A Phase 2, Single-Arm Study of Volociximab Monotherapy in Subjects With Platinum-Resistant Advanced Epithelial Ovarian Cancer or Primary Peritoneal Cancer

August 21, 2012 updated by: Facet Biotech
To evaluate the efficacy of voloxicimab when administered at 15 mg/kg qwk in subjects with platinum-resistant, advanced epithelial ovarian cancer or primary peritoneal cancer.

Study Overview

Status

Status

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

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.

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.
16

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

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

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N4N2
        • Tom Baker Cancer Center
      • Edmonton, Alberta, Canada, T6G1Z2
        • Cross Cancer Institute
    • Ontario
      • London, Ontario, Canada, NGA4L6
        • London Health Sciences Center
    • Quebec
      • Montreal, Quebec, Canada, H3A 1A1
        • McGill University Hospital
  • United States
    • California
      • Los Angeles, California, United States, 90024
        • UCLA JCCC Clinical Research Unit
      • Orange, California, United States, 92868-3201
        • UCI Medical Center
      • San Diego, California, United States, 92123
        • Sharp Hospital
    • Florida
      • Orlando, Florida, United States, 32804
        • Florida Hospital Cancer Institute
    • Georgia
      • Savannah, Georgia, United States, 31404
        • Memorial Health University Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • James Graham Brown Cancer Center
    • Maryland
      • Baltimore, Maryland, United States, 21231-1000
        • Johns Hopkins Kimmel Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02115
        • Dana Farber Cancer Institute
      • Boston, Massachusetts, United States, 02115
        • Beth Israel Deaconess Medical Center
    • Montana
      • Billings, Montana, United States, 59101
        • Billings Clinic (MCMRC network)
    • New York
      • Bronx, New York, United States, 10461
        • Montefiore Medical Center
      • New York, New York, United States, 10021
        • Memorial Sloan Kettering Cancer Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma University Health Science Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
    • Texas
      • Dallas, Texas, United States, 75246
        • Mary Crowley Medical Research Center
      • Dallas, Texas, United States, 75231
        • Texas Oncology PA, Presbyterian

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:

  • Must give written informed consent and any authorizations required by local law (e.g., Protected Health Information [PHI]).
  • 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).
  • Radiologically-documented evidence of progressive disease.
  • Platinum-resistant disease defined as having a best response of SD or disease progression during or within 6 months of discontinuing a platinum-based chemotherapy (carboplatinum, cisplatinum, or another organoplatinum compound).
  • Progression during or following treatment with topotecan or liposomal doxorubicin.
  • Three or fewer prior chemotherapy regimens (including a platinum-based therapy).
  • At least 1 measurable target lesion in accordance with RECIST criteria to assess clinical response (tumors within a previously irradiated field are designated as non-target).
  • ECOG Performance Status ≤1.
  • Life expectancy >12 weeks.
  • Available paraffin block or unstained paraffin sections on glass slides containing representative tumor tissue from the most recent tumor biopsy/resection.
  • Subjects of child-bearing potential must be willing to practice effective contraception during the study and be willing and able to continue contraception for at least 6 months after their last dose of study treatment (about 5 half lives).

Exclusion Criteria:

  • Screening clinical laboratory values:

