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

This study has been completed.
Sponsor:
Information provided by:
Adnexus, A Bristol-Myers Squibb R&D Company
ClinicalTrials.gov Identifier:
NCT00374179
First received: September 8, 2006
Last updated: February 23, 2009
Last verified: February 2009

September 8, 2006
February 23, 2009
August 2006
November 2008   (final data collection date for primary outcome measure)
Safety and tolerability of CT-322 [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
Determine the safety and tolerability of CT-322 in patients with advanced solid tumors or non-Hodgkin's lymphoma
Complete list of historical versions of study NCT00374179 on ClinicalTrials.gov Archive Site
  • To evaluate the pharmacokinetics of CT-322 in these patients; [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
  • to assess whether antibodies to this drug develop in these patients; and [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
  • to make a preliminary assessment of the biological activity of CT-322 to alter tumor growth. [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
  • To evaluate the pharmacokinetics of CT-322 in these patients;
  • to assess whether antibodies to this drug develop in these patients; and
  • to make a preliminary assessment of the biological activity of CT-322 to alter tumor growth.
Not Provided
Not Provided
 
CT-322 in Treating Patients With Advanced Solid Tumors and Non-Hodgkin's Lymphoma
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

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cancer
Drug: CT-322
IV solution, weekly or bi-weekly
Not Provided
Tolcher AW, Sweeney CJ, Papadopoulos K, Patnaik A, Chiorean EG, Mita AC, Sankhala K, Furfine E, Gokemeijer J, Iacono L, Eaton C, Silver BA, Mita M. Phase I and pharmacokinetic study of CT-322 (BMS-844203), a targeted Adnectin inhibitor of VEGFR-2 based on a domain of human fibronectin. Clin Cancer Res. 2011 Jan 15;17(2):363-71. doi: 10.1158/1078-0432.CCR-10-1411. Epub 2011 Jan 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
February 2009
November 2008   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS

  • 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

PATIENT CHARACTERISTICS

Age:

* 18 and over

Performance status:

* ECOG performance status ≤ 2

Life expectancy:

* > 3 months

Hematopoietic:

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

Hepatic:

  • 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

Renal:

  • 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

Cardiovascular:

  • 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

Immunologic:

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

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

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

Chemotherapy:

  • 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

Radiotherapy:

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

Surgery:

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

Other:

  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00374179
CT-322.001
No
Medical Director, Adnexus, A Bristol-Myers Squibb R&D Company, Adnexus, A Bristol-Myers Squibb R&D Company
Adnexus, A Bristol-Myers Squibb R&D Company
Not Provided
Not Provided
Adnexus, A Bristol-Myers Squibb R&D Company
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP