Hemato Oncology Clinic, Vedanta Institute of Medical Science (Ahmedabad, India)

Sites / IND

Hemato Oncology Clinic, Vedanta Institute of Medical Science (Ahmedabad, India)

IND · PI Dr. Ito · activated

KRI 0.32

Patients

4

Active

0

Serious AEs

1

Open QA

0

Aged queries

0

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

4

P2B-041

completed

P2B-051

completed

P2B-066

completed

P2B-080

screened

Safety

16 AEs · 1 serious

Grade 3 tumour haemorrhage with onset in cycle 5 (2013-01-24); serious (hospitalization); assessed as not related to study drug (not related); resolved 2013-02-02; action: drug interrupted.

serious P2B-041

QA findings

0 open

TUMOUR ASSESSMENT OUT OF WINDOW: CT/MRI tumour assessment performed outside the +/-7-day window of the 6-weekly schedule (subject P2B-051, 2013-01-01)

resolved minor

Visits & payments

0

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

Luna participants

0

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