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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-21

Study Completion Date

2014-03-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Avelumab, Palbociclib and Axitinib in Advanced RCC

NCT05176288

Advanced Clear Cell Renal Cell Carcinoma

WITHDRAWN PHASE2

Optimizing Pembrolizumab Therapy With Timing and Intensification With Axitinib

NCT05263609

Renal Cell Cancer

WITHDRAWN PHASE2

A Web-mediated Follow-up With the Web-application KidneyPRO Versus Standard Follow-up for Patients With Advanced Renal Cell Carcinoma Treated With Axitinib/Pembrolizumab in First Line

NCT04764487

Renal Cell Carcinoma Metastatic

UNKNOWN PHASE3

Study of Axitinib for Reducing Extent of Venous Tumour Thrombus in Renal Cancer With Venous Invasion

NCT03494816

Renal Cell Carcinoma Metastatic Renal Cell Carcinoma Non-metastatic Renal Cell Carcinoma

COMPLETED PHASE2

Oxaliplatin With Or Without Floxuridine and Leucovorin in Treating Patients With Metastatic Cancer of the Peritoneum

NCT00005860

Cancer

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Metastatic Renal Cell Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ARM A

PF-04856884 in combination with AG-013736

Group Type EXPERIMENTAL

PF-04856884

Intervention Type BIOLOGICAL

15 mg/kg/week intravenously \[IV\] until toxicity or disease progression

Axitinib (AG-013736)

Intervention Type DRUG

5 mg PO BID

ARM B

AG-013736 alone

Group Type ACTIVE_COMPARATOR

Axitinib (AG-013736)

Intervention Type DRUG

5 mg PO BID

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PF-04856884

15 mg/kg/week intravenously \[IV\] until toxicity or disease progression

Intervention Type BIOLOGICAL

Axitinib (AG-013736)

5 mg PO BID

Intervention Type DRUG

Axitinib (AG-013736)

5 mg PO BID

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No