Site
Delhi State Cancer Institute (Mandoli, India)
IND activated KRI 0.0Principal investigator Dr. Muller
Patients
2
Active
0
enrolled or consented
Withdrawn
1
Serious AEs
3
Open QA findings
1
Aged data queries
3
Studies & contracts
total budget 64000.00 USD
Patients first 2
| Ref | Status | Consented | Study |
|---|---|---|---|
| P2B-105 | 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| P2B-114 | withdrawn | 2013-05-19 | A Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the Preliminary Efficacy and Safety of INNO-206 (Doxorubicin-EMCH) Compared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 |
Luna participants 0
Safety
7 AEs · 3 serious
Grade 4 pancytopenia with onset in cycle 6 (2013-09-18); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-09-26.
Grade 3 gastritis with onset in cycle 5 (2013-08-16); serious (hospitalization); assessed as not related to study drug (not related); resolved 2013-08-26.
Grade 3 anaemia with onset in cycle 4 (2013-08-13); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-08-29.
QA findings
1 open
ELIGIBILITY CRITERIA NOT MET: Eligibility deviation found after randomization: prior anthracycline exposure above the 225 mg/m2 limit documented in outside records (subject P2B-114, 2013-06-17)
TUMOUR ASSESSMENT OUT OF WINDOW: CT/MRI tumour assessment performed outside the +/-7-day window of the 6-weekly schedule (subject P2B-114, 2013-06-03)
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.