An Open-Label Study of E7386 in Combination With Other Anticancer Drug(s) in Subjects With Solid Tumors

Conditions

Hepatocellular carcinoma, colorectal cancer, endometrial cancer, or other solid tumor

Brief summary

Safety related endpoints including DLT and/or defining the RP2D ORR defined as the proportion of subjects who have BOR of confirmed CR or PR per RECIST 1.1 by investigator assessment (Dose Optimization Parts only)

Detailed description

PK profile of study drug(s), BOR, ORR (Dose Escalation and Dose Expansion Parts), DCR: defined as the proportion of subjects who have a BOR of CR or PR, or SD, CBR: defined as the proportion of subjects who have a BOR of CR or PR, or durable SD, PFS: defined as the time from the first dose of study drug to the first documentation of PD or death due to any cause (whichever occurs first), OS (all subparts in Expansion and Dose Optimization Part and HCC Subparts in Dose Escalation Part): defined as the time from the first dose of study drug to death due to any cause, DOR: among subjects with PR or CR, defined as the time from the first documentation of PR or CR to the first documentation of PD or death due to any cause (whichever occurs first)

Related papers

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Papers published before 2008-02-04 may not appear yet. Historical indexing is in progress.

Interventions

DRUGПаклитаксел Ебеве 6 mg/ml концентрат за инфузионен разтвор

DRUGPaclitaxel Aurobindo 6 mg/ml concentrato per soluzione per infusione

DRUGDoxorubicina Aurobindo 2 mg/ml concentrato per soluzione per infusione

DRUGLENVIMA 4 mg hard capsules

DRUGE7386

DRUGLENVIMA 10 mg hard capsules

DRUGDoxorubicin EBEWE 2 mg/ml koncentratas infuziniam tirpalui

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Safety related endpoints including DLT and/or defining the RP2D ORR defined as the proportion of subjects who have BOR of confirmed CR or PR per RECIST 1.1 by investigator assessment (Dose Optimization Parts only)	—

Secondary

Measure	Time frame
PK profile of study drug(s), BOR, ORR (Dose Escalation and Dose Expansion Parts), DCR: defined as the proportion of subjects who have a BOR of CR or PR, or SD, CBR: defined as the proportion of subjects who have a BOR of CR or PR, or durable SD, PFS: defined as the time from the first dose of study drug to the first documentation of PD or death due to any cause (whichever occurs first), OS (all subparts in Expansion and Dose Optimization Part and HCC Subparts in Dose Escalation Part): defined as the time from the first dose of study drug to death due to any cause, DOR: among subjects with PR or CR, defined as the time from the first documentation of PR or CR to the first documentation of PD or death due to any cause (whichever occurs first)	—

Measure

Time frame

PK profile of study drug(s), BOR, ORR (Dose Escalation and Dose Expansion Parts), DCR: defined as the proportion of subjects who have a BOR of CR or PR, or SD, CBR: defined as the proportion of subjects who have a BOR of CR or PR, or durable SD, PFS: defined as the time from the first dose of study drug to the first documentation of PD or death due to any cause (whichever occurs first), OS (all subparts in Expansion and Dose Optimization Part and HCC Subparts in Dose Escalation Part): defined as the time from the first dose of study drug to death due to any cause, DOR: among subjects with PR or CR, defined as the time from the first documentation of PR or CR to the first documentation of PD or death due to any cause (whichever occurs first)

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Countries

Denmark, France, Italy, Spain

Outcome results

None listed