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A Trial Of PF-04856884 In Patients With Recurrent Glioblastoma

Last updated on May 9, 2018

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Glioblastoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

- 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.

NCT01225510
Pfizer
Withdrawn
A Trial Of PF-04856884 In Patients With Recurrent Glioblastoma

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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
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).
Notification of study being cancelled resulted in update in overall status change from "not yet recruiting" to "withdrawn."
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Glioblastoma
Biological: PF-04856884
PF-04856884 at a dose of 15 mg/kg/week
Other Name: CVX-060
  • Experimental: Primary Cohort
    Intervention: Biological: PF-04856884
  • Experimental: Exploratory Cohort
    Intervention: Biological: PF-04856884
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
January 2013
January 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01225510
B1131003
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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