Site
Christian Medical College (Vellore, India)
IND activated KRI 0.0Principal investigator Dr. Dubois
Patients
2
Active
0
enrolled or consented
Withdrawn
0
Serious AEs
0
Open QA findings
0
Aged data queries
1
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-099 | completed | 2013-04-09 | 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 |
| P2B-135 | completed | 2013-07-16 | 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
7 AEs · 0 serious
No serious adverse events at this site
Non-serious events are listed under Data & Safety.
QA findings
0 open
resolved
minor
Protocol deviation
VISIT OUT OF WINDOW: Cycle Day 1 visit outside the +/-3-day window without a documented toxicity delay (subject P2B-135, 2013-10-24)
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.