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A Trial Of PF-04856884 In Patients With Recurrent Glioblastoma

This study has been withdrawn prior to enrollment.
Information provided by:
Pfizer Identifier:
First received: October 19, 2010
Last updated: March 10, 2015
Last verified: March 2015
Angiopoietin-2 (Ang-2) is a protein in the body which destabilizes blood vessels and is important in stimulating tumor blood vessels. There is evidence suggesting that Ang-2 may be important for the growth and progression of Glioblastoma multiforme (GBM). PF- 04856884 (CVX-060) is a compound which binds Ang-2 and prevents its activity. The hypothesis is that PF-04856884 will be safe and effective in patients with recurrent Glioblastoma multiforme (GBM).

Condition Intervention Phase
Biological: PF-04856884
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Trial Of PF-04856884 (CVX-060), A Selective Angiopoietin-2 (Ang-2) Binding CovX-body, In Patients With Recurrent Glioblastoma

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Progression free survival rate at Month 6 (PFS6) defined as the patient progression free status at Month 6. [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Corticosteroid doses at baseline and on-study [ Time Frame: 4 months ]
  • Overall Response Rate (ORR) [ Time Frame: 2 years ]
  • PFS defined as the time from 1st dose of study drug to the 1st documentation of disease progression or death from any cause, whichever comes first. [ Time Frame: 2 years ]
  • Time to death is defined as the time from first study drug to death due to any cause. [ Time Frame: 2 years ]
  • Overall survival (OS) defined as the time from first dose of study drug to death due to any cause. [ Time Frame: 2 years ]
  • OS6 defined as the patient survival status at Month 6. The OS6 rate will be obtained as a Kaplan-Meier estimate of the time to death at Month 6. [ Time Frame: 2 years ]
  • Immunogenicity determined by measuring anti-PF-04856884 antibodies following therapy [ Time Frame: 4 months ]
  • Dynamic Contrast Enhanced Magnetic Resonance Imaging [DCE-MRI] endpoints to include changes from baseline volume transfer coefficient [Ktrans] and/or the initial area under the contrast agent concentration-time curve [IAUC] or Ki following therapy [ Time Frame: 4 months ]

Enrollment: 0
Study Start Date: January 2011
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Primary Cohort Biological: PF-04856884
PF-04856884 at a dose of 15 mg/kg/week
Other Name: CVX-060
Experimental: Exploratory Cohort Biological: PF-04856884
PF-04856884 at a dose of 15 mg/kg/week
Other Name: CVX-060

Detailed Description:
Notification of study being cancelled resulted in update in overall status change from "not yet recruiting" to "withdrawn."

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Tumor eligibility: Primary Cohort: Measurable disease; Exploratory Cohort: Measurable disease as defined above or non-measurable/evaluable disease (eg, progressing non-enhancing lesions).
  • Histologically or cytologically confirmed recurrent GBM in 1st or 2nd relapse: Primary Cohort: Recurrence following radiation therapy and temozolomide, less than or equal to 2 prior chemotherapeutic regimens; Exploratory cohort: Prior radiation therapy, temozolomide, and bevacizumab, Recurrence of disease within 2-4 weeks of last bevacizumab dose.
  • Stable dose of corticosteroids for greater than or equal to 5 days prior to baseline Magnetic Resonance Imaging (MRI)
  • Adequate organ function
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Life expectancy greater than or equal to 12 weeks.

Exclusion Criteria:

  • Patients who have previously received a trial drug containing the core platform antibody (eg, CVX-045, PF-04856884 (CVX-060), CVX-096, PF-05057459 (CVX-241), etc.).
  • History of pathologic fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months of therapy.
  • Evidence of bleeding diathesis or coagulopathy.
  • Major surgical procedure (eg, craniotomy), open biopsy, significant traumatic injury within 28 days prior to therapy or anticipation of need for a major surgical procedure during the course of the trial.
  • Minor surgical procedures, fine needle aspiration or core biopsies within 7 days prior to therapy.
  • Serious non-healing wound, ulcer, or bone fracture.
  • Active gastrointestinal bleeding, as evidenced by either hematemesis, hematochezia, or melena in prior 6 months.
  • Hemoptysis >½ teaspoon per day within 1 week of enrollment.
  • National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI CTCAE] Grade 3 hemorrhage from any cause <4 weeks prior to enrollment.
  • Participation in any investigational drug study within 28 days prior to study therapy.
  • Evidence of preexisting uncontrolled hypertension
  • Clinically significant cardiovascular disease within the 12 months prior to starting trial treatment
  • Prolongation of the QT interval corrected [QTc] interval to >450 msec for men or >470 msec for women.
  • History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody or IgG-fusion protein.

Exclusion Criteria Specific for Primary Cohort

  • Prior therapy with bevacizumab or other anti-Vascular Endothelial Growth Factor [VEGF] agents for the treatment of GBM.

Exclusion Criteria Specific for Exploratory Cohort

  • Patients discontinued from prior bevacizumab or anti-VEGF agents due to toxicity.
  • Patients who have failed 2 prior anti-VEGF therapies.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01225510

Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT01225510     History of Changes
Other Study ID Numbers: B1131003
Study First Received: October 19, 2010
Last Updated: March 10, 2015

Keywords provided by Pfizer:
recurrent glioblastoma multiforme (GBM)
phase 2

Additional relevant MeSH terms:
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue processed this record on April 28, 2017