SarcomaPhase 1NCT01605526
A Study of RO5045337 in Combination With Doxorubicin in Patients With Soft Tissue Sarcoma
A Phase 1 study testing RO5045337 and doxorubicin in people with Sarcoma, run by Hoffmann-La Roche at 9 sites in 2 countries.
Trial summary
This multicenter, open-label, Phase 1b study will evaluate the safety, pharmacokinetics and efficacy of RO5045337 in combination with doxorubicin in patients with soft tissue sarcoma. 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 and doxorubicin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 9 sitesin 2 countries
- Study dates
- May 2012to Jun 2013
- 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
- Histologically or cytologically confirmed soft tissue sarcoma
- Evaluable disease according to RECIST version 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
- Eligible for doxorubicin therapy
- Acute toxicities from prior anti-tumor therapy, surgery or radiotherapy must have resolved to NCI-CTCAE Grade </= 1 prior to start of study
- Adequate bone marrow, hepatic and renal function
- Patients with stable CNS metastases are eligible
Who cannot join
- Previous treatment with limiting doses of doxorubicin
- Patients receiving any other investigational or commercial agents or therapies administered with the intention to treat their malignancy or other ailment </= 28 days from Day 1 dosing on study treatment
- History of seizure disorders or unstable CNS metastases
- Severe and/or uncontrolled medical conditions or other conditions that could affect the participation in the study
- Pregnant or breastfeeding women
- HIV positive patients who are currently receiving combination anti-retroviral therapy
- Patients with known coagulopathy, platelet disorder or history of non-drug induced thrombocytopenia
- Patients receiving oral or parenteral anti-coagulants/anti-platelet agents
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States5 sites
Study site
Boston, Massachusetts, 02115
Study site
Hackensack, New Jersey, 07601
Study site
Philadelphia, Pennsylvania, 19111
Study site
Salt Lake City, Utah, 84132-0001
Study site
Santa Monica, California, 90403
France4 sites
Study site
Bordeaux, 33076
Study site
Lyon, 69373
Study site
Toulouse, 31059
Study site
Villejuif, 94805
About this study
Official title: A Multi-center, Open-label Phase IB Study of Escalating Doses of RO5045337, an Oral Small Molecule MDM2 Antagonist, in Combination With Doxorubicin in Patients With Soft Tissue Sarcoma
This multicenter, open-label, Phase 1b study will evaluate the safety, pharmacokinetics and efficacy of RO5045337 in combination with doxorubicin in patients with soft tissue sarcoma. Cohorts of patients will receive escalating doses of RO5045337 orally on Days 1-5 (1-3) of each 28-day cycle in combination with doxorubicin 60 mg/m2 intravenously on Day 1 of each cycle for up to 6 cycles.
- Conditions
- Sarcoma
- Being tested
- RO5045337, doxorubicin
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO5045337Drug
Multiple escalating oral doses, Days 1-5 (1-3) of each 28-day cycle, up to 6 cycles
doxorubicinDrug
60 mg/m2 (75 mg/m2, 50 mg/m2) iv on Day 1 of each 28-day cycle, up to 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Not described Receives: Drug: RO5045337; Drug: doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose/dose-limiting toxicities
Measured: approximately 12 months
Safety: Incidence of adverse events
Measured: approximately 12 months
Secondary outcomes (2)
Pharmacokinetics of RO5045337 and doxorubicin in combination therapy: Area under the concentration-time curve (AUC)
Measured: Pre-dose and up to 72 hours post-dose Days 1 and 5 of Cycle 1
Pharmacodynamics: Serum macrophage inhibitory cytokine-1 (MIC-1) levels
Measured: Pre-dose and up to 72 hours post-dose on Days 1 and 5 of Cycle 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2012 (estimated)
- Study startMay 2012
- Primary completionJun 2013
- Study completionJun 2013
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
- 23 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
- NCT01605526
- Sponsor's protocol ID
- NP28021
- Other IDs
- 2011-006279-21
- Status last verified
- Nov 2016
- First submitted
- 4 May 2012
- 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
- A Multi-center, Open-label Phase IB Study of Escalating Doses of RO5045337, an Oral Small Molecule MDM2 Antagonist, in Combination With Doxorubicin in Patients With Soft Tissue Sarcoma
- ClinicalTrials.gov ID
- NCT01605526
- Acronym / sponsor ID
- NP28021
- Conditions
- Sarcoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 25 May 2012 (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 multicenter, open-label, Phase 1b study will evaluate the safety, pharmacokinetics and efficacy of RO5045337 in combination with doxorubicin in patients with soft tissue sarcoma. Cohorts of patients will receive escalating doses of RO5045337 orally on Days 1-5 (1-3) of each 28-day cycle in combination with doxorubicin 60 mg/m2 intravenously on Day 1 of each cycle for up to 6 cycles.
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, Drug: doxorubicin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult patients, >/= 18 years of age
- Histologically or cytologically confirmed soft tissue sarcoma
- Evaluable disease according to RECIST version 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
- Eligible for doxorubicin therapy
Key exclusion criteria (8 listed)
- Previous treatment with limiting doses of doxorubicin
- Patients receiving any other investigational or commercial agents or therapies administered with the intention to treat their malignancy or other ailment </= 28 days from Day 1 dosing on study treatment
- History of seizure disorders or unstable CNS metastases
- Severe and/or uncontrolled medical conditions or other conditions that could affect the participation in the study
- Pregnant or breastfeeding women
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 |
|---|---|---|
| RO5045337Multiple escalating oral doses, Days 1-5 (1-3) of each 28-day cycle, up to 6 cycles | Drug | Single Arm |
| doxorubicin60 mg/m2 (75 mg/m2, 50 mg/m2) iv on Day 1 of each 28-day cycle, up to 6 cycles | Drug | Single Arm |
Primary outcome
Maximum tolerated dose/dose-limiting toxicities
Time frame: approximately 12 months
Safety: Incidence of adverse events
Time frame: approximately 12 months
2 secondary outcomes
Pharmacokinetics of RO5045337 and doxorubicin in combination therapy: Area under the concentration-time curve (AUC)
Time frame: Pre-dose and up to 72 hours post-dose Days 1 and 5 of Cycle 1
Pharmacodynamics: Serum macrophage inhibitory cytokine-1 (MIC-1) levels
Time frame: Pre-dose and up to 72 hours post-dose on Days 1 and 5 of Cycle 1
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
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RO5045337 and doxorubicin in people with Sarcoma, run by Hoffmann-La Roche at 9 sites in 2 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 8 inclusion and 8 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 9 sites in United States, 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?
Maximum tolerated dose/dose-limiting toxicities (time frame: approximately 12 months). 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 2 Nov 2016.