Site
Stanford University (Stanford, CA)
USA activated KRI 0.237Principal investigator Dr. Nolan
Patients
5
Active
0
enrolled or consented
Withdrawn
0
Serious AEs
3
Open QA findings
0
Aged data queries
3
Studies & contracts
total budget 92500.00 USD
Patients first 5
| Ref | Status | Consented | Study |
|---|---|---|---|
| P2B-014 | completed | 2012-06-26 | 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-019 | completed | 2012-07-13 | 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-073 | completed | 2013-02-02 | 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 |
| P2B-092 | 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-111 | completed | 2013-05-10 | 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
25 AEs · 3 serious
Grade 3 pulmonary embolism with onset in cycle 1 (2012-08-01); serious (hospitalization); assessed as not related to study drug (unlikely); resolved 2012-08-21.
Grade 3 febrile neutropenia with onset in cycle 1 (2012-07-29); serious (hospitalization); assessed as related to study drug (probable); resolved 2012-08-02.
Grade 3 dehydration with onset in cycle 1 (2012-07-23); serious (hospitalization); assessed as not related to study drug (unlikely); resolved 2012-07-26.
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-014, 2012-08-19)
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.