. | From screening until disease progression or last evaluable assessment in the absence of progression, whichever came first (up to 35 months) |
| Median Progression Free Survival (PFS) | The PFS is defined as the time from first dose of study intervention until the date of objective disease progression or death (by any cause in the absence of progression), whichever was earlier. The PFS was analyzed using the Kaplan-Meier method. | From first dose of study intervention until disease progression or last evaluable assessment in the absence of progression, whichever came first (up to 35 months) |
| Progression Free Survival at 4 Months (PFS-4) | The percentage of participants alive and free of progression at 4 months per Kaplan-Meier estimate. | At 4 months |
| Median Overall Survival (OS) | The OS is defined as the time from the start of study intervention to the date of death due to any cause. | From first dose of study intervention until death (Up to 35 months) or from first dose of study intervention until last evaluable assessment (Up to 35 months) |
| Change From Baseline in Serum Levels of Carbohydrate Antigen 19-9 (CA19-9) | Mean change from baseline was assessed for serum CA19-9 | Day 1 of each Cycle through Cycle 27 (each cycle was 28 days in length), at end of treatment and at Day 28 follow up (post last dose); up to 35 months |
| Number of Participants With Positive Anti-drug Antibodies (ADAs) Against AZD0171 in Serum | Number and percentage of participants in the below categories are provided:(i)ADA positive (+ve) at baseline and/or post-baseline visits. The percentage of these participants in a population is known as ADA prevalence(ii)ADA +ve post-baseline and not detected at baseline (treatment-induced ADA positive)(iii)Treatment-boosted ADA +ve:Baseline +ve ADA titre-boosted to a 4-fold or higher level following drug administration(iv)Treatment-emergent ADA +ve:The sum of treatment-induced ADA +ve and treatment-boosted ADA +ve. The percentage of these participants in a population is known as ADA incidence(v)Persistent +ve:ADA negative (-ve) at baseline and having at least 2 post-baseline ADA +ve measurements with ≥ 16 weeks between first and last positive, or an ADA +ve result at the last available post-baseline assessment(vi)Transient +ve:ADA -ve at baseline and at least 1 post-baseline ADA +ve measurement and not fulfilling the conditions for persistently +ve. | Cycle 1 (Days 1 and 15), Cycle 2 (Days 1 and 15), until Day 90 post last dose of study intervention (each cycle is 28 days in length), assessed up to 35 months |
| Number of Participants With Positive Anti-drug Antibodies (ADAs) Against Durvalumab in Serum | Number and percentage of participants in the below categories are provided:(i)ADA positive (+ve) at baseline and/or post-baseline visits. The percentage of these participants in a population is known as ADA prevalence(ii)ADA +ve post-baseline and not detected at baseline (treatment-induced ADA positive)(iii)Treatment-boosted ADA +ve:Baseline +ve ADA titre-boosted to a 4-fold or higher level following drug administration(iv)Treatment-emergent ADA +ve:The sum of treatment-induced ADA +ve and treatment-boosted ADA +ve. The percentage of these participants in a population is known as ADA incidence(v)Persistent +ve:ADA negative (-ve) at baseline and having at least 2 post-baseline ADA +ve measurements with ≥ 16 weeks between first and last positive, or an ADA +ve result at the last available post-baseline assessment(vi)Transient +ve:ADA -ve at baseline and at least 1 post-baseline ADA +ve measurement and not fulfilling the conditions for persistently +ve. | Cycle 1 (Days 1 and 15), Cycle 2 (Days 1 and 15), until Day 90 post last dose of study intervention (each cycle is 28 days in length), assessed up to 35 months |
| Maximum Observed Plasma Concentration (Cmax) of AZD0171 | The maximum concentration of AZD0171 was determined. | Cycle 1 Day 1 and Cycle 4 Day 1 (each cycle is 28 days in length) |
| Maximum Observed Plasma Concentration (Cmax) of Nab-paclitaxel | The Cmax of Nab-paclitaxel was determined. | Cycle 1 Day 15 and Cycle 4 Day 15 (each cycle is 28 days in length) |
| Area Under Plasma Concentration-time Curve From Zero to Infinity (AUCinf) of AZD0171 | The AUCinf of AZD0171 was determined. | Cycle 1 Day 1 (each cycle is 28 days in length) |
| Area Under the Concentration-time Curve From Zero to the Last Quantifiable Concentration (AUClast) of AZD0171 | The AUClast of AZD0171 was determined. | Cycle 1 Day 1 and Cycle 4 Day 1 (each cycle is 28 days in length) |
