Site
Epworth HealthCare Clinical Trials and Research Centre (Richmond, Australia)
AUS activated KRI 0.391Principal investigator Dr. Dubois
Patients
3
Active
0
enrolled or consented
Withdrawn
1
Serious AEs
1
Open QA findings
1
Aged data queries
1
Studies & contracts
total budget 73500.00 USD
Patients first 3
| Ref | Status | Consented | Study |
|---|---|---|---|
| P2B-081 | withdrawn | 2013-02-28 | A Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the Preliminary Efficacy and Safety of INNO-206 (Doxorubicin-EMCH) Compared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-090 | completed | 2013-03-21 | 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-136 | completed | 2013-07-17 | 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
15 AEs · 1 serious
Grade 3 febrile neutropenia with onset in cycle 4 (2013-06-14); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-06-22.
QA findings
1 open
ELIGIBILITY CRITERIA NOT MET: Eligibility deviation found after randomization: prior anthracycline exposure above the 225 mg/m2 limit documented in outside records (subject P2B-081, 2013-04-17)
TUMOUR ASSESSMENT OUT OF WINDOW: CT/MRI tumour assessment performed outside the +/-7-day window of the 6-weekly schedule (subject P2B-081, 2013-03-12)
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.