Efficacy and Safety Study of M200(Volociximab in Combination With Liposomal Doxorubicin)
Public ClinicalTrials.gov record NCT00635193. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00635193
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 138 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 30, 2007
- Primary completion
- Sep 30, 2008
- Completion
- Sep 30, 2009
- Last update posted
- Jan 17, 2013
2007 – 2009
United States locations
- U.S. sites
- 14
- U.S. states
- 10
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Site Reference ID/Investigator# 75281 | Anaheim | California | 92801 | — |
| Site Reference ID/Investigator# 75275 | Redondo Beach | California | 90277 | — |
| Site Reference ID/Investigator# 75296 | Sunrise | Florida | 33323 | — |
| Site Reference ID/Investigator# 75299 | Atlanta | Georgia | 30309 | — |
| Site Reference ID/Investigator# 75300 | Savannah | Georgia | 31404 | — |
| Site Reference ID/Investigator# 75301 | Hinsdale | Illinois | 60521 | — |
| Site Reference ID/Investigator# 75274 | Baltimore | Maryland | 21215 | — |
| Site Reference ID/Investigator# 75294 | Jackson | Missouri | 65109 | — |
| Site Reference ID/Investigator# 75279 | Oklahoma City | Oklahoma | 73104 | — |
| Site Reference ID/Investigator# 75295 | Corpus Christi | Texas | 78404 | — |
| Site Reference ID/Investigator# 75280 | Dallas | Texas | 75246 | — |
| Site Reference ID/Investigator# 75297 | Danville | Virginia | 23185 | — |
| Site Reference ID/Investigator# 75298 | Williamsburg | Virginia | 23185 | — |
| Site Reference ID/Investigator# 75278 | Green Bay | Wisconsin | 54301 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 25 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00635193, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 17, 2013 · Synced Sep 19, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00635193 live on ClinicalTrials.gov.