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Efficacy and Safety Study of M200(Volociximab in Combination With Liposomal Doxorubicin)

NCT00635193 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2013-01-18

No results posted yet for this study

Summary

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.

Conditions

  • Ovarian Cancer, Primary Peritoneal Cancer

Interventions

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.

DRUG

M200 (Volociximab)

15 mg/kg, IV infusions every week until disease progression

DRUG

M200 (Volociximab)

15 mg/kg, IV infustions every other week until disease progression

Sponsors & Collaborators

  • Biogen

    collaborator INDUSTRY

  • AbbVie (prior sponsor, Abbott)

    lead INDUSTRY

Principal Investigators

  • Mihail Obrocea, MD · AbbVie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2008-10-31
Completion
2009-10-31

Countries

  • United States
  • Australia
  • Belgium
  • Italy
  • Poland
  • Russia
  • Spain
  • Sweden
  • Switzerland

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00635193 on ClinicalTrials.gov