Back to resultsDurvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1) (TOPAZ-1)
Primary Purpose
Biliary Tract Neoplasms
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Durvalumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Biliary Tract Neoplasms focused on measuring First-Line Advanced Biliary Tract Cancers (BTC), Durvalumab, Gemcitabine/Cisplatin, Placebo
Eligibility Criteria
Inclusion
- Histologically confirmed, unresectable advanced or metastatic biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma.
- Patients with preciously untreated disease if unresectable or metastatic at initial diagnosis will be eligible.
- Patient with recurrent disease >6 months after curative surgery or >6 months after the completion of adjuvant therapy (chemotherapy and/or radiation) will be eligible.
- WHO/ECOG PS of 0 or 1
Exclusion
- History of another primary malignancy
- Brain metastases or spinal cord compression
- Uncontrolled intercurrent illness
- Major surgical procedure within 28 days prior to the first dose of IP.
- Prior locoregional therapy such as radioembolization
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment Arm
Placebo Arm
Arm Description
Durvalumab + Gemcitabine + Cisplatin
Placebo + Gemcitabine + Cisplatin
Outcomes
Primary Outcome Measures
Overall Survival (OS)
Overall Survival (OS) was defined as the time from the date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. The second interim analysis was pre-specified after approximately 397 OS events occurred in both arms (59% maturity).
Overall Survival (OS) Rate at 18 Months
Overall Survival (OS) was defined as the time from the date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. The second interim analysis was pre-specified after approximately 397 OS events occurred in both arms (59% maturity).
Overall Survival (OS) Rate at 24 Months
Overall Survival (OS) was defined as the time from the date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. The second interim analysis was pre-specified after approximately 397 OS events occurred in both arms (59% maturity).
Secondary Outcome Measures
Progression-free Survival (PFS)
PFS based on investigator assessments according to RECIST version 1.1 was defined as time from date of randomization until date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression. Progression (i.e., PD) was defined as at least a 20% increase in the sum of diameters of target lesions (TLs) and an absolute increase of ≥5mm, taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters, or a measurable increase in a non-target lesion, or the appearance of new lesions. Median PFS was calculated using the Kaplan-Meier technique.
Progression-free Survival (PFS) Rate at 9 Months
PFS based on investigator assessments according to RECIST version 1.1 was defined as time from date of randomization until date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression. Progression (i.e., PD) was defined as at least a 20% increase in the sum of diameters of target lesions (TLs) and an absolute increase of ≥5mm, taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters, or a measurable increase in a non-target lesion, or the appearance of new lesions. Median PFS was calculated using the Kaplan-Meier technique.
Progression-free Survival (PFS) Rate at 12 Months
PFS based on investigator assessments according to RECIST version 1.1 was defined as time from date of randomization until date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression. Progression (i.e., PD) was defined as at least a 20% increase in the sum of diameters of target lesions (TLs) and an absolute increase of ≥5mm, taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters, or a measurable increase in a non-target lesion, or the appearance of new lesions. Median PFS was calculated using the Kaplan-Meier technique.
Objective Response Rate (ORR)
Disease assessments based on investigator assessments were determined by using RECIST version 1.1 guidelines. The ORR was defined as the percentage of patients with confirmed complete response (CR) or confirmed partial response (PR). The CR was defined as disappearance of all target and non-target lesions and no new lesions. The PR was defined as >= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new non-target lesion. A confirmed CR or PR was defined as 2 CRs or 2 PRs with no evidence of progression in-between. Patients who discontinued randomized treatment without progression, received a subsequent anti-cancer therapy and then responded were not included as responders for ORR.
Duration of Response (DoR)
The DoR was defined as the time from the date of first documented OR (confirmed CR or confirmed PR) until date of documented progression (PD) based on investigator assessments by using RECIST version 1.1 or death in absence of disease progression (i.e. date of PFS event or censoring - date of first response + 1) . A confirmed CR was defined in above outcome measures. The PD was defined at least 20% increase in sum of diameters of target lesions (compared with nadir at 2 consecutive visits with an absolute increase of 5 mm), unequivocal progression of existing non-target lesions or new lesion. For participants who were alive and no documented PD at the time of data cutoff for analysis, DoR was censored at the last evaluable disease assessment date. Median DoR was calculated using Kaplan-Meier method.
