Myelogenous Leukemia, AcutePhase 1NCT01641250
A Study of RO5429083 Alone or in Combination With Cytarabine in Patients With Acute Myelogenous Leukemia
A Phase 1 study testing RO5429083 and cytarabine in people with Myelogenous Leukemia, Acute, run by Hoffmann-La Roche at 8 sites in 3 countries.
Trial summary
This multi-center, open-label study will evaluate the safety, pharmacokinetics, pharmacodynamics and efficacy of RO5429083 alone and in combination with cytarabine in patients with acute myelogenous leukemia. In Part A, patients will receive multiple escalating doses of RO5429083 intravenously. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelogenous Leukemia, Acute
- What is being tested?
- RO5429083 and cytarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 8 sitesin 3 countries
- Study dates
- Aug 2012to Feb 2015
- 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, acute myelogenous leukemia (all subtypes except acute promyelotic leukemia) according to WHO criteria
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- All non-hematological adverse events of any prior chemotherapy, surgery, or radiotherapy must have resolved to NCI-CTC AE Grade < 2, except alopecia
- Adequate hepatic and renal function
- Patient must be willing to submit blood and bone marrow samples for PK and PD analyses and exploratory biomarkers
Who cannot join
- Patients receiving any other investigational or commercial agents or therapies administered with the intention to treat their malignancy within 14 days of first receipt of study drug, with the exception of hydroxyurea
- History of allergic reactions attributed to components of cytarabine and/or the formulated product
- Current evidence of CNS leukemia
- Increased QTc interval (QTc > 470 ms), baseline resting bradycardia < 45 beats per minute, or baseline resting tachycardia < 100 beats per minute
- Family history of long QT syndrome or other risk factors for torsades de pointes, and/or the use of concomitant medications that prolong QT/QTc interval
- Uncontrollable intercurrent illness
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- Pregnant or breast-feeding women
- HIV-positive patients receiving anti-retroviral therapy
- Patients who refuse to potentially receive blood products and/or have a hypersensitivity to blood products
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
France4 sites
Study site
Marseille, 13273
Study site
Nantes, 44093
Study site
Paris, 75475
Study site
Toulouse, 31059
Germany3 sites
Study site
Aachen, 52074
Study site
Hamburg, 20246
Study site
Ulm, 89081
About this study
Official title: Open Label, Multicenter, Dose Escalation Phase 1a/b Study of RO5429083, Administered as Intravenous Infusion Alone or in Combination With Cytarabine in Patients With Acute Myelogenous Leukemia (AML).
This multi-center, open-label study will evaluate the safety, pharmacokinetics, pharmacodynamics and efficacy of RO5429083 alone and in combination with cytarabine in patients with acute myelogenous leukemia. In Part A, patients will receive multiple escalating doses of RO5429083 intravenously. In Part B, patients will receive RO5429083 plus up to 4 cycles of cytarabine (1000 mg/m2 iv daily for 5 consecutive days). Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
- Conditions
- Myelogenous Leukemia, Acute
- Being tested
- RO5429083, cytarabine
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO5429083Drug
Multiple escalating doses
cytarabineDrug
1000 mg/m2 iv daily for 5 consecutive days, up to 4 cycles
| Study group | Role | What they receive |
|---|---|---|
| Part A: RO5429083 | Experimental | Not described Receives: Drug: RO5429083 |
| Part B: RO5429083 + cytarabine | Experimental | Not described Receives: Drug: RO5429083; Drug: cytarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Incidence of adverse events (including maximum tolerated dose/optimal biological dose)
Measured: approximately 24 months
Secondary outcomes (4)
Clinical response according to hematologic malignancy assessments
Measured: approximately 24 months
Pharmacokinetics o RO5429083 alone and in combination with cytarabine: Area under the concentration-time curve (AUC)
Measured: Pre-dose and up to 96 hrs post-dose
Pharmacokinetics of cytarabine in combination with RO5429083: Area under the concentration-time curve (AUC)
Measured: Pre-dose and up to 24 hrs post-dose, Cycles 1 and 3
Pharmacodynamics: Biomarker levels in blood/bone marrow
Measured: Pre-dose and up to 96 hrs post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelogenous Leukemia, AcuteStudies 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
- 44 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
- NCT01641250
- Sponsor's protocol ID
- BP28085
- Other IDs
- 2012-001027-12
- Status last verified
- Nov 2016
- First submitted
- 12 Jul 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
- Open Label, Multicenter, Dose Escalation Phase 1a/b Study of RO5429083, Administered as Intravenous Infusion Alone or in Combination With Cytarabine in Patients With Acute Myelogenous Leukemia (AML).
