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 (Responsible Party):	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:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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:	September 2009
Estimated Study Completion Date:	January 2012
Estimated Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

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

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

Locations

United States, Arizona
Pfizer Investigational Site
Scottsdale, Arizona, United States, 85258
United States, California
Pfizer Investigational Site
Santa Monica, California, United States, 90404
United States, Mississippi
Pfizer Investigational Site
Southaven, Mississippi, United States, 38671
United States, Oregon
Pfizer Investigational Site
Portland, Oregon, United States, 97213
United States, Tennessee
Pfizer Investigational Site
Bartlett, Tennessee, United States, 38133
Pfizer Investigational Site
Germantown, Tennessee, United States, 38138
Pfizer Investigational Site
Memphis, Tennessee, United States, 38138
Pfizer Investigational Site
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
ClinicalTrials.gov Identifier:	NCT00982657 History of Changes
Other Study ID Numbers:	B1131001, CVX-060-102
Study First Received:	September 22, 2009
Last Updated:	January 15, 2012
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
Carcinoma
Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases

Urologic Diseases
Angiogenesis Inhibitors
Sunitinib
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012