Status:
WITHDRAWN
A Trial Of PF-04856884 In Patients With Recurrent Glioblastoma
Lead Sponsor:
Pfizer
Conditions:
Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 g...
Detailed Description
Notification of study being cancelled resulted in update in overall status change from "not yet recruiting" to "withdrawn."
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01225510
Start Date
January 1 2011
End Date
January 1 2013
Last Update
March 11 2015
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