A Study of Durvalumab in Combination With Doxorubicin for Advanced Soft Tissue Sarcoma (NCT03802071) | Clinical Trial Compass
CompletedPhase 1/2
A Study of Durvalumab in Combination With Doxorubicin for Advanced Soft Tissue Sarcoma
South Korea44 participantsStarted 2019-09-16
Plain-language summary
The yearly incidence of soft-tissue sarcomas (STS) in the USA is roughly 11,280 cases, and metastatic STS have a median overall survival of about 12 months. Sarcomas of the soft tissue are a heterogeneous group of malignant tumors of mesenchymal origin that originate in connective tissue. Local control with wide surgical resection with or without adjuvant radiation has a success rate of close to 90%. However, approximately 40% to 50% of patients with a large (\>5 cm), deep, high-grade soft-tissue sarcoma eventually develop distant metastases, primarily in the lung. Therefore, overall survival of metastatic STS remained still poor, less than 1 year. Therefore, current clinical trials with various targeted agents are ongoing add on the doxorubicin monotherapy.
Investigator planned to conduct the phase I/II trial of durvalumab in combination with standard chemotherapy, doxorubicin for metastatic/recurred sofe tissue sarcoma.
Who can participate
Age range19 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.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
✓. Measurable disease by Response Evaluation Criteria in Solid Tumors Version 1.1
✓. Body weight \>30kg
✓. Adequate normal organ and marrow function as defined below:
✓. Left ventricular ejection fraction (LVEF) ≥ 45%
✓. Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause.
✓. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
Exclusion criteria
✕. Histologically- or cytologically-confirmed Kaposi's sarcoma or GIST
✕. Participation in another clinical study with an investigational product during the last 2 weeks
✕. Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) 14 days prior to the first dose of study drug
✕. Any previous treatment with a PD1 or PD-L1 inhibitor (including durvalumab) and/or PDGFR inhibitor
✕. Mean QT interval corrected for heart rate (QTc) \> 480 ms calculated from 3 electrocardiograms (ECGs) using Fridericia's Correction
✕. Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
✕. Any concurrent chemotherapy, biologic, or hormonal therapy for cancer treatment within 14 days prior to entering the study. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable