Site
State Institution "Institute of Medical Radiology named after S.P.Grygoryev of National Academy of Medical Sciences of Ukraine" (Kharkiv, Ukraine)
UKR activated KRI 0.401Principal investigator Dr. Nolan
Patients
3
Active
0
enrolled or consented
Withdrawn
0
Serious AEs
1
Open QA findings
1
Aged data queries
0
Studies & contracts
total budget 73500.00 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
73500 USD
Patients first 3
| Ref | Status | Consented | Study |
|---|---|---|---|
| P2B-061 | completed | 2012-12-19 | 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-093 | completed | 2013-03-29 | 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-131 | completed | 2013-07-09 | 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
12 AEs · 1 serious
serious
P2B-061
assessed
Grade 3 stomatitis with onset in cycle 2 (2013-02-02); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-02-14; action: drug interrupted.
QA findings
1 open
open
major
Protocol deviation
INFORMED CONSENT PROCESS DEVIATION: Re-consent to the amended ICF (Amendment 2) obtained after the next study procedure (subject P2B-093, 2013-04-15)
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.