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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-000509-31 | EudraCT Number |
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| Name | Class |
|---|---|
| Biogen | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Other | Three subjects will be treated with liposomal doxorubicin, 40 mg/m2 q4wk, and volociximab, 7.5 mg/kg qwk |
|
| Cohort 2 | Other | liposomal doxorubicin, 40 mg/m2 q4wk, and volociximab 15 mg/kg qwk |
|
| Group A | Other | liposomal doxorubicin, 40 mg/m2 q4wk |
|
| Group B | Other | liposomal doxorubicin, 40 mg/m2 q4wk, and volociximab 15 mg/kg q2wk (or other dose and schedule) |
|
| Group C | Other | liposomal doxorubicin, 40 mg/m2 q4wk, and volociximab 15 mg/kg qwk (or other dose and schedule) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| M200 (Volociximab) | Drug | 7.5 mg/kg, IV infusion every week until disease progression |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mihail Obrocea, MD | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 75281 | Anaheim | California | 92801 | United States | ||
| Site Reference ID/Investigator# 75275 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37407274 | Derived | 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. |
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| Liposomal Doxorubicin |
| Drug |
40 mg/m2, IV infustions every 4 weeks until disease progression, the maxium number of doses a subject can receive is 12. |
|
| M200 (Volociximab) | Drug | 15 mg/kg, IV infusions every week until disease progression |
|
| M200 (Volociximab) | Drug | 15 mg/kg, IV infustions every other week until disease progression |
|
| 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 | 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 | UmeƄ | 901 85 | Sweden |
| Site Reference ID/Investigator# 75416 | Bellinzona | 6500 | Switzerland |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| C516631 | volociximab |
| C506643 | liposomal doxorubicin |
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