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Tyrosine Kinase Inhibitor
Tivozanib for Biliary Tract Cancer
Phase 1 & 2
Recruiting
Led By Jonathan M Hernandez, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >=18 years.
Patients with histologically or cytologically confirmed biliary tract cancer (BTC) (cholangiocarcinoma or gallbladder cancer). Archival tumor sample may be used but if archival tissue is not available or is not adequate, tissue biopsy will be required.
Must not have
Complex biliary obstruction requiring bile duct stents at more than one level of the biliary tree or external biliary drainage.
Pregnant or lactating women. Pregnant women are excluded from this study because based on findings in animals and its mechanism of action, tivozanib can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, administration of tivozanib to pregnant rats caused adverse developmental outcomes including embryo- fetal mortality. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with tivozanib, breastfeeding should be discontinued if the mother is treated with tivozanib. These potential risks may also apply to other agents used in this study.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 8 weeks (phase i only)
Awards & highlights
No Placebo-Only Group
Summary
This trial will test if the cancer drug tivozanib can safely and effectively treat cholangiocarcinoma.
Who is the study for?
Adults over 18 with inoperable biliary tract cancer (BTC), including cholangiocarcinoma or gallbladder cancer, who have already tried at least one chemotherapy. They must be able to perform daily activities to a certain extent and have adequate organ function. Women of childbearing potential must test negative for pregnancy and agree to use contraception.
What is being tested?
The trial is testing the safety and effectiveness of Tivozanib, an oral medication taken once daily for three weeks per cycle, with each cycle lasting four weeks. The goal is to determine the best dose that can manage BTC without causing severe side effects.
What are the potential side effects?
Potential side effects include high blood pressure which participants will monitor at home twice daily. Other risks may involve harm to organs like the liver or heart based on Tivozanib's mechanism of action seen in animal studies.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have confirmed biliary tract cancer and can provide a tissue sample.
Select...
My cholangiocarcinoma cannot be surgically removed.
Select...
I agree to use effective birth control or abstain from sex during and for 1 month after the study.
Select...
I can take care of myself but might not be able to do heavy physical work.
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I have received first-line chemotherapy treatment.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have multiple bile duct blockages and need more than one stent or external drainage.
Select...
I am not pregnant or breastfeeding.
Select...
I had hepatitis C but am cured, or I'm being treated with no detectable virus.
Select...
I do not have serious blood, stomach, clotting, or bleeding disorders.
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I have had more than one cholangitis episode in the last 3 months.
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I have been treated with Tivozanib before.
Select...
I haven't had brain issues due to liver disease or needed medicine for it in the last year.
Select...
I have chronic hepatitis B with an undetectable viral load and am on suppressive therapy if needed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 8 weeks (phase i only)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 8 weeks (phase i only)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Phase I: Determine safety and establish the recommended Phase II dose (RP2D) of tivozanib in patients with cholangiocarcinoma who were previously treated with first-line chemotherapy.
Phase II: Determine the overall response rate by RECIST of tivozanib in patients with cholangiocarcinoma who were previously treated with first-line therapy.
Secondary study objectives
Evaluate disease control response (DCR- complete response [CR] plus partial response [PR] plus stable disease [SD]) in patients with cholangiocarcinoma treated with tivozanib
Evaluate overall survival (OS) in patients with cholangiocarcinoma treated with tivozanib
Side effects data
From 2014 Phase 3 trial • 277 Patients • NCT0107601025%
Hypertension
14%
Diarrhoea
13%
Fatigue
12%
Asthenia
10%
Palmar-plantar erythrodysaesthesia syndrome
6%
Dysphonia
6%
Cough
6%
Decreased appetite
6%
Dyspnoea
2%
Renal cancer
2%
Neoplasm progression
2%
Anaemia
1%
Bronchitis
1%
Cerebral infarction
1%
Respiratory failure
1%
Bone pain
1%
Head injury
1%
Cardio-respiratory arrest
1%
Hypoglycaemia
1%
Jaundice cholestatic
1%
Metastases to soft tissue
1%
Pathological fracture
1%
Ischaemic stroke
1%
Metastases to pleura
1%
Apnoea
1%
Pneumothorax
1%
General physical health deterioration
1%
Transient ischaemic attack
1%
Hypokalaemia
1%
Metastases to the mediastinum
1%
Pleural effusion
1%
Hypercalcaemia
1%
Bile duct stone
1%
Cholangitis
1%
Acute myocardial infarction
1%
Aortic aneurysm
1%
Pulmonary embolism
1%
Death
1%
Multi-organ failure
1%
Pelvic venous thrombosis
1%
Body temperature increased
1%
Cardiopulmonary failure
1%
Myocardial infarction
1%
Cardiac failure
1%
Arteriosclerosis coronary artery
1%
Delusional disorder, somatic type
1%
Pleurisy
1%
Sepsis
1%
Myxoedema
1%
Pancreatitis acute
1%
Vena cava thrombosis
1%
Skin lesion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sorafenib Crossover to Tivozanib
First Line Tivozanib
First Line Sorafenib
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: 2/ Phase IIExperimental Treatment1 Intervention
Tivozanib at the RP2D established in Phase I
Group II: 1/ Phase IExperimental Treatment1 Intervention
Tivozanib, P.O. daily at 0.89 mg (given on Days 1-21 of every 28-day cycle) with intra-patient escalation to 1.34 mg daily (given on Days 1-21 of every 28-day cycle) and possible dose de-escalation to 0.89 mg every other day (without interruption for a 28-day cycle) if needed to determine RP2D
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tivozanib
2010
Completed Phase 3
~810
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,928 Previous Clinical Trials
41,018,007 Total Patients Enrolled
6 Trials studying Biliary Cancers
508 Patients Enrolled for Biliary Cancers
Jonathan M Hernandez, M.D.Principal InvestigatorNational Cancer Institute (NCI)
4 Previous Clinical Trials
1,920 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have multiple bile duct blockages and need more than one stent or external drainage.I have confirmed biliary tract cancer and can provide a tissue sample.My cholangiocarcinoma cannot be surgically removed.My blood pressure is controlled and hasn't required medication changes for at least 14 days.I am not pregnant or breastfeeding.I do not have an active cancer other than certain skin cancers, chronic lymphocytic leukemia not needing treatment, or thyroid cancer.I had hepatitis C but am cured, or I'm being treated with no detectable virus.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I do not have serious heart problems like recent heart attacks or uncontrolled high blood pressure.You have had allergic reactions or known allergies to drugs that are similar to tivozanib.I have not fully recovered from a major surgery within the last 4 weeks.I haven't had GI bleeding or have been treated for it if at high risk.I am HIV positive, on treatment, and my viral load is undetectable.I do not have serious blood, stomach, clotting, or bleeding disorders.I am not on blood thinners except for low-dose heparin, aspirin, or factor Xa inhibitors.I agree to use effective birth control or abstain from sex during and for 1 month after the study.I have had more than one cholangitis episode in the last 3 months.I haven't had cancer other than skin, cervical in situ, CLL, or thyroid cancer in the last 3 years.I can take care of myself but might not be able to do heavy physical work.My organs and bone marrow are working well.I have been treated with Tivozanib before.I haven't had chemotherapy, radiation, or taken cancer pills in the last 2 weeks.I haven't had brain issues due to liver disease or needed medicine for it in the last year.I have chronic hepatitis B with an undetectable viral load and am on suppressive therapy if needed.I have received first-line chemotherapy treatment.
Research Study Groups:
This trial has the following groups:- Group 1: 1/ Phase I
- Group 2: 2/ Phase II
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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