WithdrawnPhase 2

Vactosertib and Imatinib Combination in Patients with Advanced Desmoid Tumor/aggressive Fibromatosis (DT/AF)

Stopped: Changing trial strategy

South Korea0Started 2021-06-01

Plain-language summary

Vactosertib and imatinib combination in patients with advanced desmoid tumor/aggressive fibromatosis (DT/AF) compared with imatinib monotherapy

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.
✓. 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.

✕. 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.
✕. 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
✕. 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.

progression-free survival

Timeframe: 28 days

NCT IDNCT06219733

SponsorMedPacto, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-05-23

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.
✓. 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.

✕. 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.
✕. 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
✕. 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.