NeoplasmsPhase 1NCT01358903
A Study of RO5429083 in Patients With Metastatic and/or Locally Advanced, CD44-Expressing, Malignant Solid Tumors
A Phase 1 study testing RO5429083 in people with Neoplasms, run by Hoffmann-La Roche at 6 sites in 3 countries.
Trial summary
This open-label 2-arm study will assess the pharmacokinetics, pharmacodynamics, safety and efficacy of RO5429083 in patients with metastatic and/or locally advanced CD44-expressing malignant solid tumors. In Part A, cohorts of patients will receive RO5429083 intravenously at escalating doses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- RO5429083
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 6 sitesin 3 countries
- Study dates
- Jun 2011to Mar 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
- Adult patients, >/= 18 years of age
- Metastatic and/or locally advanced malignant CD44-expressing solid tumors
- Patients with disease progression on standard therapy, or have tumors that are not curable by standard therapy
- Life expectancy of over 12 weeks
Who cannot join
- Concurrent therapy with any other investigational drug
- Known or suspected CNS metastases including leptomeningeal metastases
- Active bleeding, bleeding diathesis or history of coagulation disorder
- Uncontrolled diabetes mellitus
- Active or uncontrolled infections
- Patients with HIV infections
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
United States2 sites
Study site
Houston, Texas, 77030
Study site
Seattle, Washington, 98109
Netherlands2 sites
Study site
Amsterdam, 1081 HV
Study site
Nijmegen, 6500 HB
About this study
Official title: Open-Label Multicenter 2-Arm Phase I Study of RO5429083 With Dose-Escalation and Extension Cohorts, and Imaging Cohorts With RO5429083 and 89Zr-labeled RO5429083, in Patients With Metastatic and/or Locally Advanced, CD44-Expressing, Malignant Solid Tumors
This open-label 2-arm study will assess the pharmacokinetics, pharmacodynamics, safety and efficacy of RO5429083 in patients with metastatic and/or locally advanced CD44-expressing malignant solid tumors. In Part A, cohorts of patients will receive RO5429083 intravenously at escalating doses. In Part B, patients will receive 89Zr-labelled RO5429083 in Cycles 1 and/or 2, followed by RO5429083. For all patients there will be an option to continue treatment with RO5429083 until disease progression or unacceptable toxicity occurs.
- Conditions
- Neoplasms
- Being tested
- RO5429083
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO5429083Drug
Cohorts receiving multiple escalating doses iv
RO5429083Drug
Cohorts receiving 89Zr-labelled RO5429083 plus RO5429083, followed by RO5429083 until disease progression
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: RO5429083 |
| B | Experimental | Not described Receives: Drug: RO5429083 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arm A: Safety (Incidence of adverse events related to study drug)
Measured: Until disease progression or unacceptable toxicity (approximately 2 years)
Arm A: Maximum tolerated dose of RO5429083
Measured: Until disease progression or unacceptable toxicity (approximately 2 years)
Arm A: Tumor Growth Control Rate
Measured: Until disease progression or unacceptable toxicity (approximately 2 years)
Arm B: Tissue distribution of RO5429083 assessed by positron emission tomography (PET)
Measured: Until disease progression or unacceptable toxicity (approximately 2 years)
Arm A: Pharmacokinetics (serum levels of RO5429083)
Measured: Until disease progression or unacceptable toxicity (approximately 2 years)
Secondary outcomes (3)
Arm A: Recommended dose of RO5429083 for the extension cohort
Measured: Until disease progression or unacceptable toxicity (approximately 2 years)
Arm A: Anti-tumor activity of RO5429083
Measured: Until disease progression or unacceptable toxicity (approximately 2 years)
Arm B: Target saturation of 89Zr-labelled RO5429083
Measured: Until disease progression or unacceptable toxicity (approximately 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2011 (estimated)
- Study startJun 2011
- Primary completionMar 2014
- Study completionMar 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
- 65 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
- NCT01358903
- Sponsor's protocol ID
- BP25385
- Other IDs
- 2010-021168-13
- Status last verified
- Nov 2016
- First submitted
- 18 May 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
- Open-Label Multicenter 2-Arm Phase I Study of RO5429083 With Dose-Escalation and Extension Cohorts, and Imaging Cohorts With RO5429083 and 89Zr-labeled RO5429083, in Patients With Metastatic and/or Locally Advanced, CD44-Expressing, Malignant Solid Tumors
- ClinicalTrials.gov ID
- NCT01358903
- Acronym / sponsor ID
- BP25385
- Conditions
- Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 24 May 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 2-arm study will assess the pharmacokinetics, pharmacodynamics, safety and efficacy of RO5429083 in patients with metastatic and/or locally advanced CD44-expressing malignant solid tumors. In Part A, cohorts of patients will receive RO5429083 intravenously at escalating doses. In Part B, patients will receive 89Zr-labelled RO5429083 in Cycles 1 and/or 2, followed by RO5429083. For all patients there will be an option to continue treatment with RO5429083 until disease progression or unacceptable toxicity occurs.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: RO5429083 |
| B | Experimental | Drug: RO5429083 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients, >/= 18 years of age
- Metastatic and/or locally advanced malignant CD44-expressing solid tumors
- Patients with disease progression on standard therapy, or have tumors that are not curable by standard therapy
- Life expectancy of over 12 weeks
Key exclusion criteria (6 listed)
- Concurrent therapy with any other investigational drug
- Known or suspected CNS metastases including leptomeningeal metastases
- Active bleeding, bleeding diathesis or history of coagulation disorder
- Uncontrolled diabetes mellitus
- Active or uncontrolled infections
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 |
|---|---|---|
| RO5429083Cohorts receiving multiple escalating doses iv | Drug | A |
| RO5429083Cohorts receiving 89Zr-labelled RO5429083 plus RO5429083, followed by RO5429083 until disease progression | Drug | B |
Primary outcome
Arm A: Safety (Incidence of adverse events related to study drug)
Time frame: Until disease progression or unacceptable toxicity (approximately 2 years)
Arm A: Maximum tolerated dose of RO5429083
Time frame: Until disease progression or unacceptable toxicity (approximately 2 years)
Arm A: Tumor Growth Control Rate
Time frame: Until disease progression or unacceptable toxicity (approximately 2 years)
Arm B: Tissue distribution of RO5429083 assessed by positron emission tomography (PET)
Time frame: Until disease progression or unacceptable toxicity (approximately 2 years)
Arm A: Pharmacokinetics (serum levels of RO5429083)
Time frame: Until disease progression or unacceptable toxicity (approximately 2 years)
3 secondary outcomes
Arm A: Recommended dose of RO5429083 for the extension cohort
Time frame: Until disease progression or unacceptable toxicity (approximately 2 years)
Arm A: Anti-tumor activity of RO5429083
Time frame: Until disease progression or unacceptable toxicity (approximately 2 years)
Arm B: Target saturation of 89Zr-labelled RO5429083
Time frame: Until disease progression or unacceptable toxicity (approximately 2 years)
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
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RO5429083 in people with Neoplasms, run by Hoffmann-La Roche at 6 sites in 3 countries.
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 4 inclusion and 6 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 6 sites in United States, France, Netherlands. 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?
Arm A: Safety (Incidence of adverse events related to study drug) (time frame: Until disease progression or unacceptable toxicity (approximately 2 years)). The study lists 5 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.