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Monoclonal Antibodies
Guadecitabine + Durvalumab for Liver and Pancreatic Cancer
Phase 1
Waitlist Available
Led By Anthony El-Khoueiry, MD
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Serum creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance
Hepatocellular carcinoma cohort specific criteria: Patients must have a histologically proven diagnosis of hepatocellular carcinoma that is not amenable to curative surgical therapeutic options
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of treatment to time of progression per recist 1.1 or death whichever comes first, assessed up to 2 years
Awards & highlights
Study Summary
This trial is testing the side effects and best dosage of a new cancer drug, guadecitabine, when given with another drug, durvalumab. Guadecitabine works by blocking enzymes needed for cell growth, and durvalumab works by targeting certain cells. The hope is that the two drugs will work better together than either does alone in treating liver, pancreatic, bile duct, or gallbladder cancer.
Who is the study for?
This trial is for adults with advanced liver, pancreatic, bile duct, or gallbladder cancer that has spread. Participants must be able to follow the study plan and have certain blood counts and organ functions within specific ranges. They should not be pregnant or breastfeeding and must use contraception. People who've had certain other treatments or conditions like inflammatory bowel disease, another primary malignancy within 3 years, uncontrolled brain metastases, or a history of severe immune-related side effects from previous immunotherapy are excluded.Check my eligibility
What is being tested?
The trial is testing the combination of guadecitabine (which may block enzymes needed for tumor cell growth) with durvalumab (a monoclonal antibody targeting cancer cells). It aims to determine the best dose and assess how well these drugs work together against various types of advanced cancers when they have spread beyond their original location.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system attacking normal organs (immune-related adverse events), infusion reactions due to drug administration into a vein, fatigue, digestive issues such as nausea or diarrhea, changes in blood counts leading to increased risk of infections or bleeding complications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function, measured by creatinine clearance, is good.
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I have liver cancer that cannot be cured with surgery.
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My pancreatic cancer cannot be removed by surgery or has spread.
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I am a woman who could still become pregnant.
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My cancer originates from the bile ducts or gallbladder and cannot be surgically removed.
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I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from start of treatment to time of progression per recist 1.1 or death whichever comes first, assessed up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of treatment to time of progression per recist 1.1 or death whichever comes first, assessed up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Tumor response (dose expansion)
Secondary outcome measures
Overall survival
Progression-free survival
Side effects data
From 2020 Phase 3 trial • 417 Patients • NCT0290735934%
Neutropenia
31%
Thrombocytopenia
30%
Febrile Neutropenia
27%
Pneumonia
23%
Anaemia
23%
Constipation
22%
Diarrhoea
22%
Fatigue
22%
Pyrexia
20%
Asthenia
18%
Decreased Appetite
17%
Injection Site Reaction
17%
Hypokalaemia
16%
Epistaxis
16%
Nausea
16%
Oedema Peripheral
14%
Stomatitis
14%
Cough
13%
Dizziness
13%
Headache
12%
Back Pain
12%
Leukopenia
12%
Dyspnoea
11%
Insomnia
11%
Vomiting
10%
Rash
10%
Sepsis
10%
Abdominal Pain
9%
Petechiae
9%
Contusion
8%
Weight Decreased
8%
Cellulitis
7%
Arthralgia
7%
Pruritus
6%
Fall
6%
Musculoskeletal Pain
6%
Septic Shock
6%
Upper Respiratory Tract Infection
6%
Transfusion Reaction
6%
Pain In Extremity
6%
Haematoma
6%
Haemorrhoids
6%
Hypotension
5%
Urinary Tract Infection
5%
Blood Creatinine Increased
5%
Hypomagnesaemia
5%
Oropharyngeal Pain
5%
Erythema
5%
Oedema
5%
Alanine Aminotransferase Increased
4%
Nasopharyngitis
4%
Aspartate Aminotransferase Increased
4%
Bacteraemia
2%
Atrial Fibrillation
1%
Cardiac Failure Congestive
1%
Acute Myocardial Infarction
1%
General Physical Health Deterioration
1%
Subcutaneous Abscess
1%
Cholangitis
1%
Pulmonary Embolism
1%
Tumour Lysis Syndrome
1%
Angina Pectoris
1%
Colitis
1%
Anal Abscess
1%
Device Related Infection
1%
Cardiac Failure
1%
Gastrointestinal Haemorrhage
1%
Lower Gastrointestinal Haemorrhage
1%
Multiple Organ Dysfunction Syndrome
1%
Bronchopulmonary Aspergillosis
1%
Infection
1%
Urosepsis
1%
Bronchitis
1%
Cellulitis Orbital
1%
Chronic Sinusitis
1%
Corynebacterium Infection
1%
Pseudomonal Bacteraemia
1%
Sinusitis
1%
Staphylococcal Bacteraemia
1%
Subarachnoid Haemorrhage
1%
Haematuria
1%
Respiratory Tract Infection
1%
Haemorrhage Intracranial
1%
Prostatitis
1%
Febrile Bone Marrow Aplasia
1%
Leukocytosis
1%
Leukostasis Syndrome
1%
Pancytopenia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Guadecitabine
Treatment Choice
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (guadecitabine, durvalumab)Experimental Treatment2 Interventions
Patients receive guadecitabine SC QD on days 1-5 and durvalumab IV over 60 minutes on day 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3870
Guadecitabine
2014
Completed Phase 3
~570
Find a Location
Who is running the clinical trial?