Duration of Response (DoR): Percentage Remaining in Response at 9 Months
The DoR was defined as the time from the date of first documented OR (confirmed CR or confirmed PR) until date of documented progression (PD) based on investigator assessments by using RECIST version 1.1 or death in absence of disease progression (i.e. date of PFS event or censoring - date of first response + 1) . A confirmed CR was defined in above outcome measures. The PD was defined at least 20% increase in sum of diameters of target lesions (compared with nadir at 2 consecutive visits with an absolute increase of 5 mm), unequivocal progression of existing non-target lesions or new lesion. For participants who were alive and no documented PD at the time of data cutoff for analysis, DoR was censored at the last evaluable disease assessment date. Median DoR was calculated using Kaplan-Meier method.
Duration of Response (DoR): Percentage Remaining in Response at 12 Months
The DoR was defined as the time from the date of first documented OR (confirmed CR or confirmed PR) until date of documented progression (PD) based on investigator assessments by using RECIST version 1.1 or death in absence of disease progression (i.e. date of PFS event or censoring - date of first response + 1) . A confirmed CR was defined in above outcome measures. The PD was defined at least 20% increase in sum of diameters of target lesions (compared with nadir at 2 consecutive visits with an absolute increase of 5 mm), unequivocal progression of existing non-target lesions or new lesion. For participants who were alive and no documented PD at the time of data cutoff for analysis, DoR was censored at the last evaluable disease assessment date. Median DoR was calculated using Kaplan-Meier method.
Disease Control Rate (DCR) - Overall
Disease control rate based on investigator assessments according to RECIST version 1.1 was defined as the rate of best objective response of complete response (CR), partial response (PR) or stable disease (SD).
Disease Control Rate (DCR) - 24 Weeks
Disease control rate based on investigator assessments according to RECIST version 1.1 was defined as the rate of best objective response of complete response (CR) or partial response (PR) by week 24 or who have stable disease (SD) at least 24 weeks following start of treatment.
Disease Control Rate (DCR) - 32 Weeks
Disease control rate based on investigator assessments according to RECIST version 1.1 was defined as the rate of best objective response of complete response (CR) or partial response (PR) by week 32 or who have stable disease (SD) at least 32 weeks following start of treatment.
Disease Control Rate (DCR) - 48 Weeks
Disease control rate based on investigator assessments according to RECIST version 1.1 was defined as the rate of best objective response of complete response (CR) or partial response (PR) by week 48 or who have stable disease (SD) at least 48 weeks following start of treatment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03875235
Brief Title
Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1)
Acronym
TOPAZ-1
Official Title
A Phase III Randomized, Double-Blind Placebo Controlled, Multi-Regional, International Study of Durvalumab in Combination With Gemcitabine Plus Cisplatin Versus Placebo in Combination With Gemcitabine Plus Cisplatin for Patients With First-Line Advanced Biliary Tract Cancers
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 16, 2019 (Actual)
Primary Completion Date
August 11, 2021 (Actual)
Study Completion Date
March 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1)
Detailed Description
A Phase III Randomized, Double-Blind Placebo Controlled, Multi-Regional, International Study of Durvalumab in Combination with Gemcitabine Plus Cisplatin Versus Placebo in Combination with Gemcitabine Plus Cisplatin for Patients With First-Line Advanced Biliary Tract Cancers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Tract Neoplasms
Keywords
First-Line Advanced Biliary Tract Cancers (BTC), Durvalumab, Gemcitabine/Cisplatin, Placebo
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Durvalumab in Combination with Gemcitabine plus Cisplatin Placebo in Combination with Gemcitabine plus Cisplatin
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
810 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
Durvalumab + Gemcitabine + Cisplatin
Arm Title
Placebo Arm
Arm Type
Placebo Comparator
Arm Description
Placebo + Gemcitabine + Cisplatin
Intervention Type
Drug
Intervention Name(s)
Durvalumab
Intervention Description
IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
Overall Survival (OS) was defined as the time from the date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. The second interim analysis was pre-specified after approximately 397 OS events occurred in both arms (59% maturity).