| Area Under the Concentration-time Curve From Zero to the Last Quantifiable Concentration (AUClast) of Nab-paclitaxel | The AUClast of Nab-paclitaxel was determined. | Cycle 1 Day 15 and Cycle 4 Day 15 (each cycle is 28 days in length) |
| Area Under the Concentration-time Curve in the Dose Interval (AUCtau) of AZD0171 | The AUCtau of AZD0171 was determined. | Cycle 1 Day 1 and Cycle 4 Day 1 (each cycle is 28 days in length) |
| Area Under the Concentration-time Curve in the Dose Interval (AUCtau) of Nab-paclitaxel | The AUCtau of Nab-paclitaxel was determined. | Cycle 1 Day 15 and Cycle 4 Day 15 (each cycle is 28 days in length) |
| Clearance (CL) of AZD0171 | The CL of AZD0171 was determined. | Cycle 1 Day 1 and Cycle 4 and Day 1 (each cycle is 28 days in length) |
| Clearance (CL) of Nab-paclitaxel | The CL of Nab-paclitaxel was determined. | Cycle 1 Day 15 and Cycle 4 Day 15 (each cycle is 28 days in length) |
| Terminal Elimination Half-life (t1/2λz) of AZD0171 | The t1/2λz of AZD0171 was determined. | Cycle 1 Day 1 and Cycle 4 Day 1 (each cycle is 28 days in length) |
| Terminal Elimination Half-life (t1/2λz) of Nab-paclitaxel | The t1/2λz of Nab-paclitaxel was determined. | Cycle 1 Day 15 and Cycle 4 Day 15 (each cycle is 28 days in length) |
| Change From Screening in Cluster of Differentiation 8 (CD8+) T Cell Tumour Infiltration in Central Tumour Region | The changes in CD8+ T cell tumour infiltration (on-treatment during cycle 3 minus baseline) associated with AZD0171 treatment in combination with durvalumab and chemotherapy was assessed in participants with 1L metastatic pancreatic ductal adenocarcinoma. | In cycle 3 (each cycle was 28 days in length), subsequent to the first disease assessment scan conducted at roughly 8 weeks. |
| Serum Concentration of Total Leukaemia Inhibitory Factor (LIF) Over Time | Serum concentration of LIF bound to AZD0171 (total LIF) was assessed. | Cycle 1 Day 1 and Day 15, Cycle 2 Day 1 and Day 15, Cycle 3 Day 1 and Day 15, Cycle 4 Day 1 and Day 15, Cycle 5Day 1, Cycle 6 Day 1, Cycle 7 Day 1, Cycle 8 Day 1 and Cycle 11 Day 1 (each cycle is 28 days in length) |
| Los Angeles |
| California |
| 90025 |
| United States |
| Research Site | Orange | California | 92868 | United States |
| Research Site | Ventura | California | 93003 | United States |
| Research Site | Atlanta | Georgia | 30318 | United States |
| Research Site | Coeur d'Alene | Idaho | 83814 | United States |
| Research Site | Boston | Massachusetts | 02114 | United States |
| Research Site | Ann Arbor | Michigan | 48109 | United States |
| Research Site | Grand Rapids | Michigan | 49503 | United States |
| Research Site | Buffalo | New York | 14263 | United States |
| Research Site | New York | New York | 10065 | United States |
| Research Site | Portland | Oregon | 97239 | United States |
| Research Site | San Antonio | Texas | 78229 | United States |
| Research Site | Charlottesville | Virginia | 22908 | United States |
| Research Site | Seattle | Washington | 98195 | United States |
| Research Site | Madison | Wisconsin | 53792 | United States |
| Research Site | Barrie | Ontario | L4M 6M2 | Canada |
| Research Site | Toronto | Ontario | M4N 3M5 | Canada |
| Research Site | Toronto | Ontario | M5G 2M9 | Canada |
| Research Site | Seongnam-si | 13620 | South Korea |
| Research Site | Seongnam-si | 463-712 | South Korea |
| Research Site | Seoul | 03080 | South Korea |
| Research Site | Seoul | 03722 | South Korea |
| Research Site | Seoul | 05505 | South Korea |
| Research Site | Seoul | 06351 | South Korea |
| Research Site | Seoul | 06591 | South Korea |
| Research Site | Badalona | 08916 | Spain |
| Research Site | Barcelona | 08035 | Spain |
| Research Site | Madrid | 28027 | Spain |
| Research Site | Madrid | 28034 | Spain |
| Research Site | Madrid | 28041 | Spain |
| Research Site | Madrid | 28050 | Spain |
| Research Site | Majadahonda | 28222 | Spain |
| Research Site | Pamplona | 31008 | Spain |
| Redacted SAP | View source |
| COMPLETED |
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| NOT COMPLETED |
|
|
