Myelodysplastic SyndromesPhase 1NCT00916227
A Study of ARRY-614 in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndrome
A Phase 1 study testing ARRY-614, p38/Tie2 inhibitor; oral in people with Myelodysplastic Syndromes, run by Array Biopharma, now a wholly owned subsidiary of Pfizer at 3 sites in United States.
Trial summary
This is a Phase 1 study during which patients with low or intermediate-1 risk myelodysplastic syndrome (MDS) will receive investigational study drug ARRY-614. This study has 2 parts. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndromes
- What is being tested?
- ARRY-614, p38/Tie2 inhibitor; oral
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2009to Jan 2012
- 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
- Diagnosis of MDS by bone marrow biopsy.
- International Prognostic Scoring System (IPSS) score of low or intermediate-1 risk MDS.
- May have received prior therapy for MDS.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) between 0 and 2.
- Adequate liver and renal function.
- Additional criteria exist.
Who cannot join
- History of bone marrow transplant.
- Concomitant malignancies or previous malignancies with less than a 2-year disease-free interval at the time of enrollment.
- Treatment with an investigational medicinal product that is not expected to be cleared by the first dose of study drug or that has demonstrated to have late side effects.
- Known positive serology for the human immunodeficiency virus (HIV), hepatitis C and/or active hepatitis B.
- Additional criteria exist.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Winship Cancer Institute
Atlanta, Georgia, 30322
MD Anderson Cancer Center
Houston, Texas, 77030
Moffitt Cancer Center
Tampa, Florida, 33612
About this study
This is a Phase 1 study during which patients with low or intermediate-1 risk myelodysplastic syndrome (MDS) will receive investigational study drug ARRY-614.
This study has 2 parts. In the first part, patients will receive increasing doses of study drug, given either with food or without food, in order to achieve the highest dose of the study drug possible that will not cause unacceptable side effects. Approximately 60 patients from the US will be enrolled in Part 1 (Completed).
In the second part of this study, patients will receive the best dose of study drug, given either with food or without food, determined from the first part of the study and will be followed to see what side effects and effectiveness the study drug has, if any, in treating the cancer. Approximately 40 patients from the US will be enrolled in Part 2 (Completed).
- Conditions
- Myelodysplastic Syndromes
- Being tested
- ARRY-614, p38/Tie2 inhibitor; oral
- Keywords
- Low or Intermediate-1 Risk Myelodysplastic Syndrome
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARRY-614, p38/Tie2 inhibitor; oralDrug
Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule.
| Study group | Role | What they receive |
|---|---|---|
| ARRY-614 | Experimental | Not described Receives: Drug: ARRY-614, p38/Tie2 inhibitor; oral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize the safety profile of the study drug, in either the fasted or fed state, in terms of adverse events, clinical laboratory tests and electrocardiograms.
Measured: Part 1, one year; Part 2, one year
Establish the maximum tolerated dose (MTD) of the study drug.
Measured: Part 1, one year
Characterize the pharmacokinetics of the study drug and a metabolite under either fasted or fed conditions.
Measured: Part 1, one year; Part 2, one year
Secondary outcomes (1)
Assess the efficacy of study drug in terms of response, duration of response and hematologic improvement.
Measured: Part 1, one year; Part 2, one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromesStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Array Biopharma, now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00916227
- Sponsor's protocol ID
- ARRAY-614-111
- Status last verified
- Sep 2020
- First submitted
- 3 Jun 2009
- Last updated
- 9 Sep 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of ARRY-614 in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndrome
- ClinicalTrials.gov ID
- NCT00916227
- Acronym / sponsor ID
- ARRAY-614-111
- Conditions
- Myelodysplastic Syndromes
- Keywords
- Low or Intermediate-1 Risk Myelodysplastic Syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Array Biopharma, now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Jan 2012 (actual)
- First posted
- 9 Jun 2009 (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 is a Phase 1 study during which patients with low or intermediate-1 risk myelodysplastic syndrome (MDS) will receive investigational study drug ARRY-614.
This study has 2 parts. In the first part, patients will receive increasing doses of study drug, given either with food or without food, in order to achieve the highest dose of the study drug possible that will not cause unacceptable side effects. Approximately 60 patients from the US will be enrolled in Part 1 (Completed).
In the second part of this study, patients will receive the best dose of study drug, given either with food or without food, determined from the first part of the study and will be followed to see what side effects and effectiveness the study drug has, if any, in treating the cancer. Approximately 40 patients from the US will be enrolled in Part 2 (Completed).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARRY-614 | Experimental | Drug: ARRY-614, p38/Tie2 inhibitor; oral |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of MDS by bone marrow biopsy.
- International Prognostic Scoring System (IPSS) score of low or intermediate-1 risk MDS.
- May have received prior therapy for MDS.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) between 0 and 2.
- Adequate liver and renal function.
Key exclusion criteria (5 listed)
- History of bone marrow transplant.
- Concomitant malignancies or previous malignancies with less than a 2-year disease-free interval at the time of enrollment.
- Treatment with an investigational medicinal product that is not expected to be cleared by the first dose of study drug or that has demonstrated to have late side effects.
- Known positive serology for the human immunodeficiency virus (HIV), hepatitis C and/or active hepatitis B.
- Additional criteria exist.
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 |
|---|---|---|
| ARRY-614, p38/Tie2 inhibitor; oralPart 1: multiple dose, escalating; Part 2: multiple dose, single schedule. | Drug | ARRY-614 |
Primary outcome
Characterize the safety profile of the study drug, in either the fasted or fed state, in terms of adverse events, clinical laboratory tests and electrocardiograms.
Time frame: Part 1, one year; Part 2, one year
Establish the maximum tolerated dose (MTD) of the study drug.
Time frame: Part 1, one year
Characterize the pharmacokinetics of the study drug and a metabolite under either fasted or fed conditions.
Time frame: Part 1, one year; Part 2, one year
1 secondary outcome
Assess the efficacy of study drug in terms of response, duration of response and hematologic improvement.
Time frame: Part 1, one year; Part 2, one year
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 9 Sep 2020.
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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.
Pfizer CT.gov Call Center study director
Pfizer
3 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 ARRY-614, p38/Tie2 inhibitor; oral in people with Myelodysplastic Syndromes, run by Array Biopharma, now a wholly owned subsidiary of Pfizer at 3 sites in United States.
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 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 9 Sep 2020. 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 United States. 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?
Characterize the safety profile of the study drug, in either the fasted or fed state, in terms of adverse events, clinical laboratory tests and electrocardiograms. (time frame: Part 1, one year; Part 2, one year). The study lists 3 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 9 Sep 2020.