Site
The Crown Princess Mary Cancer Centre Westmead (Sydney, Australia)
AUS activated KRI 0.276Principal investigator Dr. Kowalski
Patients
5
Active
0
enrolled or consented
Withdrawn
0
Serious AEs
4
Open QA findings
0
Aged data queries
0
Studies & contracts
total budget 83000.00 USD
Patients first 5
| Ref | Status | Consented | Study |
|---|---|---|---|
| P2B-030 | screened | 2012-08-20 | 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-049 | completed | 2012-11-01 | 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-075 | completed | 2013-02-04 | 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-112 | completed | 2013-05-12 | 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-123 | completed | 2013-06-13 | 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 |
Luna participants 0
Safety
23 AEs · 4 serious
Grade 3 stomatitis with onset in cycle 1 (2013-02-28); serious (hospitalization); assessed as related to study drug (probable); not resolved at last follow-up.
Grade 5 septic shock with onset in cycle 1 (2013-02-27); serious (death; life-threatening; hospitalization); assessed as related to study drug (probable); fatal outcome on 2013-03-01.
Grade 4 febrile neutropenia with onset in cycle 1 (2013-02-26); serious (hospitalization); assessed as related to study drug (probable); not resolved at last follow-up; action: drug interrupted.
Grade 3 dehydration with onset in cycle 1 (2013-02-25); serious (hospitalization); assessed as not related to study drug (unlikely); resolved 2013-02-28.
QA findings
0 open
STUDY DRUG ADMINISTRATION DEVIATION: Infusion duration outside protocol (aldoxorubicin 30 min / doxorubicin per label) or incorrect BSA used for dose calculation (subject P2B-123, 2013-10-14)
VISIT OUT OF WINDOW: Cycle Day 1 visit outside the +/-3-day window without a documented toxicity delay (subject P2B-112, 2013-07-31)
VISIT OUT OF WINDOW: Cycle Day 1 visit outside the +/-3-day window without a documented toxicity delay (subject P2B-049, 2013-02-08)
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.