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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

Thank you

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 Site Blendora, California  91740
Pfizer Investigational Site Flagstaff, Arizona  86001
Pfizer Investigational Site Eugene, Oregon  97401
Pfizer Investigational Site Bristol, Tennessee  37620
Pfizer Investigational Site Olive Branch, Mississippi  38654