Epworth HealthCare Clinical Trials and Research Centre (Richmond, Australia)

Sites / AUS

Epworth HealthCare Clinical Trials and Research Centre (Richmond, Australia)

AUS · PI Dr. Dubois · activated

KRI 0.391

Patients

3

Active

0

Serious AEs

1

Open QA

1

Aged queries

1

Luna users

0

Studies & contracts

1

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 · study completed · 73500 USD

executed

Patients

3

P2B-081

withdrawn

P2B-090

completed

P2B-136

completed

Safety

15 AEs · 1 serious

Grade 3 febrile neutropenia with onset in cycle 4 (2013-06-14); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-06-22.

serious P2B-090

QA findings

1 open

ELIGIBILITY CRITERIA NOT MET: Eligibility deviation found after randomization: prior anthracycline exposure above the 225 mg/m2 limit documented in outside records (subject P2B-081, 2013-04-17)

open major

TUMOUR ASSESSMENT OUT OF WINDOW: CT/MRI tumour assessment performed outside the +/-7-day window of the 6-weekly schedule (subject P2B-081, 2013-03-12)

resolved minor

Visits & payments

0

Nothing scheduled. Re-score risk to let the pipeline propose a visit.

Luna participants

0

No Luna participants here yet. Participants join once invited by the site.

Open Luna