Status:
COMPLETED
A Study to Evaluate the Safety and Efficacy of Vactosertib and Imatinib in Patients With Advanced Desmoid Tumor
Lead Sponsor:
Hyo Song Kim
Conditions:
Desmoid Tumor
Eligibility:
All Genders
19+ years
Phase:
PHASE1
PHASE2
Brief 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 pote...
Detailed Description
Desmoid tumor (aggressive fibromatosis) is a mesenchymal neoplasm associated with mutations, resulting in -catenin-mediated transcriptional activation. It is composed of a clonal proliferation of mese...
Eligibility Criteria
Inclusion
- 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
- Hemoglobin ≥ 9.0 g/dL
- Neutrophils ≥ 1000 /µL
- Platelets ≥ 75,000/µL
- Total Bilirubin ≤ 1.5 × UNL (upper normal limit): For patients with liver metastases, ≤2
- Serum creatinine ≤1.5 X ULN or \> 1.5 X Creatinine Clearance ≥50 mL/min for ULN patients (based on 24-hour urinalysis or Cockroft-Gault Formula calculations)
- AST(SGOT)/ALT(SGPT) ≤ 3.0 × UNL or ≤ 5.0 × UNL (for patients with liver or bone metastases)
- Alkaline Phosphatase (ALP): ≤ 3.0 × UNL or ≤ 5.0 × UNL (for patients with liver or bone metastases)
- 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
- 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
- Uncontrolled or active central nervous system metastasis and/or carcinomatous meningitis
- Child-Pugh B or C liver cirrhosis
- History of another primary malignancy.
- Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of investigational product(IP).
- Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of investigational product(IP).
- Current or prior use of immunosuppressive medication within 14 days before the first investigational product(IP).
Key Trial Info
Start Date :
April 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 26 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03802084
Start Date
April 15 2019
End Date
March 26 2024
Last Update
May 13 2024
Active Locations (1)
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1
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 03722