A Study to Evaluate the Safety and Efficacy of Vactosertib and Imatinib in Patients With Advanced Desmoid Tumor

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hyo Song Kim; Yonsei University
• Treatments: Imatinib Mesylate

Criteria

Inclusion Criteria:

1. Histologically confirmed desmoid tumor (aggressive fibromatosis) not available for local treatment (surgical resection or radiation therapy)

2. Eastern Cooperative Oncology Group performance status of 0-1

3. Measurable lesion (RECIST 1.1.)

4. Adequate laboratory findings

5. 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.

6. Subjects must have ejection fraction ≥ 50% and no clinically significant valvular dysfunction

Exclusion Criteria:

1. Previous TGF-β inhibitor and/or imatinib exposed patient

2. Patient who has had chemotherapy, radiotherapy, or biological therapy within 2 weeks

3. Any unresolved chronic toxicity greater than grade 2 from previous anticancer therapy.

4. Has an active infection requiring systemic therapy

5. 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

6. Uncontrolled or active central nervous system metastasis and/or carcinomatous meningitis

7. Child-Pugh B or C liver cirrhosis

8. History of another primary malignancy.

9. 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).

10. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of investigational product(IP).

11. Current or prior use of immunosuppressive medication within 14 days before the first investigational product(IP).