P2B-008

State Healthcare Institution "Republican Clinical Oncological Center of the Ministry of Health of Republic of Tatarstan" (Kazan', Russia) › P2B-008

P2B-008

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
State Healthcare Institution "Republican Clinical Oncological Center of the Ministry of Health of Republic of Tatarstan" (Kazan', Russia) · Dr. Clarke
consented 2012-05-25

completed

AEs

0

Serious

0

Dropout signal

–

Adverse events

0

No adverse events recorded. New events are triaged from the Safety tab.

Data queries

2

Visit Cycle 6 Day 1: infusion (last planned cycle) (V7) for P2B-008 occurred on 2012-10-01, 12 d late against planned day 106 (2012-09-19 ± 3 d, anchored on first dose 2012-06-06). Confirm the visit date or record a protocol deviation.

SV.occurred_on[V7] open

Visit Cycle 5 Day 1: infusion; week-12 CT/MRI and ECHO/MUGA before dosing (V6) for P2B-008 occurred on 2012-09-11, 13 d late against planned day 85 (2012-08-29 ± 3 d, anchored on first dose 2012-06-06). Confirm the visit date or record a protocol deviation.

SV.occurred_on[V6] open