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CT-322 in Treating Patients With Advanced Solid Tumors and Non-Hodgkin's Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00374179
Recruitment Status : Completed
First Posted : September 11, 2006
Last Update Posted : February 24, 2009
Information provided by:
Adnexus, A Bristol-Myers Squibb R&D Company

Brief Summary:

RATIONALE: CT-322 may stop the growth of solid tumors or non-Hodgkin's lymphoma by stopping blood flow to the cancer.

PURPOSE: This phase I trial is studying the side effects of CT-322 in treating patients with advanced solid tumors or non-Hodgkin's lymphoma.

Condition or disease Intervention/treatment Phase
Cancer Drug: CT-322 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Escalating Dose Study of CT-322, a VEGFR-2 Antagonist, as Monotherapy in Patients With Advanced Solid Tumors and Non-Hodgkin's Lymphoma
Study Start Date : August 2006
Actual Primary Completion Date : November 2008
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Intervention Details:
  • Drug: CT-322
    IV solution, weekly or bi-weekly

Primary Outcome Measures :
  1. Safety and tolerability of CT-322 [ Time Frame: Throughout the study ]

Secondary Outcome Measures :
  1. To evaluate the pharmacokinetics of CT-322 in these patients; [ Time Frame: Throughout the study ]
  2. to assess whether antibodies to this drug develop in these patients; and [ Time Frame: Throughout the study ]
  3. to make a preliminary assessment of the biological activity of CT-322 to alter tumor growth. [ Time Frame: Throughout the study ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically proven advanced solid malignancy or NHL for which no standard therapy exists or for which standard therapy had failed
  • No known brain or leptomeningeal disease
  • No prior bone marrow transplant or stem cell rescue
  • No histologically confirmed squamous non-small cell lung cancer (NSCLC) with central chest tumor(s) still in place



* 18 and over

Performance status:

* ECOG performance status ≤ 2

Life expectancy:

* > 3 months


  • ANC ≥ 1500/mL
  • Platelets ≥ 100,000/mL
  • Hemoglobin ≥ 9.0 g/dL; and not requiring transfusion > 1 unit/month


  • AST and ALT ≤ 2.5 x ULN; if liver function abnormalities are due to the underlying malignancy, then AST and ALT may be ≤ 5 x the ULN
  • Bilirubin ≤ 1.5 x ULN
  • aPTT and PT < 1.5 x ULN


  • Creatinine ≤ 1.5 x ULN; patients with serum creatinine > 1 x ULN must also have creatinine clearance (based on a 24-hour urine collection) ≤ 60 mL/min
  • No proteinuria > 1+ on dipstick analysis; in the case of > 1+ dipstick proteinuria, a 24-hour urine collection for protein must be < 500 mg/24 hours
  • Urinary protein/creatinine ratio < 1
  • No glomerulonephritis


  • No coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, unstable angina, symptomatic congestive heart failure, severe uncontrolled hypertension, hemorrhagic or thrombotic stroke or any other CNS bleeding within the preceding 12 months
  • LVEF normal by echocardiogram or MUGA within the past 12 months if there was prior exposure to anthracyclines or radiotherapy encompassing the heart


* Not known to have human immunodeficiency virus (HIV), active hepatitis virus C (HVC), or active hepatitis virus B (HVB)


  • Negative pregnancy test within 7 days prior to enrollment
  • Not pregnant or breast feeding
  • Fertile patients must agree to use effective contraception or commit to abstinence during the study period, or be surgically sterile
  • No serious nonhealing wound, ulcer, or bone fracture
  • Have the ability to understand and sign an informed consent document
  • Be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures


Biologic therapy:

  • See Disease Characteristics
  • At least 4 weeks since prior biological or immunotherapy and recovered


  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy and recovered
  • At least 6 weeks for mitomycin C and nitrosoureas prior to study entry and recovered


* At least 4 weeks since prior radiotherapy to a visceral organ and recovered


  • At least 4 weeks since prior major or laparoscopic surgery and recovered
  • At least 1 week since prior minor surgery


  • No other concurrent anticancer therapy
  • Not concurrently enrolled in another therapeutic clinical trial involving ongoing therapy
  • No concurrent full dose, therapeutic anti-coagulation with warfarin or related oral anti-coagulants or unfractionated or low molecular weight heparins; low dose warfarin for catheter prophylaxis or acetylsalicylic acid ≤ 325 mg/day is acceptable

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00374179

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United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
United States, Texas
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States, 78229
Institute for Drug Development
San Antonio, Texas, United States, 78245-3217
Sponsors and Collaborators
Adnexus, A Bristol-Myers Squibb R&D Company
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Medical Director, Adnexus, A Bristol-Myers Squibb R&D Company, Adnexus, A Bristol-Myers Squibb R&D Company Identifier: NCT00374179    
Other Study ID Numbers: CT-322.001
First Posted: September 11, 2006    Key Record Dates
Last Update Posted: February 24, 2009
Last Verified: February 2009
Additional relevant MeSH terms:
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Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases