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A Phase II Trial Of PF-04856884 (CVX-060), A Selective Angiopoietin-2 (Ang-2) Inhibitor In Combination With Axitinib In Patients With Previously Treated Metastatic Renal Cell Carcinoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Metastatic Renal Cell Carcinoma

Thank you

Trial Information

A Phase II Trial Of PF-04856884 (CVX-060), A Selective Angiopoietin-2 (Ang-2) Inhibitor In Combination With Axitinib In Patients With Previously Treated Metastatic Renal Cell Carcinoma


The study was prematurely discontinued on 06Nov2012 due to tolerability findings in patients
treated in Part I of the study that have prompted the Sponsor to re-evaluate the strategic
development of the program. An unexpected frequency of arterial thrombotic events (ATEs) and
venous thrombotic events (VTEs) were reported in patients treated in Part I.


Inclusion Criteria:



- Adult male or female patients with histologically or cytologically confirmed renal
cell cancer (RCC) with a component of clear cell subtype and evidence of metastasis

- Evidence of unidimensionally measurable disease

- Prior therapy: Part I: Having received 1 to 3 prior systemic regimens for treatment
of mRCC

- Part II: Evidence of disease progression following 1 prior regimen administered as
1st line therapy for mRCC. The prior regimen must have contained one of the
following: VEGFR2 tyrosine kinase inhibitor (TKI) or other anti VEGF [Vascular
Endothelial Growth Factor] compounds, such as bevacizumab

- adequate bone marrow, liver and renal function

Exclusion Criteria:

Part I:

- Intolerant to prior AG 013736 therapy or prior treatment with compounds which contain
the core platform antibody as PF 04856884

Part II:

- Prior AG 013736 therapy, more than one systemic first-line regimen for the treatment
of mRCC and prior treatment with compounds which contain the core platform antibody
as PF 04856884

- major surgery <4 weeks or radiation therapy <2 weeks prior to start of therapy

- clinically significant gastrointestinal abnormalities

- current use or anticipated need for drugs that are known potent CYP3A4 inhibitors and
drugs that are known CYP3A4 or CYP1A2 inducers

- history of bleeding diathesis or coagulopathy

- Grade 3 or greater hemorrhage from any cause <4 weeks prior to screening;

- hemoptysis >½ teaspoon of blood per day within 2 weeks prior to screening.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs);Part I: Safety profile characterized by type, grade and frequency of all adverse events,

Outcome Time Frame:

4 months

Safety Issue:

Yes

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

B1131004

NCT ID:

NCT01441414

Start Date:

November 2011

Completion Date:

September 2013

Related Keywords:

  • Metastatic Renal Cell Carcinoma
  • CVX-060
  • PF-04856884
  • AG-013736
  • axitinib
  • mRCC
  • metastatic renal cell cancer
  • second line
  • anti-angiogenic
  • Ang-2
  • Carcinoma
  • Carcinoma, Renal Cell

Name

Location

Pfizer Investigational SiteHouston, Texas  77030
Pfizer Investigational SiteFederal Way, Washington  98003
Pfizer Investigational SiteFlagstaff, Arizona  86001
Pfizer Investigational SiteAurora, Colorado  80012
Pfizer Investigational SiteLas Vegas, Nevada  89128
Pfizer Investigational SiteAsheville, North Carolina  28801
Pfizer Investigational SiteOmaha, Nebraska  68198