Status:
COMPLETED
Efficacy and Safety Study of M200(Volociximab in Combination With Liposomal Doxorubicin)
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Collaborating Sponsors:
Biogen
Conditions:
Ovarian Cancer, Primary Peritoneal Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is an open-label study of liposomal doxorubicin with or without volociximab for the treatment of subjects with advanced epithelial ovarian cancer or primary peritoneal cancer relapsed after prior...
Detailed Description
This is an open-label study of liposomal doxorubicin with or without volociximab for the treatment of subjects with advanced epithelial ovarian cancer or primary peritoneal cancer relapsed after prior...
Eligibility Criteria
Inclusion
- Females aged \>= 18 years old at the time of informed consent.
- Advanced (Stage III or IV) histologically documented epithelial ovarian cancer or primary peritoneal cancer (excluding small, round-cell histologies).
- Recurrent or persistent disease.
- Received no more than 2 prior cancer treatment regimens, at least one of which must have included a platinum/taxane based therapy. If the same regimen is given more than once, it will count as one regimen. If components of a regimen are given more than once using the same schedule, it will count as one regimen.
- At least 1 target lesion to assess response by RECIST criteria. (Tumors within a previously irradiated field are designated as non-target)
- Other protocol-defined inclusion criteria apply.
Exclusion
- Subjects taking immunomodulatory agents including, but not limited to, interferons, interleukins, systemic steroids, cyclosporine, tacrolimus, calcineurin inhibitors, chronic low dose methotrexate, or azathioprine. (Use of inhaled or intranasal steroids or oral steroids 10 mg/day prednisone or its equivalent are permitted.)
- Subjects who require treatment with an anti coagulant with the exception of low dose Aspirin® (81 mg/day), warfarin (1 mg/day), or heparin for IV catheter patency
- Evidence of bleeding diathesis or coagulopathy. (Prior history of DVT will not exclude subjects from participating in this study.)
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 1.
- Non-healing wound, ulcer, or bone fracture.
- Evidence of autoimmune disease including, but not limited to, ulcerative colitis, Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, scleroderma, and other disease in which immune function or immune competence is known to be impaired.
- Active infection requiring systemic antibiotics, antivirals, or antifungals including HIV/AIDS, hepatitis B, or hepatitis C infection.
- Other protocol-defined exclusion criteria apply
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT00635193
Start Date
July 1 2007
End Date
October 1 2009
Last Update
January 18 2013
Active Locations (39)
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1
Site Reference ID/Investigator# 75281
Anaheim, California, United States, 92801
2
Site Reference ID/Investigator# 75275
Redondo Beach, California, United States, 90277
3
Site Reference ID/Investigator# 75296
Sunrise, Florida, United States, 33323
4
Site Reference ID/Investigator# 75299
Atlanta, Georgia, United States, 30309