Ph II of a Novel Anti-angiogenic Agent in Combination With Chemotherapy for the Treatment of Non-Small Cell Lung Cancer
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
2 other identifiers
interventional
255
8 countries
55
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2009
Typical duration for phase_2
55 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 23, 2009
CompletedFirst Posted
Study publicly available on registry
February 25, 2009
CompletedStudy Start
First participant enrolled
June 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedOctober 12, 2015
September 1, 2015
4.2 years
February 23, 2009
September 23, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Progression free survival based on tumor assessments (CT scans/MRI)
every 6 weeks until documented progressive disease , death or initiation of subsequent therapy for NSCLC
Secondary Outcomes (3)
Overall survival (OS) between 2 arms
every 12 weeks
Objective tumor response rate (ORR) between 2 arms
every 6 weeks
Safety in the CT-322 plus carboplatin and paclitaxel arm
weekly
Study Arms (2)
Paclitaxel/Carboplatin/CT-322
ACTIVE COMPARATORPaclitaxel/Carboplatin/Bevacizumab/Placebo
ACTIVE COMPARATORInterventions
Solution, IV, 200 mg/m2, Q21days, 6 cycles
Solution, IV, AUC=6, Q21days, 6 cycles
Solution, IV, 2 mg/kg, Q7days, Until PD
Solution, IV, 15 mg/kg, Q21days, Until PD
Solution, IV, 0 mg/kg, On days 8 and 15 of a 3-weekly cycle, Until PD
Eligibility Criteria
You may qualify if:
- ECOG Performance Status (PS) \<=1
- Histologically or cytologically confirmed, stage IIIB (malignant pleural effusion), stage IV or recurrent NSCLC
- Measurable disease by RECIST guidelines
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (55)
Acrc/Arizona Clinical Research Center, Inc.
Tucson, Arizona, 85715, United States
Sharp Clinical Oncology Research
San Diego, California, 92123, United States
Cancer Institute Of Florida
Orlando, Florida, 32804, United States
Palm Beach Cancer Institute
West Palm Beach, Florida, 33401, United States
Clintell, Inc.
Skokie, Illinois, 60077, United States
Cancer Center Of Kansas
Wichita, Kansas, 67214, United States
Kentucky Cancer Clinic
Hazard, Kentucky, 41701, United States
Annapolis Oncology Center
Annapolis, Maryland, 21401, United States
Meritus Center For Clinical Research
Hagerstown, Maryland, 21740, United States
North Mississippi Hematology And Oncology Associates, Ltd
Tupelo, Mississippi, 38801, United States
Piedmont Hematology Oncology Associates, Pllc
Winston-Salem, North Carolina, 27103, United States
North Canton Medical Clinic Center
Canton, Ohio, 44710, United States
Kaiser Permanente Oncology/Hematology
Portland, Oregon, 97227, United States
Guthrie Clinic, Ltd
Sayre, Pennsylvania, 18840, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Charleston Hematology Oncology Associates, Pa
Charleston, South Carolina, 29414, United States
Cancer Center At Cookeville Regional Medical Center
Cookeville, Tennessee, 38501, United States
University Of Tennessee Cancer Institute
Memphis, Tennessee, 38104, United States
Blue Ridge Cancer Care
Christiansburg, Virginia, 24073, United States
Providence Western Washington Oncology
Lacey, Washington, 98503, United States
Local Institution
Fortaleza, Ceará, 60336550, Brazil
Local Institution
Belo Horizonte, Minas Gerais, 30130-100, Brazil
Local Institution
Rio de Janeiro, Rio de Janeiro, 20231-050, Brazil
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Porto Alegre, Rio Grande do Sul, 90050-170, Brazil
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Barretos, São Paulo, 14784-400, Brazil
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São Paulo, São Paulo, 04024-002, Brazil
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São Paulo, São Paulo, 05403-000, Brazil
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Marseille, 13915, France
Local Institution
Paris, 75005, France
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Rennes, 35033, France
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Toulouse, 31059, France
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Tours, 37044, France
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Meldola (Fc), 47014, Italy
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Ravenna, 48100, Italy
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Rimini, 47900, Italy
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Roma, 00189, Italy
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Terni, 05100, Italy
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Bialystok, 15-540, Poland
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Gdansk, 80952, Poland
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Otwock, 05-400, Poland
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Poznan, 60 569, Poland
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Szczecin, 70-891, Poland
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Warsaw, 02-781, Poland
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Chelyabinsk, 454087, Russia
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Ivanovo, 153013, Russia
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Moscow, 115 478, Russia
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Moscow, 115478, Russia
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Moscow, 143423, Russia
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Port Elizabeth, Eastern Cape, 6045, South Africa
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Pretoria, Gauteng, 0002, South Africa
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Cape Town, Western Cape, 7570, South Africa
Local Institution
Cape Town, Western Cape, 7925, South Africa
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Rondebosch, Western Cape, 7700, South Africa
Local Institution
Manchester, Greater Manchester, M23 9LT, United Kingdom
Local Institution
Leeds, West Yorkshire, LS9 7TF, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2009
First Posted
February 25, 2009
Study Start
June 1, 2009
Primary Completion
August 1, 2013
Study Completion
August 1, 2013
Last Updated
October 12, 2015
Record last verified: 2015-09