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. 2013 Jul 9;2013(7):CD006910. doi: 10.1002/14651858.CD006910.pub2

M200 2009.

Methods Multicentre open‐label RCT; enrolment in USA from July 2007 to Oct 2008. (ID: NCT00635193)
Participants 127 women with stage III/IV PS or PR ROC. Maximum of 2 prior chemotherapy treatments (at least one of which was platinum/taxane based); at least one measurable lesion to assess response by RECIST.
Interventions Volociximab (M200) is an anti‐angiogenic integrin inhibitor/monoclonal antibody. Two dosage regimes were tested combined with PLD versus PLD alone:
Arm 1: PLD 40 mg/m² q4wk (66 women)
Arm 2: M200 15 mg/kg qwk + PLD 40 mg/m² q4wk (34 women)
Arm 3: M200 15 mg/kg q2wk + PLD 40 mg/m² q4wk (27 women)
Outcomes Efficacy, safety and tolerability
Notes No useable data. Results were reported as follows: 'The most common Grade 3 to 4 AEs (≥5% in any group) were abdominal pain, intestinal obstruction, ascites, fatigue, hypoalbuminemia, and cytopenias. The incidence of AEs was balanced across treatment groups. "There were no CRs; PRs were 16%, 18%, and 19%....Preliminary analysis of PFS suggested that there was a low probability of detecting a statistically significant difference in favor of V+PLD, so the study was closed to enrollment."
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not described.
Allocation concealment (selection bias) Unclear risk Not described.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Open‐label study.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not described.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Efficacy and safety were not clearly detailed in the ASCO 2009 abstract which is the only publication for this study.
Selective reporting (reporting bias) Unclear risk Baseline data were not reported.
Other bias Unclear risk Limited information was available and results have not been published in full. Dr Obrocea of Abbott Laboratories was emailed on 28/11/2012 for final study data.