GalenOps prod · 0.1.0

Site

Blokhin Cancer Research Center (Moscow, Russia)

RUS activated KRI 0.299

Principal investigator Dr. Moreau

Sites

Patients

7

Active

0

enrolled or consented

Withdrawn

0

Serious AEs

3

Open QA findings

0

Aged data queries

8

Studies & contracts

total budget 102000.00 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 102000 USD

Patients first 7

RefStatusConsentedStudy
P2B-012 completed 2012-06-20 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-018 completed 2012-07-12 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-082 completed 2013-03-01 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-118 completed 2013-05-25 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-127 completed 2013-06-27 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-128 screened 2013-07-08 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-130 completed 2013-07-09 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

Luna participants 0

No Luna participants yet

Participants at this site have not been invited to Luna.

Open Luna users

Safety

33 AEs · 3 serious

serious P2B-130 under_review

Grade 3 anaemia with onset in cycle 4 (2013-10-17); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-11-10; action: drug interrupted.

serious P2B-018 assessed

Grade 3 diarrhoea with onset in cycle 3 (2012-09-22); serious (hospitalization); assessed as related to study drug (possible); resolved 2012-09-24; action: drug interrupted.

serious P2B-012 assessed

Grade 3 febrile neutropenia with onset in cycle 1 (2012-07-15); serious (hospitalization); assessed as related to study drug (probable); resolved 2012-07-23; action: dose reduced.

QA findings

0 open

resolved minor Protocol deviation

VISIT OUT OF WINDOW: Cycle Day 1 visit outside the +/-3-day window without a documented toxicity delay (subject P2B-012, 2012-08-23)

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.