Site
State Healthcare Institution "Republican Clinical Oncological Center of the Ministry of Health of Republic of Tatarstan" (Kazan', Russia)
RUS activated KRI 0.248Principal investigator Dr. Clarke
Patients
12
Active
0
enrolled or consented
Withdrawn
3
Serious AEs
3
Open QA findings
2
Aged data queries
7
Studies & contracts
total budget 140000.00 USD
Patients first 12
| Ref | Status | Consented | Study |
|---|---|---|---|
| P2B-007 | completed | 2012-05-22 | 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-008 | completed | 2012-05-25 | 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-015 | screened | 2012-07-01 | 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| P2B-021 | withdrawn | 2012-07-24 | A Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the Preliminary Efficacy and Safety of INNO-206 (Doxorubicin-EMCH) Compared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 |
| P2B-043 | completed | 2012-10-23 | 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-045 | completed | 2012-10-25 | 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-046 | completed | 2012-10-25 | 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| P2B-060 | withdrawn | 2012-12-12 | A Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the Preliminary Efficacy and Safety of INNO-206 (Doxorubicin-EMCH) Compared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-071 | screened | 2013-01-20 | 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-074 | completed | 2013-02-03 | 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-098 | completed | 2013-04-08 | 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-124 | withdrawn | 2013-06-14 | 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
32 AEs · 3 serious
Grade 3 atrial tachycardia with onset in cycle 6 (2013-02-26); serious (hospitalization); assessed as not related to study drug (unlikely); resolved 2013-02-27.
Grade 4 thrombocytopenia with onset in cycle 3 (2012-12-25); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-01-05.
Grade 4 febrile neutropenia with onset in cycle 2 (2012-12-03); serious (hospitalization); assessed as related to study drug (probable); resolved 2012-12-08; action: dose reduced.
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-074, 2013-05-11)
TUMOUR ASSESSMENT OUT OF WINDOW: CT/MRI tumour assessment performed outside the +/-7-day window of the 6-weekly schedule (subject P2B-045, 2013-01-27)
TUMOUR ASSESSMENT OUT OF WINDOW: CT/MRI tumour assessment performed outside the +/-7-day window of the 6-weekly schedule (subject P2B-060, 2013-01-23)
VISIT OUT OF WINDOW: Cycle Day 1 visit outside the +/-3-day window without a documented toxicity delay (subject P2B-046, 2012-11-12)
PROHIBITED CONCOMITANT THERAPY: Other systemic anticancer therapy started while on study treatment (subject P2B-021, 2012-09-28)
DOSING WITH INADEQUATE COUNTS: Study drug given with ANC <1,500/mm3 or platelets <100,000/mm3 on Day 1 (retreatment criteria not met) (subject P2B-008, 2012-06-07)
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.