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Phase II randomized open-label study of AXL1717 versus docetaxel in previously treated advanced non-small-cell lung cancer
2011-002007-15Phase 2
Key facts
- Status
- Completed
- Start
- Aug 2011
- Countries
- 1
- Sponsor
- Axelar
- Modality
- Small Molecules
- Drugs
- picropodophyllin
- Conditions
- non-small cell lung cancer (NSCLC)Pulmonary squamous cell carcinomaNon-small cell lung cancer adenocarcinoma (NSCLC)
01
Overview
Phase 2, randomised, open-label trial of picropodophyllin in non-small cell lung cancer (NSCLC), Pulmonary squamous cell carcinoma and Non-small cell lung cancer adenocarcinoma (NSCLC) (2 arms), sponsored by Axelar. Primary endpoint: Progression-free survival rate at 12 weeks. Started Aug 2011; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
AXL1717
Patients receive AXL1717 (picropodophyllin), an IGF-1R inhibitor, as monotherapy.
Docetaxel
Patients receive docetaxel chemotherapy as monotherapy.
03
Who it enrols
Adult patients with previously treated, locally advanced or metastatic non-small-cell lung cancer of squamous cell carcinoma or adenocarcinoma histology, excluding mixed squamous and non-squamous NSCLC.
04
Endpoints
Primary
Progression-free survival rate at 12 weeks
Secondary
Complete response rate after four cycles
Partial response rate after four cycles
Stable disease rate after four cycles
Progressive disease rate after four cycles
Disease control rate after four cycles
Objective response rate after four cycles
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