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A Trial Of PF-04856884 In Patients With Recurrent Glioblastoma | Clinical Trials | Clareo Health

WITHDRAWNPHASE2

A Trial Of PF-04856884 In Patients With Recurrent Glioblastoma

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

NCT01225510•Pfizer

View on ClinicalTrials.gov

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 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).

Detailed Description

Notification of study being cancelled resulted in update in overall status change from "not yet recruiting" to "withdrawn."

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+7 more criteria

Key Dates

Start Date

January 1, 2011

Primary Completion Date

January 1, 2013

Completion Date

January 1, 2013

Last Updated

March 11, 2015

Conditions

Glioblastoma

Interventions

PF-04856884

BIOLOGICAL

PF-04856884

BIOLOGICAL

Targeted Pediatric High-Grade Glioma Therapy

NCT05839379

High Grade GliomaDiffuse Intrinsic Pontine Glioma+7 more

View study

RECRUITING

Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme

NCT00083512

Glioblastoma Multiforme

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 11, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Trial Of PF-04856884 In Patients With Recurrent Glioblastoma

Inclusion Criteria

Exclusion Criteria

Targeted Pediatric High-Grade Glioma Therapy

Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme

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