A study to evaluate the safety and tolerability of doxorubicin and durvalumab, in patients with advanced soft tissue sarcoma.
- Conditions
- Neoplasms
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 45
1. Histologically confirmed soft tissue sarcoma.
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
3. Measurable disease by Response Evaluation Criteria in Solid Tumors Version 1.1
4. Body weight >30kg
5. Adequate normal organ and marrow function
6. Left ventricle ejection fraction = 45%
7. Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients.
8. 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.
9. Must have a life expectancy of at least 12 weeks
10. 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.
1. Histologically- or cytologically-confirmed Kaposi’s sarcoma or GIST
2. Previous treatment with anthracyclines
: patients received neoadjuvant/adjuvant doxorubicin can be enrolled into this study
3. Participation in another clinical study with an investigational product during the last 2 weeks
4. Receipt of the last dose of anticancer therapy 14 days prior to the first dose of study drug
5. Any previous treatment with a PD1 or PD-L1 inhibitor (including durvalumab) and/or PDGFR inhibitor
6. Mean QT interval corrected for heart rate (QTc) > 480 ms calculated from 3 electrocardiograms (ECGs) using Fridericia’s Correction
7. 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
8. 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
9. Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 14 days of the first dose of study drug
10. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP.
11. History of allogenic organ transplantation.
12. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]).
13. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris (within 6 months), cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring adverse event or compromise the ability of the patient to give written informed consent
14. Known active infection
15. History of another primary malignancy.
16. History of leptomeningeal carcinomatosis who are neurologically unstable or have required active treatment.
17. Receipt of live attenuated vaccine within 30 days prior to the first dose of IP.
18. 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.
19. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method adverse event;efficacy
- Secondary Outcome Measures
Name Time Method progression free survival