Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1) (TOPAZ-1)

February 23, 2024 updated by: AstraZeneca

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

Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1)

Study Overview

Status

Active, not recruiting

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

810

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Buenos Aires, Argentina, 1280
        • Research Site
      • Buenos Aires, Argentina, C1118AAT
        • Research Site
      • Buenos Aires, Argentina, C1426ANZ
        • Research Site
      • Caba, Argentina, C1012AAR
        • Research Site
      • Caba, Argentina, C1019ABS
        • Research Site
      • Rosario, Argentina, 2000
        • Research Site
      • San Salvador de Jujuy, Argentina, 4600
        • Research Site
      • Burgas, Bulgaria, 8000
        • Research Site
      • Sofia, Bulgaria, 1407
        • Research Site
      • Sofia, Bulgaria, 1606
        • Research Site
      • Sofia, Bulgaria, 1330
        • Research Site
      • Varna, Bulgaria, 9010
        • Research Site
      • Puerto Montt, Chile, 5480000
        • Research Site
      • Santiago, Chile, 7630370
        • Research Site
      • Temuco, Chile, 4810218
        • Research Site
      • Viña del Mar, Chile, 2540488
        • Research Site
      • Baoding, China, 071000
        • Research Site
      • Beijing, China, 100142
        • Research Site
      • Beijing, China, 100021
        • Research Site
      • Bengbu, China, 233060
        • Research Site
      • Chongqing, China, 400038
        • Research Site
      • Foshan, China, 528000
        • Research Site
      • Guangzhou, China, 510062
        • Research Site
      • Hangzhou, China, 310003
        • Research Site
      • Hangzhou, China, 310009
        • Research Site
      • Harbin, China, 150081
        • Research Site
      • Hefei, China, 230001
        • Research Site
      • Hefei, China, 230601
        • Research Site
      • Jinan, China, 250014
        • Research Site
      • Nanchang, China, 330006
        • Research Site
      • Nanjing, China, 210002
        • Research Site
      • Shandong, China
        • Research Site
      • Shanghai, China, 200032
        • Research Site
      • Shenyang, China, 100003
        • Research Site
      • Suzhou, China, 215004
        • Research Site
      • Xian, China, 710061
        • Research Site
      • Zhengzhou, China, 450008
        • Research Site
      • Zhuhai, China, 519000
        • Research Site
      • Clichy, France, 92210
        • Research Site
      • Dijon Cedex, France, 21079
        • Research Site
      • Montpellier CEDEX 5, France, 34295
        • Research Site
      • Nice, France, 6189
        • Research Site
      • PARIS Cedex 12, France, 75571
        • Research Site
      • Pessac, France, 33604
        • Research Site
      • Poitiers, France, 86021
        • Research Site
      • Hong Kong, Hong Kong
        • Research Site
      • Hong Kong, Hong Kong, 150001
        • Research Site
      • HongKong, Hong Kong, 00000
        • Research Site
      • Kowloon, Hong Kong
        • Research Site
      • Gurgaon, India, 122001
        • Research Site
      • Kolkata, India, 700160
        • Research Site
      • Mumbai, India, 400012
        • Research Site
      • New Delhi, India, 110085
        • Research Site
      • Faenza, Italy, 48018
        • Research Site
      • Firenze, Italy, 50134
        • Research Site
      • Milano, Italy, 20132
        • Research Site
      • Napoli, Italy, 80131
        • Research Site
      • Roma, Italy, 00168
        • Research Site
      • Verona, Italy, 37134
        • Research Site
      • Chuo-ku, Japan, 104-0045
        • Research Site
      • Kashiwa, Japan, 227-8577
        • Research Site
      • Kitaadachi-gun, Japan, 362-0806
        • Research Site
      • Mitaka-shi, Japan, 181-8611
        • Research Site
      • Osaka-shi, Japan, 541-8567
        • Research Site
      • Suita-shi, Japan, 565-0871
        • Research Site
      • Wakayama-shi, Japan, 641-8510
        • Research Site
      • Yokohama-shi, Japan, 241-8515
        • Research Site
      • Seongnam-si, Korea, Republic of, 13620
        • Research Site
      • Seoul, Korea, Republic of, 03722
        • Research Site
      • Seoul, Korea, Republic of, 03080
        • Research Site
      • Seoul, Korea, Republic of, 06351
        • Research Site
      • Seoul, Korea, Republic of, 06591
        • Research Site
      • Seoul, Korea, Republic of, 152-703
        • Research Site
      • Gdańsk, Poland, 80-214
        • Research Site
      • Kościerzyna, Poland, 83-400
        • Research Site
      • Olsztyn, Poland, 10-228
        • Research Site
      • Poznan, Poland, 60-780
        • Research Site
      • Warszawa, Poland, 02-106
        • Research Site
      • Wrocław, Poland, 50-556
        • Research Site
      • Łódź, Poland, 93-513
        • Research Site
      • Barnaul, Russian Federation, 656049
        • Research Site
      • Kostroma, Russian Federation, 156005
        • Research Site
      • Moscow, Russian Federation, 115478
        • Research Site
      • Moscow, Russian Federation, 125284
        • Research Site
      • Moscow, Russian Federation, 121467
        • Research Site
      • Omsk, Russian Federation, 644033
        • Research Site
      • Saint-Petersburg, Russian Federation, 197758
        • Research Site
      • Saint-Petersburg, Russian Federation, 197022
        • Research Site
      • Chiayi, Taiwan, 613
        • Research Site
      • Kaohsiung, Taiwan, 82445
        • Research Site
      • Kaohsiung, Taiwan, 83301
        • Research Site
      • Taichung, Taiwan, 40705
        • Research Site
      • Tainan, Taiwan, 704
        • Research Site
      • Taipei, Taiwan, 11217
        • Research Site
      • Taipei City, Taiwan, 10050
        • Research Site
      • Taoyuan, Taiwan, 333
        • Research Site
      • Bangkok, Thailand, 10330
        • Research Site
      • Bangkok, Thailand, 10400
        • Research Site
      • Hat Yai, Thailand, 90110
        • Research Site
      • Khon Kaen, Thailand, 40002
        • Research Site
      • Muang, Thailand, 50200
        • Research Site
      • Sisaket, Thailand, 33000
        • Research Site
      • Ankara, Turkey, 06100
        • Research Site
      • Istanbul, Turkey, 34030
        • Research Site
      • Izmir, Turkey, 35100
        • Research Site
      • Mersin, Turkey, 33110
        • Research Site
      • Bristol, United Kingdom, BS2 8ED
        • Research Site
      • Cambridge, United Kingdom, CB2 0QQ
        • Research Site
      • London, United Kingdom, NW3 2QG
        • Research Site
      • London, United Kingdom, W12 0NN
        • Research Site
      • Manchester, United Kingdom, M20 4BX
        • Research Site
      • Oxford, United Kingdom, OX3 7LE
        • Research Site
      • Romford, United Kingdom, RM7 0AG
        • Research Site
      • Sheffield, United Kingdom, S10 2SJ
        • Research Site
    • California
      • Los Angeles, California, United States, 90027
        • Research Site
      • Orange, California, United States, 92868
        • Research Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Research Site
    • Florida
      • Fort Myers, Florida, United States, 33905
        • Research Site
      • Saint Petersburg, Florida, United States, 33705
        • Research Site
    • Kansas
      • Westwood, Kansas, United States, 66205
        • Research Site
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Research Site
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
        • Research Site
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Research Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Research Site
    • Oregon
      • Portland, Oregon, United States, 97213
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Research Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Research Site
      • Nashville, Tennessee, United States, 37203
        • Research Site
    • Washington
      • Seattle, Washington, United States, 98109
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 130 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion

