Site
Royal North Shore (St Leonards, Australia)
AUS activated KRI 0.0Principal investigator Dr. Rossi
Patients
2
Active
0
enrolled or consented
Withdrawn
0
Serious AEs
1
Open QA findings
0
Aged data queries
2
Studies & contracts
total budget 64000.00 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
64000 USD
Patients first 2
| Ref | Status | Consented | Study |
|---|---|---|---|
| P2B-031 | completed | 2012-09-03 | 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-115 | completed | 2013-05-20 | 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
9 AEs · 1 serious
serious
P2B-115
assessed
Grade 3 anaemia with onset in cycle 5 (2013-09-08); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-09-29; action: dose reduced.
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-115, 2013-06-06)
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.