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A Phase 2 Trial Of PF-04856884 (CVX-060), A Selective Angiopoietin-2 (Ang-2) Binding CovX-body, In Patients With Recurrent Glioblastoma

Phase 2
18 Years
Not Enrolling

Thank you

Trial Information

A Phase 2 Trial Of PF-04856884 (CVX-060), A Selective Angiopoietin-2 (Ang-2) Binding CovX-body, In Patients With Recurrent Glioblastoma

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yet recruiting" to "withdrawn."

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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival rate at Month 6 (PFS6) defined as the patient progression free status at Month 6.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Pfizer Call Center

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

January 2011

Completion Date:

January 2013

Related Keywords:

  • Glioblastoma
  • recurrent glioblastoma multiforme (GBM)
  • CVX-060
  • PF-04856884
  • phase 2
  • open-label
  • bevacizumab
  • anti-angiogenic
  • Glioblastoma