GalenOps prod · 0.1.0

Site

Royal Perth Hospital (Perth, Australia)

AUS activated KRI 0.496

Principal investigator Dr. Silva

Sites

Patients

4

Active

0

enrolled or consented

Withdrawn

1

Serious AEs

2

Open QA findings

0

Aged data queries

4

Studies & contracts

total budget 64000.00 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 64000 USD

Patients first 4

RefStatusConsentedStudy
P2B-022 screened 2012-07-28 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-036 completed 2012-09-22 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-094 screened 2013-03-30 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P2B-116 withdrawn 2013-05-24 A Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the Preliminary Efficacy and Safety of INNO-206 (Doxorubicin-EMCH) Compared to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

14 AEs · 2 serious

serious P2B-036 assessed

Grade 3 febrile neutropenia with onset in cycle 2 (2012-11-02); serious (hospitalization); assessed as related to study drug (probable); resolved 2012-11-09; action: dose reduced.

serious P2B-036 assessed

Grade 3 hypersensitivity with onset in cycle 2 (2012-10-29); serious (hospitalization); assessed as related to study drug (probable); resolved 2012-10-30; action: drug interrupted.

QA findings

0 open

No findings recorded

Findings are filed by monitoring visits.

Monitoring visits 1

on_site 2026-10-13 risk-flagged

Proposed by centralized statistical monitoring (risk score 0.496, composite |z| 1.37): visit-window compliance 50% vs study mean 88%, z=-2.92; missed-visit rate 12% vs study mean 3%, z=2.73. Pending CRA confirmation.

Payments 0

No payments on file

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