  1. Histologically confirmed, unresectable advanced or metastatic biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma.
  2. Patients with previously untreated disease if unresectable or metastatic at initial diagnosis will be eligible.
  3. 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.
  4. WHO/ECOG PS of 0 or 1

Exclusion

  1. History of another primary malignancy
  2. Brain metastases or spinal cord compression
  3. Uncontrolled intercurrent illness
  4. Major surgical procedure within 28 days prior to the first dose of IP.
  5. Prior locoregional therapy such as radioembolization

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Arm
Durvalumab + Gemcitabine + Cisplatin
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.
Placebo Comparator: Placebo Arm
Placebo + Gemcitabine + Cisplatin
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
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)
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).
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)
Overall Survival (OS) Rate at 18 Months
Time Frame: From date of randomization until death due to any cause. Calculated at 18 months using the Kaplan-Meier technique.
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).
From date of randomization until death due to any cause. Calculated at 18 months using the Kaplan-Meier technique.
Overall Survival (OS) Rate at 24 Months
Time Frame: From date of randomization until death due to any cause. Calculated at 24 months using the Kaplan-Meier technique.
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).
From date of randomization until death due to any cause. Calculated at 24 months using the Kaplan-Meier technique.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival (PFS)
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.
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.
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.
Progression-free Survival (PFS) Rate at 9 Months
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.
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.
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.
Progression-free Survival (PFS) Rate at 12 Months
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
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.
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
Objective Response Rate (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.
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.
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.
Duration of Response (DoR)
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.
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.
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.
Duration of Response (DoR): Percentage Remaining in Response at 9 Months
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
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.
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
Duration of Response (DoR): Percentage Remaining in Response at 12 Months
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
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.
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
Disease Control Rate (DCR) - Overall
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.
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).
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.
Disease Control Rate (DCR) - 24 Weeks
Time Frame: Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization.
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.
Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization.
Disease Control Rate (DCR) - 32 Weeks
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.
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.
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.
Disease Control Rate (DCR) - 48 Weeks
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.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Gordon Cohen, AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2019

Primary Completion (Actual)

August 11, 2021

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

March 13, 2019

First Submitted That Met QC Criteria

March 13, 2019

First Posted (Actual)

March 14, 2019

Study Record Updates

Last Update Posted (Estimated)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 23, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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 Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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