A Study to Evaluate the Safety and Efficacy of Vactosertib and Imatinib in Patients With Advanced… (NCT03802084) | Clinical Trial Compass
CompletedPhase 1/2
A Study to Evaluate the Safety and Efficacy of Vactosertib and Imatinib in Patients With Advanced Desmoid Tumor
South Korea24 participantsStarted 2019-04-15
Plain-language summary
This is a phase I/II, open-label, non-randomized, multicentre study to evaluate the clinical activity of vactosertib plus imatinib in desmoid tumor. Based on the background, TGF-β inhibition as a potential therapeutic target for desmoid tumor and convey significant implications for the clinical development. Therefore, investigator will conduct the phase II trial of vactosertib in combined with imatinib in desmoid tumor.
Who can participate
Age range19 Years
SexALL
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Inclusion criteria
✓. Histologically confirmed desmoid tumor (aggressive fibromatosis) not available for local treatment (surgical resection or radiation therapy)
✓. Eastern Cooperative Oncology Group performance status of 0-1
✓. Measurable lesion (RECIST 1.1.)
✓. Patients with sufficient organ function according to laboratory findings
✓. All patients must be able to provide a newly acquired tumor biopsy during screening (preferred) or provide an available tumor sample taken ≤3 years prior to screening.
✓. Subjects must have ejection fraction ≥ 50% and no clinically significant valvular dysfunction
Exclusion criteria
✕. Previous TGF-β inhibitor exposed patient
✕. Patient who has had chemotherapy, radiotherapy, or biological therapy within 2 weeks
✕. Any unresolved chronic toxicity greater than grade 2 from previous anticancer therapy.
✕. Has an active infection requiring systemic therapy
✕. Uncontrolled intercurrent illness, including symptomatic congestive heart failure (NYHA Class III/IV), uncontrolled hypertension (≥150/90mmHg), unstable angina pectoris or myocardial infarction (≤ 6 months prior to screening), uncontrolled cardiac arrhythmia, cardiac valulopathy
✕
What they're measuring
1
adverse event
Timeframe: 4 weeks
2
clinical benefit rate was determined using RECIST 1.1