DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Solid Tumor

Intervention: CVX-060 + sunitinib (Drug); CVX-060 + sunitinib (Drug); CVX-060 + sunitinib (Drug); CVX-060 + sunitinib (Drug); CVX-060 + sunitinib (Drug); Sunitinib (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer


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).

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Maximum Tolerated Dose (MTD)

Progression-free Survival (PFS)

Secondary outcome:

Pharmacokinetic Parameters of CVX-060

Number of Participants With Dose-limiting Toxicities (DLT)

Serum Angiopoietin-2 (Ang-2) and Plasma Vascular Endothelial Growth Factor (VEGF) Levels

Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) and Non-Serious Adverse Events (Non-SAEs)

Percentage of Participants With Objective Response

Duration of Response

Number of Participants With Anti- CVX-060 Antibodies

Detailed description: On 23-Nov-2010, B1131001 (CVX-060-102) was closed to enrollment due to emerging clinical data which led to a re-assessment of the strategic goals of the PF-04856884 program. The study enrolled the Phase 1b portion only. Subsequently, on 25-Oct-2012, due to data safety signals in a separate clinical trial with PF-04856884 (CVX-060), all PF-04856884 studies were discontinued and ongoing patients on B1131001 were permitted to remain on study at a reduced PF-04856884 dose if determined to have been deriving clinical benefit.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Premiere Oncology of Arizona, Scottsdale, Arizona 85258, United States

Premiere Oncology, A Medical Corporation, Santa Monica, California 90404, United States

Boston Baskin Cancer Foundation, Southaven, Mississippi 38671, United States

Providence Portland Medical Center, Portland, Oregon 97213, United States

Boston Baskin Cancer Foundation, Bartlett, Tennessee 38133, United States

Boston Baskin Cancer Foundation, Germantown, Tennessee 38138, United States

Boston Baskin Cancer Foundation, Memphis, Tennessee 38120, United States

Additional Information

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

Starting date: September 2009
Last updated: July 24, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017