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Non-small Cell Lung Cancer (NSCLC)Phase 2NCT00850577

Ph II of a Novel Anti-angiogenic Agent in Combination With Chemotherapy for the Treatment of Non-Small Cell Lung Cancer

A Phase 2 study testing Paclitaxel, Carboplatin and CT-322 in people with Non-small Cell Lung Cancer (NSCLC), run by Bristol-Myers Squibb at 55 sites in 8 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to determine the efficacy of CT-322 comparative to bevacizumab, both in combination with carboplatin and paclitaxel in the treatment of chemonaive subjects with recurrent or advanced non-squamous NSCLC Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer (NSCLC)
What is being tested?
Paclitaxel, Carboplatin and CT-322
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
255 participants
Where
55 sitesin 8 countries
Study dates
Jun 2009to Aug 2013
Phase
Phase 2
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

Who may be able to join

  • ECOG Performance Status (PS) <=1
  • Histologically or cytologically confirmed, stage IIIB (malignant pleural effusion), stage IV or recurrent NSCLC
  • Measurable disease by RECIST guidelines

Who cannot join

  • Evidence of predominantly squamous-cell histology
  • Known CNS metastases
  • Any prior antineoplastic systemic regimens for NSCLC
  • Excessive risk of bleeding (including use of therapeutic anticoagulation) and history of thrombotic or embolic cerebrovascular accident
  • Gross hemoptysis (≥1/2 tsp of red blood)
  • Uncontrolled hypertension
Show all 9Show fewer
  • Clinically significant cardiovascular disease
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
  • Serious non-healing wound, active peptic ulcer, non-healing bone fracture, or bleeding skin metastasis

Trial locations and contacts

55 sites in 8 countries.

55 sites in 8 countries

United States20 sites

  • Annapolis Oncology Center

    Annapolis, Maryland, 21401

  • North Canton Medical Clinic Center

    Canton, Ohio, 44710

  • Charleston Hematology Oncology Associates, Pa

    Charleston, South Carolina, 29414

  • Blue Ridge Cancer Care

    Christiansburg, Virginia, 24073

  • Cancer Center At Cookeville Regional Medical Center

    Cookeville, Tennessee, 38501

  • Meritus Center For Clinical Research

    Hagerstown, Maryland, 21740

  • Kentucky Cancer Clinic

    Hazard, Kentucky, 41701

  • Providence Western Washington Oncology

    Lacey, Washington, 98503

  • University Of Tennessee Cancer Institute

    Memphis, Tennessee, 38104

  • Cancer Institute Of Florida

    Orlando, Florida, 32804

  • Kaiser Permanente Oncology/Hematology

    Portland, Oregon, 97227

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Sharp Clinical Oncology Research

    San Diego, California, 92123

  • Guthrie Clinic, Ltd

    Sayre, Pennsylvania, 18840

  • Clintell, Inc.

    Skokie, Illinois, 60077

  • Acrc/Arizona Clinical Research Center, Inc.

