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

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

May 31, 2011

Primary Completion Date

December 31, 2012

Study Completion Date

January 31, 2013

Conditions
Solid Tumors or Mantle Cell Lymphoma
Interventions
DRUG

CEP-9722

CEP-9722 will be administered orally from day 2 through day 7 of each cycle beginning with cycle 2. The starting dose will be 150 mg twice daily. Following cycle 2, the dose will either be decreased to 150 mg daily or increased to 200 mg twice daily in a cohort of 3 to 4 new patients. Subsequent cycles will increase the dose by 100 mg twice daily in cohorts of 3 to 4 patients (with criteria to expand to 6 patients) to a maximum of 400 mg twice daily. Patients must receive CEP-9722 to remain in the study. Once treatment with CEP-9722 is discontinued, patients will withdraw from the study.

DRUG

Gemcitabine

Gemcitabine will be administered at 1250 mg/m\^2 intravenously on day 1 and day 8 of each 21-day cycle. Dosage reduction may be applied on day 8 (within a cycle) or on day 1 of the next cycle based upon the grade of toxicity experienced by the patient.

DRUG

Cisplatin

Cisplatin will be administered at 75 mg/m\^2 intravenously on day 1 of each cycle, after the infusion of gemcitabine. Dosage reduction may be applied on day 1 of the next cycle based upon the grade of toxicity experienced by the patient.

Trial Locations (3)

Unknown

Teva Investigational Site 3, Brussels

Teva Investigational Site 1, Nantes

Teva Investigational Site 2, Villejuif

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Cephalon

INDUSTRY

NCT01345357 - Study of CEP-9722 in Combination With Gemcitabine and Cisplatin in Patients With Advanced Solid Tumors or Mantle Cell Lymphoma | Biotech Hunter | Biotech Hunter