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Beta-catenin/TBL1 Inhibitor
Tegavivint for Recurrent or Refractory Cancer
Phase 1 & 2
Recruiting
Led By Sarah B Whittle
Research Sponsored by Children's Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or a creatinine based on age/gender as follows (within 7 days prior to enrollment):
PART A: Patients must be >= 12 months and =< 21 years of age at the time of study enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 60 months
Awards & highlights
Study Summary
This trial is testing a new drug to see if it can stop the growth of cancer cells.
Who is the study for?
This trial is for young people aged up to 21 or 30 years with recurrent or refractory solid tumors, including lymphomas and desmoid tumors. They must have measurable disease, be recovered from previous cancer treatments, meet specific blood count criteria, and not have severe bone diseases or uncontrolled infections. Pregnant individuals can't participate and those of reproductive potential must use effective birth control.Check my eligibility
What is being tested?
The trial is testing Tegavivint's highest safe dose and its effects on patients with stubborn solid tumors that resist treatment. Tegavivint aims to block tumor growth by disrupting signals within cells that encourage cell proliferation.See study design
What are the potential side effects?
Possible side effects include reactions related to the disruption of cellular signaling which could affect organ function but specifics are not detailed in the provided information.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function is good based on recent tests.
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I am between 12 and 21 years old.
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I have a confirmed diagnosis of a solid tumor, non-Hodgkin lymphoma, or desmoid tumor that has come back or did not respond to treatment.
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I am between 12 months and 30 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 60 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 60 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Area under the drug concentration curve of tegavivint
Frequency of adverse events attributable to tegavivint
Frequency of dose limiting toxicities of tegavivint
Secondary outcome measures
Antitumor effects of tegavivint in patients with solid tumors
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (tegavivint)Experimental Treatment4 Interventions
Tegavivint will be administered IV over 4 hours on days 1, 8, and 15 of each cycle. Administer D5W flush after completion of each tegavivint infusion. Treatment repeats every 28 days for up to 26 cycles or 24 months in the absence of disease progression or unacceptable toxicity. Drug doses should be adjusted based on the weight (height and BSA will also be captured) measured within 7 days prior to the beginning of each cycle. The starting dose will be 5 mg/kg with dose levels for subsequent cohorts increasing to 6.5 mg/kg and 8 mg/kg if excessive toxicity does not occur. If the MTD has been exceeded at the first dose level, then the subsequent cohort of patients will be treated at a dose of 4 mg/kg. Patients undergo an x-ray at baseline, after cycle 1, and then every 3 cycles while on treatment and DEXA scan at baseline and every 6 cycles while on treatment, then at 12 months, 24 months, and annually up to 60 months following end of therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1720
Dual X-ray Absorptiometry
2015
N/A
~50
Tegavivint
2018
Completed Phase 1
~30
Find a Location
Who is running the clinical trial?
Children's Oncology GroupLead Sponsor
456 Previous Clinical Trials
239,639 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,703 Previous Clinical Trials
40,931,603 Total Patients Enrolled
75 Trials studying Endometrial Cancer
73,374 Patients Enrolled for Endometrial Cancer
Sarah B WhittlePrincipal InvestigatorPediatric Early Phase Clinical Trial Network
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a tumor that cannot be removed by surgery or is dangerous, and it can be measured.I do not have a known metabolic bone disease.I do not have brain metastasis, except for craniopharyngeal tumors.I have a tumor that cannot be removed by surgery or is serious enough to consider treatment.I am not taking medication to prevent graft-versus-host disease after a bone marrow transplant.I have had a stem cell infusion, with or without full-body radiation.I do not have any infections that are not under control.I have a solid tumor, non-Hodgkin lymphoma, or desmoid tumor that has not responded to treatment.My kidney function is good based on recent tests.I am between 12 and 21 years old.I am not pregnant or breastfeeding and will use two forms of birth control during the study.I have a confirmed diagnosis of a solid tumor, non-Hodgkin lymphoma, or desmoid tumor that has come back or did not respond to treatment.I have a specific type of cancer or genetic mutation listed for PART B.My bilirubin levels are within the normal range for my age.My calcium levels are normal or can be corrected with oral supplements.I have recovered from previous cancer treatments and meet the required health criteria.I do not have a condition that affects how my bones process minerals.Your SGPT (ALT) level in your blood should be no higher than 135 U/L, with the normal upper limit being 45 U/L.Your albumin level in your blood is at least 2 g/dL within the last 7 days before joining the study.I have been on a stable or decreasing dose of corticosteroids for at least 7 days.I can join the study if my blood counts are okay, even with bone marrow cancer.I will take vitamin D (and calcium if needed) supplements if my levels are low.I do not have severe osteoporosis.I am between 12 months and 30 years old.I have not taken bisphosphonates in the last 4 weeks.I have not taken denosumab in the last 6 months.I do not have a primary brain tumor.I can take care of myself but might not be able to do active work.I am not taking any strong medication that affects enzyme CYP3A4.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (tegavivint)
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.
Is this trial taking place in more than one state?
"There are a number of hospitals participating in this trial, 20 in total. Some notable locations include Children's Hospital Colorado in Aurora, UCSF Medical Center-Mission Bay in San Francisco, and Children's Hospital of Alabama in Birmingham."
Answered by AI
For this particular test, are older individuals welcome to participate?
"According to the eligibility requirements, patients who wish to participate in this trial must be between 12 months and 30 years old. Out of the 11,076 total clinical trials taking place, 1,089 are for people under 18 while 9,187 are for those over 65."
Answered by AI
How many candidates will be allowed to enroll in the research?
"In order for this research to be conducted, 147 individuals that fit the pre-determined inclusion criteria must participate. These potential participants can be found at Children's Hospital Colorado in Aurora, Colorado and UCSF Medical Center-Mission Bay in San Francisco, California among other locations."
Answered by AI
Which type of person is this research looking for?
"This clinical trial is looking for 147 individuals that have been diagnosed with wilms tumor. The patients must be between 12 months and 30 years old, though there are different age requirements depending on which part of the study they hope to enroll in. Furthermore, candidates should meet one or more of the following criteria: having relapsed or refractory solid tumors (including non-Hodgkin lymphoma and desmoid tumors), being12 months to 21 years old at time of enrollment (for PART A), being recurrent or refractory Ewing sarcoma, desmoid tumors, osteosarcoma, liver tumors ("
Answered by AI
Are people still being accepted into the trial program?
"According to the information displayed on clinicaltrials.gov, this trial is still looking for participants. The study was first advertised on October 25th 2021 and was last updated September 22nd 2022. So far, 147 patients have been recruited from 20 different centres."
Answered by AI
Who else is applying?
What portion of applicants met pre-screening criteria?
Did not meet criteria
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