Colorectal Cancer, Ovarian CancerPhase 1NCT01148758
A Dose-finding Study of RO5323441 in Patients With Metastatic Treatment-Refractory Colorectal or Ovarian Cancer
A Phase 1 study testing RO5323441 in people with Colorectal Cancer, Ovarian Cancer, run by Hoffmann-La Roche at 3 sites in 3 countries.
Trial summary
This exploratory, open label study will assess the the dose-effect relationship, efficacy and safety of RO5323441 in patients with metastatic treatment-refractory colorectal or ovarian cancer. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Colorectal Cancer, Ovarian Cancer
- What is being tested?
- RO5323441
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 3 sitesin 3 countries
- Study dates
- May 2010to Sep 2010
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients, >/=19 years of age
- metastatic or unresectable colorectal or ovarian cancer refractory to, or unsuitable for standard therapy
- presence of tumor lesions suitable for DCE-MRI evaluation
- WHO performance status 0-1
- adequate bone marrow, liver and renal function
Who cannot join
- patient unsuitable for MRI scanning (e.g. metal implants, pacemaker, claustrophobia, hypersensitivity to DCE-MRI contrast material)
- brain metastases
- clinically significant ascites
- active bleeding, bleeding diathesis, oral anti-vitamin K medication (other than low dose coumarin) or history of coagulation disorders
- radiation therapy within 3 weeks, or anti-neoplastic therapy <30 days prior to first dose of study drug
- chronic therapy with systemic steroids or another immunosuppressive agent <2 weeks prior to first dose of study drug
- treated with bevacizumab in last regimen of systemic therapy
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Open-label, Exploratory, Pharmacodynamic (PD) Dose-finding Study of Intravenous RO5323441 in Patients With Metastatic Treatment-refractory Colorectal and Ovarian Cancer
This exploratory, open label study will assess the the dose-effect relationship, efficacy and safety of RO5323441 in patients with metastatic treatment-refractory colorectal or ovarian cancer. Cohorts of patients will receive doses of intravenous RO5323441 in the range of 25mg to 3g every 1 or 2 weeks and will undergo serial dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) assessments. In the absence of disease progression and unacceptable toxicity, patients may continue to receive their maximum dose of RO5323441 for a core treatment phase of up to a total of 6 months. Treatment with RO5323441 can be extended at the investigator's discretion until disease progression or unacceptable toxicity occurs. Target sample size is <100.
- Conditions
- Colorectal Cancer, Ovarian Cancer
- Being tested
- RO5323441
- Medical subject headings
- Colorectal Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO5323441Drug
cohorts receiving multiple doses iv
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Not described Receives: Drug: RO5323441 |
What is being measured
The primary outcome is the main question the study is designed to answer.
RO5323441 concentration - pharmacodynamic effect relationship using DCE-MRI
Measured: up to 19.5 months
Secondary outcomes (6)
Feasibility of within-patient dose escalation
Measured: from baseline to Day 127 (+/-3)
Additional DCE-MRI effects (time-course of DCE-MRI effects, test-retest reproducibility)
Measured: up to 19.5 months
Candidate biomarkers associated with PD effect of RO5323441
Measured: up to 19.5 months
Pharmacokinetics: maximum and trough concentrations of RO5323441
Measured: up to 19.5 months
Safety and tolerability: Adverse events, vital signs, laboratory parameters
Measured: up to 19.5 months
Efficacy: ORR, duration of response, progression-free survival according to RECIST criteria, CTI/MRI assessments
Measured: up to 19.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startMay 2010
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer, Ovarian CancerStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 7 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
- NCT01148758
- Sponsor's protocol ID
- BP22909
- Other IDs
- 2009-016014-25, 2009
- Status last verified
- Nov 2016
- First submitted
- 5 May 2010
- 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, Exploratory, Pharmacodynamic (PD) Dose-finding Study of Intravenous RO5323441 in Patients With Metastatic Treatment-refractory Colorectal and Ovarian Cancer
- ClinicalTrials.gov ID
- NCT01148758
- Acronym / sponsor ID
- BP22909
- Conditions
- Colorectal Cancer, Ovarian Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 22 Jun 2010 (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 exploratory, open label study will assess the the dose-effect relationship, efficacy and safety of RO5323441 in patients with metastatic treatment-refractory colorectal or ovarian cancer. Cohorts of patients will receive doses of intravenous RO5323441 in the range of 25mg to 3g every 1 or 2 weeks and will undergo serial dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) assessments. In the absence of disease progression and unacceptable toxicity, patients may continue to receive their maximum dose of RO5323441 for a core treatment phase of up to a total of 6 months. Treatment with RO5323441 can be extended at the investigator's discretion until disease progression or unacceptable toxicity occurs. Target sample size is <100.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: RO5323441 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- adult patients, >/=19 years of age
- metastatic or unresectable colorectal or ovarian cancer refractory to, or unsuitable for standard therapy
- presence of tumor lesions suitable for DCE-MRI evaluation
- WHO performance status 0-1
- adequate bone marrow, liver and renal function
Key exclusion criteria (7 listed)
- patient unsuitable for MRI scanning (e.g. metal implants, pacemaker, claustrophobia, hypersensitivity to DCE-MRI contrast material)
- brain metastases
- clinically significant ascites
- active bleeding, bleeding diathesis, oral anti-vitamin K medication (other than low dose coumarin) or history of coagulation disorders
- radiation therapy within 3 weeks, or anti-neoplastic therapy <30 days prior to first dose of study drug
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 |
|---|---|---|
| RO5323441cohorts receiving multiple doses iv | Drug | Single Arm |
Primary outcome
RO5323441 concentration - pharmacodynamic effect relationship using DCE-MRI
Time frame: up to 19.5 months
6 secondary outcomes
Feasibility of within-patient dose escalation
Time frame: from baseline to Day 127 (+/-3)
Additional DCE-MRI effects (time-course of DCE-MRI effects, test-retest reproducibility)
Time frame: up to 19.5 months
Candidate biomarkers associated with PD effect of RO5323441
Time frame: up to 19.5 months
Pharmacokinetics: maximum and trough concentrations of RO5323441
Time frame: up to 19.5 months
Safety and tolerability: Adverse events, vital signs, laboratory parameters
Time frame: up to 19.5 months
Efficacy: ORR, duration of response, progression-free survival according to RECIST criteria, CTI/MRI assessments
Time frame: up to 19.5 months
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
3 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 RO5323441 in people with Colorectal Cancer, Ovarian Cancer, run by Hoffmann-La Roche at 3 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 5 inclusion and 7 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 3 sites in Belgium, Spain, United Kingdom. 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?
RO5323441 concentration - pharmacodynamic effect relationship using DCE-MRI (time frame: up to 19.5 months). 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; AzTrials last refreshed its copy on 7 Nov 2026.