NCT03798106

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) and advanced STS. For this orphan tumor, STS, PD-L1 targeting may be a promising strategy and favorable toxicity may warrant further combination.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2019

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 9, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

April 10, 2019

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2022

Completed
Last Updated

June 12, 2023

Status Verified

June 1, 2023

Enrollment Period

3.3 years

First QC Date

January 7, 2019

Last Update Submit

June 8, 2023

Conditions

Sarcoma

Outcome Measures

Primary Outcomes (1)

  • Objective Response Rate

    antitumor efficacy of durvalumab and pazopanib

    12 weeks

Study Arms (1)

durvalumab+pazopanib

EXPERIMENTAL

Durvalumab 1500mg IV 1hr q3weeks Pazopanib 800mg QD PO q3wwks

Drug: Durvalumab, pazopanib

Interventions

Durvalumab, pazopanibDRUG

Durvalumab 1500mg IV 1hr q3weeks Pazopanib 800mg QD PO q3wwks

durvalumab+pazopanib

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 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).
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

MeSH Terms

Conditions

Sarcoma

Interventions

durvalumabpazopanib

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

January 7, 2019

First Posted

January 9, 2019

Study Start

April 10, 2019

Primary Completion

August 10, 2022

Study Completion

August 10, 2022

Last Updated

June 12, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)