Site
Spitalul Judetean de Urgenta "Dr. Constantin Opris" Baia-Mare, Sectia Oncologie (Baia Mare, Romania)
ROU activated KRI 0.0Principal investigator Dr. Jansen
Patients
2
Active
0
enrolled or consented
Withdrawn
0
Serious AEs
4
Open QA findings
0
Aged data queries
3
Studies & contracts
total budget 64000.00 USD
Patients first 2
| Ref | Status | Consented | Study |
|---|---|---|---|
| P2B-063 | completed | 2012-12-21 | 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 |
| P2B-132 | completed | 2013-07-10 | 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
11 AEs · 4 serious
Grade 3 cholecystitis with onset in cycle 4 (2013-09-29); serious (hospitalization); assessed as not related to study drug (unlikely); resolved 2013-10-13.
Grade 3 febrile neutropenia with onset in cycle 1 (2013-08-03); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-08-10.
Grade 3 mucosal inflammation with onset in cycle 1 (2013-08-03); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-08-13.
Grade 3 febrile neutropenia with onset in cycle 5 (2013-04-06); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-04-15.
QA findings
0 open
TUMOUR ASSESSMENT OUT OF WINDOW: CT/MRI tumour assessment performed outside the +/-7-day window of the 6-weekly schedule (subject P2B-132, 2013-07-27)
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.