    Tucson, Arizona, 85715

  • North Mississippi Hematology And Oncology Associates, Ltd

    Tupelo, Mississippi, 38801

  • Palm Beach Cancer Institute

    West Palm Beach, Florida, 33401

  • Cancer Center Of Kansas

    Wichita, Kansas, 67214

  • Piedmont Hematology Oncology Associates, Pllc

    Winston-Salem, North Carolina, 27103

Other trials in United States

Brazil7 sites

  • Local Institution

    Barretos, São Paulo, 14784-400

  • Local Institution

    Belo Horizonte, Minas Gerais, 30130-100

  • Local Institution

    Fortaleza, Ceará, 60336550

  • Local Institution

    Porto Alegre, Rio Grande do Sul, 90050-170

  • Local Institution

    Rio de Janeiro, Rio de Janeiro, 20231-050

  • Local Institution

    São Paulo, São Paulo, 04024-002

  • Local Institution

    São Paulo, São Paulo, 05403-000

Other trials in Brazil

Poland6 sites

  • Local Institution

    Bialystok, 15-540

  • Local Institution

    Gdansk, 80952

  • Local Institution

    Otwock, 05-400

  • Local Institution

    Poznan, 60 569

  • Local Institution

    Szczecin, 70-891

  • Local Institution

    Warsaw, 02-781

Other trials in Poland

France5 sites

  • Local Institution

    Marseille, 13915

  • Local Institution

    Paris, 75005

  • Local Institution

    Rennes, 35033

  • Local Institution

    Toulouse, 31059

  • Local Institution

    Tours, 37044

Other trials in France

Italy5 sites

  • Local Institution

    Meldola (Fc), 47014

  • Local Institution

    Ravenna, 48100

  • Local Institution

    Rimini, 47900

  • Local Institution

    Roma, 00189

  • Local Institution

    Terni, 05100

Other trials in Italy

Russia5 sites

  • Local Institution

    Chelyabinsk, 454087

  • Local institution

    Ivanovo, 153013

  • Local Institution

    Moscow, 115 478

  • Local Institution

    Moscow, 115478

  • Local Institution

    Moscow, 143423

Other trials in Russia

South Africa5 sites

  • Local Institution

    Cape Town, Western Cape, 7570

  • Local Institution

    Cape Town, Western Cape, 7925

  • Local Institution

    Port Elizabeth, Eastern Cape, 6045

  • Local Institution

    Pretoria, Gauteng, 0002

  • Local Institution

    Rondebosch, Western Cape, 7700

Other trials in South Africa

United Kingdom2 sites

  • Local Institution

    Leeds, West Yorkshire, LS9 7TF

  • Local Institution

    Manchester, Greater Manchester, M23 9LT

Other trials in United Kingdom

About this study

Official title: A Randomized Double-Blinded Phase II Study of Carboplatin/Paclitaxel/CT-322 Versus Carboplatin/Paclitaxel/Bevacizumab as First-Line Treatment for Recurrent or Advanced Non-Small Cell Lung Cancer With Non-Squamous Histology

The purpose of this study is to determine the efficacy of CT-322 comparative to bevacizumab, both in combination with carboplatin and paclitaxel in the treatment of chemonaive subjects with recurrent or advanced non-squamous NSCLC

Being tested
Paclitaxel, Carboplatin, CT-322, Bevacizumab, Bevacizumab placebo (ie saline solution)
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • PaclitaxelDrug

    Also called Taxol

    Solution, IV, 200 mg/m2, Q21days, 6 cycles

  • CarboplatinDrug

    Also called Paraplatin

    Solution, IV, AUC=6, Q21days, 6 cycles

  • CT-322Drug

    Also called BMS-844203

    Solution, IV, 2 mg/kg, Q7days, Until PD

  • BevacizumabDrug

    Also called Avastin

    Solution, IV, 15 mg/kg, Q21days, Until PD

  • Bevacizumab placebo (ie saline solution)Drug

    Also called Saline solution

    Solution, IV, 0 mg/kg, On days 8 and 15 of a 3-weekly cycle, Until PD

Study groups in NCT00850577
Study groupRoleWhat they receive
Paclitaxel/Carboplatin/CT-322Active comparatorNot described
Receives: Drug: Paclitaxel; Drug: Carboplatin; Drug: CT-322
Paclitaxel/Carboplatin/Bevacizumab/PlaceboActive comparatorNot described
Receives: Drug: Paclitaxel; Drug: Carboplatin; Drug: Bevacizumab; Drug: Bevacizumab placebo (ie saline solution)

What is being measured

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

  1. Progression free survival based on tumor assessments (CT scans/MRI)

    Measured: every 6 weeks until documented progressive disease , death or initiation of subsequent therapy for NSCLC

Secondary outcomes (3)

  1. Overall survival (OS) between 2 arms

    Measured: every 12 weeks

  2. Objective tumor response rate (ORR) between 2 arms

    Measured: every 6 weeks

  3. Safety in the CT-322 plus carboplatin and paclitaxel arm

    Measured: weekly

Timeline

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

  1. First posted25 Feb 2009 (estimated)
  2. Study startJun 2009
  3. Primary completionAug 2013
  4. Study completionAug 2013

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
255 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00850577
Sponsor's protocol ID
CA196-005
Other IDs
EUDRACT# 2008-007768-41
Status last verified
Sep 2015
First submitted
23 Feb 2009
Last updated
12 Oct 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Paclitaxel, Carboplatin and CT-322 in people with Non-small Cell Lung Cancer (NSCLC), run by Bristol-Myers Squibb at 55 sites in 8 countries.

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

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. 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: stopped early, as of the sponsor's last update on 12 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 sites in United States, Brazil, Poland, France, Italy and 3 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 was stopped early. Results are not available in the source record.

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?

Progression free survival based on tumor assessments (CT scans/MRI) (time frame: every 6 weeks until documented progressive disease , death or initiation of subsequent therapy for NSCLC). 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 NCT00850577.

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 12 Oct 2015.

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