An Open-Label, Multicenter, Phase 1/2 Study of Poly(ADP-Ribose) Polymerase (PARP) Inhibitor E7449 as Single Agent in Subjects With Advanced Solid Tumors or With B-cell Malignancies and in Combination With Temozolomide (TMZ) or With Carboplatin and Paclitaxel in Subjects With Advanced Solid Tumors

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

41

Participants

Timeline

Start Date

January 31, 2012

Primary Completion Date

July 31, 2015

Study Completion Date

July 31, 2015

Conditions
Malignant Solid TumourOvarian CancerTriple Negative Breast CancerAdvanced MelanomaB-cell Malignancy, Low-grade
Interventions
DRUG

E7449 alone

Will be administered as single agent orally, once daily (QD) continuously in 28-day cycles to determine the MTD. In these subjects, a food-effect component will be conducted under fed/fasted conditions to determine the effect of food on the bioavailability of E7449 administered orally QD.

DRUG

E7449 plus TMZ

Dose escalation,will be administered orally, once daily for 7 consecutive days along with 150 mg/m2/d TMZ administered orally, once daily for 5 consecutive days in 28-day cycles to determine the MTD of E7449 in combination with TMZ.

DRUG

E7449 plus carboplatin and paclitaxel

Dose escalation, E7449 will be administered orally, once daily continuously in 21-day cycles along with carboplatin and paclitaxel, which will be administered via i.v. infusion on Day 1 of the cycle only, to determine the MTD of E7449 in combination with carboplatin and paclitaxel.

Trial Locations (2)

SE1 9RT

King's College London Guy's Hospital Campus, London

NE7 7DN

Newcastle Upon Tyne NHS Foundation Trust, Newcastle Upon Tyne and Wear

All Listed Sponsors
lead

Eisai Limited

INDUSTRY

NCT01618136 - An Open-Label, Multicenter, Phase 1/2 Study of Poly(ADP-Ribose) Polymerase (PARP) Inhibitor E7449 as Single Agent in Subjects With Advanced Solid Tumors or With B-cell Malignancies and in Combination With Temozolomide (TMZ) or With Carboplatin and Paclitaxel in Subjects With Advanced Solid Tumors | Biotech Hunter | Biotech Hunter