Oncological Institute "Prof. Dr. I. Chiricuta", Cluj-Napoca (Cluj-Napoca, Romania) › P2B-052

P2B-052

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
Oncological Institute "Prof. Dr. I. Chiricuta", Cluj-Napoca (Cluj-Napoca, Romania) · Dr. Novak
consented 2012-11-21

completed

AEs

Serious

Dropout signal

–

Adverse events

Grade 2 stomatitis with onset in cycle 6 (2013-03-25); assessed as related to study drug (probable); resolved 2013-04-01.

moderate assessed

Grade 3 febrile neutropenia with onset in cycle 2 (2013-01-03); assessed as related to study drug (probable); resolved 2013-01-10; action: drug interrupted.

severe assessed

Grade 1 neutropenia with onset in cycle 2 (2013-01-02); assessed as related to study drug (probable); resolved 2013-01-11.

mild assessed

Grade 2 mucosal inflammation with onset in cycle 2 (2012-12-31); assessed as related to study drug (probable); resolved 2013-01-09.

moderate assessed

Grade 2 vomiting with onset in cycle 2 (2012-12-23); assessed as not related to study drug (unlikely); resolved 2012-12-25.

moderate assessed

Grade 3 neutropenia with onset in cycle 1 (2012-12-11); serious (hospitalization); assessed as related to study drug (probable); resolved 2012-12-20; action: dose reduced.

severe serious assessed

Grade 2 leukopenia with onset in cycle 1 (2012-12-08); assessed as related to study drug (probable); resolved 2012-12-17.

moderate assessed

Grade 1 pyrexia with onset in cycle 1 (2012-12-07); assessed as not related to study drug (unlikely); resolved 2012-12-08.

mild assessed

Grade 3 stomatitis with onset in cycle 1 (2012-12-04); serious (hospitalization); assessed as related to study drug (probable); resolved 2012-12-10; action: drug interrupted.

severe serious assessed

Data queries

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