NCT01605162

Phase 2 Study of the Poly(ADP-Ribose) Polymerase Inhibitor E7016 in Combination With Temozolomide in Subjects With Wild Type BRAF Stage IV or Unresectable Stage III Melanoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2, open-label, multicenter study to assess the PFS-6m of E7016 at the selected dose of 320-mg once daily (QD) in combination with 150-mg/m2 of Temozolomide (TMZ) in subjects with wt BRAF Stage IV or unresectable Stage III melanoma with disease progression. Eligible subjects must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST).

Conditions

• Wild Type BRAF Stage IV Melanoma
• Unresectable Stage III Melanoma

Interventions

Type	Name	Description
DRUG	TMZ	TMZ (at 150 mg/m2) will be administered orally according to the instructions on the product label, on Days 1 through 5 of the same 28-day cycle as E7016. TMZ capsules should be taken immediately after E7016. No food or drink intake, except water, will be allowed for 2 hours before or after administration.
DRUG	E7016	E7016 capsules will be administered in the morning after at least a 2-hour fast. Subjects will be instructed not to eat or drink anything except water in the 2 hours prior and 2 hours after drug administration. Subjects will record the time at which they ate. For the Single-Dose PK Period, 320 mg of E7016 will be administered once on Day -2. For the Multiple-Dose Treatment Cycle(s), 320 mg E7016 will be administered QD on Days 1 through 7 of each 28-day cycle.

Timeline

• Start date: 2012-05-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2012-05-24
• Last updated: 2016-07-28

Locations

1 site across 1 country: United States