NCT01752023

A Randomized Phase II Study of SUBATM-itraconazole in Patients With Untreated Squamous NSCLC.

A Randomized Phase II Study of SUBATM-itraconazole With Cisplatin/Gemcitabine in Patients With Previously Untreated Metastatic Squamous Non-Small Cell Lung Cancer.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

Response rates. Changes in tumor blood flow.

Detailed description

To determine the objective response rates of cisplatin and gemcitabine with or without SUBATM-itraconazole in patients with chemotherapy-naïve metastatic squamous non-small cell lung cancer. To assess the changes in tumor blood flow as measured by contrast enhanced MRI scanning in patients with metastatic squamous non-small cell lung cancer treated with cisplatin and gemcitabine with or without SUBATM-itraconazole.

Conditions

• Non-small Cell Lung Cancer Metastatic

Interventions

Type	Name	Description
DRUG	Cisplatin + Gemcitabine with SUBATM-itraconazole	Experimental Arm
DRUG	Cisplatin + Gemcitabine	Active Comparator

Timeline

• Start date: 2013-03-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2012-12-18
• Last updated: 2018-10-17
• Results posted: 2017-06-02

Locations

2 sites across 1 country: United States