Waldenstrom's MacroglobulinemiaPhase 1/2NCT02363439
Extension Study of IMO-8400 in Patients With Waldenström's Macroglobulinemia Who Completed Study 8400-401
A Phase 1/2 study testing IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg twice weekly in people with Waldenstrom's Macroglobulinemia, run by Idera Pharmaceuticals, Inc..
Trial summary
An extension study for patients who complete 24 weeks of IMO-8400 on study 8400-401. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Waldenstrom's Macroglobulinemia
- What is being tested?
- IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg twice weekly
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Dec 2016
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Completed 24 weeks of treatment in Protocol 8400-401
Who cannot join
- Grade 3 (or higher) adverse event assessed as treatment-related at any time during the course of treatment under Protocol 8400-401.
- Has evidence of disease progression under Protocol 8400-401.
- Has received other anti-cancer therapies other than IMO-8400 since enrolling in Protocol 8400-401.
About this study
Official title: An Extension Study to Evaluate the Long-Term Safety, Tolerability, and Clinical Activity of IMO-8400 in Patients With Relapsed or Refractory Waldenström's Macroglobulinemia Who Completed Study 8400-401
An extension study for patients who complete 24 weeks of IMO-8400 on study 8400-401.
Read the detailed description
Patients who had no evidence of disease progression or toxicity while participating in study 8400-401 (NCT02092909) will continue to receive IMO-8400 until disease progression, adverse event or the investigator deems the goals of extended treatment with IMO-8400 have been met.
- Conditions
- Waldenstrom's Macroglobulinemia
- Being tested
- IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg twice weekly
- Medical subject headings
- Waldenstrom Macroglobulinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg twice weeklyDrug
IMO-8400 at 0.6 mg/kg/wk or 1.2 mg/kg twice weekly as defined per Protocol 8400-401
| Study group | Role | What they receive |
|---|---|---|
| IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg 2xwk | Experimental | Subcutaneous injection of IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg twice weekly per Protocol 8400-401 Receives: Drug: IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg twice weekly |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
Long term safety and tolerability of IMO-8400 in patients with Waldenstrom's Macroglobulinemia
Measured: During receipt of study treatment on the trial.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2015 (estimated)
- Study startNov 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Waldenstrom's MacroglobulinemiaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Idera Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Cornfeld, MD, MPH, Study director, Idera Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02363439
- Sponsor's protocol ID
- 8400-404
- Status last verified
- Dec 2017
- First submitted
- 19 Nov 2014
- Last updated
- 9 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Extension Study to Evaluate the Long-Term Safety, Tolerability, and Clinical Activity of IMO-8400 in Patients With Relapsed or Refractory Waldenström's Macroglobulinemia Who Completed Study 8400-401
- ClinicalTrials.gov ID
- NCT02363439
- Acronym / sponsor ID
- 8400-404
- Conditions
- Waldenstrom's Macroglobulinemia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Idera Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 16 Feb 2015 (estimated)
- Results
- Posted 13 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An extension study for patients who complete 24 weeks of IMO-8400 on study 8400-401.
Detailed description
Patients who had no evidence of disease progression or toxicity while participating in study 8400-401 (NCT02092909) will continue to receive IMO-8400 until disease progression, adverse event or the investigator deems the goals of extended treatment with IMO-8400 have been met.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg 2xwk | Experimental | Drug: IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg twice weeklySubcutaneous injection of IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg twice weekly per Protocol 8400-401 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Completed 24 weeks of treatment in Protocol 8400-401
Key exclusion criteria (3 listed)
- Grade 3 (or higher) adverse event assessed as treatment-related at any time during the course of treatment under Protocol 8400-401.
- Has evidence of disease progression under Protocol 8400-401.
- Has received other anti-cancer therapies other than IMO-8400 since enrolling in Protocol 8400-401.
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 |
|---|---|---|
| IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg twice weeklyIMO-8400 at 0.6 mg/kg/wk or 1.2 mg/kg twice weekly as defined per Protocol 8400-401 | Drug | IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg 2xwk |
Primary outcome
Number of Participants With Adverse Events
Time frame: During receipt of study treatment on the trial.
Long term safety and tolerability of IMO-8400 in patients with Waldenstrom's Macroglobulinemia
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Mark Cornfeld, MD, MPH study director
Idera Pharmaceuticals, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg twice weekly in people with Waldenstrom's Macroglobulinemia, run by Idera Pharmaceuticals, Inc..
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 1 inclusion and 3 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 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Adverse Events (time frame: During receipt of study treatment on the trial.). 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 Jan 2018.