DermoidPhase 2MP-VAC-206NCT06219733
Vactosertib and Imatinib Combination in Patients with Advanced Desmoid Tumor/aggressive Fibromatosis (DT/AF)
A Phase 2 study testing Vactosertib and Imatinib in people with Dermoid, run by MedPacto, Inc. at 1 site in South Korea.
Trial summary
Vactosertib and imatinib combination in patients with advanced desmoid tumor/aggressive fibromatosis (DT/AF) compared with imatinib monotherapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dermoid
- What is being tested?
- Vactosertib and Imatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2021to 23 May 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Be capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Provision of signed and dated, written informed consent form prior to any mandatory study specific procedures, sampling, and analyses.
- Have diagnosed with DT/AF histologically.
- Meet one of the following criteria to be eligible:
- Progression by radiographic image by RECIST v1.1 or increase in tumor size equal to, or greater than (≥) 10% within 6 months prior to C1D1
- Patients with documented symptomatic disease related to DT/AF including pain, limitation of function, etc.
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- Have at least one measurable lesion based on RECIST v1.1: Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
- Have a performance status of ≤ 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
- Be able to swallow tablets and absorb vactosertib and imatinib.
- Have adequate organ function as indicated by the following laboratory values
- Have no history of additional malignancy that is progressing or has required active treatment within the past 3 years, with the exception of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or in situ cervical cancer, or have undergone potentially curative therapy with no evidence of that disease recurrence.
- Be able to provide a newly acquired (within 6 months prior to C1D1) tumor sample during screening (preferred) or provide an available archived tumor sample. At least 10 subjects in each treatment group should be able to provide newly acquired (within 6 months prior to C1D1) tumor sample. Tumor lesions used for newly acquired biopsies should not be target lesions, unless there are no other lesions suitable for biopsy, and in this instance only core needle (not excisional/incisional) biopsy is allowed. Samples with limited tumor content and fine needle aspirate specimens are not acceptable. The tumor specimen should be of sufficient quantity to allow for exploratory biomarker analyses and is preferred in formalin fixed paraffin embedded blocks.
- For a female of childbearing potential, have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required (Refer to Section 4.6.2).
- For a female of childbearing potential, be willing to use an adequate method of contraception as outlined in the protocol for the course of the study through 90 days after the last dose of study treatment.
- For a male subject with a female partner(s) of child-bearing potential, must agree to use an adequate method of contraception as outlined in the protocol, starting with the first dose of study therapy through 90 days after the last dose of study therapy. Males with pregnant partners must agree to use an adequate method according to the protocol (Refer to Section 4.6.2) no additional method of contraception is required for the pregnant partner.
Who cannot join
- Is 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 treatment.
- Note: Subjects who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
- Has exposed to vactosertib or imatinib for treatment purpose
- Before the first dose of trial treatment (<2 weeks prior to first dose):
- Has received prior systemic cytotoxic chemotherapy
- Has received antineoplastic biological therapy
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- Had major surgery *Note: Subjects should recover from therapy related toxicity to less than CTCAE Grade 2 in order to participate in this trial.
- Is taking prohibited medications when using vactosertib as following (Refer to Appendix D Prohibited Concurrent Medications with Vactosertib (Ver 06Mar2020)
- A minimal washout period of 5 half-lives for the following drugs is mandatory prior to the first dosing.
- Concurrent use of drugs or foods that are known strong CYP3A4 inhibitors including but not limited to grapefruit juice, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, voriconazole. The topical use of these medications (if applicable), such as 2% ketoconazole cream, may be allowed.
- Concurrent use of drugs that are known potent CYP3A4 inducers including but not limited to phenytoin, rifampin, St. John's wort.
- Concurrent use of drugs that are CYP3A4, CYP1A2, CYP2B6 substrates with narrow therapeutic indices including but not limited to theophylline, astemizole, cisapride, cyclosporine, dihydroergotamine, ergotamine, sirolimus, tacrolimus, terfenadine (astemizole, cisapride, and terfenadine have been withdrawn from the US market).
- Concurrent use of drugs that are sensitive CYP3A4, CYP1A2, CYP2B6 substrates including but not limited to efavirenz, darunavir, dasatinib, everolimus, lopinavir, midazolam, sirolimus, ticagrelor.
- Has severe hypersensitivity to vactosertib, imatinib, and/or any of its excipients
- Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
- Has an active infection requiring systemic therapy. Has a known history of Hepatitis B (defined as HBsAg reactive) or known active Hepatitis C virus (defined as HCV RNA is detected) infection.
- Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association Class III/IV), uncontrolled hypertension (≥150/90mmHg), unstable angina pectoris or myocardial infarction (≤6 months prior to screening), uncontrolled cardiac arrhythmia, clinically significant cardiac valvulopathy requiting treatment, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the subject to give written informed consent.
- QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥450 ms in male and ≥470 ms in female calculated from 12-lead ECGs.
