Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING Phase 3

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

NCT03875235 · View on ClinicalTrials.gov ↗

Study Summary

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

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Durvalumab

Study Locations (20)

Other

  • Research Site — Buenos Aires
  • Research Site — CABA
  • Research Site — CABA
  • Research Site — Ciudad de Buenos Aires
  • Research Site — Ciudad de Buenos Aires

California

  • Research Site — Los Angeles
  • Research Site — Orange

Florida

  • Research Site — Fort Myers
  • Research Site — St. Petersburg

Tennessee

  • Research Site — Chattanooga
  • Research Site — Nashville

District of Columbia

  • Research Site — Washington D.C.

Kansas

  • Research Site — Westwood

Kentucky

  • Research Site — Louisville

Massachusetts

  • Research Site — Burlington

Trial Details

FieldValue
Enrollment Target 810 participants
Start Date 2019-04-16
Est. Completion 2027-05-16
Phase Phase 3

Sponsor

AstraZeneca

1,053 total trials

Interested in This Trial?

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03875235

The ClinicalTrials.gov registry entry for NCT03875235 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 810 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,053 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Biliary Tract Neoplasms appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03875235 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Other, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03875235 about?

NCT03875235 is a clinical study titled "Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1)". Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1).

What is the current status of trial NCT03875235?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 810 participants. The study started on 2019-04-16. Estimated completion is 2027-05-16.

What conditions does trial NCT03875235 study?

This clinical trial studies the following conditions: Biliary Tract Neoplasms. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03875235?

The interventions under investigation include: Placebo (DRUG), Durvalumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03875235?

This trial is sponsored by AstraZeneca, which has 1,053 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03875235 being conducted?

This trial has 20 study locations across California, District of Columbia, Florida, Kansas, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial