Site
Municipal institution "Chernivtsi Regional Clinical Oncologic Dispensary" (Chernivtsi, Ukraine)
UKR activated KRI 0.0Principal investigator Dr. Ito
Patients
1
Active
0
enrolled or consented
Withdrawn
0
Serious AEs
0
Open QA findings
0
Aged data queries
0
Studies & contracts
total budget 54500.00 USD
A Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the Preliminary Efficacy and Safety of INNO-206 (Doxorubicin-EMCH) Compared to Doxorubicin in Subjects With Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcoma
Phase II
study completed
contract executed
54500 USD
Patients first 1
| Ref | Status | Consented | Study |
|---|---|---|---|
| P2B-091 | completed | 2013-03-21 | A Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the Preliminary Efficacy and Safety of INNO-206 (Doxorubicin-EMCH) Compared to Doxorubicin in Subjects With Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcoma |
Luna participants 0
Safety
4 AEs · 0 serious
No serious adverse events at this site
Non-serious events are listed under Data & Safety.
QA findings
0 open
resolved
minor
Protocol deviation
TUMOUR ASSESSMENT OUT OF WINDOW: CT/MRI tumour assessment performed outside the +/-7-day window of the 6-weekly schedule (subject P2B-091, 2013-04-29)
Monitoring visits 0
No visits recorded
Re-score risk to propose an on-site visit.
Payments 0
No payments on file
Milestone payments are proposed by the finance step and approved in the review queue.