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Monoclonal Antibodies
Durvalumab + Chemotherapy for Biliary Tract Cancer (TOPAZ-1 Trial)
Phase 3
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
WHO/ECOG PS of 0 or 1
Histologically confirmed, unresectable advanced or metastatic biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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.
Awards & highlights
TOPAZ-1 Trial Summary
This trial is testing if adding durvalumab (a cancer immunotherapy drug) to gemcitabine/cisplatin (a chemotherapy combination) can help people with biliary tract cancer.
Who is the study for?
This trial is for adults with advanced biliary tract cancer, including cholangiocarcinoma and gallbladder carcinoma. They should be in good physical condition (WHO/ECOG PS of 0 or 1) and have not been treated before if their disease was inoperable or metastatic at diagnosis. Those who had surgery or adjuvant therapy must have completed it over six months ago.Check my eligibility
What is being tested?
The study tests Durvalumab (an immunotherapy drug) combined with Gemcitabine/Cisplatin chemotherapy versus a placebo plus the same chemotherapy in patients facing their first line of treatment for advanced biliary tract cancer.See study design
What are the potential side effects?
Durvalumab may cause immune-related side effects such as inflammation of organs, skin rash, fatigue, nausea, and potential infusion reactions. Gemcitabine/Cisplatin can lead to blood cell count changes, kidney issues, nausea/vomiting, and hair loss.
TOPAZ-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
Select...
My cancer is in the bile ducts or gallbladder and cannot be surgically removed.
TOPAZ-1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival (OS)
Overall Survival (OS) Rate at 18 Months
Overall Survival (OS) Rate at 24 Months
Secondary outcome measures
Disease Control Rate (DCR) - 24 Weeks
Disease Control Rate (DCR) - 32 Weeks
Disease Control Rate (DCR) - 48 Weeks
+8 moreSide effects data
From 2022 Phase 2 trial • 80 Patients • NCT0301512965%
Fatigue
63%
Abdominal pain
55%
Diarrhea
43%
Pain
40%
Weight loss
35%
Hypertension
30%
Constipation
30%
Anorexia
28%
Nausea
28%
Pruritus
25%
Vomiting
20%
Dyspnea
20%
Urinary tract infection
18%
Rash maculo-papular
15%
Back pain
15%
Cough
15%
Abdominal Pain
15%
Weight gain
15%
Increased Urinary Frequency
13%
Arthralgia
10%
Anxiety
10%
Bladder infection
10%
Dizziness
10%
Nasal congestion
10%
Vaginal discharge
8%
Edema limbs
8%
Fever
8%
Anal pain
8%
Dry skin
8%
Colitis
8%
Thromboembolic event
8%
Dry mouth
8%
Flatulence
8%
Headache
8%
Hot flashes
8%
Myalgia
8%
Urinary tract pain
8%
Urinary frequency
8%
Small intestinal obstruction
5%
Anemia
5%
Ascites
5%
Confusion
5%
Pneumonitis
5%
Sinus bradycardia
5%
Renal and urinary disorders - Other, specify
5%
Adrenal insufficiency
5%
Memory impairment
5%
Vaginal hemorrhage
5%
Hypomagnesemia
5%
Upper respiratory infection
5%
Mucositis oral
5%
Rash acneiform
5%
Urinary urgency
5%
Gastroesophageal reflux disease
5%
Lymphedema
3%
Rectal hemorrhage
3%
Colonic perforation
3%
Generalized muscle weakness
3%
Hyperkalemia
3%
Lethargy
3%
Myocarditis
3%
Fall
3%
Skin infection
3%
Hypothyroidism
3%
Muscle weakness left-sided
3%
Alanine aminotransferase increased
3%
Hyperglycemia
3%
Pleural effusion
3%
Creatinine increased
3%
Rectal pain
3%
Aspartate aminotransferase increased
3%
Dysarthria
3%
Myositis
3%
CPK increased
3%
Pain in extremity
3%
Peripheral sensory neuropathy
3%
Alkaline phosphatase increased
3%
Blood bilirubin increased
3%
Left ventricular systolic dysfunction
3%
Weight Loss
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalubmab
Durvalubmab + Tremelimumab
TOPAZ-1 Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment ArmExperimental Treatment1 Intervention
Durvalumab + Gemcitabine + Cisplatin
Group II: Placebo ArmPlacebo Group1 Intervention
Placebo + Gemcitabine + Cisplatin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3870
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,253 Previous Clinical Trials
288,537,373 Total Patients Enrolled
Gordon CohenStudy DirectorAstraZeneca
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have cancer that has spread to my brain or spinal cord.I haven't had major surgery in the last 28 days.I have had another type of cancer in the past.I do not have any unmanaged ongoing illnesses.I am fully active or can carry out light work.My disease was advanced or spread to other parts when first diagnosed and hasn't been treated yet.My cancer is in the bile ducts or gallbladder and cannot be surgically removed.My cancer returned more than 6 months after treatment or surgery aimed at curing it.I have had targeted radiation therapy for my cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo Arm
- Group 2: Treatment Arm
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What sort of people are best suited for this research?
"This study is looking for 810 patients with biliary tract cancer who are aged 18 or older. The most important criteria that patients must meet are as follows: they must have histologically confirmed, unresectable advanced or metastatic biliary tract cancer (this includes cholangiocarcinoma and gallbladder carcinoma), they cannot have had previous treatment if their disease is unresectable or metastatic at initial diagnosis, they must be more than 6 months post-surgery or post-adjuvant therapy if they have recurrent disease, and they must have a WHO/ECOG PS of 0 or 1"
Answered by AI
What is the efficacy of Durvalumab in other medical research?
"There are a total of 338 trials currently underway studying the effects of Durvalumab. Of these, 51 are Phase 3 clinical trials. The majority of these studies taking place in Cordoba, Texas; though there are 12904 locations running similar investigations worldwide."
Answered by AI
Does this test allow people who are over 45 years old to participate?
"According to the screening process for this clinical trial, patients must be between 18-130 years old."
Answered by AI
What are some of the possible negative effects of Durvalumab?
"There is both prior clinical data supporting the safety of Durvalumab, as well as multiple rounds of new data, so it received a score of 3."
Answered by AI
Are there any empty slots in this clinical trial for new patients?
"No, the clinical trial is not recruiting patients at this time. However, there are other 443 medical studies that are currently looking for participants."
Answered by AI
What are some of the most common reasons why a doctor would prescribe Durvalumab?
"Typically, patients with unresectable stage III non-small cell lung cancer are treated with durvalumab. This medication can also be effective for treating other conditions, such as previously untreated metastatic urothelial carcinoma and advanced directives."
Answered by AI
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