    • Absolute neutrophil count <1500/µL
    • Platelet count <75,000/µL
    • Hemoglobin <8.5 g/dL (hemoglobin may be supported by transfusion, erythropoietin, or other approved hematopoietic growth factors; darbopoeitin [Aranesp®] is permitted)
    • Serum bilirubin >2.0 x upper limit of normal (ULN)
    • AST and ALT >2.5 x ULN (AST and ALT >5 × ULN for subjects with liver metastasis)
    • Serum creatinine >2.0 mg/dL
    • International normalized ratio (INR) >1.5
    • Activated partial thromboplastin time (aPTT) >1.5 × ULN
  • Clinically significant peripheral vascular disease.
  • Non-epithelial ovarian tumors.
  • Active infection requiring systemic antibiotics, antivirals, or antifungals including HIV/AIDS, hepatitis B, or hepatitis C infection.
  • History of abdominal fistula, gastrointestinal (GI) perforation, or intra-abdominal abscess within 6 months prior to Day 1.
  • Serious, non-healing wound, or bone fracture.
  • Known central nervous system or brain metastases.
  • History of uncontrolled psychiatric condition within 6 months prior to Day 1.
  • History of other malignancies within 3 years of Day 1, except for adequately treated carcinoma in situ of the cervix, ductal carcinoma in situ (DCIS) of breast, or basal or squamous cell skin cancer.
  • Evidence of autoimmune disease including, but not limited to, ulcerative colitis, Crohn's disease, rheumatoid arthritis (RA), systemic lupus erythematosus (SLE) sceloderma, or another diseases in which immune function or immune competence is known to be impaired.
  • Any history of lymphoproliferative disorder.
  • Known human anti-murine antibody (HAMA) and/or human anti-chimeric antibody (HACA).
  • Any medical condition that may be exacerbated by bleeding, including a known bleeding disorder such as a coagulation defect, thrombocytopenia, active gastric or duodenal ulcer, or history of GI bleeding.
  • Significant hemoptysis within one year prior to Study Day 1.
  • Any investigational, anti-cancer therapy within 6 weeks prior to Day 1.
  • Any non-investigational, anti-cancer therapy within 4 weeks prior to Day 1.
  • Prior treatment with anti-angiogenic agents.
  • 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.
  • Subjects who are taking concomitant immunomodulatory agents including, but not limited to, interferons, interleukins, systemic steroids, cyclosporine, tacrolimus, calcineurin inhibitors, chronic low-dose methotrexate, or azathioprine. (The use of inhaled or intranasal steroids or oral steroids at a dose of ≤10 mg/day prednisone or its equivalent are permitted.)
  • Active, unstable severe cardiovascular disease, including poorly controlled angina, congestive heart failure (CHF), arrhythmias, myocardial infarction (MI), cardiomyopathy, atrioventricular (AV) block, electrocardiogram (ECG) evidence of acute ischemia, or significant conduction abnormality.
  • History of thromboembolic or cerebrovascular events, such as stroke, or transient ischemic attack (TIA). (Note: Prior history of deep vein thrombosis will not exclude subjects from participating in this study.)
  • Pregnant (positive pregnancy test) or lactating.
  • Inability to comply with study and follow-up procedures.
  • Any condition that, in the opinion of the Investigator, makes the subject unsuitable for study participation.
  • Known hypersensitivity to murine or chimeric antibodies.
  • Major surgery within 4 weeks prior to Day 1.

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: N/A
  • Interventional Model: Single Group 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.
Experimental: volociximab
15 mg/kg volociximab once weekly
Drug: Volociximab
15 mg/kg weekly, IV infusions, for 8 weeks or until disease progression or unacceptable toxicity develops
Other Names:
  • M200

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
Efficacy as measured by objective response rate (ORR). Tumor response based on RECIST criteria.
Time Frame: Baseline, and every 8 weeks on study
Baseline, and every 8 weeks on study

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.
Facet Biotech

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

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Carolyn Matthews, MD, Mary Crowley Medical Research Center
  • Principal Investigator: Minal Barve, MD, Texas Oncology PA, Presbyterian
  • Principal Investigator: James Burke, MD, Billings Clinic (MCMRC network)
  • Principal Investigator: Dana Glenn, MD, Sharp Hospital
  • Principal Investigator: Russell Schilder, MD, Fox Chase Cancer Center
  • Principal Investigator: Nikki Spellman, MD, Indiana University
  • Principal Investigator: Michael Gold, MD, Oklahoma University Health Science Center
  • Principal Investigator: Richard Penson, MD, Massachusetts General Hospital
  • Principal Investigator: Mark Einstein, MD, Montefiore Medical Center
  • Principal Investigator: Robert Holloway, MD, Florida Hospital Cancer Institute
  • Principal Investigator: Deborah Armstrong, MD, Johns Hopkins Kimmel Cancer Center
  • Principal Investigator: Snehel Bhoola, MD, Memorial Health University Medical Center
  • Principal Investigator: Eric Winquist, MD, London Health Sciences Center
  • Principal Investigator: Ernst Lengyel, MD, University of Chicago
  • Principal Investigator: John Glaspy, MD, UCLA JCCC Clinical Research Unit
  • Principal Investigator: Krish Tewari, MD, UCI Medical Center
  • Principal Investigator: C. William Helm, MD, James Graham Brown Cancer Center
  • Principal Investigator: John Glaspy, MD, University of California, Los Angeles
  • Principal Investigator: Michael Sawyer, MD, Cross Cancer Institute

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.
August 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.
April 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.
April 1, 2008

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).
August 14, 2007

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.
August 15, 2007

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.
August 16, 2007

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.
August 23, 2012

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.
August 21, 2012

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.
August 1, 2012

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.
  • 206OC201

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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