drugset / Trial / NCT01345357

Study of CEP-9722 in Combination With Gemcitabine and Cisplatin in Patients With Advanced Solid Tumors or Mantle Cell Lymphoma

NCT01345357 ↗

Phase 1 Completed 24 enrolled Cephalon
NaSingle-groupOpen-labelTreatment

Summary

The primary objective of the study is to determine the maximum tolerated dose (MTD) of CEP-9722 in combination with gemcitabine and cisplatin in patients with advanced solid tumors or mantle cell lymphoma.

Timeline

Start
2011-05
Primary completion
2012-12
Completion
2013-01

Drugs

EvaluationDrugModalityDoseRoute
Subject CEP-9722 Small molecule 150 mg Oral
Subject CEP-9722 Small molecule 200 mg Oral
Subject CEP-9722 Small molecule 300 mg Oral
Subject CEP-9722 Small molecule 400 mg Oral
Background Cisplatin Other / unclassified 75 mg/m2 Intravenous
Background Gemcitabine Small molecule 1250 mg/m2 Intravenous

Indications