Intent-to-treat (ITT) set, which included all participants who received any dose of study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | AZD0171 + Durvalumab + Chemotherapy | Participants received AZD0171 (intravenous [IV]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) | The safety and tolerability of study intervention (AZD0171, durvalumab, and standard-of-care chemotherapy) was assessed. The grading scales found in the revised National Cancer Institute CTCAE latest version was utilized for all events with an assigned CTCAE grading. Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living (ADL); Grade 4: Life-threatening, urgent intervention required; Grade 5: Death related to AE. | Safety set, which included all participants who received any amount of study treatment. As specified in the below data table, in the row entitled, 'Any AE leading to dose reduction of AZD0171', one participant had recorded one reduced dose event of AZD0171 by error. This event was not a dose reduction; but, the study treatment was interrupted due to an AE of infusion related reaction, therefore only partial dose was administered. | Posted | Count of Participants | Participants | From Cycle 1 Day 1 (each cycle was 28 days in length) until Day 90 (post last dose of study intervention), up to 34 months |
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| Primary | Overall Survival at 12 Months (OS-12) | Percentage of participants alive at 12 months after initiation of study intervention per Kaplan- Meier estimate of OS at 12 months. | The ITT set, which included all participants who received any dose of study treatment. | Posted | Number | 80% Confidence Interval | Percentage | At 12 months |
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| Secondary | Objective Response Rate (ORR) | The ORR is defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) that occurred prior to the initiation of subsequent anti-cancer treatment and prior to progression. The ORR was assessed per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1. | Response Evaluable Set (RES), which included all participants who had measurable disease at baseline. | Posted | Number | 80% Confidence Interval | Percentage | From Cycle 1 Day 1 (each cycle was 28 days in length) until initiation of subsequent anti-cancer treatment and prior to progression (up to 35 months). |
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| Secondary | Disease Control Rate (DCR) | The DCR is defined as the percentage of participants with a best overall response of confirmed CR or PR, or who had stable disease (SD) maintained for 16 weeks from first dose. DCR was assessed per RECIST v1.1 criteria. | The ITT set, which included all participants who received any dose of study treatment. | Posted | Number | 80% Confidence Interval | Percentage | Up to 16 weeks |
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| Secondary | Duration of Response (DoR) | The DoR is defined as the time from first documented objective response (confirmed CR or confirmed PR) until date of first documented disease progression or death (by any cause in the absence of disease progression). The DoR was assessed per RECIST v1.1 criteria. | The ITT set, which included all participants who received any dose of study treatment. | Posted | Median | 80% Confidence Interval | Months | From screening until disease progression or last evaluable assessment in the absence of progression, whichever came first (up to 35 months) |
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| Secondary | Median Progression Free Survival (PFS) | The PFS is defined as the time from first dose of study intervention until the date of objective disease progression or death (by any cause in the absence of progression), whichever was earlier. The PFS was analyzed using the Kaplan-Meier method. | The ITT set, which included all participants who received any dose of study treatment. | Posted | Median | 80% Confidence Interval | Months | From first dose of study intervention until disease progression or last evaluable assessment in the absence of progression, whichever came first (up to 35 months) |
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| Secondary | Progression Free Survival at 4 Months (PFS-4) | The percentage of participants alive and free of progression at 4 months per Kaplan-Meier estimate. | The ITT set, which included all participants who received any dose of study treatment. | Posted | Number | 80% Confidence Interval | Percentage | At 4 months |
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| Secondary | Median Overall Survival (OS) | The OS is defined as the time from the start of study intervention to the date of death due to any cause. | The ITT set, which included all participants who received any dose of study treatment. | Posted | Median | 80% Confidence Interval | Months | From first dose of study intervention until death (Up to 35 months) or from first dose of study intervention until last evaluable assessment (Up to 35 months) |
