GalenOps prod · 0.1.0

Site

Lviv State Oncological Regional Treatment - Diagnostics Center, Chemotherapy Department (Lviv, Ukraine)

UKR activated KRI 0.34

Principal investigator Dr. Okafor

Sites

Patients

3

Active

0

enrolled or consented

Withdrawn

0

Serious AEs

2

Open QA findings

0

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 3

RefStatusConsentedStudy
P2B-085 completed 2013-03-08 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-089 completed 2013-03-18 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-129 completed 2013-07-08 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

Luna participants 0

No Luna participants yet

Participants at this site have not been invited to Luna.

Open Luna users

Safety

20 AEs · 2 serious

serious P2B-129 under_review

Grade 3 anaemia with onset in cycle 5 (2013-10-30); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-12-02; action: drug interrupted.

serious P2B-129 assessed

Grade 3 thrombocytopenia with onset in cycle 1 (2013-08-06); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-08-17.

QA findings

0 open

resolved minor Protocol deviation

LABORATORY ASSESSMENT NOT DONE: Pre-dose haematology or chemistry panel not performed within 72 h of Day 1 (subject P2B-129, 2013-09-09)

Monitoring visits 1

on_site 2026-10-13 risk-flagged

Proposed by centralized statistical monitoring (risk score 0.34, composite |z| 0.83): lab flags per patient 18.00 vs study mean 9.74, z=2.54. Pending CRA confirmation.

Payments 0

No payments on file

Milestone payments are proposed by the finance step and approved in the review queue.