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AboundPS2: Abraxane + Carboplatin in Advanced NSCLC Patients with ECOG PS 2
NCT02289456Phase 2
Key facts
- Status
- Completed
- Start
- Apr 2015
- Primary completion
- Feb 2017
- Countries
- 1
- Sponsor
- Celgene Corporation
- Modality
- Polymer-based Nanoparticles, Small Molecules
- Drugs
- nab-paclitaxel
- Conditions
- non-small cell lung cancer (NSCLC)
01
Overview
Phase 2, open-label, single-arm trial of nab-paclitaxel in non-small cell lung cancer (NSCLC), sponsored by Celgene Corporation. Primary endpoint: Percentage of Participants Who Discontinued Study Treatment During the Induction Period Due to Treatment Emergent Adverse Events. Started Apr 2015; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
nab-Paclitaxel + Carboplatin
Induction with nab-Paclitaxel + Carboplatin followed by nab-Paclitaxel monotherapy
03
Who it enrols
Patients with histologically confirmed Stage IIIB or IV NSCLC, ECOG PS 2, and no prior anti-cancer therapy for metastatic disease. Excludes active brain metastases, grade 2+ neuropathy, and significant cardiac history.
04
Endpoints
Primary
Percentage of Participants Who Discontinued Study Treatment During the Induction Period Due to Treatment Emergent Adverse Events
Secondary
Percentage of Participants Who Discontinued Study Treatment During the Induction Period
Dose Intensity of Nab-Paclitaxel During the Entire Study
Dose Intensity of Carboplatin During the Entire Study
Percentage of Participants With Dose Reductions During the Entire Study
Progression-Free Survival
Disease Control Rate
Overall Survival
Objective Response Rate
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