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A Trial Of PF-04856884 In Patients With Recurrent Glioblastoma

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT01225510
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Pfizer
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Pfizer CT.gov Call Center
Principal Investigator Affiliation	Pfizer
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Withdrawn
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma
Study Website:	View Trial Website

Additional Details

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

Arms & Interventions

Arms

Experimental: Primary Cohort

Experimental: Exploratory Cohort

Interventions

Biological: - PF-04856884

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