NCT00465491

Study of Picoplatin Efficacy After Relapse

A Randomized, Controlled Phase III Trial of Picoplatin and BSC Versus BSC Alone in Patients With Small Cell Lung Cancer (SCLC), Refractory or Progressive Within Six Months of Completing First-Line, Platinum-Containing Chemotherapy.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 399 (estimated)
• Sponsor: Poniard Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Picoplatin is a new type of platinum drug that has been investigated in several clinical trials, and may provide an improved safety profile over current treatment options. This study is designed to compare the efficacy and safety of picoplatin plus Best Supportive Care (BSC) with BSC alone. Best Supportive Care includes care and treatment to optimize the comfort of patients and their ability to function, as well as to minimize the side-effects of anti-cancer treatments.

Detailed description

This Phase 3 study will enroll subjects with Small Cell Lung Cancer (SCLC) who are refractory or progressive within 6 months of completing first-line, platinum-containing chemotherapy. Subjects will be centrally randomized 2:1 to receive picoplatin plus BSC every 3 weeks, or BSC alone. After discontinuation of picoplatin, all subjects will continue to receive BSC and will continue to be evaluated every 3 weeks until discontinuation from the study, death, or the end of the study. After discontinuation of picoplatin, subjects may be treated with another chemotherapy at their physician's discretion and then will be followed for survival.

Conditions

• Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	picoplatin	IV picoplatin 150mg/m2 q3wk
OTHER	best supportive care	best supportive care

Timeline

• Start date: 2007-04-01
• Primary completion: 2009-05-01
• First posted: 2007-04-25
• Last updated: 2009-04-14

Locations

143 sites across 15 countries: Argentina, Belarus, Bosnia and Herzegovina, Bulgaria, Chile, Croatia, Hungary, India, Latvia, Montenegro, Poland, Romania, Russia, Serbia, Ukraine