- ClinicalTrials.gov ID
- NCT01641250
- Acronym / sponsor ID
- BP28085
- Conditions
- Myelogenous Leukemia, Acute
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 16 Jul 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 multi-center, open-label study will evaluate the safety, pharmacokinetics, pharmacodynamics and efficacy of RO5429083 alone and in combination with cytarabine in patients with acute myelogenous leukemia. In Part A, patients will receive multiple escalating doses of RO5429083 intravenously. In Part B, patients will receive RO5429083 plus up to 4 cycles of cytarabine (1000 mg/m2 iv daily for 5 consecutive days). Anticipated time on study treatment is 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 |
|---|---|---|
| Part A: RO5429083 | Experimental | Drug: RO5429083 |
| Part B: RO5429083 + cytarabine | Experimental | Drug: RO5429083, Drug: cytarabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patients, >/= 18 years of age
- Histologically or cytologically confirmed, acute myelogenous leukemia (all subtypes except acute promyelotic leukemia) according to WHO criteria
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- All non-hematological adverse events of any prior chemotherapy, surgery, or radiotherapy must have resolved to NCI-CTC AE Grade < 2, except alopecia
- Adequate hepatic and renal function
Key exclusion criteria (9 listed)
- Patients receiving any other investigational or commercial agents or therapies administered with the intention to treat their malignancy within 14 days of first receipt of study drug, with the exception of hydroxyurea
- History of allergic reactions attributed to components of cytarabine and/or the formulated product
- Current evidence of CNS leukemia
- Increased QTc interval (QTc > 470 ms), baseline resting bradycardia < 45 beats per minute, or baseline resting tachycardia < 100 beats per minute
- Family history of long QT syndrome or other risk factors for torsades de pointes, and/or the use of concomitant medications that prolong QT/QTc interval
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 |
|---|---|---|
| RO5429083Multiple escalating doses | Drug | Part A: RO5429083, Part B: RO5429083 + cytarabine |
| cytarabine1000 mg/m2 iv daily for 5 consecutive days, up to 4 cycles | Drug | Part B: RO5429083 + cytarabine |
Primary outcome
Safety: Incidence of adverse events (including maximum tolerated dose/optimal biological dose)
Time frame: approximately 24 months
4 secondary outcomes
Clinical response according to hematologic malignancy assessments
Time frame: approximately 24 months
Pharmacokinetics o RO5429083 alone and in combination with cytarabine: Area under the concentration-time curve (AUC)
Time frame: Pre-dose and up to 96 hrs post-dose
Pharmacokinetics of cytarabine in combination with RO5429083: Area under the concentration-time curve (AUC)
Time frame: Pre-dose and up to 24 hrs post-dose, Cycles 1 and 3
Pharmacodynamics: Biomarker levels in blood/bone marrow
Time frame: Pre-dose and up to 96 hrs post-dose
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
8 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 and cytarabine in people with Myelogenous Leukemia, Acute, run by Hoffmann-La Roche at 8 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 6 inclusion and 9 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 8 sites in France, Germany, Italy. 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?
Safety: Incidence of adverse events (including maximum tolerated dose/optimal biological dose) (time frame: approximately 24 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.