Relapsed/Refractory LeukemiasPhase 1NCT01239108
Study of SGI-1776, a PIM Kinase Inhibitor, in Subjects With Relapsed/Refractory Leukemias
A Phase 1 study testing SGI-1776 in people with Relapsed/Refractory Leukemias, run by Astex Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
Dose escalation study for subjects with Leukemia that has returned or has not responded to standard treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Relapsed/Refractory Leukemias
- What is being tested?
- SGI-1776
- Type of treatment
- Pill or oral medicine
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Apr 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women with a confirmed diagnosis of leukemia unresponsive to curative therapy
- Eastern Cooperative Oncology Group performance status of 0 to 2
- Total bilirubin ≤ 1.5 X upper limit of normal (ULN); aspartate transaminase (AST/SGOT) and alanine transaminase (ALT/SGPT) ≤ 3 X ULN; serum creatinine ≤ 2 X ULN
- Normal cardiac function with left ventricular ejection fraction ≥ 50% at screening
- No clinically significant abnormalities on screening electrocardiogram (ie, QTc interval must be < 470 msec for women and < 450 msec for men and no history of torsades de pointes)
- No reproductive potential or willing to use 2 methods of contraception during the study and for 30 days after the last dose
- Able to understand the purpose and risks of the study and provide informed consent and authorization to use protected health information
Who cannot join
- A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of oral SGI-1776, or put the study outcomes at undue risk
- Significant cardiovascular disease
- Malabsorption syndrome
- Symptomatic central nervous system metastases or lesions for which treatment is required
- Received prior radiation therapy within 4 weeks of first dose
- Grade ≥ 2 toxicity (other than alopecia) continuing from prior anticancer therapy including radiation
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- Treatment with any investigational drug within 3 weeks of the first dose
- Use of systemic corticosteroids (other than for premedications or intermittent doses such as those used for allergic reactions and control of asthma) or myelosuppressive chemotherapy within 2 weeks of the first dose treatment with nitrosoureas or mitomycin C within 3 weeks of the first dose of SGI 1776
- Uncontrolled active systemic infections
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Multicenter, Open-label, Dose-escalation Study of SGI-1776, a PIM Kinase Inhibitor, in Subjects With Relapsed/Refractory Leukemias
Dose escalation study for subjects with Leukemia that has returned or has not responded to standard treatment.
Read the detailed description
A Phase 1, Multicenter, Open-label, Dose-escalation Study of SGI-1776, a PIM Kinase Inhibitor, in Subjects with Relapsed/Refractory Leukemias
- Conditions
- Relapsed/Refractory Leukemias
- Being tested
- SGI-1776
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGI-1776Drug
SGI-1776 will be administered orally at escalating dose levels ranging from 350 to 1600 mg/day based on the dose escalation levels of the ongoing, first-in-human study.
What is being measured
The primary outcome is the main question the study is designed to answer.
The MTD as determined by the incidence of DLTs in the first 4 weeks of each dosing cohort
Measured: July 2011
Secondary outcomes (1)
• Frequency, severity, and relationship of adverse events (AEs) and serious adverse events (SAEs) •
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2010 (estimated)
- Study startOct 2010
- Primary completionApr 2012 (estimated)
- Study completionApr 2012 (estimated)
Why it stopped: The dose limiting toxicity of cardiac QTc prolongation was identified and demonstrated unsafe to continue clinical development of this molecule.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory LeukemiasStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astex Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01239108
- Sponsor's protocol ID
- SGI-1776-02
- Status last verified
- Aug 2024
- First submitted
- 5 Nov 2010
- Last updated
- 2 Aug 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multicenter, Open-label, Dose-escalation Study of SGI-1776, a PIM Kinase Inhibitor, in Subjects With Relapsed/Refractory Leukemias
- ClinicalTrials.gov ID
- NCT01239108
- Acronym / sponsor ID
- SGI-1776-02
- Conditions
- Relapsed/Refractory Leukemias
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The dose limiting toxicity of cardiac QTc prolongation was identified and demonstrated unsafe to continue clinical development of this molecule.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Astex Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Apr 2012 (estimated)
- Study completion
- Apr 2012 (estimated)
- First posted
- 11 Nov 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.
Dose escalation study for subjects with Leukemia that has returned or has not responded to standard treatment.
Detailed description
A Phase 1, Multicenter, Open-label, Dose-escalation Study of SGI-1776, a PIM Kinase Inhibitor, in Subjects with Relapsed/Refractory Leukemias
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men and women with a confirmed diagnosis of leukemia unresponsive to curative therapy
- Eastern Cooperative Oncology Group performance status of 0 to 2
- Total bilirubin ≤ 1.5 X upper limit of normal (ULN); aspartate transaminase (AST/SGOT) and alanine transaminase (ALT/SGPT) ≤ 3 X ULN; serum creatinine ≤ 2 X ULN
- Normal cardiac function with left ventricular ejection fraction ≥ 50% at screening
- No clinically significant abnormalities on screening electrocardiogram (ie, QTc interval must be < 470 msec for women and < 450 msec for men and no history of torsades de pointes)
Key exclusion criteria (9 listed)
- A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of oral SGI-1776, or put the study outcomes at undue risk
- Significant cardiovascular disease
- Malabsorption syndrome
- Symptomatic central nervous system metastases or lesions for which treatment is required
- Received prior radiation therapy within 4 weeks of first dose
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 |
|---|---|---|
| SGI-1776SGI-1776 will be administered orally at escalating dose levels ranging from 350 to 1600 mg/day based on the dose escalation levels of the ongoing, first-in-human study. | Drug | – |
Primary outcome
The MTD as determined by the incidence of DLTs in the first 4 weeks of each dosing cohort
Time frame: July 2011
1 secondary outcome
• Frequency, severity, and relationship of adverse events (AEs) and serious adverse events (SAEs) •
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SGI-1776 in people with Relapsed/Refractory Leukemias, run by Astex Pharmaceuticals, Inc. at 1 site 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 7 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: withdrawn, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was withdrawn before enrolling participants, so there are no results.
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?
The MTD as determined by the incidence of DLTs in the first 4 weeks of each dosing cohort (time frame: July 2011). 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 Aug 2024.