Sarcoma Oncology Center (Santa Monica, CA) › P2B-005

P2B-005

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 2012-04-22

completed

AEs

Serious

Dropout signal

–

Adverse events

Grade 4 febrile neutropenia with onset in cycle 5 (2012-08-20); serious (hospitalization); assessed as related to study drug (probable); resolved 2012-08-24; action: dose reduced.

severe serious assessed

Grade 2 tooth infection with onset in cycle 3 (2012-07-04); serious (hospitalization); assessed as not related to study drug (unlikely); resolved 2012-07-09.

moderate serious assessed

Grade 2 aspartate aminotransferase increased with onset in cycle 2 (2012-06-18); assessed as not related to study drug (unlikely); resolved 2012-07-09.

moderate assessed

Grade 1 anaemia with onset in cycle 2 (2012-06-06); assessed as related to study drug (probable); resolved 2012-07-13.

mild assessed

Grade 2 febrile neutropenia with onset in cycle 1 (2012-05-16); assessed as related to study drug (probable); resolved 2012-05-24.

moderate assessed

Data queries

Visit Cycle 6 Day 1: infusion (last planned cycle) (V7) for P2B-005 occurred on 2012-08-29, 7 d late against planned day 106 (2012-08-22 ± 3 d, anchored on first dose 2012-05-09). 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-005 occurred on 2012-08-07, 6 d late against planned day 85 (2012-08-01 ± 3 d, anchored on first dose 2012-05-09). Confirm the visit date or record a protocol deviation.

SV.occurred_on[V6] open

Visit Cycle 4 Day 1: infusion (V5) for P2B-005 occurred on 2012-07-16, 5 d late against planned day 64 (2012-07-11 ± 3 d, anchored on first dose 2012-05-09). Confirm the visit date or record a protocol deviation.

SV.occurred_on[V5] open

Visit Cycle 3 Day 1: infusion; week-6 CT/MRI and ECHO/MUGA before dosing (V4) for P2B-005 occurred on 2012-06-24, 4 d late against planned day 43 (2012-06-20 ± 3 d, anchored on first dose 2012-05-09). Confirm the visit date or record a protocol deviation.

SV.occurred_on[V4] open

Visit Cycle 2 Day 1: infusion (V3) for P2B-005 occurred on 2012-06-04, 5 d late against planned day 22 (2012-05-30 ± 3 d, anchored on first dose 2012-05-09). Confirm the visit date or record a protocol deviation.

SV.occurred_on[V3] open