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.
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
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.
Safety and tolerability of CT-322
Measured: Throughout the study
Secondary outcomes (3)
To evaluate the pharmacokinetics of CT-322 in these patients;
Measured: Throughout the study
to assess whether antibodies to this drug develop in these patients; and
Measured: Throughout the study
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.
- First posted11 Sep 2006 (estimated)
- Study startAug 2006
- Primary completionNov 2008
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Adnexus, A Bristol-Myers Squibb R&D Company
- Sponsor type
- Industry (pharma, biotech, devices)
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00374179
- Acronym / sponsor ID
- CT-322.001
- Conditions
- Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Adnexus, A Bristol-Myers Squibb R&D CompanyIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Nov 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 11 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT-322IV solution, weekly or bi-weekly | Drug | – |
Primary outcome
Safety and tolerability of CT-322
Time frame: Throughout the study
3 secondary outcomes
To evaluate the pharmacokinetics of CT-322 in these patients;
Time frame: Throughout the study
to assess whether antibodies to this drug develop in these patients; and
Time frame: Throughout the study
to make a preliminary assessment of the biological activity of CT-322 to alter tumor growth.
Time frame: Throughout the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2009.
- Derived from this study: PubMed 21224368Tolcher 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.
Related trials for Cancer
Enrolling by invitation
Exercise Intervention for Breast Cancer Patients With Sarcopenia
Sarcopenia, Breast Cancer
RecruitingPhase 3
A Study Comparing TAK-928 With Docetaxel in Adults With Non-Small Cell Lung Cancer
IO Resistant Squamous and Nonsquamous NSCLC
Not yet recruitingPhase 2
Saruparib in HRDsig+ Solid Tumors
Malignant Neoplastic Disease (Disorder)
RecruitingPhase 2
IGFBP-2 Vaccine to Prevent Ovarian Cancer Progression in Patients With Serologic Detection of Recurrence
Fallopian Tube Carcinoma, Ovarian Carcinoma
Not yet recruitingPhase 2
Nemtabrutinib for Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Leukemia (SLL) Refractory to Covalent Bruton Tyrosine Kinase Inhibitor or Pirtobrutinib and Previously Treated With a BCL2 Inhibitor
Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
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.