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

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ClinicalTrials.gov Identifier: NCT00850577
Recruitment Status : Terminated
First Posted : February 25, 2009
Last Update Posted : October 12, 2015
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer (NSCLC) Drug: Paclitaxel Drug: Carboplatin Drug: CT-322 Drug: Bevacizumab Drug: Bevacizumab placebo (ie saline solution) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 255 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : June 2009
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Active Comparator: Paclitaxel/Carboplatin/CT-322 Drug: Paclitaxel
Solution, IV, 200 mg/m2, Q21days, 6 cycles
Other Name: Taxol

Drug: Carboplatin
Solution, IV, AUC=6, Q21days, 6 cycles
Other Name: Paraplatin

Drug: CT-322
Solution, IV, 2 mg/kg, Q7days, Until PD
Other Name: BMS-844203

Active Comparator: Paclitaxel/Carboplatin/Bevacizumab/Placebo Drug: Paclitaxel
Solution, IV, 200 mg/m2, Q21days, 6 cycles
Other Name: Taxol

Drug: Carboplatin
Solution, IV, AUC=6, Q21days, 6 cycles
Other Name: Paraplatin

Drug: Bevacizumab
Solution, IV, 15 mg/kg, Q21days, Until PD
Other Name: Avastin

Drug: Bevacizumab placebo (ie saline solution)
Solution, IV, 0 mg/kg, On days 8 and 15 of a 3-weekly cycle, Until PD
Other Name: Saline solution




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Overall survival (OS) between 2 arms [ Time Frame: every 12 weeks ]
  2. Objective tumor response rate (ORR) between 2 arms [ Time Frame: every 6 weeks ]
  3. Safety in the CT-322 plus carboplatin and paclitaxel arm [ Time Frame: weekly ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit www.BMSStudyConnect.com for more information on clinical trial participation.

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00850577


  Show 55 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00850577     History of Changes
Other Study ID Numbers: CA196-005
EUDRACT# 2008-007768-41
First Posted: February 25, 2009    Key Record Dates
Last Update Posted: October 12, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Pharmaceutical Solutions
Paclitaxel
Albumin-Bound Paclitaxel
Bevacizumab
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors