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

February 23, 2009 updated by: Adnexus, A Bristol-Myers Squibb R&D Company

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Cancer Center
    • Texas
      • San Antonio, Texas, United States, 78229
        • South Texas Accelerated Research Therapeutics
      • San Antonio, Texas, United States, 78245-3217
        • Institute for Drug Development

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability of CT-322
Time Frame: Throughout the study
Throughout the study

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adnexus, A Bristol-Myers Squibb R&D Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

September 8, 2006

First Submitted That Met QC Criteria

September 8, 2006

First Posted (Estimate)

September 11, 2006

Study Record Updates

Last Update Posted (Estimate)

February 24, 2009

Last Update Submitted That Met QC Criteria

February 23, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT-322.001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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