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Completed

NCT Number: NCT01308723

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

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.

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Key information

Conditions

Carcinoma, Hepatocellular Adenocarcinoma Carcinoma Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Singapore

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RO5323441

Drug

escalating doses iv

Sorafenib

Drug

400 mg orally twice daily to once every other day

Primary outcomes

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

    Time frame: up to 12 months

  2. Part I: Determination of recommended Part II dose

    Time frame: up to 12 months

  3. Part II: Safety/tolerability: Incidence of adverse events

    Time frame: up to 28 months

Secondary outcomes

  1. Pharmacokinetics of RO5323441 in combination with sorafenib

    Time frame: up to 40 months

  2. Pharmacokinetics of sorafenib in combination with RO5323441

    Time frame: up to 12 months

  3. Pharmacodynamic biomarkers (DCE-Magnetic Resonance Imaging evaluations, Placental Growth Factor, Vascular Endothelial Growth Factor Receptors)

    Time frame: up to 40 months

  4. Efficacy: tumor assessments by Magnetic Resonance Imaging or Computed Tomography according to RECIST criteria

    Time frame: up to 40 months

  5. Impact on wound healing (skin biopsies)

    Time frame: up to 40 months

  6. Safety: additional anti-drug antibodies sampling after termination of study drug treatment

    Time frame: 2 and 4 months after last dose of study drug

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 4, 2011
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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