State Institution "Institute of Medical Radiology named after S.P.Grygoryev of National Academy of Medical Sciences of Ukraine" (Kharkiv, Ukraine)

Sites / UKR

State Institution "Institute of Medical Radiology named after S.P.Grygoryev of National Academy of Medical Sciences of Ukraine" (Kharkiv, Ukraine)

UKR · PI Dr. Nolan · activated

KRI 0.401

Patients

3

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

3

P2B-061

completed

P2B-093

completed

P2B-131

completed

Safety

12 AEs · 1 serious

Grade 3 stomatitis with onset in cycle 2 (2013-02-02); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-02-14; action: drug interrupted.

serious P2B-061

QA findings

1 open

INFORMED CONSENT PROCESS DEVIATION: Re-consent to the amended ICF (Amendment 2) obtained after the next study procedure (subject P2B-093, 2013-04-15)

open major

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