A Trial Of PF-04856884 In Patients With Recurrent Glioblastoma

NCT01225510

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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 <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.

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GlioblastomaA Trial Of PF-04856884 In Patients With Recurrent Glioblastoma NCT01225510
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years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Trial Of PF-04856884 In Patients With Recurrent Glioblastoma
Official Title  ICMJE A Phase 2 Trial Of PF-04856884 (CVX-060), A Selective Angiopoietin-2 (Ang-2) Binding CovX-body, In Patients With Recurrent Glioblastoma
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 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."
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glioblastoma
Intervention  ICMJE Biological: PF-04856884
PF-04856884 at a dose of 15 mg/kg/week
Other Name: CVX-060
Study Arms  ICMJE
  • Experimental: Primary Cohort
    Intervention: Biological: PF-04856884
  • Experimental: Exploratory Cohort
    Intervention: Biological: PF-04856884
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: March 10, 2015)
0
Original Estimated Enrollment  ICMJE
 (submitted: October 19, 2010)
50
Estimated Study Completion Date  ICMJE January 2013
Estimated Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01225510
Other Study ID Numbers  ICMJE B1131003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP