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MGI-114 in Recurrent or Persistent Ovarian Cancer
NCT00019552Phase 2
Key facts
- Status
- Completed
- Start
- Sep 1998
- Countries
- 1
- Sponsor
- National Cancer Institute
- Modality
- Small Molecules
- Drugs
- irofulven
- Conditions
- ovarian cancerfallopian tube cancer (PFTC)primary peritoneal cancer (PPC)
01
Overview
Phase 2, open-label, single-arm trial of irofulven in ovarian cancer, fallopian tube cancer (PFTC) and primary peritoneal cancer (PPC), sponsored by National Cancer Institute. Primary endpoint: Clinical Activity (Objective Response Rate). Started Sep 1998; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
MGI-114
Patients receive irofulven IV over 5 minutes on days 1-5 every 4 weeks.
03
Who it enrols
Patients with recurrent/persistent ovarian, fallopian tube, or peritoneal cancer who failed prior standard chemotherapy. Excludes brain metastases, unstable angina/MI within 6 months, NYHA class II-IV heart failure, and chronic obstructive lung disease requiring oxygen.
04
Endpoints
Primary
Clinical Activity (Objective Response Rate)
Secondary
Pharmacokinetic Profile
Pharmacodynamic Relationship
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