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| Secondary | Change From Baseline in Serum Levels of Carbohydrate Antigen 19-9 (CA19-9) | Mean change from baseline was assessed for serum CA19-9 | The Pharmacodynamic (PD) set, which included all participants who received any amount of study treatment with at least one reportable PD measurement. The number analyzed "n" refers to the number of participants included in analysis in specific time points. | Posted | Mean | Standard Deviation | Units/milliliter (U/mL) | Day 1 of each Cycle through Cycle 27 (each cycle was 28 days in length), at end of treatment and at Day 28 follow up (post last dose); up to 35 months |
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| Secondary | Number of Participants With Positive Anti-drug Antibodies (ADAs) Against AZD0171 in Serum | Number and percentage of participants in the below categories are provided:(i)ADA positive (+ve) at baseline and/or post-baseline visits. The percentage of these participants in a population is known as ADA prevalence(ii)ADA +ve post-baseline and not detected at baseline (treatment-induced ADA positive)(iii)Treatment-boosted ADA +ve:Baseline +ve ADA titre-boosted to a 4-fold or higher level following drug administration(iv)Treatment-emergent ADA +ve:The sum of treatment-induced ADA +ve and treatment-boosted ADA +ve. The percentage of these participants in a population is known as ADA incidence(v)Persistent +ve:ADA negative (-ve) at baseline and having at least 2 post-baseline ADA +ve measurements with ≥ 16 weeks between first and last positive, or an ADA +ve result at the last available post-baseline assessment(vi)Transient +ve:ADA -ve at baseline and at least 1 post-baseline ADA +ve measurement and not fulfilling the conditions for persistently +ve. | Immunogenicity set, which included all participants who received at least one dose of investigational product (IP) with at least one reportable immunogenicity assessment. The number analyzed "n" refers to the number of participants included in analysis of specific ADA category as mentioned below, [a] Participants with ADA result at baseline and/or post-baseline [b] Participants with ADA result at baseline and ≥1 post-baseline [c] Participants with ADA result at baseline only. | Posted | Count of Participants | Participants | Cycle 1 (Days 1 and 15), Cycle 2 (Days 1 and 15), until Day 90 post last dose of study intervention (each cycle is 28 days in length), assessed up to 35 months |
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| Secondary | Number of Participants With Positive Anti-drug Antibodies (ADAs) Against Durvalumab in Serum | Number and percentage of participants in the below categories are provided:(i)ADA positive (+ve) at baseline and/or post-baseline visits. The percentage of these participants in a population is known as ADA prevalence(ii)ADA +ve post-baseline and not detected at baseline (treatment-induced ADA positive)(iii)Treatment-boosted ADA +ve:Baseline +ve ADA titre-boosted to a 4-fold or higher level following drug administration(iv)Treatment-emergent ADA +ve:The sum of treatment-induced ADA +ve and treatment-boosted ADA +ve. The percentage of these participants in a population is known as ADA incidence(v)Persistent +ve:ADA negative (-ve) at baseline and having at least 2 post-baseline ADA +ve measurements with ≥ 16 weeks between first and last positive, or an ADA +ve result at the last available post-baseline assessment(vi)Transient +ve:ADA -ve at baseline and at least 1 post-baseline ADA +ve measurement and not fulfilling the conditions for persistently +ve. | Immunogenicity set, which included all participants who received at least one dose of IP with at least one reportable immunogenicity assessment. The number analyzed "n" refers to the number of participants included in analysis of specific ADA category as mentioned below, [a] Number of participants with ADA result at baseline and/or post-baseline [b] Number of participants with ADA result at baseline and ≥1 post-baseline [c] Number of participants with ADA result at baseline only. | Posted | Count of Participants | Participants | Cycle 1 (Days 1 and 15), Cycle 2 (Days 1 and 15), until Day 90 post last dose of study intervention (each cycle is 28 days in length), assessed up to 35 months |
