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

History of Changes

Tracking Information
First Received Date ^ICMJE	September 8, 2006
Last Updated Date	February 23, 2009
Start Date ^ICMJE	August 2006
Primary Completion Date	November 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 7, 2008)	Safety and tolerability of CT-322 [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE (submitted: September 8, 2006)	Determine the safety and tolerability of CT-322 in patients with advanced solid tumors or non-Hodgkin's lymphoma
Change History	Complete list of historical versions of study NCT00374179 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 7, 2008)	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 ]
Original Secondary Outcome Measures ^ICMJE (submitted: September 8, 2006)	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.
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	CT-322 in Treating Patients With Advanced Solid Tumors and Non-Hodgkin's Lymphoma
Official Title ^ICMJE	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
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Cancer
Intervention ^ICMJE	Drug: CT-322 IV solution, weekly or bi-weekly
Study Arm (s)	Not Provided
Publications *	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. Epub 2011 Jan 11.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	40
Completion Date	February 2009
Primary Completion Date	November 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00374179
Other Study ID Numbers ^ICMJE	CT-322.001
Has Data Monitoring Committee	No
Responsible Party	Medical Director, Adnexus, A Bristol-Myers Squibb R&D Company, Adnexus, A Bristol-Myers Squibb R&D Company
Study Sponsor ^ICMJE	Adnexus, A Bristol-Myers Squibb R&D Company
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Adnexus, A Bristol-Myers Squibb R&D Company
Verification Date	February 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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