State Healthcare Institution "Republican Clinical Oncological Center of the Ministry of Health of Republic of Tatarstan" (Kazan', Russia) › P2B-045

P2B-045

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 2012-10-25

completed

AEs

Serious

Dropout signal

–

Adverse events

Grade 3 atrial tachycardia with onset in cycle 6 (2013-02-26); serious (hospitalization); assessed as not related to study drug (unlikely); resolved 2013-02-27.

severe serious assessed

Grade 2 thrombocytopenia with onset in cycle 6 (2013-02-24); assessed as related to study drug (probable); resolved 2013-03-01.

moderate assessed

Grade 1 fatigue with onset in cycle 6 (2013-02-23); assessed as not related to study drug (unlikely); resolved 2013-03-13.

mild assessed

Grade 1 constipation with onset in cycle 6 (2013-02-19); assessed as not related to study drug (not related); resolved 2013-02-23.

mild assessed

Grade 1 decreased appetite with onset in cycle 5 (2013-02-06); assessed as not related to study drug (unlikely); resolved 2013-02-17.

mild assessed

Grade 2 stomatitis with onset in cycle 5 (2013-01-30); assessed as related to study drug (probable); resolved 2013-02-08.

moderate assessed

Grade 1 anaemia with onset in cycle 4 (2013-01-14); assessed as related to study drug (probable); resolved 2013-01-31.

mild assessed

Grade 1 hypokalaemia with onset in cycle 3 (2012-12-31); assessed as not related to study drug (unlikely); resolved 2013-01-03.

mild assessed

Grade 4 thrombocytopenia with onset in cycle 3 (2012-12-25); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-01-05.

severe serious assessed

Grade 4 febrile neutropenia with onset in cycle 2 (2012-12-03); serious (hospitalization); assessed as related to study drug (probable); resolved 2012-12-08; action: dose reduced.

severe serious assessed

Grade 2 febrile neutropenia with onset in cycle 1 (2012-11-16); assessed as related to study drug (probable); resolved 2012-11-24.

moderate assessed

Data queries

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