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

NCT01441414 | Terminated Phase 2 Results

• 2 other identifiers: B11310042011-002190-33
• Study Type: interventional
• Target: 18
• Locations: 2 countries
• Sites: 29

Brief Summary

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.

Conditions

Metastatic Renal Cell Carcinoma

Keywords

CVX-060; PF-04856884; AG-013736; axitinib; mRCC; metastatic renal cell cancer; second line; anti-angiogenic; Ang-2

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Non-serious Adverse Events (AEs) in Part I (Reported in ≥2 of the Participants Overall).

  Incidence and severity of all treatment-emergent AEs (TEAEs) of both all-causality and treatment-related by preferred term (PT) categorized according to Common Terminology Criteria for Adverse Events (CTCAE) grades reported in ≥2 participants overall (CTCAE Grades 3, 4 and 5, combined) for any PT are presented. Participants who are included under all-causality TEAE PT are coded as NA if they appear for the same PT under treatment-related TEAE below. Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice daily. Following the decision on 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).

  4 months

• Number of Participants With Serious Adverse Events (SAEs) in Part I

  Incidence and severity of all-causality serious adverse events (SAEs) are presented by PT categorized according to Common Terminology Criteria for Adverse Events (CTCAE) grades. Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice daily. Following the decision on 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week). Participants with treatment-related TEAE are coded as NA if they appear for the same preferred term under all-causality TEAE.

  4 months

• Progression Free Survival (PFS) in Adult Participants With Previously Treated Metastatic Renal Cell Cancer (mRCC) in Part II

  PFS is defined as the time (in days) from date of randomization to first documentation of investigator assessed tumor progression or death, whichever comes first. Progression free survival was to be calculated as (first event date - the date of randomization +1).

  3 years

Secondary Outcomes (9)

• Number of Participants With Non-serious AEs and SAEs

  3 years

• Overall Response Rate (ORR) in Metastatic Renal Cell Cancer (mRCC) Patients Treated With PF-04856884 in Combination With AG-013736 vs. AG-013736 Alone.

  4 months

• Duration of Response (DR) in Metastatic Renal Cell Cancer (mRCC) Patients Treated With PF-04856884 in Combination With AG-013736 vs. AG-013736 Alone

  3 years

• Tmax (Time When Maximum Serum PF-04856884 Concentration Was Reached)

  Pre-dose, 1, 2, 4, 6, 8, 192, 360, 361, 362, 365, 367 hours post dose and end of treatment

• Cmax (Observed Peak Serum PF-04856884 Concentration)

  Pre-dose, 1, 2, 4, 6, 8, 192, 360, 361, 362, 365, 367 hours post dose and end of treatment

Study Arms (2)

ARM A

EXPERIMENTAL

PF-04856884 in combination with AG-013736

Biological: PF-04856884; Drug: Axitinib (AG-013736)

ARM B

ACTIVE COMPARATOR

AG-013736 alone

Drug: Axitinib (AG-013736)

Interventions

PF-04856884 BIOLOGICAL

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

ARM A

Axitinib (AG-013736) DRUG

5 mg PO BID

ARM A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (29)

Pinnacle Oncology Hematology

Scottsdale, Arizona, 85258, United States

Location

Arizona Oncology Associates, PC - HOPE

Tucson, Arizona, 85704, United States

Location

Arizona Oncology Associates, PC-HOPE

Tucson, Arizona, 85710, United States

Location

Rocky Mountain Cancer Centers

Aurora, Colorado, 80012, United States

Location

Rocky Mountain Cancer Centers

Boulder, Colorado, 80303, United States

Location

Rocky Mountain Cancer Centers

Centennial, Colorado, 80112, United States

Location

Rocky Mountain Cancer Centers

Colorado Springs, Colorado, 80907, United States

Location

Rocky Mountain Cancer Centers

Colorado Springs, Colorado, 80909, United States

Location

Rocky Mountain Cancer Centers

Denver, Colorado, 80218, United States

Location

Rocky Mountain Cancer Centers

Denver, Colorado, 80220, United States

Location

Rocky Mountain Cancer Centers

Lakewood, Colorado, 80228, United States

Location

Rocky Mountain Cancer Centers

Littleton, Colorado, 80120-4413, United States

Location

Rocky Mountain Cancer Centers

Lone Tree, Colorado, 80124, United States

Location

Rocky Mountain Cancer Centers

Longmont, Colorado, 80501, United States

Location

Rocky Mountain Cancer Centers

Parker, Colorado, 80138, United States

Location

Rocky Mountain Cancer Centers

Pueblo, Colorado, 81008, United States

Location

Rocky Mountain Cancer Centers

Thornton, Colorado, 80260, United States

Location

Nebraska Methodist Hospital

Omaha, Nebraska, 68114, United States

Location

Comprehensive Cancer Centers of Nevada

Henderson, Nevada, 89014, United States

Location

Comprehensive Cancer Centers of Nevada

Henderson, Nevada, 89052, United States

Location

Comprehensive Cancer Centers of Nevada

Henderson, Nevada, 89074, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89128, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89148, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89169, United States

Location

Regional Cancer Care-Durham

Durham, North Carolina, 27704, United States

Location

Texas Oncology-Tyler

Tyler, Texas, 75702, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Masarykuv onkologicky ustav

Brno, 65653, Czechia

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Axitinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

On 06 Nov 2012, based on Part I safety findings and due to strategic considerations, Pfizer decided not to open enrolment onto Part II of the study and terminated the study. For primary OM, AEs reported in ≥2 participants overall are presented.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2011
• First Posted: September 27, 2011
• Study Start: November 21, 2011
• Primary Completion: March 27, 2014
• Study Completion: March 27, 2014
• Last Updated: January 8, 2019
• Results First Posted: January 18, 2016

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will share

Locations

US (28); CZ (1)