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| Secondary | Maximum Observed Plasma Concentration (Cmax) of AZD0171 | The maximum concentration of AZD0171 was determined. | The PK set which included all participants who received any amount of study treatment with at least one reportable PK measurement. The number analyzed, 'n', refers to participants with intensive PK sampling at specific time points, who were included in the noncompartmental analysis (NCA). Additional population PK/PK analyses are available under reference: 39041713. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram/mililiter (ug/mL) | Cycle 1 Day 1 and Cycle 4 Day 1 (each cycle is 28 days in length) |
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| Secondary | Maximum Observed Plasma Concentration (Cmax) of Nab-paclitaxel | The Cmax of Nab-paclitaxel was determined. | The PK set which included all participants who received any amount of study treatment with at least one reportable PK measurement. The number analyzed, 'n', refers to participants with intensive PK sampling at specific time points, who were included in the NCA. Additional population PK/PK analyses are available under reference: 39041713. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram/mililiter (ng/ml) | Cycle 1 Day 15 and Cycle 4 Day 15 (each cycle is 28 days in length) |
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| Secondary | Area Under Plasma Concentration-time Curve From Zero to Infinity (AUCinf) of AZD0171 | The AUCinf of AZD0171 was determined. | The PK set which included all participants who received any amount of study treatment with at least one reportable PK measurement. The number analyzed, 'n', refers to participants with intensive PK sampling at specific time points, who were included in the NCA. Additional population PK/PK analyses are available under reference: 39041713. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ug/mL | Cycle 1 Day 1 (each cycle is 28 days in length) |
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| Secondary | Area Under the Concentration-time Curve From Zero to the Last Quantifiable Concentration (AUClast) of AZD0171 | The AUClast of AZD0171 was determined. | The PK set which included all participants who received any amount of study treatment with at least one reportable PK measurement. The number analyzed, 'n', refers to participants with intensive PK sampling at specific time points, who were included in the NCA. Additional population PK/PK analyses are available under reference: 39041713. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ug/mL | Cycle 1 Day 1 and Cycle 4 Day 1 (each cycle is 28 days in length) |
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| Secondary | Area Under the Concentration-time Curve From Zero to the Last Quantifiable Concentration (AUClast) of Nab-paclitaxel | The AUClast of Nab-paclitaxel was determined. | The PK set which included all participants who received any amount of study treatment with at least one reportable PK measurement. The number analyzed, 'n', refers to participants with intensive PK sampling at specific time points, who were included in the NCA. Additional population PK/PK analyses are available under reference: 39041713. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour*nanogram/milliliter (h*ng/mL) | Cycle 1 Day 15 and Cycle 4 Day 15 (each cycle is 28 days in length) |
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| Secondary | Area Under the Concentration-time Curve in the Dose Interval (AUCtau) of AZD0171 | The AUCtau of AZD0171 was determined. | The PK set which included all participants who received any amount of study treatment with at least one reportable PK measurement. The number analyzed, 'n', refers to participants with intensive PK sampling at specific time points, who were included in the NCA. Additional population PK/PK analyses are available under reference: 39041713. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour*microgram/milliliter (h*ug/mL) | Cycle 1 Day 1 and Cycle 4 Day 1 (each cycle is 28 days in length) |
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| Secondary | Area Under the Concentration-time Curve in the Dose Interval (AUCtau) of Nab-paclitaxel | The AUCtau of Nab-paclitaxel was determined. | The PK set which included all participants who received any amount of study treatment with at least one reportable PK measurement. The number analyzed, 'n', refers to participants with intensive PK sampling at specific time points, who were included in the NCA. Additional population PK/PK analyses are available under reference: 39041713. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour*nanogram/milliliter (h*ng/mL) | Cycle 1 Day 15 and Cycle 4 Day 15 (each cycle is 28 days in length) |
