University of Iowa (Iowa City, IA) › P2B-106

P2B-106

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
University of Iowa (Iowa City, IA) · Dr. Okafor
consented 2013-04-26

completed

AEs

Serious

Dropout signal

–

Adverse events

Grade 1 leukopenia with onset in cycle 6 (2013-09-05); assessed as related to study drug (probable); resolved 2013-09-11.

mild assessed

Grade 1 cough with onset in cycle 4 (2013-07-31); assessed as not related to study drug (unlikely); resolved 2013-08-09.

mild assessed

Grade 1 fatigue with onset in cycle 4 (2013-07-17); assessed as not related to study drug (not related); resolved 2013-08-12.

mild assessed

Grade 3 pelvic neoplasm with onset in cycle 2 (2013-06-12); serious (hospitalization); assessed as not related to study drug (unlikely); resolved 2013-06-22.

severe serious assessed

Grade 3 deep vein thrombosis with onset in cycle 2 (2013-06-03); serious (hospitalization); assessed as not related to study drug (unlikely); resolved 2013-06-22; action: drug interrupted.

severe serious assessed

Grade 2 alopecia with onset in cycle 1 (2013-05-23); assessed as related to study drug (probable); not resolved at last follow-up.

moderate assessed

Grade 3 leukopenia with onset in cycle 1 (2013-05-17); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-05-24.

severe serious assessed

Grade 3 neutropenia with onset in cycle 1 (2013-05-16); assessed as related to study drug (probable); resolved 2013-05-25; action: drug interrupted.

severe assessed

Data queries

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