Ovarian Cancer Clinical Trial

Efficacy and Safety Study of M200(Volociximab in Combination With Liposomal Doxorubicin)

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 therapy with Plat/Taxane-based chemo. Volociximab is an anti-angiogenic integrin inhibitor being developed for the treatment of solid tumors. Preclinical data with a surrogate volociximab antibody administered as monotherapy indicate encouraging efficacy in terms of tumor reduction and anti-angiogenic effects in mouse ovarian cancer xenograft models. In clinical studies, volociximab has been evaluated in several solid tumor types, including pancreatic, renal, and melanoma, with many subjects who entered the studies with progressive disease remaining progression-free for several months. In all studies in solid tumors, volociximab has shown a favorable safety profile when administered at 10 mg/kg q2wks and more recently at 15 mg/kg qwk. A study of volociximab in combination with liposomal doxorubicin in subjects with ovarian cancer or primary peritoneal cancer who have relapsed after prior platin/taxane therapies is warranted to further evaluate the drug's efficacy and safety. The investigators have thus far activated stage 2 of this study at 11/25 sites. Worldwide, the study aims to enroll 150 subjects.

View Full Description

Full 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 therapy with Plat/Taxane-based chemo. Volociximab is an anti-angiogenic integrin inhibitor being developed for the treatment of solid tumors. Preclinical data with a surrogate volociximab antibody administered as monotherapy indicate encouraging efficacy in terms of tumor reduction and anti-angiogenic effects in mouse ovarian cancer xenograft models. In clinical studies, volociximab has been evaluated in several solid tumor types, including pancreatic, renal, and melanoma, with many subjects who entered the studies with progressive disease remaining progression-free for several months.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

138

Study ID:

NCT00635193

Recruitment Status:

Completed

Sponsor:

AbbVie (prior sponsor, Abbott)

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There are 38 Locations for this study

See Locations Near You

Site Reference ID/Investigator# 75281
Anaheim California, 92801, United States
Site Reference ID/Investigator# 75275
Redondo Beach California, 90277, United States
Site Reference ID/Investigator# 75296
Sunrise Florida, 33323, United States
Site Reference ID/Investigator# 75299
Atlanta Georgia, 30309, United States
Site Reference ID/Investigator# 75300
Savannah Georgia, 31404, United States
Site Reference ID/Investigator# 75301
Hinsdale Illinois, 60521, United States
Site Reference ID/Investigator# 75274
Baltimore Maryland, 21215, United States
Site Reference ID/Investigator# 75294
Jackson City Missouri, 65109, United States
Site Reference ID/Investigator# 75279
Oklahoma City Oklahoma, 73104, United States
Site Reference ID/Investigator# 75295
Corpus Christi Texas, 78404, United States
Site Reference ID/Investigator# 75280
Dallas Texas, 75246, United States
Site Reference ID/Investigator# 75297
Danville Virginia, 23185, United States
Site Reference ID/Investigator# 75298
Williamsburg Virginia, 23185, United States
Site Reference ID/Investigator# 75278
Green Bay Wisconsin, 54301, United States
Site Reference ID/Investigator# 75334
Toorak Gardens , 5065, Australia
Site Reference ID/Investigator# 75335
Woodville South , 5011, Australia
Site Reference ID/Investigator# 75337
Antwerp , 2020, Belgium
Site Reference ID/Investigator# 75336
Brussels , 1200, Belgium
Site Reference ID/Investigator# 75338
Leuven , 3000, Belgium
Site Reference ID/Investigator# 75415
Milan , 20133, Italy
Site Reference ID/Investigator# 75333
Milan , 20141, Italy
Site Reference ID/Investigator# 75344
Bialystok , 15-02, Poland
Site Reference ID/Investigator# 75339
Krakow , 31-53, Poland
Site Reference ID/Investigator# 75341
Lublin , 20-09, Poland
Site Reference ID/Investigator# 75342
Poznan , 61-00, Poland
Site Reference ID/Investigator# 75343
Poznan , 61-84, Poland
Site Reference ID/Investigator# 75345
Szczecin , 70-11, Poland
Site Reference ID/Investigator# 75340
Wroclaw , 50-36, Poland
Site Reference ID/Investigator# 75346
Moscow , 12912, Russian Federation
Site Reference ID/Investigator# 75348
Moscow , 14342, Russian Federation
Site Reference ID/Investigator# 75347
St. Petersburg , 19825, Russian Federation
Site Reference ID/Investigator# 75349
Barcelona , 08035, Spain
Site Reference ID/Investigator# 75351
Barcelona , 08036, Spain
Site Reference ID/Investigator# 75352
Barcelona , 08208, Spain
Site Reference ID/Investigator# 75350
Girona , 17007, Spain
Site Reference ID/Investigator# 75353
Madrid , 28040, Spain
Site Reference ID/Investigator# 75354
Stockholm , 17176, Sweden
Site Reference ID/Investigator# 75355
Umea , 901 8, Sweden
Site Reference ID/Investigator# 75416
Bellinzona , 6500, Switzerland

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

138

Study ID:

NCT00635193

Recruitment Status:

Completed

Sponsor:


AbbVie (prior sponsor, Abbott)

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