GalenOps prod · 0.1.0

Site

Royal Hobart Hospital (Hobart, Australia)

AUS activated KRI 0.409

Principal investigator Dr. Novak

Sites

Patients

3

Active

0

enrolled or consented

Withdrawn

1

Serious AEs

4

Open QA findings

1

Aged data queries

2

Studies & contracts

total budget 73500.00 USD

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 contract executed 73500 USD

Patients first 3

RefStatusConsentedStudy
P2B-097 completed 2013-04-01 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
P2B-110 completed 2013-05-09 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
P2B-125 withdrawn 2013-06-26 A Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the Preliminary Efficacy and Safety of INNO-206 (Doxorubicin-EMCH) Compared to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

Luna participants 0

No Luna participants yet

Participants at this site have not been invited to Luna.

Open Luna users

Safety

19 AEs · 4 serious

serious P2B-110 assessed

Grade 3 leukopenia with onset in cycle 6 (2013-09-22); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-09-30.

serious P2B-110 assessed

Grade 3 pulmonary embolism with onset in cycle 4 (2013-08-16); serious (hospitalization); assessed as not related to study drug (unlikely); resolved 2013-09-04; action: drug interrupted.

serious P2B-125 assessed

Grade 3 transient ischaemic attack with onset in cycle 2 (2013-07-31); serious (hospitalization); assessed as not related to study drug (unlikely); resolved 2013-08-02.

serious P2B-110 assessed

Grade 3 febrile neutropenia with onset in cycle 1 (2013-06-03); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-06-12; action: dose reduced.

QA findings

1 open

open major Protocol deviation

PROHIBITED CONCOMITANT THERAPY: Other systemic anticancer therapy started while on study treatment (subject P2B-125, 2013-10-12)

resolved minor Protocol deviation

TUMOUR ASSESSMENT OUT OF WINDOW: CT/MRI tumour assessment performed outside the +/-7-day window of the 6-weekly schedule (subject P2B-110, 2013-08-04)

Monitoring visits 0

No visits recorded

Re-score risk to propose an on-site visit.

Payments 0

No payments on file

Milestone payments are proposed by the finance step and approved in the review queue.