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) |
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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. |