Time Frame
From date of randomization until death due to any cause. Assessed up to maximum of approximately 27 months (from date of randomization to primary analysis data cut-off)
Title
Overall Survival (OS) Rate at 18 Months
Description
Overall Survival (OS) was defined as the time from the date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. The second interim analysis was pre-specified after approximately 397 OS events occurred in both arms (59% maturity).
Time Frame
From date of randomization until death due to any cause. Calculated at 18 months using the Kaplan-Meier technique.
Title
Overall Survival (OS) Rate at 24 Months
Description
Overall Survival (OS) was defined as the time from the date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. The second interim analysis was pre-specified after approximately 397 OS events occurred in both arms (59% maturity).
Time Frame
From date of randomization until death due to any cause. Calculated at 24 months using the Kaplan-Meier technique.
Secondary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Description
PFS based on investigator assessments according to RECIST version 1.1 was defined as time from date of randomization until date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression. Progression (i.e., PD) was defined as at least a 20% increase in the sum of diameters of target lesions (TLs) and an absolute increase of ≥5mm, taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters, or a measurable increase in a non-target lesion, or the appearance of new lesions. Median PFS was calculated using the Kaplan-Meier technique.
Time Frame
Tumor assessments every 6 weeks after randomization for the first 24 weeks and then every 8 weeks thereafter until date of RECIST 1.1 defined radiological progressive disease or death. Assessed up to maximum of approximately 27 months.
Title
Progression-free Survival (PFS) Rate at 9 Months
Description
PFS based on investigator assessments according to RECIST version 1.1 was defined as time from date of randomization until date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression. Progression (i.e., PD) was defined as at least a 20% increase in the sum of diameters of target lesions (TLs) and an absolute increase of ≥5mm, taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters, or a measurable increase in a non-target lesion, or the appearance of new lesions. Median PFS was calculated using the Kaplan-Meier technique.
Time Frame
Tumor assessments every 6 weeks after randomization for the first 24 weeks and then every 8 weeks thereafter until date of RECIST 1.1 defined radiological progressive disease or death. Calculated at 9 months using the Kaplan-Meier technique.
Title
Progression-free Survival (PFS) Rate at 12 Months
Description
PFS based on investigator assessments according to RECIST version 1.1 was defined as time from date of randomization until date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression. Progression (i.e., PD) was defined as at least a 20% increase in the sum of diameters of target lesions (TLs) and an absolute increase of ≥5mm, taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters, or a measurable increase in a non-target lesion, or the appearance of new lesions. Median PFS was calculated using the Kaplan-Meier technique.
Time Frame
Tumor assessments every 6 weeks after randomization for the first 24 weeks and then every 8 weeks thereafter until date of RECIST 1.1 defined radiological progressive disease or death. Calculated at 12 months using the Kaplan-Meier technique
Title
Objective Response Rate (ORR)
Description
Disease assessments based on investigator assessments were determined by using RECIST version 1.1 guidelines. The ORR was defined as the percentage of patients with confirmed complete response (CR) or confirmed partial response (PR). The CR was defined as disappearance of all target and non-target lesions and no new lesions. The PR was defined as >= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new non-target lesion. A confirmed CR or PR was defined as 2 CRs or 2 PRs with no evidence of progression in-between. Patients who discontinued randomized treatment without progression, received a subsequent anti-cancer therapy and then responded were not included as responders for ORR.
Time Frame
Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization and then every 8 weeks thereafter. Assessed up to maximum of approximately 27 months.
Title
Duration of Response (DoR)
Description
The DoR was defined as the time from the date of first documented OR (confirmed CR or confirmed PR) until date of documented progression (PD) based on investigator assessments by using RECIST version 1.1 or death in absence of disease progression (i.e. date of PFS event or censoring - date of first response + 1) . A confirmed CR was defined in above outcome measures. The PD was defined at least 20% increase in sum of diameters of target lesions (compared with nadir at 2 consecutive visits with an absolute increase of 5 mm), unequivocal progression of existing non-target lesions or new lesion. For participants who were alive and no documented PD at the time of data cutoff for analysis, DoR was censored at the last evaluable disease assessment date. Median DoR was calculated using Kaplan-Meier method.
Time Frame
Tumor assessments (per RECIST 1.1) every 6 weeks for first 24 weeks relative to the date of randomization and then every 8 weeks thereafter. Assessed up to maximum of approximately 27 months.
