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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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Solid Tumor, Kidney Neoplasms, Advanced Renal Cell Carcinoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To determine the Maximum Tolerated Dose (MTD) of the combination of CVX-060 plus sunitinib in adult patients with advanced solid tumors

Outcome Time Frame:

6 months

Safety Issue:

Yes

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

B1131001

NCT ID:

NCT00982657

Start Date:

September 2009

Completion Date:

June 2013

Related Keywords:

  • Solid Tumor
  • Kidney Neoplasms
  • Advanced Renal Cell Carcinoma
  • Phase Ib Phase II Advanced solid tumor Clear cell renal cancer Sunitinib plus / minus CVX-060
  • Neoplasms
  • Carcinoma
  • Carcinoma, Renal Cell
  • Kidney Neoplasms

Name

Location

Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteFlagstaff, Arizona  86001
Pfizer Investigational SiteEugene, Oregon  97401
Pfizer Investigational SiteBristol, Tennessee  37620
Pfizer Investigational SiteOlive Branch, Mississippi  38654