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Tests treatment safety and results for Osteosarcoma
Official title Study to Assess Safety and Efficacy of Vactosertib in Adolescents and Adults With Recurrent, Refractory or Progressive Osteosarcoma
ClinicalTrials.gov ID: NCT05588648
What this study is testing
What is Vactosertib?
Vactosertib is an investigational medicine, given as a twice-daily pill taken by mouth, being studied as a potential treatment for osteosarcoma.
Also referred to as TEW-7197.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- MP-VAC-209 is a Phase I/II, open label, single arm, multi-center study to assess safety, tolerability, and antitumor activity of vactosertib as a single agent in adolescents and adults with recurrent, refractory, or progressive osteosarcoma. Vactosertib is given orally, twice a day, to people 12 years of age and older who meet the criteria for study enrollment.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- people must meet all the following to be eligible for enrollment: Informed Consent/Assent Capable of giving signed informed consent which includes...
- people may be male or female and must be equal to or greater than 12 years of age. No large studies have evaluated the use of vactosertib in younger...
- people must have histologic verification of Osteosarcoma (OS)
- people must have measurable disease per RECIST 1.1 (Appendix C), documented by clinical, radiographic and histologic criteria, and have progressed...
- people must have recovered from the acute toxic effects with ≤ Grade 1 as defined by the National Cancer Institute Common Terminology Criteria for...
You likely can't join if
- The subject must be excluded from participating in the trial if:
- people who have moderate or severe cardiovascular disease
- people who have uncontrolled intercurrent illness, including but not limited to, ongoing or active infection requiring systemic therapy, symptomatic...
- people who have major abnormalities at the Investigator's discretion based on electrocardiogram (ECG)and Doppler ECHO and MUGA results at screening...
- people who have increase in brain natriuretic peptide (BNP) or increase in troponin (over 99th percentile upper reference limit) at Screening (based...
- people who have risk factors for ascending aortic aneurysm such as genetic disorder and trauma and risk factors for aortic stenosis
See the full eligibility criteria
Who can join
- people must meet all the following to be eligible for enrollment: Informed Consent/Assent Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed...
- people may be male or female and must be equal to or greater than 12 years of age. No large studies have evaluated the use of vactosertib in younger pediatric people, for this reason, children younger than 12 years of...
- people must have histologic verification of Osteosarcoma (OS)
- people must have measurable disease per RECIST 1.1 (Appendix C), documented by clinical, radiographic and histologic criteria, and have progressed, relapsed or become refractory to conventional therapy.
- people must have recovered from the acute toxic effects with ≤ Grade 1 as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0 of all prior chemotherapy and...
- Myelosuppressive chemotherapy: Must have adequate recovery of counts from previous treatment prior to entry onto this study.
- include adequate renal function, ECOG performance status 0-2, and either Lansky performance status of 50-100% (\<16 years old), or Karnofsky performance status 50-100% (≥16 years old). people who are unable to walk...
- people must have normal organ and marrow function as defined below: a. Adequate bone marrow function defined as: i. Peripheral absolute neutrophil count (ANC) ≥ 750/mcL ii. Platelet count ≥ 75,000/mcL (transfusion...
- people must have the ability to understand and the willingness to sign a written informed consent document if ≥ 18 years of age and an assent document if \< 18 years of age (per country).
- Renal laboratory inclusion:
- Relapsed osteosarcoma (first, second, third or any relapse, subject who have recovered from chemotherapy and any other investigational drug/agent treatment, radiotherapy or surgical procedure), with histological...
What rules you out
- The subject must be excluded from participating in the trial if:
- people who have moderate or severe cardiovascular disease
- people who have uncontrolled intercurrent illness, including but not limited to, ongoing or active infection requiring systemic therapy, symptomatic congestive heart failure (New York Heart Association Class III/IV)...
- people who have major abnormalities at the Investigator's discretion based on electrocardiogram (ECG)and Doppler ECHO and MUGA results at screening or within 14 days before screening. QT interval corrected for heart...
- people who have increase in brain natriuretic peptide (BNP) or increase in troponin (over 99th percentile upper reference limit) at Screening (based on the normal range of relevant study center)
- people who have risk factors for ascending aortic aneurysm such as genetic disorder and trauma and risk factors for aortic stenosis
- people who have a history of heart or aorta surgery
- people who have clinically significant gastrointestinal bleeding within 4 weeks before screening
- people who have a known history or suspected hypersensitivity to any excipients of the investigational product.
- people who have received prior treatment targeting the signaling pathway of TGF-β
- people who have a disease or condition that affects the mechanism of the investigational product, or are currently using or planning to use:
- Drugs that are exclusively or primarily eliminated by cytochrome P-450 isozyme (CYP) including CYP1A2, CYP2D6, CYP2B6, or CYP3A4 (Concurrent use of drugs that are known potent CYP3A4 inducers including but not limited...
- Drugs that are exclusively or primarily eliminated by UDP glucuronyltransferase (UGT) 1A1 (UGT1A1)
- Drugs that are substrates for the drug transporter multidrug resistance protein 1 (MDR1) have a narrow therapeutic window or are strong inhibitors of drug transporter MDR1
- people who are unable to swallow tablets
- people who have a history of or are suspected of drug abuse
- Female people of child-bearing potential who have a positive result on a pregnancy test at screening or are unable to agree to use an effective barrier method of birth control to avoid pregnancy during the study period...
- people, in the opinion of the Investigator, who are unsuitable to participate in the study
- people who were treated with other investigational products within 28 days before screening or within a period shorter than 5-times the half-life of the investigational product
- people currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study drug Note: people who have entered the...
- people taking prohibited medications when using vactosertib as following. A minimal washout period of 5 half-lives for the following drugs is recommended prior to the first dosing
- people with a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study...
- HIV-positive people and HIV-positive people on antiretroviral therapy are ineligible because of the risk for developing a lethal infection when treated with immunosuppressive therapy.
- Concurrent active/acute infection.
- Non-metastatic osteosarcoma (OS) for whom standard therapy are possible at the time of the study may be excluded.
- Chronic use of corticosteroids or other immunosuppressive agents. Note: High dose is defined as a prescription of \>5 mg oral prednisolone and long term as duration of treatment \>1 month (based on NICE. Corticosteroids...
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, United States
- Gyeonggi-do, South Korea
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cleveland, Ohio, United States; Gyeonggi-do, South Korea; Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.