Title
Duration of Response (DoR): Percentage Remaining in Response at 9 Months
Description
The DoR was defined as the time from the date of first documented OR (confirmed CR or confirmed PR) until date of documented progression (PD) based on investigator assessments by using RECIST version 1.1 or death in absence of disease progression (i.e. date of PFS event or censoring - date of first response + 1) . A confirmed CR was defined in above outcome measures. The PD was defined at least 20% increase in sum of diameters of target lesions (compared with nadir at 2 consecutive visits with an absolute increase of 5 mm), unequivocal progression of existing non-target lesions or new lesion. For participants who were alive and no documented PD at the time of data cutoff for analysis, DoR was censored at the last evaluable disease assessment date. Median DoR was calculated using Kaplan-Meier method.
Time Frame
Tumor assessments (per RECIST 1.1) every 6 weeks for first 24 weeks relative to the date of randomization and then every 8 weeks thereafter. Calculated at 9 months using the Kaplan-Meier technique
Title
Duration of Response (DoR): Percentage Remaining in Response at 12 Months
Description
The DoR was defined as the time from the date of first documented OR (confirmed CR or confirmed PR) until date of documented progression (PD) based on investigator assessments by using RECIST version 1.1 or death in absence of disease progression (i.e. date of PFS event or censoring - date of first response + 1) . A confirmed CR was defined in above outcome measures. The PD was defined at least 20% increase in sum of diameters of target lesions (compared with nadir at 2 consecutive visits with an absolute increase of 5 mm), unequivocal progression of existing non-target lesions or new lesion. For participants who were alive and no documented PD at the time of data cutoff for analysis, DoR was censored at the last evaluable disease assessment date. Median DoR was calculated using Kaplan-Meier method.
Time Frame
Tumor assessments (per RECIST 1.1) every 6 weeks for first 24 weeks relative to the date of randomization and then every 8 weeks thereafter. Calculated at 12 months using the Kaplan-Meier technique
Title
Disease Control Rate (DCR) - Overall
Description
Disease control rate based on investigator assessments according to RECIST version 1.1 was defined as the rate of best objective response of complete response (CR), partial response (PR) or stable disease (SD).
Time Frame
Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization and then every 8 weeks thereafter. Assessed up to maximum of approximately 27 months.
Title
Disease Control Rate (DCR) - 24 Weeks
Description
Disease control rate based on investigator assessments according to RECIST version 1.1 was defined as the rate of best objective response of complete response (CR) or partial response (PR) by week 24 or who have stable disease (SD) at least 24 weeks following start of treatment.
Time Frame
Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization.
Title
Disease Control Rate (DCR) - 32 Weeks
Description
Disease control rate based on investigator assessments according to RECIST version 1.1 was defined as the rate of best objective response of complete response (CR) or partial response (PR) by week 32 or who have stable disease (SD) at least 32 weeks following start of treatment.
Time Frame
Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization and then every 8 weeks thereafter.
Title
Disease Control Rate (DCR) - 48 Weeks
Description
Disease control rate based on investigator assessments according to RECIST version 1.1 was defined as the rate of best objective response of complete response (CR) or partial response (PR) by week 48 or who have stable disease (SD) at least 48 weeks following start of treatment.
Time Frame
Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization and then every 8 weeks thereafter.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
130 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion
Histologically confirmed, unresectable advanced or metastatic biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma.
Patients with previously untreated disease if unresectable or metastatic at initial diagnosis will be eligible.
Patient with recurrent disease >6 months after curative surgery or >6 months after the completion of adjuvant therapy (chemotherapy and/or radiation) will be eligible.
WHO/ECOG PS of 0 or 1
Exclusion
History of another primary malignancy
Brain metastases or spinal cord compression
Uncontrolled intercurrent illness
Major surgical procedure within 28 days prior to the first dose of IP.
