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

Sites / ROU

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

ROU · PI Dr. Silva · activated

KRI 0.313

Patients

4

Active

0

Serious AEs

1

Open QA

1

Aged queries

0

Luna users

0

Studies & contracts

1

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 · 73500 USD

executed

Patients

4

P2B-023

completed

P2B-048

screened

P2B-076

withdrawn

P2B-083

completed

Safety

13 AEs · 1 serious

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.

serious P2B-083

QA findings

1 open

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

open major

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

resolved minor

Visits & payments

0

Nothing scheduled. Re-score risk to let the pipeline propose a visit.

Luna participants

0

No Luna participants here yet. Participants join once invited by the site.

Open Luna