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

Pfizer

Status and phase

Terminated

Phase 2

Conditions

Metastatic Renal Cell Carcinoma

Treatments

Biological: PF-04856884

Drug: Axitinib (AG-013736)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01441414

2011-002190-33 (EudraCT Number)

B1131004

Details and patient eligibility

About

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.

Full description

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.

Enrollment

18 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.