Clinical Trial: A Study of LY2940680 in Pediatric Medulloblastoma or Rhabdomyosarcoma
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: A Phase 1 Trial of LY2940680 in Pediatric Patients With Recurrent or Refractory Rhabdomyosarcoma or Medulloblastoma
Brief Summary: The purpose of this study is to find a recommended dose level of LY2940680 that can be safely given to children with medulloblastoma or rhabdomyosarcoma that has returned or doesn't respond to initial treatment. The study will also explore the changes in a cancer marker levels. Finally, the study will help document any antitumor activity.
Detailed Summary:
Sponsor: Eli Lilly and Company
Current Primary Outcome: Maximum Tolerated Dose of LY2940680 [ Time Frame: Baseline to Part A Completion (estimated as 12 months) ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Pharmacokinetics: Area Under the Concentration - Time Curve (AUC) of LY2940680 and LSN2941091 [ Time Frame: Predose up to 24 hours Postdose ]
- Pharmacokinetics: Maximum Concentration (Cmax) of LY2940680 and LSN2941091 [ Time Frame: Predose up to 24 hours Postdose ]
- Pharmacokinetics: Time of Maximal Concentration (Tmax) of LY2940680 and LSN2941091 [ Time Frame: Predose up to 24 hours Postdose ]
- Number of Participants with Tumor Response [ Time Frame: Baseline to Study Completion (estimated as 44 months) ]
Original Secondary Outcome: Same as current
Information By: Eli Lilly and Company
Dates:
Date Received: September 28, 2012
Date Started: July 2013
Date Completion: July 2016
Last Updated: August 26, 2013
Last Verified: August 2013
