Myelogenous Leukemia, AcutePhase 1NCT01635296
A Study of RO5045337 in Combination With Cytarabine in Patients With Acute Myelogenous Leukemia
A Phase 1 study testing RO5045377 and cytarabine in people with Myelogenous Leukemia, Acute, run by Hoffmann-La Roche at 9 sites in 5 countries.
Trial summary
This multi-center, open-label, Phase 1b study will evaluate the safety, pharmacokinetics and efficacy of RO5045337 in combination with cytarabine in patients with acute myelogenous leukemia. 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?
- RO5045377 and cytarabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 9 sitesin 5 countries
- Study dates
- Jul 2012to Oct 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
- Patients with histologically or cytologically documented acute myelogenous leukemia appropriate for cytarabine therapy including:
- Arm A: Patients who have not received prior standard induction chemotherapy, considered unsuitable for standard induction therapy
- Arm B: Patients who have failed their 1st or greater line of standard induction chemotherapy (primary refractory) or patients who originally achieved a complete response but are currently in first or greater relapse
- 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
- Adequate hepatic and renal function
- Patient must be willing to submit the blood sampling and bone marrow sampling for PK and PD analyses and exploratory biomarkers
Who cannot join
- History of allergic or toxic reactions attributed to cytarabine or a history of allergic reactions to components of the formulated product
- Current evidence of CNS leukemia
- Any severe and/or uncontrolled medical condition or other conditions that could affect the participation in the study
- Pregnant or breastfeeding women
- HIV-positive patients receiving combination anti-retroviral therapy
Trial locations and contacts
9 sites in 5 countries.
9 sites in 5 countries
United States3 sites
Study site
Philadelphia, Pennsylvania, 19107
Study site
San Antonio, Texas, 78229
Study site
Valhalla, New York, 10595
Canada2 sites
Study site
Montreal, Quebec, H3T 1E2
Study site
Toronto, Ontario, M5G 2M9
United Kingdom2 sites
Study site
Glasgow, G12 0YN
Study site
Manchester, M204BX
About this study
Official title: A Multicenter, Open Label, Phase 1B Study of Escalating Doses of RO5045337 Administered Orally, With Cytarabine Administered A) Subcutaneously, or B) Intravenously, in Patients With Acute Myelogenous Leukemia (AML)
This multi-center, open-label, Phase 1b study will evaluate the safety, pharmacokinetics and efficacy of RO5045337 in combination with cytarabine in patients with acute myelogenous leukemia. In Arm A, cohorts of previously untreated patients deemed unsuitable for standard induction therapy will receive escalating oral doses of RO5045377 and cytarabine 20 mg/m2 subcutaneously daily for Days 1 to 10 of each 28-day cycle. In Arm B, cohorts of patients who have relapsed or are refractory after at least one cytarabine/anthracycline containing regimen will receive escalating oral doses of RO5045377 on Days 1 to 5 and cytarabine 1 gm/m2 intravenously on Days 1 to 6 of each 28-day cycle. Patients will receive up to 4 cycles of therapy, patients in Arm A who achieve hematologic response may continue additional cycles until disease progression.
- Conditions
- Myelogenous Leukemia, Acute
- Being tested
- RO5045377, 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.