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| Secondary | Clearance (CL) of AZD0171 | The CL of AZD0171 was determined. | The PK set which included all participants who received any amount of study treatment with at least one reportable PK measurement. The number analyzed, 'n', refers to participants with intensive PK sampling at specific time points, who were included in the NCA. Additional population PK/PK analyses are available under reference: 39041713. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter/hour (L/h) | Cycle 1 Day 1 and Cycle 4 and Day 1 (each cycle is 28 days in length) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Clearance (CL) of Nab-paclitaxel | The CL of Nab-paclitaxel was determined. | PK set which included all participants who received any amount of study treatment with at least one reportable PK measurement. The number analyzed, 'n', refers to participants with intensive PK sampling at specific time points, who were included in the NCA. Additional population PK/PK analyses are available under reference: 39041713. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter/hour/meter square (L/h/m**2) | Cycle 1 Day 15 and Cycle 4 Day 15 (each cycle is 28 days in length) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Terminal Elimination Half-life (t1/2λz) of AZD0171 | The t1/2λz of AZD0171 was determined. | The PK set which included all participants who received any amount of study treatment with at least one reportable PK measurement. The number analyzed, 'n', refers to participants with intensive PK sampling at specific time points, who were included in the NCA. Additional population PK/PK analyses are available under reference: 39041713. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours | Cycle 1 Day 1 and Cycle 4 Day 1 (each cycle is 28 days in length) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Terminal Elimination Half-life (t1/2λz) of Nab-paclitaxel | The t1/2λz of Nab-paclitaxel was determined. | The PK set which included all participants who received any amount of study treatment with at least one reportable PK measurement. The number analyzed, 'n', refers to participants with intensive PK sampling at specific time points, who were included in the NCA. Additional population PK/PK analyses are available under reference: 39041713. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours | Cycle 1 Day 15 and Cycle 4 Day 15 (each cycle is 28 days in length) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Screening in Cluster of Differentiation 8 (CD8+) T Cell Tumour Infiltration in Central Tumour Region | The changes in CD8+ T cell tumour infiltration (on-treatment during cycle 3 minus baseline) associated with AZD0171 treatment in combination with durvalumab and chemotherapy was assessed in participants with 1L metastatic pancreatic ductal adenocarcinoma. | The PD set, which included all participants who received any amount of study treatment with at least one reportable PD measurement. The number analyzed "n" refers to the number of participants included in analysis in specific time points. | Posted | Mean | Standard Deviation | Cells/millimeter square | In cycle 3 (each cycle was 28 days in length), subsequent to the first disease assessment scan conducted at roughly 8 weeks. |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Serum Concentration of Total Leukaemia Inhibitory Factor (LIF) Over Time | Serum concentration of LIF bound to AZD0171 (total LIF) was assessed. | The PD set, which included all participants who received any amount of study treatment with at least one reportable PD measurement. The number analyzed, 'n', refers to participants with intensive PK sampling at specific time points, who were included in the NCA. Additional population PK/PK analyses are available under reference: 39041713. | Posted | Geometric Mean | Geometric Coefficient of Variation | picogram/millilitre (pg/mL) | Cycle 1 Day 1 and Day 15, Cycle 2 Day 1 and Day 15, Cycle 3 Day 1 and Day 15, Cycle 4 Day 1 and Day 15, Cycle 5Day 1, Cycle 6 Day 1, Cycle 7 Day 1, Cycle 8 Day 1 and Cycle 11 Day 1 (each cycle is 28 days in length) |
|
|
From Cycle 1 Day 1 (each cycle was 28 days in length) until Day 90 (post last dose of study intervention), up to 34 months.
