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Hypoxia-activating Agent

Tirapazamine + Embolization for Liver Cancer

Phase 1 & 2

Waitlist Available

Led By Michael Soulen, 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

Study 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.Check my eligibility

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.See study design

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

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My liver tumors take up less than half of my liver.

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I am 20 or older, can care for myself, and don't have serious heart, lung, or kidney problems.

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I am eligible for TAE or TACE and do not have a blocked portal vein.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Response rate (ORR) by RECIST

Secondary outcome measures

Duration of Response

Overall Response Rate

Other outcome measures

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)

Dyspnea (shortness of breath)

Mucositis/stomatitis (clinical exam) - Oral cavity

Sodium, serum-low (hyponatremia)

Pain - Joint

Hypotension

Rigors/chills

Pain - Abdomen NOS

Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Lung (pneumon

Hypoxia

Heartburn/dyspepsia

Albumin, serum-low (hypoalbuminemia)

Alkaline phosphatase

ALT, SGPT (serum glutamic pyruvic transaminase)

Hemorrhage, GI - Esophagus

Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Blood

Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Catheter-rela

Syncope (fainting)

100%

80%

60%

40%

20%

Study treatment Arm

Consolidation Cisplatin + Etoposide

Tirapazamine + Cisplatin + Etoposide + Concurrent Radiotherapy

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Teclison Ltd.Lead Sponsor

3 Previous Clinical Trials

298 Total Patients Enrolled

Michael Soulen, MDPrincipal InvestigatorUniv. of Pennsylvania

2 Previous Clinical Trials

305 Total Patients Enrolled

Nadine Abi-Jaoudeh, MDPrincipal InvestigatorUniv. of California, Irvine

4 Previous Clinical Trials

203 Total Patients Enrolled

1 Trials studying Liver Cancer

Media Library

Tirapazamine (Hypoxia-activating Agent) Clinical Trial Eligibility Overview. Trial Name: NCT02174549 — Phase 1 & 2

Liver Cancer Research Study Groups: Tirapazamine

Liver 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research trial accept individuals who are younger than 60 years of age?

"For this trial, candidates must be aged between 20-80 years old."

Answered by AI

Can you provide a summary of previous research into the use of Tirapazamine?

"As of current, two clinical studies involving Tirapazamine are active; none have reached phase 3. All trials are being conducted in Orange, California but they span across three different locations."

Answered by AI

Are there opportunities for recruitment in this investigation?

"Unfortunately, this experiment has concluded its recruitment process. Originally posted on September 1st 2014 and last updated April 25th 2022, it is not currently accepting participants. However, 1083 trials are available for those hoping to join a study looking at neuroendocrine tumors; two studies offer Tirapazamine as well."

Answered by AI

Might I be a suitable candidate for this experiment?

"This medical trial is searching for 50 individuals aged between 20 and 80 who have neuroendocrine tumors."

Answered by AI

How many participants is the clinical trial enrolling?

"Unfortunately, this research project is no longer accepting participants. It was originally made available on September 1st 2014 and last updated April 25th 2022. Nevertheless, for those looking to take part in clinical trials related to neuroendocrine tumors or Tirapazamine there are currently 1083 studies open and 2 trials recruiting respectively."

Answered by AI

Does this medical experiment represent a groundbreaking approach?

"Since 2014, Tirapazamine has been subject to clinical trials. Initially funded by Teclison Ltd., the first trial in 2014 involved 50 patients and eventually earned FDA approval for Phase I & II drugs. Currently, two active studies are taking place across two cities within one country."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Dose-defining Study of Tirapazamine Combined With Embolization in Liver Cancer

2014. "Dose-defining Study of Tirapazamine Combined With Embolization in Liver Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02174549.

All > Liver Cancer > Neuroendocrine Tumor