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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
Must not have
Any prior grade >= 3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE > grade 1
Active or prior documented inflammatory bowel disease (e.g., Crohn?s disease, ulcerative colitis)
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
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had severe side effects from previous immunotherapy.
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I have or had Crohn's disease or ulcerative colitis.
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I do not have any severe illnesses that could interfere with the study.
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I have been previously diagnosed with tuberculosis.
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I have brain metastases that need treatment.
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I have fluid in my abdomen that isn't controlled by medicine or needed draining recently.
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I have or had pneumonitis.
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I have never had cancer spread to the lining of my brain or uncontrolled seizures.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of adverse events
Tumor response (dose expansion)
Secondary study objectives
Overall survival
Progression-free survival
Side effects data
From 2020 Phase 3 trial • 417 Patients • NCT0290735920%
Pyrexia
20%
Thrombocytopenia
18%
Anaemia
17%
Epistaxis
16%
Febrile Neutropenia
16%
Neutropenia
16%
Diarrhoea
14%
Pneumonia
12%
Nausea
11%
Oedema Peripheral
10%
Leukopenia
10%
Constipation
10%
Asthenia
9%
Fatigue
9%
Dyspnoea
7%
Contusion
7%
Aspartate Aminotransferase Increased
7%
Dizziness
7%
Headache
7%
Oedema
7%
Alanine Aminotransferase Increased
7%
Cough
6%
Nasopharyngitis
6%
Rash
6%
Upper Respiratory Tract Infection
6%
Urinary Tract Infection
6%
Pain In Extremity
6%
Stomatitis
6%
Vomiting
5%
Weight Decreased
5%
Abdominal Pain
5%
Hypokalaemia
4%
Arthralgia
4%
Fall
4%
Decreased Appetite
4%
Hypomagnesaemia
4%
Blood Creatinine Increased
4%
Insomnia
4%
Haematoma
3%
Haemorrhoids
3%
Cellulitis
3%
Sepsis
2%
Cardiac Failure
2%
Transfusion Reaction
2%
Haemorrhage Intracranial
2%
Acute Kidney Injury
2%
Back Pain
2%
Musculoskeletal Pain
2%
Petechiae
2%
Pruritus
2%
General Physical Health Deterioration
2%
Death
2%
Septic Shock
2%
Oropharyngeal Pain
2%
Erythema
2%
Rectal Haemorrhage
2%
Hypotension
1%
Atrial Fibrillation
1%
Bone Marrow Failure
1%
Agranulocytosis
1%
Cardiac Arrest
1%
Angina Pectoris
1%
Melaena
1%
Retroperitoneal Haematoma
1%
Device Related Infection
1%
Streptococcal Infection
1%
Candida Infection
1%
Lower Respiratory Tract Infection
1%
Femur Fracture
1%
Hyperkalaemia
1%
Osteoporotic Fracture
1%
Central Nervous System Leukaemia
1%
Central Nervous System Haemorrhage
1%
Cerebral Infarction
1%
Renal Impairment
1%
Pulmonary Mass
1%
Disseminated Intravascular Coagulation
1%
Gastrointestinal Haemorrhage
1%
Aphthous Ulcer
1%
Intestinal Obstruction
1%
Megacolon
1%
Infection
1%
Brain Abscess
1%
Pyelonephritis Acute
1%
Nocardiosis
1%
Arthritis
1%
Bone Pain
1%
Tumour Associated Fever
1%
Cerebrovascular Accident
1%
Syncope
1%
Haematuria
1%
Shock Haemorrhagic
1%
Mouth Haemorrhage
1%
Non-Cardiac Chest Pain
1%
Pleural Effusion
1%
Bacteraemia
1%
Clostridium Bacteraemia
1%
Erysipelas
1%
Gastroenteritis
1%
Toxicity To Various Agents
1%
Lumbar Vertebral Fracture
1%
Rib Fracture
1%
Rhabdomyolysis
1%
Sciatica
1%
Respiratory Failure
1%
Bronchopneumopathy
1%
Choking
1%
Haemothorax
1%
Injection Site Reaction
1%
Febrile Bone Marrow Aplasia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment Choice
Guadecitabine
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
~3840
Guadecitabine
2014
Completed Phase 3
~680
Find a Location
Who is running the clinical trial?
University of Southern CaliforniaLead Sponsor
936 Previous Clinical Trials
1,613,426 Total Patients Enrolled
1 Trials studying Liver Cancer
76 Patients Enrolled for Liver Cancer
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,945 Total Patients Enrolled
105 Trials studying Liver Cancer
26,544 Patients Enrolled for Liver Cancer
Van Andel Research InstituteOTHER
27 Previous Clinical Trials
5,134 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.
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