Carcinoma, HepatocellularPhase 1NCT01308723
A Dose-Finding and Exploratory Study of RO5323441 in Combination With Sorafenib in Patients With Hepatocellular Carcinoma
A Phase 1 study testing RO5323441 and sorafenib in people with Carcinoma, Hepatocellular, run by Hoffmann-La Roche at 2 sites in Singapore.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- RO5323441 and sorafenib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesSingapore
- Study dates
- Mar 2011to Jan 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
Official 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
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.
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- RO5323441, sorafenib
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO5323441Drug
escalating doses iv
RO5323441Drug
iv every 2 weeks
sorafenibDrug
400 mg orally twice daily to once every other day
| Study group | Role | What they receive |
|---|---|---|
| Part I | Experimental | Not described Receives: Drug: RO5323441; Drug: sorafenib |
| Part II (A) | Experimental | Not described Receives: Drug: RO5323441; Drug: sorafenib |
| Part II (B) | Active comparator | Not described Receives: Drug: sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part I : Safety/dose-limiting toxicity: Incidence of adverse events
Measured: up to 12 months
Part I: Determination of recommended Part II dose
Measured: up to 12 months
Part II: Safety/tolerability: Incidence of adverse events
Measured: up to 28 months
Secondary outcomes (6)
Pharmacokinetics of RO5323441 in combination with sorafenib
Measured: up to 40 months
Pharmacokinetics of sorafenib in combination with RO5323441
Measured: up to 12 months
Pharmacodynamic biomarkers (DCE-Magnetic Resonance Imaging evaluations, Placental Growth Factor, Vascular Endothelial Growth Factor Receptors)
Measured: up to 40 months
Efficacy: tumor assessments by Magnetic Resonance Imaging or Computed Tomography according to RECIST criteria
Measured: up to 40 months
Impact on wound healing (skin biopsies)
Measured: up to 40 months
Safety: additional anti-drug antibodies sampling after termination of study drug treatment
Measured: 2 and 4 months after last dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01308723
- Sponsor's protocol ID
- BP25497
- Status last verified
- Nov 2016
- First submitted
- 2 Mar 2011
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01308723
- Acronym / sponsor ID
- BP25497
- Conditions
- Carcinoma, Hepatocellular
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 4 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part I | Experimental | Drug: RO5323441, Drug: sorafenib |
| Part II (A) | Experimental | Drug: RO5323441, Drug: sorafenib |
| Part II (B) | Active comparator | Drug: sorafenib |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RO5323441escalating doses iv | Drug | Part I |
| RO5323441iv every 2 weeks | Drug | Part II (A) |
| sorafenib400 mg orally twice daily to once every other day | Drug | Part I, Part II (A), Part II (B) |
Primary outcome
Part I : Safety/dose-limiting toxicity: Incidence of adverse events
Time frame: up to 12 months
Part I: Determination of recommended Part II dose
Time frame: up to 12 months
Part II: Safety/tolerability: Incidence of adverse events
Time frame: up to 28 months
6 secondary outcomes
Pharmacokinetics of RO5323441 in combination with sorafenib
Time frame: up to 40 months
Pharmacokinetics of sorafenib in combination with RO5323441
Time frame: up to 12 months
Pharmacodynamic biomarkers (DCE-Magnetic Resonance Imaging evaluations, Placental Growth Factor, Vascular Endothelial Growth Factor Receptors)
Time frame: up to 40 months
Efficacy: tumor assessments by Magnetic Resonance Imaging or Computed Tomography according to RECIST criteria
Time frame: up to 40 months
Impact on wound healing (skin biopsies)
Time frame: up to 40 months
Safety: additional anti-drug antibodies sampling after termination of study drug treatment
Time frame: 2 and 4 months after last dose of study drug
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RO5323441 and sorafenib in people with Carcinoma, Hepatocellular, run by Hoffmann-La Roche at 2 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part I : Safety/dose-limiting toxicity: Incidence of adverse events (time frame: up to 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.