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Trial record 1 of 1 for:    NCT03875235
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Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1) (TOPAZ-1)

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ClinicalTrials.gov Identifier: NCT03875235
Recruitment Status : Recruiting
First Posted : March 14, 2019
Last Update Posted : December 12, 2019
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE March 13, 2019
First Posted Date  ICMJE March 14, 2019
Last Update Posted Date December 12, 2019
Actual Study Start Date  ICMJE April 16, 2019
Estimated Primary Completion Date March 25, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2019)
Overall survival [ Time Frame: 36 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 13, 2019)
Overall survival [ Time Frame: 36 months ]
Assessments for Overall survival will be collected regularly at predefined time points until death
Change History Complete list of historical versions of study NCT03875235 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2019)
  • PFS according to RECIST 1.1 using investigator assessment [ Time Frame: 36 months ]
  • ORR according to RECIST 1.1 using investigator assessment [ Time Frame: 36 months ]
  • DoR according to RECIST 1.1 using investigator assessment [ Time Frame: 36 months ]
  • EORTC QLQ-C30 and EORTC QLQ-BIL21 [ Time Frame: 36 months ]
  • PFS, ORR, DoR, and DCR according to RECIST 1.1 using Investigator assessments and OS by PD-L1 expression [ Time Frame: 36 months ]
  • Serum concentration of durvalumab (peak and trough concentration) [ Time Frame: 36 months ]
  • Tiered results of ADAs for durvalumab [ Time Frame: 36 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2019)
  • PFS accorridng RECSIST1.1 using investigator assessment [ Time Frame: 36 months ]
    Assessments will be made regularly until disease progression or until the end of the study
  • ORR according to RECIST 1.1 using investigator assessment [ Time Frame: 36 months ]
    Assessments will be made regularly until disease progression or until the end of the study
  • DoR accroding to RECSIST1.1 using investigator assessment [ Time Frame: 36 months ]
    Assessments will be made regularly until disease progression or until the end of the study
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1)
Official Title  ICMJE 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
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Durvalumab in Combination with Gemcitabine plus Cisplatin Placebo in Combination with Gemcitabine plus Cisplatin
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Biliary Tract Neoplasms
Intervention  ICMJE
  • Drug: Durvalumab
    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.
  • Drug: Placebo
    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.
Study Arms  ICMJE
  • Experimental: Treatment Arm
    Durvalumab + Gemcitabine + Cisplatin
    Intervention: Drug: Durvalumab
  • Placebo Comparator: Placebo Arm
    Placebo + Gemcitabine + Cisplatin
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 13, 2019)
474
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 25, 2022
Estimated Primary Completion Date March 25, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion

  1. Histologically confirmed, unresectable advanced or metastatic biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma.
  2. Patients with preciously 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 130 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com
Contact: AstraZeneca Cancer Study Locator Service 1-877-400-4656 AstraZeneca@emergingmed.com
Listed Location Countries  ICMJE Argentina,   Bulgaria,   Chile,   China,   France,   Hong Kong,   Italy,   Japan,   Korea, Republic of,   Poland,   Taiwan,   Thailand,   Turkey,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03875235
Other Study ID Numbers  ICMJE D933AC00001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gordana Vlahovic AstraZeneca
PRS Account AstraZeneca
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP