P2B-007

State Healthcare Institution "Republican Clinical Oncological Center of the Ministry of Health of Republic of Tatarstan" (Kazan', Russia) › P2B-007

P2B-007

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 2012-05-22

completed

AEs

3

Serious

0

Dropout signal

–

Adverse events

3

Grade 1 anaemia with onset in cycle 4 (2012-08-17); assessed as related to study drug (probable); resolved 2012-09-09.

mild assessed

Grade 2 leukopenia with onset in cycle 1 (2012-06-10); assessed as related to study drug (probable); resolved 2012-06-17.

moderate assessed

Grade 2 nausea with onset in cycle 1 (2012-06-06); assessed as not related to study drug (unlikely); resolved 2012-06-08.

moderate assessed

Data queries

0

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