Site
University of Iowa (Iowa City, IA)
USA activated KRI 0.218Principal investigator Dr. Okafor
Patients
5
Active
0
enrolled or consented
Withdrawn
0
Serious AEs
3
Open QA findings
0
Aged data queries
3
Studies & contracts
total budget 83000.00 USD
Patients first 5
| Ref | Status | Consented | Study |
|---|---|---|---|
| P2B-003 | completed | 2012-03-13 | 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-004 | completed | 2012-03-23 | 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-027 | screened | 2012-08-11 | 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-106 | completed | 2013-04-26 | 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-120 | completed | 2013-06-02 | 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
21 AEs · 3 serious
Grade 3 pelvic neoplasm with onset in cycle 2 (2013-06-12); serious (hospitalization); assessed as not related to study drug (unlikely); resolved 2013-06-22.
Grade 3 deep vein thrombosis with onset in cycle 2 (2013-06-03); serious (hospitalization); assessed as not related to study drug (unlikely); resolved 2013-06-22; action: drug interrupted.
Grade 3 leukopenia with onset in cycle 1 (2013-05-17); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-05-24.
QA findings
0 open
VISIT OUT OF WINDOW: Cycle Day 1 visit outside the +/-3-day window without a documented toxicity delay (subject P2B-004, 2012-07-23)
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.