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PF-04856884 (CVX-060) In Combination With Axitinib In Patients With Previously Treated Metastatic Renal Cell Carcinoma

Last updated on May 10, 2018

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Study Location
Pinnacle Oncology Hematology
Scottsdale, Arizona, 85258 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Metastatic Renal Cell Carcinoma
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

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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

- 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

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

NCT01441414
Pfizer
Terminated
PF-04856884 (CVX-060) In Combination With Axitinib In Patients With Previously Treated Metastatic Renal Cell Carcinoma

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PF-04856884 (CVX-060) In Combination With Axitinib In Patients With Previously Treated Metastatic Renal Cell Carcinoma
A Phase II Trial Of PF-04856884 (CVX-060), A Selective Angiopoietin-2 (ANG-2) Inhibitor In Combination With AG-013736 (Axitinib) In Patients With Previously Treated Metastatic Renal Cell Carcinoma
To evaluate the combination of PF-04856884 (CVX-060) in combination with Axitinib (AG-013736) in patients that have received one prior systemic regimen for metastatic renal cell carcinoma (mRCC) vs. axitinib alone.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Metastatic Renal Cell Carcinoma
  • Biological: PF-04856884
    15 mg/kg/week intravenously [IV] until toxicity or disease progression
  • Drug: Axitinib (AG-013736)
    5 mg PO BID
  • Experimental: ARM A
    PF-04856884 in combination with AG-013736
    Interventions:
    • Biological: PF-04856884
    • Drug: Axitinib (AG-013736)
  • Active Comparator: ARM B
    AG-013736 alone
    Intervention: Drug: Axitinib (AG-013736)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
18
March 2014
March 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   United States
Canada,   Germany,   Italy,   Poland,   Singapore,   Spain
 
NCT01441414
B1131004
2011-002190-33 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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