SarcomaPhase 1NCT01143740
A Study of RO5045337 in Patients With Liposarcomas Prior to Debulking Surgery
A Phase 1 study testing RO5045337 in people with Sarcoma, run by Hoffmann-La Roche at 4 sites in France.
Trial summary
This open-label study will evaluate efficacy, safety and tolerability of RO5045337 in patients with liposarcoma who are eligible for debulking surgery. Prior to surgery, patients will receive 2-3 cycles of RO5045337, orally for 10 days followed by 18 days of rest per cycle. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma
- What is being tested?
- RO5045337
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 4 sitesFrance
- Study dates
- Jun 2010to Mar 2011
- 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
- well differentiated and/or dedifferentiated liposarcoma eligible for tumor debulking surgery
- willing to undergo tumor biopsies before, during and after treatment
- ECOG performance status 0-1
Who cannot join
- previous chemotherapy and/or radiation for liposarcoma; previous debulking surgery is acceptable
- patients receiving any other agent or therapy to treat their malignancy
- patients requiring anticoagulant therapy and/or anti-platelet therapy
- pre-existing gastrointestinal disorders which may interfere with absorption of drugs
- history of seizure disorders or unstable CNS metastases
- clinically significant cardiovascular disease
- history of long QT syndrome
Trial locations and contacts
4 sites in 1 country.
France4 sites
Study site
Bordeaux, 33076
Study site
Lille, 59020
Study site
Lyon, 69373
Study site
Villejuif, 94805
About this study
Official title: An Exploratory Biomarker Study of RO5045337 in Patients With Liposarcomas Prior to Debulking Surgery
This open-label study will evaluate efficacy, safety and tolerability of RO5045337 in patients with liposarcoma who are eligible for debulking surgery. Prior to surgery, patients will receive 2-3 cycles of RO5045337, orally for 10 days followed by 18 days of rest per cycle. Anticipated time on study treatment is 3 months. Patients with an incomplete resection may be treated for an additional 3 cycles with RO5045337.
- Conditions
- Sarcoma
- Being tested
- RO5045337
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO5045337Drug
orally day 1-10 each 28-day cycle, 3 cycles
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Not described Receives: Drug: RO5045337 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarker evidence of MDM2 and p53 pathway alterations (histologic, molecular and imaging analyses)
Measured: from baseline to week 12
Secondary outcomes (3)
Safety and tolerability: Adverse events, laboratory parameters, ECG
Measured: up to approximately 4 months after study start
Tumor response according to RECIST criteria assessed by CT or MRI
Measured: from baseline to week 7
Correlation pharmacokinetics (AUC, Cmax, tmax, t1/2, CL/V, V/F) - pharmacodynamics/biomarkers
Measured: multiple sampling weeks 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies 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
- 20 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
- NCT01143740
- Sponsor's protocol ID
- NP22890
- Other IDs
- 2009-015522-10, 2009
- Status last verified
- Nov 2016
- First submitted
- 11 Jun 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
- An Exploratory Biomarker Study of RO5045337 in Patients With Liposarcomas Prior to Debulking Surgery
- ClinicalTrials.gov ID
- NCT01143740
- Acronym / sponsor ID
- NP22890
- Conditions
- Sarcoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 14 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 open-label study will evaluate efficacy, safety and tolerability of RO5045337 in patients with liposarcoma who are eligible for debulking surgery. Prior to surgery, patients will receive 2-3 cycles of RO5045337, orally for 10 days followed by 18 days of rest per cycle. Anticipated time on study treatment is 3 months. Patients with an incomplete resection may be treated for an additional 3 cycles with RO5045337.
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: RO5045337 |
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
- well differentiated and/or dedifferentiated liposarcoma eligible for tumor debulking surgery
- willing to undergo tumor biopsies before, during and after treatment
- ECOG performance status 0-1
Key exclusion criteria (7 listed)
- previous chemotherapy and/or radiation for liposarcoma; previous debulking surgery is acceptable
- patients receiving any other agent or therapy to treat their malignancy
- patients requiring anticoagulant therapy and/or anti-platelet therapy
- pre-existing gastrointestinal disorders which may interfere with absorption of drugs
- history of seizure disorders or unstable CNS metastases
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 |
|---|---|---|
| RO5045337orally day 1-10 each 28-day cycle, 3 cycles | Drug | Single Arm |
Primary outcome
Biomarker evidence of MDM2 and p53 pathway alterations (histologic, molecular and imaging analyses)
Time frame: from baseline to week 12
3 secondary outcomes
Safety and tolerability: Adverse events, laboratory parameters, ECG
Time frame: up to approximately 4 months after study start
Tumor response according to RECIST criteria assessed by CT or MRI
Time frame: from baseline to week 7
Correlation pharmacokinetics (AUC, Cmax, tmax, t1/2, CL/V, V/F) - pharmacodynamics/biomarkers
Time frame: multiple sampling weeks 1 and 2
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
4 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 RO5045337 in people with Sarcoma, run by Hoffmann-La Roche at 4 sites in France.
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 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 4 sites in France. 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?
Biomarker evidence of MDM2 and p53 pathway alterations (histologic, molecular and imaging analyses) (time frame: from baseline to week 12). 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.