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Protein Kinase Inhibitor
Vactosertib for Osteosarcoma
Phase 1 & 2
Recruiting
Research Sponsored by MedPacto, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post two cycle of treatment, evaluation. through study completion, an average of 1 year.
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new drug to treat bone cancer in teens and adults; it's given orally twice daily to those who meet enrollment criteria.
Who is the study for?
This trial is for adolescents and adults aged 14 or older with recurrent, refractory, or progressive osteosarcoma. Participants must have normal organ and marrow function, measurable disease per RECIST 1.1 criteria, and be recovered from prior treatments' acute effects to ≤ Grade 1 toxicity (except certain conditions). They should not have uncontrolled illnesses or be on medications that could interfere with the study.
What is being tested?
The MP-VAC-209 study is testing the safety and effectiveness of an oral drug called Vactosertib in treating osteosarcoma that has returned or hasn't responded to treatment. It's a Phase I/II trial where all participants receive Vactosertib twice daily to evaluate its antitumor activity.
What are the potential side effects?
While specific side effects are not listed here, potential risks may include those commonly associated with cancer therapies such as nausea, fatigue, blood count changes, liver function alterations, and gastrointestinal issues due to the oral nature of Vactosertib.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ post two cycle of treatment, evaluation. through study completion, an average of 1 year.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post two cycle of treatment, evaluation. through study completion, an average of 1 year.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Dose finding associated with the overall nature and severity of AEs associated with treatment.
Secondary study objectives
Overall survival.
Time to response(TTR)
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: Single ArmExperimental Treatment1 Intervention
Single arm, open-label, no blinding or randomization procedure will be involved.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vactosertib
2017
Completed Phase 1
~20
Find a Location
Who is running the clinical trial?
MedPacto, Inc.Lead Sponsor
10 Previous Clinical Trials
500 Total Patients Enrolled
Timothy Allen, MD, PHDStudy ChairMedPacto, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have recovered from previous cancer treatments, except for hair loss, loss of appetite, bone, or tumor pain.My kidneys work well, I don't have an active infection, and I can do most activities on my own.I do not have any severe ongoing illnesses that my doctor has told me are not under control.My organ and bone marrow functions are normal.My diagnosis of osteosarcoma has been confirmed through tissue examination.I am 14 years old or older.My blood cell counts have recovered from my last chemotherapy.I have had heart or aorta surgery in the past.I have risk factors for aortic aneurysm or stenosis, like genetic conditions or past trauma.I have had serious bleeding in my stomach or intestines in the last month.I have moderate or severe heart disease.I have received treatment targeting the TGF-β pathway before.I can understand and am willing to sign the consent form.I don't use drugs affecting CYP enzymes, can swallow tablets, don't abuse drugs, agree to use birth control, haven't been in a drug study recently, am not allergic to vactosertib, and don't have HIV.My cancer can be measured, has gotten worse or hasn't responded to standard treatments.I weigh more than 30 kilograms.
Research Study Groups:
This trial has the following groups:- Group 1: Single Arm
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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