A Trial Of CVX-060, An Anti-Angiogenic COVX-Body, In Combination With Sunitinib In Patients With Advanced Renal Cell Carcinoma - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00982657

Purpose

The safety and tolerability of CVX-060 have been established in the first-in-human clinical trial, CVX-060-101. Thus, this phase Ib/II trial is to assess the safety and pharmacokinetics (PK) profiles of combining CVX-060 with sunitinib in patients with advanced solid tumors, and to subsequently assess the treatment efficacy of the combination treatment, as well as that of sunitinib alone in patients with advanced renal cell carcinoma (mRCC).

Condition	Intervention	Phase
Solid Tumor Kidney Neoplasms Advanced Renal Cell Carcinoma	Drug: CVX-060 + sunitinib Drug: Sunitinib	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase Ib/II, Multicenter, Trial Of CVX-060, A Selective Angiopoietin-2 (ANG-2) Binding, Anti-Angiogenic COVX-Body, In Combination With Sunitinib In Patients With Advanced Renal Cell Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Kidney Cancer

Drug Information available for: Sunitinib malate Sunitinib

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

To determine the Maximum Tolerated Dose (MTD) of the combination of CVX-060 plus sunitinib in adult patients with advanced solid tumors [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Assess the treatment efficacy of the combination treatment as well as that of sunitinib alone in patients with advanced renal cell carcinoma (mRCC). [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
To document clinical activity of the combination of CVX-060 plus sunitinib, or sunitinib alone, by measuring progression-free survival (PFS) in patients with mRCC who have not received prior systemic treatment [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate the potential for immunogenicity in patients treated with CVX-060 [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
To determine safety and tolerability and to identify Dose Limiting Toxicities (DLTs), of the combination of CVX-060 plus sunitinib [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
To evaluate the plasma pharmacokinetics (PK) of CVX-060 when it is administered in combination with sunitinib [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
To evaluate serum Ang-2 and plasma VEGF levels as potential biomarkers in patients treated with CVX-060 [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	124
Study Start Date:	October 2009
Estimated Study Completion Date:	July 2013
Estimated Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Cohort 1: Experimental CVX-060 + sunitinib	Drug: CVX-060 + sunitinib CVX-060 weekly infusions at 6.0 mg/kg + 50 mg sunitinib daily (4 out of 6 weeks)
Cohort 2: Experimental CVX-060 + sunitinib	Drug: CVX-060 + sunitinib CVX-060 weekly infusions at 12.0 mg/kg + 50 mg sunitinib daily (4 out of 6 weeks)
Cohort 3: Experimental CVX-060 + sunitinib	Drug: CVX-060 + sunitinib CVX-060 weekly infusions at 15.0 mg/kg + 50 mg sunitinib daily (4 out of 6 weeks)
Expanded cohort: Experimental CVX-060 + sunitinib	Drug: CVX-060 + sunitinib CVX-060 weekly infusions at TBD mg/kg + 50 mg sunitinib daily (4 out of 6 weeks)
Phase II - Arm A: Experimental CVX-060 + sunitinib	Drug: CVX-060 + sunitinib CVX-060 weekly infusions at TBD mg/kg + 50 mg sunitinib daily (4 out of 6 weeks)
Phase II - Arm B: Active Comparator sunitinib alone	Drug: Sunitinib 50 mg sunitinib daily (4 out of 6 weeks)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically or cytologically confirmed advanced/metastatic solid tumor
Having received at least 1 prior systemic therapy for the treatment of advanced/metastatic solid tumors
Histologically or cytologically confirmed renal cell carcinoma with clear cell histology and evidence of metastasis (No previous systemic therapy for the treatment of metastatic renal cell carcinoma)
Adequate laboratory tests
Eastern Cooperative Oncology Group (ECOG) 0-1, Life expectancy > or = 12 weeks and age > or = 18 years

Exclusion Criteria:

Patients intolerant of prior anti-angiogenic agents
Recent history of bleeding or bleeding disorders
History of tumors in the brain
History of heart problems
History of severe allergic reaction to antibody therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00982657

Contacts

Contact: Pfizer CT.gov Call Center	1-800-718-1021
Contact: Pfizer Oncology Clinical Trial Information Service	1-877-369-9753	PfizerCancerTrials@emergingmed.com

Locations

United States, Arizona
Pfizer Investigational Site	Recruiting
Scottsdale, Arizona, United States, 85260
United States, California
Pfzer Investigational Site	Recruiting
Santa Monica, California, United States, 90404
United States, Tennessee
Pfizer Investigational Site	Recruiting
Memphis, Tennessee, United States, 38104

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	B1131001, CVX-060-102
Study First Received:	September 22, 2009
Last Updated:	February 8, 2010
ClinicalTrials.gov Identifier:	NCT00982657 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Phase Ib
Phase II
Advanced solid tumor
Clear cell renal cancer
Sunitinib plus / minus CVX-060

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Urogenital Neoplasms
Urologic Neoplasms
Angiogenesis Inhibitors
Pharmacologic Actions
Carcinoma
Neoplasms
Neoplasms by Site

Urologic Diseases
Sunitinib
Kidney Neoplasms
Therapeutic Uses
Carcinoma, Renal Cell
Growth Inhibitors
Angiogenesis Modulating Agents
Kidney Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on February 08, 2010