Status:
COMPLETED
A Study of Pazopanib and Durvalumab for Metastatic Soft Tissue Sarcoma
Lead Sponsor:
Yonsei University
Conditions:
Sarcoma
Eligibility:
All Genders
19+ years
Phase:
PHASE2
Brief Summary
Pazopanib is an angiogenesis inhibitor targeting VEGFR-1, -2, and -3; PDGFR-α and -β; and the receptor c-Kit, and is indicated for the treatment of subjects with advanced renal cell carcinoma (RCC) an...
Detailed Description
Pazopanib is an angiogenesis inhibitor targeting VEGFR-1, -2, and -3; PDGFR-α and -β; and the receptor c-Kit, and is indicated for the treatment of subjects with advanced renal cell carcinoma (RCC) an...
Eligibility Criteria
Inclusion
- Histologically confirmed STS progression to 1 or 2 prior chemotherapy
- Age \> 18 years at time of study entry.
- 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 laboratory findings
- Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients.
- Patient is willing and able to comply with the protocol for the duration of the study
- Must have a life expectancy of at least 12 weeks
- 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.
- Patients with evidence of portal hypertension (including splenomegaly detected radiographically) or any prior history of variceal bleeding must have had endoscopic evaluation within the 3 months immediately prior to enrollment, and the findings do not represent a high bleeding risk.
Exclusion
- More than 4 prior cytotoxic regimens
- Participation in another clinical study with an investigational product during the last 2 weeks
- Receipt of the last dose of anticancer therapy 14 days prior to the first dose of study drug
- Any previous treatment with a PD1 or PD-L1 inhibitor (including durvalumab) and/or pazopanib
- 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 2 weeks prior to entering the study. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable
- Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug
- Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP.
- History of allogenic organ transplantation.
- Active or prior documented autoimmune or inflammatory disorders
- Uncontrolled intercurrent illness
- History of active infection
- History of another primary malignancy
- History of leptomeningeal carcinomatosis who are neurologically unstable or have required active treatment
- Receipt of live attenuated vaccine within 30 days prior to the first dose of investigational product(IP).
- 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.
- Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
- No history of any of the following in the past 6 months: cardiac angioplasty or stenting, myocardial infarction, unstable angina, coronary artery bypass graft surgery, symptomatic peripheral vascular disease class III or IV congestive heart failure, as defined by the New York Heart Association), thromboembolic events
Key Trial Info
Start Date :
April 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 10 2022
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT03798106
Start Date
April 10 2019
End Date
August 10 2022
Last Update
June 12 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 03722