Site
Vinnytsya Regional Clinical Oncologic Dispensary, Surgical Department (Vinnytsia, Ukraine)
UKR activated KRI 0.0Principal investigator Dr. Tanaka
Patients
1
Active
0
enrolled or consented
Withdrawn
0
Serious AEs
2
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-035 | completed | 2012-09-11 | 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
6 AEs · 2 serious
serious
P2B-035
assessed
Grade 2 mucosal inflammation with onset in cycle 5 (2012-12-27); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-01-05.
serious
P2B-035
assessed
Grade 3 febrile neutropenia with onset in cycle 1 (2012-10-07); serious (hospitalization); assessed as related to study drug (probable); resolved 2012-10-13.
QA findings
0 open
No findings recorded
Findings are filed by monitoring visits.
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.