NeoplasmsPhase 1NCT02031731
The Pharmacokinetics and Safety of Onartuzumab (MetMAb) in Chinese Patients With Locally Advanced or Metastatic Solid Tumors
A Phase 1 study testing 4 mg/kg Onartuzumab (MetMAb), 15 mg/kg Onartuzumab (MetMAb) and 30 mg/kg Onartuzumab (MetMAb) in people with Neoplasms, run by Hoffmann-La Roche at 3 sites in China.
Trial summary
This phase I study will examine the pharmacokinetics and safety of Onartuzumab (MetMAb) in chinese patients with locally advanced or metastatic solid tumors. Patients will be divided into 3 cohorts, which will each be given a different dose of MetMAb. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- 4 mg/kg Onartuzumab (MetMAb), 15 mg/kg Onartuzumab (MetMAb) and 30 mg/kg Onartuzumab (MetMAb)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesChina
- Study dates
- 13 Jan 2014to 14 Apr 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >/= 18 years
- Histologically confirmed locally advanced or metastatic solid tumor that does not respond to standard treatment or for which there is no further standard treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status from 0 to 2.
- Use of effective contraception
- Life expectancy > 3 months
Who cannot join
- Brain metastasis or spinal cord compression that has not yet been definitively treated with surgery and/or radiation, and/or patients with brain metastasis that have been receiving corticosteroids.
- Previously diagnosed and treated central nervous system (CNS) metastases or spinal cord compression that has not been clinically stable for at least 2 months.
- Treatment with anti-tumor therapy within 4 weeks before the start of study treatment, with the following exception: Patients with metastatic prostate cancer on maintenance hormonal therapy, provided they meet all other eligibility criteria.
- Current, serious or uncontrolled, systemic illness.
- Recent stroke (within the past 6 months).
- Active autoimmune disease that is not controlled by nonsteroidal anti-inflammatory drugs (NSAIDs).
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- History of cardiovascular conditions.
- Any other disease, gastrointestinal abnormality, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications.
- Receipt of any investigational agent, or participation in any other clinical study, within 4 weeks before the start of study treatment.
- Major surgery within 4 weeks before the start of study treatment, without complete recovery.
- Significant traumatic injury within 3 weeks before the start of study treatment (All wounds must be fully healed prior to Day 1).
- Uncontrolled excess calcium levels.
- Known human immunodeficiency virus (HIV) infection.
- Inadequate organ function
- Pregnancy
Trial locations and contacts
3 sites in 1 country.
China3 sites
Beijing Cancer Hospital
Beijing, 100142
the First Hospital of Jilin University
Changchun, 130021
Sun Yet-sen University Cancer Center
Guangzhou, 510060
About this study
Official title: A PHASE I STUDY OF THE PHARMACOKINETICS AND SAFETY OF ONARTUZUMAB IN CHINESE PATIENTS WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS
This phase I study will examine the pharmacokinetics and safety of Onartuzumab (MetMAb) in chinese patients with locally advanced or metastatic solid tumors. Patients will be divided into 3 cohorts, which will each be given a different dose of MetMAb. The cohorts will be treated sequentially, starting with the lowest dose. MetMAb will be administered intravenously every 3 weeks. Patients may be treated for up to 16 cycles (21 days each) or 1 year, whichever occurs first, in the absence of disease progression.
- Conditions
- Neoplasms
- Being tested
- 4 mg/kg Onartuzumab (MetMAb), 15 mg/kg Onartuzumab (MetMAb), 30 mg/kg Onartuzumab (MetMAb)
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4 mg/kg Onartuzumab (MetMAb)Drug
4 mg/kg Onartuzumab (MetMAb) will be administered intravenously every 3 weeks.
15 mg/kg Onartuzumab (MetMAb)Drug
15 mg/kg Onartuzumab (MetMAb) will be administered intravenously every 3 weeks.
30 mg/kg Onartuzumab (MetMAb)Drug
30 mg/kg Onartuzumab (MetMAb) will be administered intravenously every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 4 mg/kg Onartuzumab (MetMAb) | Experimental | Not described Receives: Drug: 4 mg/kg Onartuzumab (MetMAb) |
| 15 mg/kg Onartuzumab (MetMAb) | Experimental | Not described Receives: Drug: 15 mg/kg Onartuzumab (MetMAb) |
| 30 mg/kg Onartuzumab (MetMAb) | Experimental | Not described Receives: Drug: 30 mg/kg Onartuzumab (MetMAb) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Measured: Up to 1 year
Total exposure of MetMAb, as measured by area under the concentration-time curve (AUC)
Measured: Up to 1 year
Secondary outcomes (1)
Incidence of anti-therapeutic antibodies against MetMAb
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2014 (estimated)
- Study start13 Jan 2014
- Primary completion14 Apr 2014
- Study completion14 Apr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
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
- NCT02031731
- Sponsor's protocol ID
- YO28211
- Status last verified
- Mar 2017
- First submitted
- 8 Jan 2014
- Last updated
- 14 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE I STUDY OF THE PHARMACOKINETICS AND SAFETY OF ONARTUZUMAB IN CHINESE PATIENTS WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS
- ClinicalTrials.gov ID
- NCT02031731
- Acronym / sponsor ID
- YO28211
- Conditions
- Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 13 Jan 2014 (actual)
- Primary completion
- 14 Apr 2014 (actual)
- Study completion
- 14 Apr 2014 (actual)
- First posted
- 9 Jan 2014 (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 phase I study will examine the pharmacokinetics and safety of Onartuzumab (MetMAb) in chinese patients with locally advanced or metastatic solid tumors. Patients will be divided into 3 cohorts, which will each be given a different dose of MetMAb. The cohorts will be treated sequentially, starting with the lowest dose. MetMAb will be administered intravenously every 3 weeks. Patients may be treated for up to 16 cycles (21 days each) or 1 year, whichever occurs first, in the absence of disease progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 4 mg/kg Onartuzumab (MetMAb) | Experimental | Drug: 4 mg/kg Onartuzumab (MetMAb) |
| 15 mg/kg Onartuzumab (MetMAb) | Experimental | Drug: 15 mg/kg Onartuzumab (MetMAb) |
| 30 mg/kg Onartuzumab (MetMAb) | Experimental | Drug: 30 mg/kg Onartuzumab (MetMAb) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age >/= 18 years
- Histologically confirmed locally advanced or metastatic solid tumor that does not respond to standard treatment or for which there is no further standard treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status from 0 to 2.
- Use of effective contraception
- Life expectancy > 3 months
Key exclusion criteria (15 listed)
- Brain metastasis or spinal cord compression that has not yet been definitively treated with surgery and/or radiation, and/or patients with brain metastasis that have been receiving corticosteroids.
- Previously diagnosed and treated central nervous system (CNS) metastases or spinal cord compression that has not been clinically stable for at least 2 months.
- Treatment with anti-tumor therapy within 4 weeks before the start of study treatment, with the following exception: Patients with metastatic prostate cancer on maintenance hormonal therapy, provided they meet all other eligibility criteria.
- Current, serious or uncontrolled, systemic illness.
- Recent stroke (within the past 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 |
|---|---|---|
| 4 mg/kg Onartuzumab (MetMAb)4 mg/kg Onartuzumab (MetMAb) will be administered intravenously every 3 weeks. | Drug | 4 mg/kg Onartuzumab (MetMAb) |
| 15 mg/kg Onartuzumab (MetMAb)15 mg/kg Onartuzumab (MetMAb) will be administered intravenously every 3 weeks. | Drug | 15 mg/kg Onartuzumab (MetMAb) |
| 30 mg/kg Onartuzumab (MetMAb)30 mg/kg Onartuzumab (MetMAb) will be administered intravenously every 3 weeks. | Drug | 30 mg/kg Onartuzumab (MetMAb) |
Primary outcome
Incidence of adverse events
Time frame: Up to 1 year
Total exposure of MetMAb, as measured by area under the concentration-time curve (AUC)
Time frame: Up to 1 year
1 secondary outcome
Incidence of anti-therapeutic antibodies against MetMAb
Time frame: Up to 1 year
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 14 Mar 2017.
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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
3 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 4 mg/kg Onartuzumab (MetMAb), 15 mg/kg Onartuzumab (MetMAb) and 30 mg/kg Onartuzumab (MetMAb) in people with Neoplasms, run by Hoffmann-La Roche at 3 sites in China.
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 5 inclusion and 15 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 14 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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?
Incidence of adverse events (time frame: Up to 1 year). The study lists 2 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 14 Mar 2017.