A Trial Of PF-04856884 In Patients With Recurrent Glioblastoma

NCT01225510 | Withdrawn Phase 2

• 1 other identifier: B1131003
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Glioblastoma

Keywords

recurrent glioblastoma multiforme (GBM); CVX-060; PF-04856884; phase 2; open-label; bevacizumab; anti-angiogenic

Outcome Measures

Primary Outcomes (1)

• Progression free survival rate at Month 6 (PFS6) defined as the patient progression free status at Month 6.

  1 year

Secondary Outcomes (8)

• Corticosteroid doses at baseline and on-study

  4 months

• Overall Response Rate (ORR)

  2 years

• 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.

  2 years

• Time to death is defined as the time from first study drug to death due to any cause.

  2 years

• Overall survival (OS) defined as the time from first dose of study drug to death due to any cause.

  2 years

Study Arms (2)

Primary Cohort

EXPERIMENTAL

Biological: PF-04856884

Exploratory Cohort

EXPERIMENTAL

Biological: PF-04856884

Interventions

PF-04856884 BIOLOGICAL

PF-04856884 at a dose of 15 mg/kg/week

Also known as: CVX-060

Primary Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Prior therapy with bevacizumab or other anti-Vascular Endothelial Growth Factor \[VEGF\] agents for the treatment of GBM.

Sponsors & Collaborators

• Pfizer: lead

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 19, 2010
• First Posted: October 21, 2010
• Study Start: January 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: March 11, 2015

Record last verified: 2015-03