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Hypoxia-activating Agent

Tirapazamine + Embolization for Liver Cancer

Phase 1 & 2
Recruiting
Led By Nadine Abi-Jaoudeh, MD
Research Sponsored by Teclison Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No limitation in hepatic lesion tumor size or number but the total volume of liver tumors cannot exceed 50% of the liver volume.
Age 20 or higher, ECOG functional status 0-1, and with no known major cardiac, pulmonary, or renal dysfunction.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new cancer treatment involving two drugs. The first drug is given before the second drug, which is used to block blood flow to the tumor. The treatment will be given to people with liver cancer who are eligible based on their health. The effects of the treatment will be monitored with MRIs.

Who is the study for?
This trial is for liver cancer patients with a good performance status (ECOG score 0-1) and adequate liver function (Child-Pugh A or B7). Candidates should have no more than 4 tumor nodules, no portal vein invasion, and be between ages 20-80. Prior treatments are allowed if there's progression, but not within the last 4 weeks. Excluded are those with certain neuroendocrine tumors or metastatic solid tumors.
What is being tested?
The study tests the optimal dose of Tirapazamine combined with Transarterial Embolization (TAE) in treating liver cancer. Patients receive Tirapazamine intra-arterially before embolization to target hypoxic tumor areas. The treatment's effect is monitored by MRI using mRECIST criteria, with repeat treatments based on disease progression.
What are the potential side effects?
Potential side effects include typical reactions related to embolization procedures such as post-embolization syndrome (fever, pain, nausea), as well as any specific reactions to Tirapazamine which may involve fatigue, nausea, and changes in blood counts leading to increased risk of infection or bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My liver tumors take up less than half of my liver.
Select...
I am 20 or older, can care for myself, and don't have serious heart, lung, or kidney problems.
Select...
I am eligible for TAE or TACE and do not have a blocked portal vein.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall Response rate (ORR) by RECIST
Secondary study objectives
Duration of Response
Overall Response Rate
Other study objectives
Progressive Free Survival
Response Rate in TATE-treated target lesions

Side effects data

From 2009 Phase 2 trial • 72 Patients • NCT00066742
82%
Hemoglobin
77%
Leukocytes (total WBC)
77%
Neutrophils/granulocytes (ANC/AGC)
77%
Fatigue (asthenia, lethargy, malaise)
67%
Hair loss/Alopecia (scalp or body)
62%
Platelets
46%
Nausea
33%
Weight loss
33%
Dysphagia (difficulty swallowing)
31%
Esophagitis
28%
Vomiting
23%
Magnesium, serum-low (hypomagnesemia)
23%
Dehydration
21%
Constipation
21%
Pain - Muscle
18%
Calcium, serum-low (hypocalcemia)
18%
Potassium, serum-low (hypokalemia)
15%
Diarrhea
15%
Anorexia
15%
Neuropathy: sensory
15%
Mucositis/stomatitis (functional/symptomatic) - Oral cavity
15%
Glucose, serum-high (hyperglycemia)
10%
Creatinine
10%
Taste alteration (dysgeusia)
10%
Febrile neutropenia
10%
Fever (in the absence of neutropenia, where neutropenia is defined as ANC lt1.0 x 10e9/L)
8%
Mucositis/stomatitis (clinical exam) - Oral cavity
8%
Dyspnea (shortness of breath)
8%
Sodium, serum-low (hyponatremia)
8%
Pain - Joint
8%
Hypotension
8%
Rigors/chills
5%
Hypoxia
5%
Pain - Abdomen NOS
5%
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Lung (pneumon
5%
Heartburn/dyspepsia
5%
Albumin, serum-low (hypoalbuminemia)
5%
Alkaline phosphatase
5%
ALT, SGPT (serum glutamic pyruvic transaminase)
3%
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Catheter-rela
3%
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Blood
3%
Hemorrhage, GI - Esophagus
3%
Syncope (fainting)
100%
80%
60%
40%
20%
0%
Study treatment Arm
Consolidation Cisplatin + Etoposide
Tirapazamine + Cisplatin + Etoposide + Concurrent Radiotherapy

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: TirapazamineExperimental Treatment2 Interventions
Intra-arterial administration with tirapazamine before embolization to evaluate the response in metastatic liver lesions of NET
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tirapazamine
2005
Completed Phase 3
~380

Find a Location

Who is running the clinical trial?

Teclison Ltd.Lead Sponsor
3 Previous Clinical Trials
170 Total Patients Enrolled
Nadine Abi-Jaoudeh, MDPrincipal InvestigatorUniv. of California, Irvine
5 Previous Clinical Trials
105 Total Patients Enrolled
Michael Soulen, MDPrincipal InvestigatorUniv. of Pennsylvania
2 Previous Clinical Trials
305 Total Patients Enrolled

Media Library

Tirapazamine (Hypoxia-activating Agent) Clinical Trial Eligibility Overview. Trial Name: NCT02174549 — Phase 1 & 2
Gastrointestinal Cancer Research Study Groups: Tirapazamine
Gastrointestinal Cancer Clinical Trial 2023: Tirapazamine Highlights & Side Effects. Trial Name: NCT02174549 — Phase 1 & 2
Tirapazamine (Hypoxia-activating Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02174549 — Phase 1 & 2
~2 spots leftby Dec 2025
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