- Has 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, or is not in the best interest of the subject to participate, in the opinion of the treating Investigator.
- Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study.
- Has been unable to comply with study procedures (including, but not limited to, the completion of patient report outcomes (PROs) or the PRO questionnaires are not available in the subject's preferred language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II, Open-Label, Randomized, Controlled Study to Evaluate Efficacy and Safety of Vactosertib and Imatinib Combination in Patients with Advanced Desmoid Tumor (Aggressive Fibromatosis) Compared with Imatinib Monotherapy
Vactosertib and imatinib combination in patients with advanced desmoid tumor/aggressive fibromatosis (DT/AF) compared with imatinib monotherapy
Read the detailed description
This is an open-label, multi-center, randomized controlled study to evaluate the safety and efficacy of vactosertib 200 mg BID in combination with imatinib versus imatinib alone.
- Conditions
- Dermoid
- Being tested
- Vactosertib, Imatinib
- Medical subject headings
- Dermoid Cyst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VactosertibDrug
200 mg PO BID 5 days on / 2 days off
ImatinibDrug
Imatinib 400 mg PO QD daily
| Study group | Role | What they receive |
|---|---|---|
| Vactosertib and imatinib combination | Experimental | Vactosertib 200 mg PO BID 5 days on / 2 days off in combination with imatinib 400 mg PO QD daily Receives: Drug: Vactosertib |
| Imatinib alone | Active comparator | Imatinib 400 mg PO QD daily Receives: Drug: Imatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
To evaluate the progression-free survival (PFS) of vactosertib and imatinib combination compared with imatinib alone up to 2 years. The subject will be assessed until disease progression is observed or death, which comes first. The disease progression will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Criteria. The date of progression will be determined by a blinded, independent, central radiologic review (BICR).
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start1 Jun 2021
- Primary completion23 May 2022
- Study completion23 May 2022
Why it stopped: Changing trial strategy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DermoidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 allocation into two arms
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedPacto, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sunjin Hwang, MD, Study director, MedPacto, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06219733
- Sponsor's protocol ID
- MP-VAC-206
- Acronym
- MP-VAC-206
- Status last verified
- Dec 2024
- First submitted
- 12 Jan 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-Label, Randomized, Controlled Study to Evaluate Efficacy and Safety of Vactosertib and Imatinib Combination in Patients with Advanced Desmoid Tumor (Aggressive Fibromatosis) Compared with Imatinib Monotherapy
- ClinicalTrials.gov ID
- NCT06219733
- Acronym / sponsor ID
- MP-VAC-206 / MP-VAC-206
- Conditions
- Dermoid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Changing trial strategy
- Enrolment
- 0 participants (actual)
- Lead sponsor
- MedPacto, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 23 May 2022 (actual)
- Study completion
- 23 May 2022 (actual)
- First posted
- 23 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vactosertib and imatinib combination in patients with advanced desmoid tumor/aggressive fibromatosis (DT/AF) compared with imatinib monotherapy
Detailed description
This is an open-label, multi-center, randomized controlled study to evaluate the safety and efficacy of vactosertib 200 mg BID in combination with imatinib versus imatinib alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1 allocation into two arms
| Arm | Type | Receives |
|---|---|---|
| Vactosertib and imatinib combination | Experimental | Drug: VactosertibVactosertib 200 mg PO BID 5 days on / 2 days off in combination with imatinib 400 mg PO QD daily |
| Imatinib alone | Active comparator | Drug: ImatinibImatinib 400 mg PO QD daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age ≥ 18 years
- Be capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Provision of signed and dated, written informed consent form prior to any mandatory study specific procedures, sampling, and analyses.
- Have diagnosed with DT/AF histologically.
- Meet one of the following criteria to be eligible:
- Have at least one measurable lesion based on RECIST v1.1: Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
Key exclusion criteria (21 listed)
- Is 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 treatment.
- Note: Subjects who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
- Has exposed to vactosertib or imatinib for treatment purpose
- Before the first dose of trial treatment (<2 weeks prior to first dose):
- Is taking prohibited medications when using vactosertib as following (Refer to Appendix D Prohibited Concurrent Medications with Vactosertib (Ver 06Mar2020)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vactosertib200 mg PO BID 5 days on / 2 days off | Drug | Vactosertib and imatinib combination |
| ImatinibImatinib 400 mg PO QD daily | Drug | Imatinib alone |
Primary outcome
progression-free survival
Time frame: 28 days
To evaluate the progression-free survival (PFS) of vactosertib and imatinib combination compared with imatinib alone up to 2 years. The subject will be assessed until disease progression is observed or death, which comes first. The disease progression will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Criteria. The date of progression will be determined by a blinded, independent, central radiologic review (BICR).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sunjin Hwang, MD study director
MedPacto, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vactosertib and Imatinib in people with Dermoid, run by MedPacto, Inc. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.