All adverse events during the trial are reported.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AZD0171 + Durvalumab + Chemotherapy | Participants received AZD0171 (intravenous [IV]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first. | 76 | 126 | 72 | 126 | 126 | 126 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Duodenal obstruction | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Gastritis erosive | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Small intestinal haemorrhage | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Acute hepatic failure | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Biliary obstruction | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cholangitis acute | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Immune-mediated hepatitis | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Appendicitis perforated | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Biliary tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Catheter site infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Haemophilus infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Hepatic infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Liver abscess | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Necrotising fasciitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pancreatic abscess | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Left ventricular failure | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Toxic encephalopathy | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Immune-mediated lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Drug reaction with eosinophilia and systemic symptoms | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypertensive urgency | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA 27.1 | Non-systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA 27.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.1 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Neurotoxicity | Nervous system disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 27.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 27.1 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 27.1 | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 27.1 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 27.1 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 27.1 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 27.1 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 27.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 27.1 | Non-systematic Assessment |
|
No unpublished information may be disclosed without prior written approval from AstraZeneca.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Lead | AstraZeneca | 1-877-240-9479 | information.center@astrazeneca.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 26, 2024 | Oct 6, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| C000613593 | durvalumab |
| D000093542 | Gemcitabine |
| C520255 | 130-nm albumin-bound paclitaxel |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided
| American Indian or Alaska Native |
|
| Asian |
|
| White |
|
| Other |
|
| Not Reported |
|
| Unknown |
|
| Missing |
|
| Title | Measurements |
|---|---|
|
| Any AE possibly related to Durvalumab |
|
| Any AE possibly related to Nab-paclitaxel |
|
| Any AE possibly related to Gemcitabine |
|
| Any AE of >= Common Terminology Criteria for Adverse Events (CTCAE) grade 3 |
|
| Any AE of >= CTCAE grade 3, possibly related to treatment |
|
| Any AE of >= CTCAE grade 3, possibly related to AZD0171 |
|
| Any AE of >= CTCAE grade 3, possibly related to Durvalumab |
|
| Any AE of >= CTCAE grade 3, possibly related to Nab-paclitaxel |
|
| Any AE of >= CTCAE grade 3, possibly related to Gemcitabine |
|
| Any SAE (Serious Adverse Event) |
|
| Any SAE possibly related to treatment |
|
| Any SAE possibly related to AZD0171 |
|
| Any SAE possibly related to Durvalumab |
|
| Any SAE possibly related to Nab-paclitaxel |
|
| Any SAE possibly related to Gemcitabine |
|
| Any SAE of >= CTCAE grade 3 |
|
| Any SAE of >= CTCAE grade 3, possibly related to treatment |
|
| Any SAE of >= CTCAE grade 3, possibly related to AZD0171 |
