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

• Status: Terminated
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Albumin-Bound Paclitaxel; Bevacizumab; Carboplatin; Paclitaxel; Pharmaceutical Solutions

Criteria

For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email[email protected]. 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