Efficacy and Safety Study of M200(Volociximab in Combination With Liposomal Doxorubicin)
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ClinicalTrials.gov Identifier: NCT00635193 |
Recruitment Status
:
Completed
First Posted
: March 13, 2008
Last Update Posted
: January 18, 2013
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ovarian Cancer, Primary Peritoneal Cancer | Drug: M200 (Volociximab) Drug: Liposomal Doxorubicin | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 138 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | July 2007 |
Actual Primary Completion Date : | October 2008 |
Actual Study Completion Date : | October 2009 |

Arm | Intervention/treatment |
---|---|
Cohort 1
Three subjects will be treated with liposomal doxorubicin, 40 mg/m2 q4wk, and volociximab, 7.5 mg/kg qwk
|
Drug: M200 (Volociximab)
7.5 mg/kg, IV infusion every week until disease progression
Drug: Liposomal Doxorubicin
40 mg/m2, IV infustions every 4 weeks until disease progression, the maxium number of doses a subject can receive is 12.
|
Cohort 2
liposomal doxorubicin, 40 mg/m2 q4wk, and volociximab 15 mg/kg qwk
|
Drug: Liposomal Doxorubicin
40 mg/m2, IV infustions every 4 weeks until disease progression, the maxium number of doses a subject can receive is 12.
Drug: M200 (Volociximab)
15 mg/kg, IV infusions every week until disease progression
|
Group A
liposomal doxorubicin, 40 mg/m2 q4wk
|
Drug: Liposomal Doxorubicin
40 mg/m2, IV infustions every 4 weeks until disease progression, the maxium number of doses a subject can receive is 12.
|
Group B
liposomal doxorubicin, 40 mg/m2 q4wk, and volociximab 15 mg/kg q2wk (or other dose and schedule)
|
Drug: Liposomal Doxorubicin
40 mg/m2, IV infustions every 4 weeks until disease progression, the maxium number of doses a subject can receive is 12.
Drug: M200 (Volociximab)
15 mg/kg, IV infustions every other week until disease progression
|
Group C
liposomal doxorubicin, 40 mg/m2 q4wk, and volociximab 15 mg/kg qwk (or other dose and schedule)
|
Drug: Liposomal Doxorubicin
40 mg/m2, IV infustions every 4 weeks until disease progression, the maxium number of doses a subject can receive is 12.
Drug: M200 (Volociximab)
15 mg/kg, IV infusions every week until disease progression
|
- 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. [ Time Frame: 50-57 days ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00635193

Study Director: | Mihail Obrocea, MD | AbbVie |
Responsible Party: | AbbVie (prior sponsor, Abbott) |
ClinicalTrials.gov Identifier: | NCT00635193 History of Changes |
Other Study ID Numbers: |
206OC202 2007-000509-31 ( EudraCT Number ) |
First Posted: | March 13, 2008 Key Record Dates |
Last Update Posted: | January 18, 2013 |
Last Verified: | January 2013 |
Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
Ovarian neoplasms Angiogenesis inhibitors Angiogenesis Volociximab |
Ovarian cancer Antibody Monoclonals |
Additional relevant MeSH terms:
Ovarian Neoplasms Peritoneal Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Abdominal Neoplasms Digestive System Neoplasms |
Digestive System Diseases Peritoneal Diseases Doxorubicin Liposomal doxorubicin Antibodies, Monoclonal Antibiotics, Antineoplastic Antineoplastic Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs |