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Exploratory Open Label Dose-escalation Phase Ib Study to Evaluate Safety, Pharmacokinetics and Therapeutic Activity of RO5323441, Administered Intravenously, in Combination With Sorafenib (Nexavar®), in Patients With Advanced or Metastatic and/or Unresectable Hepatocellular Carcinoma


Phase 1
21 Years
N/A
Not Enrolling
Both
Liver Cancer

Thank you

Trial Information

Exploratory Open Label Dose-escalation Phase Ib Study to Evaluate Safety, Pharmacokinetics and Therapeutic Activity of RO5323441, Administered Intravenously, in Combination With Sorafenib (Nexavar®), in Patients With Advanced or Metastatic and/or Unresectable Hepatocellular Carcinoma


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 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Part I : Safety/dose-limiting toxicity: Incidence of adverse events

Outcome Time Frame:

up to 12 months

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Singapore: Ministry of Health

Study ID:

BP25497

NCT ID:

NCT01308723

Start Date:

March 2011

Completion Date:

January 2012

Related Keywords:

  • Liver Cancer
  • Carcinoma
  • Liver Neoplasms
  • Carcinoma, Hepatocellular

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