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CancerPhase 1NCT00374179

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

A Phase 1 study testing CT-322 in people with Cancer, run by Adnexus, A Bristol-Myers Squibb R&D Company at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
What is being tested?
CT-322
Type of treatment
Injection or infusion
How many people
40 participants
Where
3 sitesUnited States
Study dates
Aug 2006to Feb 2009
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

3 sites in 1 country.

United States3 sites
  • Indiana University Cancer Center

    Indianapolis, Indiana, 46202

  • South Texas Accelerated Research Therapeutics

    San Antonio, Texas, 78229

  • Institute for Drug Development

    San Antonio, Texas, 78245-3217

Other trials in United States

About this study

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

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.

Conditions
Cancer
Being tested
CT-322
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CT-322Drug

    IV solution, weekly or bi-weekly

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and tolerability of CT-322

    Measured: Throughout the study

Secondary outcomes (3)
  1. To evaluate the pharmacokinetics of CT-322 in these patients;

    Measured: Throughout the study

  2. to assess whether antibodies to this drug develop in these patients; and

    Measured: Throughout the study

  3. to make a preliminary assessment of the biological activity of CT-322 to alter tumor growth.

    Measured: Throughout the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2006 (estimated)
  2. Study startAug 2006
  3. Primary completionNov 2008
  4. Study completionFeb 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00374179
Sponsor's protocol ID
CT-322.001
Status last verified
Feb 2009
First submitted
8 Sep 2006
Last updated
24 Feb 2009
Results posted
No
Data monitoring committee
No

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. doi: 10.1158/1078-0432.CCR-10-1411. Epub 2011 Jan 11.

    PubMed 21224368

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CT-322 in people with Cancer, run by Adnexus, A Bristol-Myers Squibb R&D Company at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability of CT-322 (time frame: Throughout the study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00374179, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2009; AzTrials last refreshed its copy on 3 Nov 2026.

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