Site
Oncological Institute "Prof. Dr. I. Chiricuta", Cluj-Napoca (Cluj-Napoca, Romania)
ROU activated KRI 0.383Principal investigator Dr. Novak
Patients
3
Active
0
enrolled or consented
Withdrawn
0
Serious AEs
3
Open QA findings
0
Aged data queries
1
Studies & contracts
total budget 73500.00 USD
Patients first 3
| Ref | Status | Consented | Study |
|---|---|---|---|
| P2B-034 | completed | 2012-09-10 | 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 |
| P2B-052 | completed | 2012-11-21 | 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-056 | completed | 2012-12-02 | 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
21 AEs · 3 serious
Grade 3 neutropenia with onset in cycle 1 (2012-12-11); serious (hospitalization); assessed as related to study drug (probable); resolved 2012-12-20; action: dose reduced.
Grade 3 stomatitis with onset in cycle 1 (2012-12-04); serious (hospitalization); assessed as related to study drug (probable); resolved 2012-12-10; action: drug interrupted.
Grade 3 cellulitis with onset in cycle 3 (2012-11-13); serious (hospitalization); assessed as not related to study drug (not related); resolved 2012-11-27.
QA findings
0 open
LABORATORY ASSESSMENT NOT DONE: Pre-dose haematology or chemistry panel not performed within 72 h of Day 1 (subject P2B-034, 2013-01-04)
CARDIAC ASSESSMENT NOT DONE: Protocol-required ECHO/MUGA after cycle 2 or 4 not performed (subject P2B-056, 2012-12-17)
TUMOUR ASSESSMENT OUT OF WINDOW: CT/MRI tumour assessment performed outside the +/-7-day window of the 6-weekly schedule (subject P2B-056, 2012-12-17)
VISIT OUT OF WINDOW: Cycle Day 1 visit outside the +/-3-day window without a documented toxicity delay (subject P2B-056, 2012-12-16)
TUMOUR ASSESSMENT OUT OF WINDOW: CT/MRI tumour assessment performed outside the +/-7-day window of the 6-weekly schedule (subject P2B-034, 2012-11-02)
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.