Prior locoregional therapy such as radioembolization
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gordon Cohen
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Research Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Research Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Research Site
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33905
Country
United States
Facility Name
Research Site
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Research Site
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
Research Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Research Site
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
Research Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Research Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Research Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Research Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Research Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Research Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Research Site
City
Buenos Aires
ZIP/Postal Code
1280
Country
Argentina
Facility Name
Research Site
City
Buenos Aires
ZIP/Postal Code
C1118AAT
Country
Argentina
Facility Name
Research Site
City
Buenos Aires
ZIP/Postal Code
C1426ANZ
Country
Argentina
Facility Name
Research Site
City
Caba
ZIP/Postal Code
C1012AAR
Country
Argentina
Facility Name
Research Site
City
Caba
ZIP/Postal Code
C1019ABS
Country
Argentina
Facility Name
Research Site
City
Rosario
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Research Site
City
San Salvador de Jujuy
ZIP/Postal Code
4600
Country
Argentina
Facility Name
Research Site
City
Burgas
ZIP/Postal Code
8000
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1330
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Research Site
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
Research Site
City
Puerto Montt
ZIP/Postal Code
5480000
Country
Chile
Facility Name
Research Site
City
Santiago
ZIP/Postal Code
7630370
Country
Chile
Facility Name
Research Site
City
Temuco
ZIP/Postal Code
4810218
Country
Chile
Facility Name
Research Site
City
Viña del Mar
ZIP/Postal Code
2540488
Country
Chile
Facility Name
Research Site
City
Baoding
ZIP/Postal Code
071000
Country
China
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100021
Country
China
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Research Site
City
Bengbu
ZIP/Postal Code
233060
Country
China
Facility Name
Research Site
City
Chongqing
ZIP/Postal Code
400038
Country
China
Facility Name
Research Site
City
Foshan
ZIP/Postal Code
528000
Country
China
Facility Name
Research Site
City
Guangzhou
ZIP/Postal Code
510062
Country
China
Facility Name
Research Site
City
Hangzhou
ZIP/Postal Code
310003
Country
China
Facility Name
Research Site
City
Hangzhou
ZIP/Postal Code
310009
Country
China
Facility Name
Research Site
City
Harbin
ZIP/Postal Code
150081
Country
China
Facility Name
Research Site
City
Hefei
ZIP/Postal Code
230001
Country
China
Facility Name
Research Site
City
Hefei
ZIP/Postal Code
230601
Country
China
Facility Name
Research Site
City
Jinan
ZIP/Postal Code
250014
Country
China
Facility Name
Research Site
City
Nanchang
ZIP/Postal Code
330006
Country
China
Facility Name
Research Site
City
Nanjing
ZIP/Postal Code
210002
Country
China
Facility Name
Research Site
City
Shandong
Country
China
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Research Site
City
Shenyang
ZIP/Postal Code
100003
Country
China
Facility Name
Research Site
City
Suzhou
ZIP/Postal Code
215004
Country
China
Facility Name
Research Site
City
Xian
ZIP/Postal Code
710061
Country
China
Facility Name
Research Site
City
Zhengzhou
ZIP/Postal Code
450008
Country
China
Facility Name
Research Site
City
Zhuhai
ZIP/Postal Code
519000
Country
China
Facility Name
Research Site
City
Clichy
ZIP/Postal Code
92210
Country
France
Facility Name
Research Site
City
Dijon Cedex
ZIP/Postal Code
21079
Country
France
Facility Name
Research Site
City
Montpellier CEDEX 5
ZIP/Postal Code
34295
Country
France
Facility Name
Research Site
City
Nice
ZIP/Postal Code
6189
Country
France
Facility Name
Research Site
City
PARIS Cedex 12
ZIP/Postal Code
75571
Country
France
Facility Name
Research Site
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Research Site
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Research Site
City
Hong Kong
ZIP/Postal Code
150001
Country
Hong Kong
Facility Name
Research Site
City
Hong Kong
Country
Hong Kong
Facility Name
Research Site
City
HongKong
ZIP/Postal Code
00000
Country
Hong Kong
Facility Name
Research Site
City
Kowloon
Country
Hong Kong
Facility Name
Research Site
City
Gurgaon
ZIP/Postal Code
122001
Country
India
Facility Name
Research Site
City
Kolkata
ZIP/Postal Code
700160
Country
India
Facility Name
Research Site
City
Mumbai
ZIP/Postal Code
400012
Country
India
Facility Name
Research Site
City
New Delhi
ZIP/Postal Code
110085
Country
India
Facility Name
Research Site
City
Faenza
ZIP/Postal Code
48018
Country
Italy
