Description:
Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1)
Clinical Trials /
Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1)
NCT03875235
Related Conditions:
- Biliary Tract Carcinoma
Recruiting Status:
Recruiting
Phase:
Phase 3
Trial Eligibility
Document
Title
- Brief Title: Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (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
Clinical Trial IDs
- ORG STUDY ID: D933AC00001
- NCT ID: NCT03875235
Conditions
- Biliary Tract Neoplasms
Interventions
| Drug | Synonyms | Arms |
|---|---|---|
| Durvalumab | Treatment Arm | |
| Placebo | Placebo Arm |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|---|---|---|
| Treatment Arm | Experimental | Durvalumab + Gemcitabine + Cisplatin |
|
| Placebo Arm | Placebo Comparator | Placebo + Gemcitabine + Cisplatin |
|
Eligibility Criteria
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
| Maximum Eligible Age: | 130 Years |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Overall survival |
| Time Frame: | 40 months |
| Safety Issue: | |
| Description: |
Secondary Outcome Measures
| Measure: | PFS according to RECIST 1.1 using investigator assessment |
| Time Frame: | 40 months |
| Safety Issue: | |
| Description: |
| Measure: | ORR according to RECIST 1.1 using investigator assessment |
| Time Frame: | 40 months |
| Safety Issue: | |
| Description: |
| Measure: | DoR according to RECIST 1.1 using investigator assessment |
| Time Frame: | 40 months |
| Safety Issue: | |
| Description: |
| Measure: | EORTC QLQ-C30 and EORTC QLQ-BIL21 |
| Time Frame: | 40 months |
| Safety Issue: | |
| Description: |
| Measure: | PFS, ORR, DoR, and DCR according to RECIST 1.1 using Investigator assessments and OS by PD-L1 expression |
| Time Frame: | 40 months |
| Safety Issue: | |
| Description: |
| Measure: | Serum concentration of durvalumab (peak and trough concentration) |
| Time Frame: | 40 months |
| Safety Issue: | |
| Description: |
| Measure: | Tiered results of ADAs for durvalumab |
| Time Frame: | 40 months |
| Safety Issue: | |
| Description: |
Details
| Phase: | Phase 3 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | AstraZeneca |
Trial Keywords
- First-Line Advanced Biliary Tract Cancers (BTC)
- Durvalumab
- Gemcitabine/Cisplatin
- Placebo
Last Updated
August 18, 2021
