Overview

This trial is active, not recruiting.

Condition hepatocellular carcinoma
Treatments sorafenib
Phase phase 1/phase 2
Targets RAF, FLT-3, KIT, PDGF, VEGF
Sponsor Eisai Inc.
Collaborator PharmaBio Development Inc.
Start date April 2011
End date January 2016
Trial size 95 participants
Trial identifier NCT01271504, 2011-000752-41, E7050-701

Summary

The purpose of this study is to determine whether patients with hepatocellular carcinoma who receive either E7050 administered with Sorafenib or Sorafenib alone experience greater benefit (cancer responds to treatment) when E7050 is administered with Sorafenib.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Phase Ib: Cohort 1; 200 mg E7050 + 400 mg Sorafenib Cohort 2; 300 mg E7050 + 400 mg Sorafenib Cohort 3; 400 mg E7050 + Sorafenib
sorafenib
Phase Ib: Cohort 1; 200 mg E7050 + 400 mg Sorafenib Cohort 2; 300 mg E7050 + 400 mg Sorafenib Cohort 3; 400 mg E7050 + Sorafenib
(Active Comparator)
Phase II: Arm 1; E7050 + 400 mg Sorafenib Arm 2; 400 mg Sorafenib
sorafenib
E7050 given orally at 200, 300 or 400 mg once daily. Sorafenib given orally, 400 mg twice daily.

Primary Outcomes

Measure
Safety Parameters-Adverse Event (AEs)
time frame: Until study termination
Safety Parameter-Concomitant Meds
time frame: Until study termination
Safety Parameter- Clinical Laboratory Evaluations
time frame: Day 1 and every 28 days until study termination; 3 years
Safety Parameter-ECGS
time frame: Day 1 and every 28 days until study termination; 3 years
Safety Parameters-Vital signs
time frame: until study termination
Safety Parameters- ECOG PS
time frame: until study termination

Secondary Outcomes

Measure
Efficacy Parameter
time frame: Time to progression (TTP)-Until the date of first documented progression of such patient's disease
Efficacy Parameter
time frame: Overall survival (OS)-Until the date of first documented progresssion of such patient's disease
Efficacy Parameter
time frame: Overall response rate (ORR)-Until the date of first documented progression of such patient's disease

Eligibility Criteria

Male or female participants from 18 years up to 99 years old.

Inclusion Criteria - Unresectable locally advanced or metastatic HCC; - Histologic confirmation not required if other diagnostic criteria are met; - No previous systemic anti-cancer therapy permitted (2 prior systemic anti-cancer regimen are allowed in Phase Ib). Previous chemoembolization, radioembolization, radiofrequency ablation, or other local ablative therapies are permitted if greater than 6 weeks of first day of study-defined treatment; - ECOG PS 0 or 1; Child-Pugh Cirrhotic Status A or B with a score of 7; - Blood pressure must be well-controlled (less than or equal to 140/90 mmHg at screening) with or without antihypertensive medication. Patients must have no history of hypertensive crisis or hypertensive encephalopathy; Exclusion Criteria - Previously received E7050 anti-cmet, or anti-angiogenic therapy (prior anti-angiogenic therapy is permitted in Phase Ib only); - Presence of brain metastases, unless the patient has received adequate treatment at least 4 weeks prior to randomization, and is stable, asymptomatic, and off steroids for at least 4 weeks prior to randomization; - Palliative radiotherapy is not permitted throughout the study period; - Active hemoptysis - Serious non-healing wound, ulcer, or active bone fracture; - Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to commencing study treatment, or anticipation of need for a major surgical procedure during the course of the study; - Clinically significant gastrointestinal bleeding (bleeding requiring procedural intervention, eg. variceal banding, transjugular intrahepatic portosystemic shunt (TIPS) procedure, arterial embolization, topical coagulation therapy) within 6 months prior to first dose.

Additional Information

Official title An Open-Label, Multicenter, Randomized, Phase Ib/II Study of E7050 in Combination With Sorafenib Versus Sorafenib Alone as First Line Therapy in Patients With Hepatocellular Carcinoma
Description This open-label, multicenter, randomized study will consist of a Phase Ib: a safety run-in period with 3 ascending doses of E7050 in combination with sorafenib; and a Phase II portion: a randomized 2-arm period. Approximately 95 patients with hepatocellular carcinoma will be enrolled in the study (10-15 patients in the Phase Ib portion and 80 patients in the Phase II portion). Patients will only participate in either the Phase Ib or the Phase II portion of the study. In both Phase Ib and phase II, Patients will receive study treatment (E7050 plus sorafenib or sorafenib alone) until the occurrence of progressive disease (PD)for approximately six 28-day cycles (24 weeks). After 6 cycles. ath the discretion of the Investigator and in consultation with the Medical Monitor, patients who are experiencing clinical benefit may continue E7050, with or without sorafenib (Arm 1), or may continue sorafenib alone (Arm 2), depending on the original randomization treatment arm, for as long as clinical benefit is sustained and the treatment is well tolerated. Patients will be followed until death following completion of therapy.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Eisai Inc..