Site
Sarcoma Oncology Center (Santa Monica, CA)
USA activated KRI 0.21Principal investigator Dr. Reyes
Patients
16
Active
0
enrolled or consented
Withdrawn
2
Serious AEs
12
Open QA findings
2
Aged data queries
20
Studies & contracts
total budget 197000.00 USD
Patients first 16
| Ref | Status | Consented | Study |
|---|---|---|---|
| P2B-001 | withdrawn | 2012-01-11 | A Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the Preliminary Efficacy and Safety of INNO-206 (Doxorubicin-EMCH) Compared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| P2B-002 | withdrawn | 2012-02-09 | A Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the Preliminary Efficacy and Safety of INNO-206 (Doxorubicin-EMCH) Compared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-005 | completed | 2012-04-22 | 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-011 | completed | 2012-06-19 | 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-013 | completed | 2012-06-22 | 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-025 | completed | 2012-08-08 | 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-029 | completed | 2012-08-15 | 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-057 | completed | 2012-12-05 | 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-062 | completed | 2012-12-19 | 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-068 | completed | 2013-01-10 | 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 |
| P2B-078 | completed | 2013-02-17 | 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 |
| P2B-079 | completed | 2013-02-22 | 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-104 | completed | 2013-04-25 | 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-126 | completed | 2013-06-26 | 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-134 | completed | 2013-07-12 | 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-139 | completed | 2013-07-24 | 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
71 AEs · 12 serious
Grade 4 febrile neutropenia with onset in cycle 5 (2013-10-29); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-11-04; action: drug interrupted.
Grade 3 anaemia with onset in cycle 5 (2013-10-22); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-11-26; action: dose reduced.
Grade 3 deep vein thrombosis with onset in cycle 4 (2013-09-28); serious (hospitalization); assessed as not related to study drug (unlikely); resolved 2013-11-04.
Grade 3 lower respiratory tract infection with onset in cycle 3 (2013-08-30); serious (hospitalization); assessed as related to study drug (possible); resolved 2013-09-10.
Grade 3 vomiting with onset in cycle 5 (2013-08-10); serious (hospitalization); assessed as related to study drug (possible); resolved 2013-08-13; action: drug interrupted.
Grade 4 neutropenic sepsis with onset in cycle 1 (2013-07-28); serious (life-threatening; hospitalization); assessed as related to study drug (probable); resolved 2013-08-05; action: drug interrupted.
Grade 2 pyrexia with onset in cycle 1 (2013-07-17); serious (hospitalization); assessed as not related to study drug (not related); resolved 2013-07-19.
Grade 3 atrial fibrillation with onset in cycle 6 (2013-05-16); serious (hospitalization); assessed as not related to study drug (not related); resolved 2013-05-19.
QA findings
2 open
TUMOUR ASSESSMENT OUT OF WINDOW: CT/MRI tumour assessment performed outside the +/-7-day window of the 6-weekly schedule (subject P2B-139, 2013-09-19)
INFORMED CONSENT PROCESS DEVIATION: Re-consent to the amended ICF (Amendment 2) obtained after the next study procedure (subject P2B-139, 2013-07-28)
TUMOUR ASSESSMENT OUT OF WINDOW: CT/MRI tumour assessment performed outside the +/-7-day window of the 6-weekly schedule (subject P2B-068, 2013-03-25)
TUMOUR ASSESSMENT OUT OF WINDOW: CT/MRI tumour assessment performed outside the +/-7-day window of the 6-weekly schedule (subject P2B-078, 2013-03-06)
INFORMED CONSENT PROCESS DEVIATION: Re-consent to the amended ICF (Amendment 2) obtained after the next study procedure (subject P2B-078, 2013-02-22)
LABORATORY ASSESSMENT NOT DONE: Pre-dose haematology or chemistry panel not performed within 72 h of Day 1 (subject P2B-062, 2013-01-12)
STUDY DRUG ADMINISTRATION DEVIATION: Infusion duration outside protocol (aldoxorubicin 30 min / doxorubicin per label) or incorrect BSA used for dose calculation (subject P2B-005, 2012-08-10)
STUDY DRUG ADMINISTRATION DEVIATION: Infusion duration outside protocol (aldoxorubicin 30 min / doxorubicin per label) or incorrect BSA used for dose calculation (subject P2B-011, 2012-07-26)
VISIT OUT OF WINDOW: Cycle Day 1 visit outside the +/-3-day window without a documented toxicity delay (subject P2B-002, 2012-02-28)
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.