GalenOps prod · 0.1.0

Site

Clinical County Hospital Mures, Medical Oncology Department (Târgu Mureş, Romania)

ROU activated KRI 0.313

Principal investigator Dr. Silva

Sites

Patients

4

Active

0

enrolled or consented

Withdrawn

1

Serious AEs

1

Open QA findings

1

Aged data queries

0

Studies & contracts

total budget 73500.00 USD

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
Phase II study completed contract executed 73500 USD

Patients first 4

RefStatusConsentedStudy
P2B-023 completed 2012-08-04 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-048 screened 2012-10-31 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P2B-076 withdrawn 2013-02-11 A Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the Preliminary Efficacy and Safety of INNO-206 (Doxorubicin-EMCH) Compared to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-083 completed 2013-03-02 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

Luna participants 0

No Luna participants yet

Participants at this site have not been invited to Luna.

Open Luna users

Safety

13 AEs · 1 serious

serious P2B-083 assessed

Grade 3 cellulitis with onset in cycle 2 (2013-04-09); serious (hospitalization); assessed as not related to study drug (not related); resolved 2013-04-20; action: drug interrupted.

QA findings

1 open

open major Protocol deviation

ELIGIBILITY CRITERIA NOT MET: Eligibility deviation found after randomization: central pathology review reclassified histology as an excluded subtype (subject P2B-076, 2013-05-12)

resolved minor Protocol deviation

VISIT OUT OF WINDOW: Cycle Day 1 visit outside the +/-3-day window without a documented toxicity delay (subject P2B-083, 2013-04-29)

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.