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A Phase 1/2, Open-Label, Adaptive, Randomized Study of Liposomal Doxorubicin With or Without M200 (Volociximab) for the Treatment of Subjects With Advanced Epithelial Ovarian Cancer or Primary Peritoneal Cancer That Have Relapsed After Prior Therapy With a Platinum/Taxane-Based Chemotherapy
Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
interventional
138
9 countries
39
Study Start
July 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2008
Actual (reported)Study Completion
October 2009
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2009
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2007
Date type not reportedThis date has not been verified as actual or estimated.
March 5, 2008
Actual (reported)March 13, 2008
Actual (reported)October 2008
Actual (reported)October 2009
Actual (reported)To evaluate the efficacy of volociximab in combination with liposomal doxorubicin in advanced epithelial ovarian cancer or primary peritoneal cancer. To evaluate the safety and tolerability of volociximab in combination with liposomal doxorubicin.
50-57 days
Three subjects will be treated with liposomal doxorubicin, 40 mg/m2 q4wk, and volociximab, 7.5 mg/kg qwk
liposomal doxorubicin, 40 mg/m2 q4wk, and volociximab 15 mg/kg qwk
7.5 mg/kg, IV infusion every week until disease progression
40 mg/m2, IV infustions every 4 weeks until disease progression, the maxium number of doses a subject can receive is 12.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
Liposomal Doxorubicin
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
View registry recordSite 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
Newhouse R, Nelissen E, El-Shakankery KH, Rogozinska E, Bain E, Veiga S, Morrison J. Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Jul 5;7(7):CD006910. doi: 10.1002/14651858.CD006910.pub3.
Mihail Obrocea, MD
AbbVie
138 participants (actual enrollment reported by the registry).
First Submitted
March 5, 2008
First Posted
March 13, 2008
Study Start
July 2007
Date type not reportedThis date has not been verified as actual or estimated.
liposomal doxorubicin, 40 mg/m2 q4wk
liposomal doxorubicin, 40 mg/m2 q4wk, and volociximab 15 mg/kg q2wk (or other dose and schedule)
liposomal doxorubicin, 40 mg/m2 q4wk, and volociximab 15 mg/kg qwk (or other dose and schedule)
15 mg/kg, IV infusions every week until disease progression
15 mg/kg, IV infustions every other week until disease progression
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Baltimore, Maryland, 21215, United States
Site Reference ID/Investigator# 75294
Jackson, 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, 15-027, Poland
Site Reference ID/Investigator# 75339
Krakow, 31-531, Poland
Site Reference ID/Investigator# 75341
Lublin, 20-090, Poland
Site Reference ID/Investigator# 75342
Poznan, 61-001, Poland
Site Reference ID/Investigator# 75343
Poznan, 61-848, Poland
Site Reference ID/Investigator# 75345
Szczecin, 70-111, Poland
Site Reference ID/Investigator# 75340
Wroclaw, 50-367, Poland
Site Reference ID/Investigator# 75346
Moscow, 129128, Russia
Site Reference ID/Investigator# 75348
Moscow, 143423, Russia
Site Reference ID/Investigator# 75347
Saint Petersburg, 198255, Russia
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
Umeå, 901 85, Sweden
Site Reference ID/Investigator# 75416
Bellinzona, 6500, Switzerland
Primary Completion
October 2008
Actual (reported)Study Completion
October 2009
Actual (reported)Last Updated
January 18, 2013
Record last verified: 2013-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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