|
| Any SAE of >= CTCAE grade 3, possibly related to Durvalumab |
|
| Any SAE of >= CTCAE grade 3, possibly related to Nab-paclitaxel |
|
| Any SAE of >= CTCAE grade 3, possibly related to Gemcitabine |
|
| Any SAE with outcome death |
|
| Any SAE with outcome death, possibly related to treatment |
|
| Any SAE with outcome death, possibly related to AZD0171 |
|
| Any SAE with outcome death, possibly related to Durvalumab |
|
| Any SAE with outcome death, possibly related to Nab-paclitaxel |
|
| Any SAE with outcome death, possibly related to Gemcitabine |
|
| Any AE leading to discontinuation of treatment |
|
| Any AE leading to discontinuation of AZD0171 |
|
| Any AE leading to discontinuation of Durvalumab |
|
| Any AE leading to discontinuation of Nab-paclitaxel |
|
| Any AE leading to discontinuation of Gemcitabine |
|
| Any AE leading to discontinuation of treatment, possibly related to treatment |
|
| Any AE leading to discontinuation of AZD0171, possibly related to AZD0171 |
|
| Any AE leading to discontinuation of Durvalumab, possibly related to Durvalumab |
|
| Any AE leading to discontinuation of Nab-paclitaxel, possibly related to Nab-paclitaxel |
|
| Any AE leading to discontinuation of Gemcitabine, possibly related to Gemcitabine |
|
| Any AE leading to drug interruption of treatment |
|
| Any AE leading to drug interruption of AZD0171 |
|
| Any AE leading to drug interruption of Durvalumab |
|
| Any AE leading to drug interruption of Nab-paclitaxel |
|
| Any AE leading to drug interruption of Gemcitabine |
|
| Any AE leading to dose reduction of treatment |
|
| Any AE leading to dose reduction of AZD0171 |
|
| Any AE leading to dose reduction of Durvalumab |
|
| Any AE leading to dose reduction of Nab-paclitaxel |
|
| Any AE leading to dose reduction of Gemcitabine |
|
| Any AE leading to dose modification of treatment |
|
| Any AE leading to dose modification of AZD0171 |
|
| Any AE leading to dose modification of Durvalumab |
|
| Any AE leading to dose modification of Nab-paclitaxel |
|
| Any AE leading to dose modification of Gemcitabine |
|
| Any SAE leading to discontinuation of treatment |
|
| Any SAE leading to discontinuation of AZD0171 |
|
| Any SAE leading to discontinuation of Durvalumab |
|
| Any SAE leading to discontinuation of Nab-paclitaxel |
|
| Any SAE leading to discontinuation of Gemcitabine |
|
| Any SAE leading to discontinuation of treatment, possibly related to treatment |
|
| Any SAE leading to discontinuation of AZD0171, possibly related to AZD0171 |
|
| Any SAE leading to discontinuation of Durvalumab, possibly related to Durvalumab |
|
| Any SAE leading to discontinuation of Nab-paclitaxel, possibly related to Nab-paclitaxel |
|
| Any SAE leading to discontinuation of Gemcitabine, possibly related to Gemcitabine |
|
| Any SAE leading to drug interruption of treatment |
|
| Any SAE leading to drug interruption of AZD0171 |
|
| Any SAE leading to drug interruption of Durvalumab |
|
| Any SAE leading to drug interruption of Nab-paclitaxel |
|
| Any SAE leading to drug interruption of Gemcitabine |
|
| Any SAE leading to dose reduction of treatment |
|
| Any SAE leading to dose reduction of AZD0171 |
|
| Any SAE leading to dose reduction of Durvalumab |
|
| Any SAE leading to dose reduction of Nab-paclitaxel |
|
| Any SAE leading to dose reduction of Gemcitabine |
|
| Any SAE leading to dose modification of treatment |
|
| Any SAE leading to dose modification of AZD0171 |
|
| Any SAE leading to dose modification of Durvalumab |
|
| Any SAE leading to dose modification of Nab-paclitaxel |
|
| Any SAE leading to dose modification of Gemcitabine |
|
| Any SAE leading to hospitalisation |
|
| Any immune mediated AEs |
|
| Any infusion reaction AEs |
|
|
|
|
|
|
|
|
|
Participants received AZD0171 (intravenous [IV]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first. |
|
|
Participants received AZD0171 (intravenous [IV]) along with durvalumab IV in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel) until disease progression, death, lost to follow-up or consent withdrawal which ever occurred first. |
|
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