NCT00682981

A Phase I/II Study of Carboplatin and Etoposide With or Without Obatoclax in Extensive-stage Small Cell Lung Cancer (ES-SCLC)

A Phase I Followed by a Randomized, Phase II Study of Carboplatin and Etoposide With or Without Obatoclax Administered Every 3 Weeks to Patients With Extensive- Stage Small Cell Lung Cancer (ES-SCLC)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 218 (actual)
• Sponsor: Gemin X · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The Phase I portion of this protocol will determine the best phase II dose and schedule of obatoclax with carboplatin and etoposide in patients with extensive-stage small cell lung cancer. The Phase II portion will evaluate the response rate to this regimen.

Detailed description

In the Phase I portion, both 3 hour and 24 hour infusions of obatoclax with carboplatin and etoposide every 3 weeks will be evaluated at different doses. In the Phase II portion, 3 hour infusions of obatoclax with or without carboplatin and etoposide every three weeks will be evaluated for response rates.

Conditions

• Extensive-stage Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Obatoclax	IV Infusions for 3 consecutive days of either 3-hours, 2 hours duration
DRUG	Carboplatin/etoposide	Carboplatin/etoposide combination

Timeline

• Start date: 2008-05-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2008-05-23
• Last updated: 2016-07-21

Locations

75 sites across 10 countries: United States, Bulgaria, Canada, Czechia, Hungary, India, Poland, Romania, Serbia, United Kingdom