Facility Name
Research Site
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Research Site
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Research Site
City
Verona
ZIP/Postal Code
37134
Country
Italy
Facility Name
Research Site
City
Chuo-ku
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Research Site
City
Kashiwa
ZIP/Postal Code
227-8577
Country
Japan
Facility Name
Research Site
City
Kitaadachi-gun
ZIP/Postal Code
362-0806
Country
Japan
Facility Name
Research Site
City
Mitaka-shi
ZIP/Postal Code
181-8611
Country
Japan
Facility Name
Research Site
City
Osaka-shi
ZIP/Postal Code
541-8567
Country
Japan
Facility Name
Research Site
City
Suita-shi
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Research Site
City
Wakayama-shi
ZIP/Postal Code
641-8510
Country
Japan
Facility Name
Research Site
City
Yokohama-shi
ZIP/Postal Code
241-8515
Country
Japan
Facility Name
Research Site
City
Seongnam-si
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
152-703
Country
Korea, Republic of
Facility Name
Research Site
City
Gdańsk
ZIP/Postal Code
80-214
Country
Poland
Facility Name
Research Site
City
Kościerzyna
ZIP/Postal Code
83-400
Country
Poland
Facility Name
Research Site
City
Olsztyn
ZIP/Postal Code
10-228
Country
Poland
Facility Name
Research Site
City
Poznan
ZIP/Postal Code
60-780
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
02-106
Country
Poland
Facility Name
Research Site
City
Wrocław
ZIP/Postal Code
50-556
Country
Poland
Facility Name
Research Site
City
Łódź
ZIP/Postal Code
93-513
Country
Poland
Facility Name
Research Site
City
Barnaul
ZIP/Postal Code
656049
Country
Russian Federation
Facility Name
Research Site
City
Kostroma
ZIP/Postal Code
156005
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
121467
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
Research Site
City
Omsk
ZIP/Postal Code
644033
Country
Russian Federation
Facility Name
Research Site
City
Saint-Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Research Site
City
Saint-Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Research Site
City
Chiayi
ZIP/Postal Code
613
Country
Taiwan
Facility Name
Research Site
City
Kaohsiung
ZIP/Postal Code
824
Country
Taiwan
Facility Name
Research Site
City
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
Research Site
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
Research Site
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
Research Site
City
Taipei City
ZIP/Postal Code
10050
Country
Taiwan
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Research Site
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Research Site
City
Hat Yai
ZIP/Postal Code
90110
Country
Thailand
Facility Name
Research Site
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Research Site
City
Muang
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Research Site
City
Sisaket
ZIP/Postal Code
33000
Country
Thailand
Facility Name
Research Site
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Research Site
City
Istanbul
ZIP/Postal Code
34030
Country
Turkey
Facility Name
Research Site
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Research Site
City
Mersin
ZIP/Postal Code
33110
Country
Turkey
Facility Name
Research Site
City
Bristol
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Research Site
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Research Site
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Research Site
City
London
ZIP/Postal Code
W12 0NN
Country
United Kingdom
Facility Name
Research Site
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Research Site
City
Oxford
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Facility Name
Research Site
City
Romford
ZIP/Postal Code
RM7 0AG
Country
United Kingdom
Facility Name
Research Site
City
Sheffield
ZIP/Postal Code
S10 2SJ
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
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.
IPD Sharing Access Criteria
When a request has been approved AstraZeneca will provide access to the de-identified 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.
IPD Sharing URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home
Links:
URL
https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D933AC00001&attachmentIdentifier=f0f0274f-a72a-4d83-8200-e6a74d44d8fe&fileName=D933AC00001_-___Statistical_Analysis_Plan-redact.pdf&versionIdentifier=
Description
Related Info
URL
https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D933AC00001&attachmentIdentifier=88a80119-302b-4810-bce2-623ab0a77f31&fileName=d933ac00001-oncology-late-phase-master-csp-v8-redact.pdf&versionIdentifier=
Description
Related Info
URL
https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D933AC00001&attachmentIdentifier=7f0ef0d5-6fe8-4acc-8de5-143b4c68c4d9&fileName=d933ac00001-study-synopsis-redact.pdf&versionIdentifier=
Description
Related Info
Learn more about this trial
Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1)
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