University of Southern CaliforniaLead Sponsor
905 Previous Clinical Trials
1,596,223 Total Patients Enrolled
1 Trials studying Liver Cancer
76 Patients Enrolled for Liver Cancer
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,434 Total Patients Enrolled
104 Trials studying Liver Cancer
26,668 Patients Enrolled for Liver Cancer
Van Andel Research InstituteOTHER
27 Previous Clinical Trials
5,342 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My hemoglobin level is at least 8.0 g/dL, or it has been maintained at this level for over a week after a transfusion.You have a history of a weakened immune system from birth.You have had an organ transplant from someone else.Your liver enzymes (AST and ALT) should not be more than 2.5 times the normal limit, unless you have liver metastases or chronic liver disease (hepatitis), in which case they should not be more than 5 times the normal limit.My kidney function, measured by creatinine clearance, is good.Patients must have a disease that can be measured using specific criteria.I have liver cancer that cannot be cured with surgery.My pancreatic cancer cannot be removed by surgery or has spread.I have not been treated with specific immune system targeting drugs for my condition.I haven't had hepatic encephalopathy in the last year.My white blood cell count is high enough for the trial.My cancer originates from the bile ducts or gallbladder and cannot be surgically removed.I had cancer before, but it was treated successfully over 3 years ago.I received my last cancer treatment less than 28 days ago, or within 6 weeks if it was nitrosourea or mitomycin C.I have not received a live vaccine within 30 days before joining the study or before getting durvalumab.I don't have lasting side effects from cancer treatment, except for hair loss, hearing loss, or tingling in my limbs.I have had severe side effects from previous immunotherapy.I have an autoimmune disease, but it's not vitiligo, Graves' disease, or psoriasis that hasn't needed systemic treatment in the past 2 years.I have brain metastases that need treatment.I have fluid in my abdomen that isn't controlled by medicine or needed draining recently.I have or had Crohn's disease or ulcerative colitis.I do not have any severe illnesses that could interfere with the study.I have been previously diagnosed with tuberculosis.I have or had pneumonitis.I am a woman who could still become pregnant.I am willing and able to follow the study's requirements, including treatments and visits.Your bilirubin levels in your blood are not more than 2.5 times the normal limit.Your platelet count is at least 100,000 per mm^3, unless you have liver cancer, in which case a count of at least 60,000 per mm^3 is acceptable.You have had a bad reaction to durvalumab or guadecitabine before.I am fully active or can carry out light work.Your blood protein level (serum albumin) is at least 2.5 grams per deciliter.Your heart's electrical activity, called the QT interval, is longer than 470 milliseconds when measured from 3 ECGs.I have not had bleeding from esophageal or stomach veins in the last 6 months.I have never had cancer spread to the lining of my brain or uncontrolled seizures.I haven't taken strong immune system suppressing drugs or live vaccines recently.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (guadecitabine, durvalumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
How many participants are being welcomed into this experiment?
"At this moment, enrollment in the trial is not available. The study was originally posted on February 7th 2018 and underwent its most recent update August 5th 2022. Alternatively, there are 4585 clinical trials for carcinoma hepatocellular enrolling patients along with 339 studies utilising Guadecitabine that are actively recruiting participants."
Answered by AI
Are patients exposed to any considerable risk when taking Guadecitabine?
"There is limited evidence for guadecitabine's safety and efficacy, consequently the Power team has assigned it a score of 1."
Answered by AI
What prior research exists regarding Guadecitabine's efficacy?
"Guadecitabine was initially researched in 2010 at the City of Hope. There are currently 120 completed studies on record and 339 ongoing trials, many of which take place in Los Angeles and Maryland."
Answered by AI
Are there any open slots for prospective participants in this experiment?
"Unfortunately, this clinical trial is not taking new participants right now. The study was posted online on February 7th 2018 and last updated August 5th 2022. There are currently 4585 trials recruiting patients with carcinoma, hepatocellular and 339 studies for Guadecitabine actively seeking enrolment."
Answered by AI
What therapeutic applications is Guadecitabine commonly employed for?
"Guadecitabine is typically prescribed to manage advanced-stage, non-small cell lung cancer that cannot be surgically removed. It can also assist with the treatment of metastatic urothelial carcinoma and other conditions like advance directives."
Answered by AI
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