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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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Hepatocellular Carcinoma

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Trial Information

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


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.

Inclusion Criteria


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 > 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 (≤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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety Parameters- Adverse Event (AEs)

Outcome Description:

Phase Ib: To determine the MTD/recommended Phase II dose and characterize the pharmacokinetics (PK) of E7050 when administered in combination with sorafenib in patients with locally advanced or metastatic HCC; Phase II: To evaluate the safety and tolerability of E7050 when administered in combination with sorafenib as compared with sorafenib alone in patients with locally advanced or metastatic HCC.

Outcome Time Frame:

until study termination

Safety Issue:

Yes

Principal Investigator

Melissa J Versola, RN

Investigator Role:

Study Director

Investigator Affiliation:

Quintiles

Authority:

United States: Food and Drug Administration

Study ID:

E7050-701

NCT ID:

NCT01271504

Start Date:

April 2011

Completion Date:

December 2014

Related Keywords:

  • Hepatocellular Carcinoma
  • Cancer, liver, hepatocellular carcinoma, phase I, phase II
  • Carcinoma
  • Carcinoma, Hepatocellular

Name

Location

Tufts University School of MedicineBoston, Massachusetts  02111
Florida Cancer SpecialistsFort Myers, Florida  33901
Henry Ford Health SystemDetroit, Michigan  48202
University of CincinnatiCincinnati, Ohio  45267-0502
University of North Carolina at Chapel HillChapel Hill, North Carolina  27599
Tennessee OncologyNashville, Tennessee  37203
Florida Cancer Specialists-BroadwayFt. Myers, Florida  33916
Arizona Oncology Associates, PC-CASATucson, Arizona  85715
Peggy & Charles Stephenson Oklahoma Cancer CtrOklahoma City, Oklahoma  73104
Mercy Cancer Center at St. AnneToledo, Ohio  43623