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

January 10, 2013 updated by: AbbVie (prior sponsor, Abbott)

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
138

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Toorak Gardens, Australia, 5065
        • Site Reference ID/Investigator# 75334
      • Woodville South, Australia, 5011
        • Site Reference ID/Investigator# 75335
  • Belgium
      • Antwerp, Belgium, 2020
        • Site Reference ID/Investigator# 75337
      • Brussels, Belgium, 1200
        • Site Reference ID/Investigator# 75336
      • Leuven, Belgium, 3000
        • Site Reference ID/Investigator# 75338
  • Italy
      • Milan, Italy, 20133
        • Site Reference ID/Investigator# 75415
      • Milan, Italy, 20141
        • Site Reference ID/Investigator# 75333
  • Poland
      • Bialystok, Poland, 15-027
        • Site Reference ID/Investigator# 75344
      • Krakow, Poland, 31-531
        • Site Reference ID/Investigator# 75339
      • Lublin, Poland, 20-090
        • Site Reference ID/Investigator# 75341
      • Poznan, Poland, 61-001
        • Site Reference ID/Investigator# 75342
      • Poznan, Poland, 61-848
        • Site Reference ID/Investigator# 75343
      • Szczecin, Poland, 70-111
        • Site Reference ID/Investigator# 75345
      • Wroclaw, Poland, 50-367
        • Site Reference ID/Investigator# 75340
  • Russian Federation
      • Moscow, Russian Federation, 129128
        • Site Reference ID/Investigator# 75346
      • Moscow, Russian Federation, 143423
        • Site Reference ID/Investigator# 75348
      • St. Petersburg, Russian Federation, 198255
        • Site Reference ID/Investigator# 75347
  • Spain
      • Barcelona, Spain, 08035
        • Site Reference ID/Investigator# 75349
      • Barcelona, Spain, 08036
        • Site Reference ID/Investigator# 75351
      • Barcelona, Spain, 08208
        • Site Reference ID/Investigator# 75352
      • Girona, Spain, 17007
        • Site Reference ID/Investigator# 75350
      • Madrid, Spain, 28040
        • Site Reference ID/Investigator# 75353
  • Sweden
      • Stockholm, Sweden, 17176
        • Site Reference ID/Investigator# 75354
      • Umea, Sweden, 901 85
        • Site Reference ID/Investigator# 75355
  • Switzerland
      • Bellinzona, Switzerland, 6500
        • Site Reference ID/Investigator# 75416
  • United States
    • California
      • Anaheim, California, United States, 92801
        • Site Reference ID/Investigator# 75281
      • Redondo Beach, California, United States, 90277
        • Site Reference ID/Investigator# 75275
    • Florida
      • Sunrise, Florida, United States, 33323
        • Site Reference ID/Investigator# 75296
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Site Reference ID/Investigator# 75299
      • Savannah, Georgia, United States, 31404
        • Site Reference ID/Investigator# 75300
    • Illinois
      • Hinsdale, Illinois, United States, 60521
        • Site Reference ID/Investigator# 75301
    • Maryland
      • Baltimore, Maryland, United States, 21215
        • Site Reference ID/Investigator# 75274
    • Missouri
      • Jackson City, Missouri, United States, 65109
        • Site Reference ID/Investigator# 75294
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Site Reference ID/Investigator# 75279
    • Texas
      • Corpus Christi, Texas, United States, 78404
        • Site Reference ID/Investigator# 75295
      • Dallas, Texas, United States, 75246
        • Site Reference ID/Investigator# 75280
    • Virginia
      • Danville, Virginia, United States, 23185
        • Site Reference ID/Investigator# 75297
      • Williamsburg, Virginia, United States, 23185
        • Site Reference ID/Investigator# 75298
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54301
        • Site Reference ID/Investigator# 75278

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: 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.
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
Other: Cohort 2
liposomal doxorubicin, 40 mg/m2 q4wk, and volociximab 15 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.
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
Other: 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.
Other: Group B
liposomal doxorubicin, 40 mg/m2 q4wk, and volociximab 15 mg/kg q2wk (or other dose and schedule)
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
Other: Group C
liposomal doxorubicin, 40 mg/m2 q4wk, and volociximab 15 mg/kg qwk (or other dose and schedule)
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
50-57 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie (prior sponsor, Abbott)

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 5, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 18, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 206OC202
  • 2007-000509-31 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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