State Healthcare Institution "Republican Clinical Oncological Center of the Ministry of Health of Republic of Tatarstan" (Kazan', Russia) › P2B-074

P2B-074

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 2013-02-03

completed

AEs

Serious

Dropout signal

–

Adverse events

Grade 1 nausea with onset in cycle 6 (2013-06-03); assessed as not related to study drug (not related); resolved 2013-06-07.

mild assessed

Grade 1 hypocalcaemia with onset in cycle 4 (2013-05-10); assessed as not related to study drug (not related); resolved 2013-05-20.

mild assessed

Grade 2 fatigue with onset in cycle 2 (2013-03-16); assessed as not related to study drug (not related); resolved 2013-04-03.

moderate assessed

Grade 1 blood alkaline phosphatase increased with onset in cycle 1 (2013-02-27); assessed as not related to study drug (unlikely); resolved 2013-03-19.

mild assessed

Grade 1 diarrhoea with onset in cycle 1 (2013-02-25); assessed as not related to study drug (unlikely); resolved 2013-02-28.

mild assessed

Grade 1 asthenia with onset in cycle 1 (2013-02-22); assessed as related to study drug (possible); resolved 2013-03-23.

mild assessed

Data queries

No data queries. Open queries would appear here for this patient.