Site
Hemato Oncology Clinic, Vedanta Institute of Medical Science (Ahmedabad, India)
IND activated KRI 0.32Principal investigator Dr. Ito
Patients
4
Active
0
enrolled or consented
Withdrawn
0
Serious AEs
1
Open QA findings
0
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 4
| Ref | Status | Consented | Study |
|---|---|---|---|
| P2B-041 | completed | 2012-10-13 | 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-051 | completed | 2012-11-06 | 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-066 | completed | 2013-01-05 | 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-080 | screened | 2013-02-24 | 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
16 AEs · 1 serious
serious
P2B-041
assessed
Grade 3 tumour haemorrhage with onset in cycle 5 (2013-01-24); serious (hospitalization); assessed as not related to study drug (not related); resolved 2013-02-02; action: drug interrupted.
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-051, 2013-01-01)
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.