A Trial Of PF-04856884 In Patients With Recurrent Glioblastoma
This study has been withdrawn prior to enrollment.
Information provided by:
First received: October 19, 2010
Last updated: December 22, 2010
Last verified: December 2010
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).
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Phase 2 Trial Of PF-04856884 (CVX-060), A Selective Angiopoietin-2 (Ang-2) Binding CovX-body, In Patients With Recurrent Glioblastoma
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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Corticosteroid doses at baseline and on-study [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
- Overall Response Rate (ORR) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Time to death is defined as the time from first study drug to death due to any cause. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Overall survival (OS) defined as the time from first dose of study drug to death due to any cause. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Immunogenicity determined by measuring anti-PF-04856884 antibodies following therapy [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||January 2013 (Final data collection date for primary outcome measure)
Experimental: Primary Cohort
PF-04856884 at a dose of 15 mg/kg/week
Other Name: CVX-060
Experimental: Exploratory Cohort
PF-04856884 at a dose of 15 mg/kg/week
Other Name: CVX-060
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
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01225510
||Pfizer CT.gov Call Center
No publications provided
||Director, Clinical Trial Disclosure Group, Pfizer, Inc.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 19, 2010
||December 22, 2010
||United States: Food and Drug Administration
Keywords provided by Pfizer:
recurrent glioblastoma multiforme (GBM)
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 17, 2014
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue