AzTrials
AzTrials

GlioblastomaPhase 2NCT01225510

A Trial Of PF-04856884 In Patients With Recurrent Glioblastoma

A Phase 2 study testing PF-04856884 in people with Glioblastoma, run by Pfizer.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glioblastoma
What is being tested?
PF-04856884
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Jan 2011to Jan 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 17Show fewer
  • 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.
  • Patients discontinued from prior bevacizumab or anti-VEGF agents due to toxicity.
  • Patients who have failed 2 prior anti-VEGF therapies.

About this study

Official title: 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).

Read the detailed description

Notification of study being cancelled resulted in update in overall status change from "not yet recruiting" to "withdrawn."

Conditions
Glioblastoma
Being tested
PF-04856884
Keywords
recurrent glioblastoma multiforme (GBM), CVX-060, PF-04856884, phase 2, open-label, bevacizumab, anti-angiogenic
Medical subject headings
Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-04856884Biological

    Also called CVX-060

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

  • PF-04856884Biological

    Also called CVX-060

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

Study groups in NCT01225510
Study groupRoleWhat they receive
Primary CohortExperimentalNot described
Receives: Biological: PF-04856884
Exploratory CohortExperimentalNot described
Receives: Biological: PF-04856884

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 1 year

Secondary outcomes (8)

  1. Corticosteroid doses at baseline and on-study

    Measured: 4 months

  2. Overall Response Rate (ORR)

    Measured: 2 years

  3. 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.

    Measured: 2 years

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

    Measured: 2 years

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

    Measured: 2 years

  6. 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.

    Measured: 2 years

  7. Immunogenicity determined by measuring anti-PF-04856884 antibodies following therapy

    Measured: 4 months

  8. 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

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2010 (estimated)
  2. Study startJan 2011
  3. Primary completionJan 2013 (estimated)
  4. Study completionJan 2013 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01225510
Sponsor's protocol ID
B1131003
Status last verified
Mar 2015
First submitted
19 Oct 2010
Last updated
11 Mar 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PF-04856884 in people with Glioblastoma, run by Pfizer.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 11 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival rate at Month 6 (PFS6) defined as the patient progression free status at Month 6. (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01225510.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in