RO5045377Drug
Multiple escalating oral doses, Days 1 to 10 of each 28-day cycle
RO5045377Drug
Multiple escalating oral doses, Days 1 to 5 of each 28-day cycle
cytarabineDrug
20 mg/m2 sc, Days 1 to 10 of each 28-day cycle
cytarabineDrug
1 gm/m2 iv, Days 1 to 6 of each 28-day cycle
| Study group | Role | What they receive |
|---|---|---|
| A: Previously untreated | Experimental | Not described Receives: Drug: RO5045377; Drug: cytarabine |
| B: Relapse/Refractory | Experimental | Not described Receives: Drug: RO5045377; Drug: cytarabine |
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 (3)
Efficacy: Hematologic response
Measured: approximately 1 year
Pharmacodynamics: Biomarkers (MIC-1, protein, nucleic acid, other) from bone marrow/buccal tissue/blood
Measured: Pre-dose (and up to 12 hours post-dose Day 1 and Day 10 or Day 5)
Pharmacokinetics: Cmax/area under the concentration-time curve
Measured: Pre-dose and up to 12 hours post-dose Day 1 and Day 10 or Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionOct 2013
- Study completionOct 2013
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
- 43 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
- NCT01635296
- Sponsor's protocol ID
- NP28023
- Other IDs
- 2011-006252-36
- Status last verified
- Nov 2016
- First submitted
- 12 Jun 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 Multicenter, Open Label, Phase 1B Study of Escalating Doses of RO5045337 Administered Orally, With Cytarabine Administered A) Subcutaneously, or B) Intravenously, in Patients With Acute Myelogenous Leukemia (AML)
- ClinicalTrials.gov ID
- NCT01635296
- Acronym / sponsor ID
- NP28023
- Conditions
- Myelogenous Leukemia, Acute
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 9 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, Phase 1b study will evaluate the safety, pharmacokinetics and efficacy of RO5045337 in combination with cytarabine in patients with acute myelogenous leukemia. In Arm A, cohorts of previously untreated patients deemed unsuitable for standard induction therapy will receive escalating oral doses of RO5045377 and cytarabine 20 mg/m2 subcutaneously daily for Days 1 to 10 of each 28-day cycle. In Arm B, cohorts of patients who have relapsed or are refractory after at least one cytarabine/anthracycline containing regimen will receive escalating oral doses of RO5045377 on Days 1 to 5 and cytarabine 1 gm/m2 intravenously on Days 1 to 6 of each 28-day cycle. Patients will receive up to 4 cycles of therapy, patients in Arm A who achieve hematologic response may continue additional cycles until disease progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: Previously untreated | Experimental | Drug: RO5045377, Drug: cytarabine |
| B: Relapse/Refractory | Experimental | Drug: RO5045377, Drug: cytarabine |
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
- Patients with histologically or cytologically documented acute myelogenous leukemia appropriate for cytarabine therapy including:
- Arm A: Patients who have not received prior standard induction chemotherapy, considered unsuitable for standard induction therapy
- Arm B: Patients who have failed their 1st or greater line of standard induction chemotherapy (primary refractory) or patients who originally achieved a complete response but are currently in first or greater relapse
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
Key exclusion criteria (5 listed)
- History of allergic or toxic reactions attributed to cytarabine or a history of allergic reactions to components of the formulated product
- Current evidence of CNS leukemia
- Any severe and/or uncontrolled medical condition or other conditions that could affect the participation in the study
- Pregnant or breastfeeding women
- HIV-positive patients receiving combination anti-retroviral therapy
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 |
|---|---|---|
| RO5045377Multiple escalating oral doses, Days 1 to 10 of each 28-day cycle | Drug | A: Previously untreated |
| RO5045377Multiple escalating oral doses, Days 1 to 5 of each 28-day cycle | Drug | B: Relapse/Refractory |
| cytarabine20 mg/m2 sc, Days 1 to 10 of each 28-day cycle | Drug | A: Previously untreated |
| cytarabine1 gm/m2 iv, Days 1 to 6 of each 28-day cycle | Drug | B: Relapse/Refractory |
Primary outcome
Maximum tolerated dose/dose-limiting toxicities
Time frame: approximately 12 months
Safety: Incidence of adverse events
Time frame: approximately 12 months
3 secondary outcomes
Efficacy: Hematologic response
Time frame: approximately 1 year
Pharmacodynamics: Biomarkers (MIC-1, protein, nucleic acid, other) from bone marrow/buccal tissue/blood
Time frame: Pre-dose (and up to 12 hours post-dose Day 1 and Day 10 or Day 5)
Pharmacokinetics: Cmax/area under the concentration-time curve
Time frame: Pre-dose and up to 12 hours post-dose Day 1 and Day 10 or Day 5
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 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RO5045377 and cytarabine in people with Myelogenous Leukemia, Acute, run by Hoffmann-La Roche at 9 sites in 5 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 5 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, Canada, United Kingdom, France, 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?
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.