NCT02151149

Safety and Efficacy Study of Abraxane in Combination With Carboplatin to Treat Advanced NSCL Cancer in the Elderly

Safety and Efficacy of Nab-paclitaxel (Abraxane) in Combination With Carboplatin as First Line Treatment in Elderly Subjects With Advance Non-Small Cell Lung Cancer (NSCLC): A Phase IV, Randomized, Open-Label, Multicenter Study (Abound.70+)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 143 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

Study comparing two regimens of nab-paclitaxel and carboplatin combination in elderly subjects (≥ 70 years old) with advanced NSCLC

Detailed description

This is a Phase IV, randomized, open-label, multicenter study of continuous weekly versus weekly times three with one-week break nab-paclitaxel in combination with carboplatin as first-line treatment in elderly subjects (≥ 70 years old) with advanced non small cell lung cancer who have not received prior chemotherapy for their advanced disease and are not candidates for curative surgery or radiation therapy. The primary study endpoint is the percentage of subjects with either peripheral neuropathy or myelosuppression adverse events. Patients will continue treatment until they develop progressive disease, unacceptable side-effects or wish to withdraw from the study, according to local standard of care. Patients will have radiographic evaluations every 6 weeks while on treatment.

Conditions

• Non-Small Cell Lung Cancer
• Carcinoma
• Squamous Cell Carcinoma
• Adenocarcinoma
• Carcinoma, Large Cell
• Lung Neoplasm

Interventions

Type	Name	Description
DRUG	nab-paclitaxel
DRUG	Carboplatin

Timeline

• Start date: 2014-06-09
• Primary completion: 2017-07-14
• Completion: 2017-07-14
• First posted: 2014-05-30
• Last updated: 2018-09-24
• Results posted: 2018-09-24

Locations

55 sites across 1 country: United States