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A Dose-Finding and Exploratory Study of RO5323441 in Combination With Sorafenib in Patients With Hepatocellular Carcinoma

NCT ID: NCT01308723

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-01-31

Brief Summary

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This open-label study will assess the safety, efficacy and pharmacokinetics of RO5323441 in combination with sorafenib in patients with advanced or metastatic hepatocellular carcinoma previously untreated with systemic therapy. In the dose-finding Part I, cohorts of patients will receive escalating doses of RO5323441 intravenously (iv) every 2 weeks in combination with sorafenib 400 mg orally twice daily. In the exploratory Part II, patients will be randomized to receive either the previously established dose of RO5323441 iv every 2 weeks plus continuous oral sorafenib or sorafenib alone. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs. For patients in the sorafenib arm with disease progression crossover to combination treatment with RO5323441 will be allowed.

Detailed Description

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Conditions

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Carcinoma, Hepatocellular

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part I

Group Type EXPERIMENTAL

RO5323441

Intervention Type DRUG

escalating doses iv

sorafenib

Intervention Type DRUG

400 mg orally twice daily to once every other day

Part II (A)

Group Type EXPERIMENTAL

RO5323441

Intervention Type DRUG

iv every 2 weeks

sorafenib

Intervention Type DRUG

400 mg orally twice daily to once every other day

Part II (B)

Group Type ACTIVE_COMPARATOR

sorafenib

Intervention Type DRUG

400 mg orally twice daily to once every other day

Interventions

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RO5323441

escalating doses iv

Intervention Type DRUG

RO5323441

iv every 2 weeks

Intervention Type DRUG

sorafenib

400 mg orally twice daily to once every other day

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult patients \>/= 21 years of age
* Advanced or metastatic and/or unresectable hepatocellular carcinoma
* At least 1 measurable lesion according to RECIST criteria
* Primary tumor in situ (Expansion Cohort Part I, Part II)
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Adequate bone marrow, liver and renal function

Exclusion Criteria

* Prior systemic treatment for metastatic hepatocellular carcinoma or patients who had tumor removed (Expansion Cohort Part I, Part II)
* Major surgery within previous 4 weeks or planned major surgical procedure during course of study
* Radiation therapy within 28 days prior to start of study treatment
* Serious non-healing wound, ulcer ore bone fracture
* History of uncontrolled seizures or encephalopathy within the last 6 months
* Current central nervous system (CNS) metastases or spinal cord compression
* History of gastrointestinal perforation or esophageal/gastric bleeding within 6 months prior to study enrollment
* History of another primary malignancy and off treatment for \</= 3 years, except for non-melanoma skin cancer and carcinoma in situ of the cervix
* Patients with prior liver transplant
* Inadequately controlled hypertension or prior history of hypertensive crisis or hypertensive encephalopathy
* Active bleeding diathesis
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Singapore, , Singapore

Site Status

Singapore, , Singapore

Site Status

Countries

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Singapore

Other Identifiers

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BP25497

Identifier Type: -

Identifier Source: org_study_id