Site
CTRC Institute for Drug Development, University of Texas (San Antonio, TX)
USA activated KRI 0.312Principal investigator Dr. Muller
Patients
11
Active
0
enrolled or consented
Withdrawn
1
Serious AEs
17
Open QA findings
1
Aged data queries
2
Studies & contracts
total budget 140000.00 USD
Patients first 11
| Ref | Status | Consented | Study |
|---|---|---|---|
| P2B-009 | completed | 2012-06-09 | 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-020 | completed | 2012-07-23 | 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-028 | completed | 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-042 | screened | 2012-10-19 | 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| P2B-050 | withdrawn | 2012-11-05 | A Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the Preliminary Efficacy and Safety of INNO-206 (Doxorubicin-EMCH) Compared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-053 | completed | 2012-11-21 | 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-069 | completed | 2013-01-15 | 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-102 | completed | 2013-04-18 | 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-117 | completed | 2013-05-24 | 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 |
| P2B-122 | completed | 2013-06-12 | 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-137 | 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
72 AEs · 17 serious
Grade 3 anaemia with onset in cycle 4 (2013-07-16); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-07-23; action: drug withdrawn.
Grade 3 vomiting with onset in cycle 1 (2013-06-17); serious (hospitalization); assessed as not related to study drug (unlikely); resolved 2013-06-24; action: drug withdrawn.
Grade 3 gastrointestinal haemorrhage with onset in cycle 1 (2013-06-09); serious (hospitalization); assessed as not related to study drug (unlikely); resolved 2013-06-14; action: drug interrupted.
Grade 3 leukopenia with onset in cycle 1 (2013-06-09); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-06-18; action: dose reduced.
Grade 3 febrile neutropenia with onset in cycle 1 (2013-05-22); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-05-28; action: drug interrupted.
Grade 2 pertussis with onset in cycle 6 (2012-12-07); serious (hospitalization); assessed as not related to study drug (unlikely); resolved 2012-12-18.
Grade 3 pneumonia with onset in cycle 1 (2012-12-04); serious (hospitalization); assessed as not related to study drug (not related); resolved 2012-12-20; action: drug interrupted.
Grade 3 cholecystitis acute with onset in cycle 5 (2012-12-02); serious (hospitalization); assessed as not related to study drug (unlikely); resolved 2012-12-14; action: drug interrupted.
QA findings
1 open
VISIT OUT OF WINDOW: Cycle Day 1 visit outside the +/-3-day window without a documented toxicity delay (subject P2B-028, 2012-12-05)
LABORATORY ASSESSMENT NOT DONE: Pre-dose haematology or chemistry panel not performed within 72 h of Day 1 (subject P2B-050, 2012-11-27)
INFORMED CONSENT PROCESS DEVIATION: Re-consent to the amended ICF (Amendment 2) obtained after the next study procedure (subject P2B-050, 2012-11-08)
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.