A study to evaluate the safety and efficacy of Vactosertib and Imatinib in patients with advanced desmoid tumor (aggressive fibromatosis)

A Phase 1b/2a, Open-label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of Vactosertib in Combination with Imatinb in Patients with Advanced Desmoid Tumor (aggressive fibromatosis)

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0003449

Enrollment

Registered

2019-01-25

Start date

2019-04-15

Completion date

Unknown

Last updated

2024-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Phase 1 : About 3-6 patients enrollment is expected at dose 1 and -1. Dose escalation will be preceded with 3 patients/cohort until the first DLT with 3 weeks’ observation. The recommend phase

Eligibility

Sex/Gender

All

Inclusion 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-Response evaluation criteria criteria in solid tumors 1.1.) 4. Adequate laboratory findings -Hb = 9.0 g/dL -Absolute neutrophil count (ANC) = 1000 /µL -Platelet = 75,000/ µL -Total Bilirubin: = 1.5 × UNL (upper normal limit) (= 2 × UNL in patients with liver metastasis) -Serum Creatinine 1) =1.5 X ULN OR 2) for > 1.5 X ULN : measured creatinine clearance (CL) >50 mL/min (by 24h urine test or Calculated creatinine clearance [CL] ) -AST(SGOT)/ALT(SGPT): = 3.0 × UNL or = 5.0 × UNL (in patients with liver metastasis) -Alkaline Phosphatase (ALP): = 3.0 × UNL or = 5.0 × UNL (in patients with liver or bone metastasis) 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

Exclusion criteria: 1. Previous TGF-ß 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 CTC 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 CNS 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 IP 10. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. 11. Current or prior use of immunosuppressive medication within 14 days before the first IP.

Design outcomes

Primary

Measure	Time frame
Phase 1: To evaluate the safety and tolerability of vactosertib in combination with imatinib including estimation of the maximum tolerated dose (MTD) and/or characterization of DLTs.;Phase 2 : Clinical benefic rate	—

Secondary

Measure	Time frame
Adverse event	—

Countries

Korea, Republic of

Contacts

Public ContactHyosong Kim

Yonsei University Health System, Severance Hospital

hyosong77@yuhs.ac+82-2-2228-8124

Outcome results