Sarcoma Oncology Center (Santa Monica, CA) › P2B-134

P2B-134

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
Sarcoma Oncology Center (Santa Monica, CA) · Dr. Reyes
consented 2013-07-12

completed

AEs

Serious

Dropout signal

–

Adverse events

Grade 1 anaemia with onset in cycle 6 (2013-11-22); assessed as related to study drug (probable); resolved 2013-12-07.

mild assessed

Grade 3 thrombocytopenia with onset in cycle 6 (2013-11-16); assessed as related to study drug (probable); resolved 2013-11-27.

severe assessed

Grade 4 febrile neutropenia with onset in cycle 5 (2013-10-29); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-11-04; action: drug interrupted.

severe serious under_review

Grade 3 anaemia with onset in cycle 5 (2013-10-22); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-11-26; action: dose reduced.

severe serious under_review

Grade 1 vomiting with onset in cycle 5 (2013-10-20); assessed as not related to study drug (not related); resolved 2013-10-23.

mild assessed

Grade 3 neutropenia with onset in cycle 4 (2013-10-02); assessed as related to study drug (probable); resolved 2013-10-12.

severe assessed

Grade 3 leukopenia with onset in cycle 3 (2013-09-16); assessed as related to study drug (probable); resolved 2013-09-25.

severe assessed

Grade 3 asthenia with onset in cycle 3 (2013-09-14); assessed as not related to study drug (unlikely); resolved 2013-10-10.

severe assessed

Grade 2 febrile neutropenia with onset in cycle 2 (2013-08-22); assessed as related to study drug (probable); resolved 2013-08-27.

moderate assessed

Grade 2 alopecia with onset in cycle 1 (2013-08-05); assessed as related to study drug (probable); not resolved at last follow-up.

moderate assessed

Grade 3 abdominal pain with onset in cycle 1 (2013-07-29); assessed as not related to study drug (unlikely); resolved 2013-08-06; action: drug interrupted.

severe assessed

Grade 4 neutropenic sepsis with onset in cycle 1 (2013-07-28); serious (life-threatening; hospitalization); assessed as related to study drug (probable); resolved 2013-08-05; action: drug interrupted.

severe serious assessed

Data queries

Visit Cycle 6 Day 1: infusion (last planned cycle) (V7) for P2B-134 occurred on 2013-11-08, 5 d late against planned day 106 (2013-11-03 ± 3 d, anchored on first dose 2013-07-21). Confirm the visit date or record a protocol deviation.

SV.occurred_on[V7] open

Visit Cycle 5 Day 1: infusion; week-12 CT/MRI and ECHO/MUGA before dosing (V6) for P2B-134 occurred on 2013-10-17, 4 d late against planned day 85 (2013-10-13 ± 3 d, anchored on first dose 2013-07-21). Confirm the visit date or record a protocol deviation.

SV.occurred_on[V6] open