LymphomaPhase 2NCT01244009
A Study of MK-4827 for the Treatment of Mantle Cell Lymphoma (MK-4827-002)
A Phase 2 study testing MK-4827 in people with Lymphoma and Mantle-Cell, run by Tesaro, Inc..
Trial summary
This study will investigate the efficacy and safety of MK-4827 in participants with relapsed mantle cell lymphoma (MCL) and in a subset of participants with inactivation of the Ataxia-Telangiectasia Mutated (ATM) gene. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Mantle-Cell
- What is being tested?
- MK-4827
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2010to Aug 2013
- Phase
- Phase 2
- 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
- Participant must have a diagnosis of MCL that has relapsed after at least one prior chemotherapy regimen or for which the participant has refused standard therapy
- Participant has measureable disease defined by lymphadenopathy, organomegaly, bone marrow involvement and/or circulating lymphoma cells. At least one lesion must be > 2 cm in the longest diameter and measurable in 2 perpendicular dimensions
- Participant has a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
- Female participants of child-bearing potential agree to use two approved contraceptive methods or remain abstinent throughout the study
- Male participants agree to use an adequate method of contraception throughout the study
- Participant has no history of prior cancer except certain cervical, skin, or prostate cancers, or has undergone potentially curative therapy with no recurrence for five years, or is deemed at low risk for recurrence
- Participant has not had any platelet or red blood cell transfusions or colony stimulating factor support during the month prior to treatment
- Participant has a pre-study diagnostic formalin fixed paraffin-embedded tumor tissue sample available
Who cannot join
- Participant has had chemotherapy, radiotherapy, or biological therapy within 4 weeks of screening
- Participant has a history of central nervous system (CNS) lymphoma
- Participant requires the use of corticosteroids
- Participant is pregnant, breastfeeding, or expecting to conceive or father children during the study
- Participant is known to be human immunodeficiency virus (HIV)-positive
- Participant has a history of Hepatitis B or C
About this study
Official title: A Phase II Efficacy Study of MK-4827 in Patients With Mantle Cell Lymphoma
This study will investigate the efficacy and safety of MK-4827 in participants with relapsed mantle cell lymphoma (MCL) and in a subset of participants with inactivation of the Ataxia-Telangiectasia Mutated (ATM) gene.
- Conditions
- Lymphoma, Mantle-Cell
- Being tested
- MK-4827
- Keywords
- Poly (ADP-ribose) polymerase (PARP) inhibitor
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-4827Drug
MK-4827 will be administered daily as an oral formulation in continuous 21-day cycles.
| Study group | Role | What they receive |
|---|---|---|
| MK-4827 | Experimental | All Participants Receives: Drug: MK-4827 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who have a complete response (CR) or partial response (PR) during the study
Measured: Tumor assessments will be performed every 9 weeks for the first year the participant is on treatment, every 12 weeks in year 2, and every 6 months in year 3 and beyond
Secondary outcomes (2)
Number of Participants with adverse events
Measured: From the day of enrollment through 30 days after the last dose of study drug
Time from allocation to disease progression or death from any cause (Progression-free survival)
Measured: Tumor assessments will be performed every 9 weeks for the first year the participant is on treatment, every 12 weeks in year 2, and every 6 months in year 3 and beyond
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2010 (estimated)
- Study startDec 2010
- Primary completionAug 2013 (estimated)
- Study completionAug 2013 (estimated)
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tesaro, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01244009
- Sponsor's protocol ID
- MK-4827-002
- Status last verified
- Nov 2016
- First submitted
- 17 Nov 2010
- Last updated
- 7 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Efficacy Study of MK-4827 in Patients With Mantle Cell Lymphoma
- ClinicalTrials.gov ID
- NCT01244009
- Acronym / sponsor ID
- MK-4827-002
- Conditions
- Lymphoma, Mantle-Cell
- Keywords
- Poly (ADP-ribose) polymerase (PARP) inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tesaro, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 19 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.
This study will investigate the efficacy and safety of MK-4827 in participants with relapsed mantle cell lymphoma (MCL) and in a subset of participants with inactivation of the Ataxia-Telangiectasia Mutated (ATM) gene.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MK-4827 | Experimental | Drug: MK-4827All Participants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participant must have a diagnosis of MCL that has relapsed after at least one prior chemotherapy regimen or for which the participant has refused standard therapy
- Participant has measureable disease defined by lymphadenopathy, organomegaly, bone marrow involvement and/or circulating lymphoma cells. At least one lesion must be > 2 cm in the longest diameter and measurable in 2 perpendicular dimensions
- Participant has a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
- Female participants of child-bearing potential agree to use two approved contraceptive methods or remain abstinent throughout the study
- Male participants agree to use an adequate method of contraception throughout the study
Key exclusion criteria (6 listed)
- Participant has had chemotherapy, radiotherapy, or biological therapy within 4 weeks of screening
- Participant has a history of central nervous system (CNS) lymphoma
- Participant requires the use of corticosteroids
- Participant is pregnant, breastfeeding, or expecting to conceive or father children during the study
- Participant is known to be human immunodeficiency virus (HIV)-positive
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 |
|---|---|---|
| MK-4827MK-4827 will be administered daily as an oral formulation in continuous 21-day cycles. | Drug | MK-4827 |
Primary outcome
Number of participants who have a complete response (CR) or partial response (PR) during the study
Time frame: Tumor assessments will be performed every 9 weeks for the first year the participant is on treatment, every 12 weeks in year 2, and every 6 months in year 3 and beyond
2 secondary outcomes
Number of Participants with adverse events
Time frame: From the day of enrollment through 30 days after the last dose of study drug
Time from allocation to disease progression or death from any cause (Progression-free survival)
Time frame: Tumor assessments will be performed every 9 weeks for the first year the participant is on treatment, every 12 weeks in year 2, and every 6 months in year 3 and beyond
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 7 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MK-4827 in people with Lymphoma and Mantle-Cell, run by Tesaro, 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 8 inclusion and 6 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 7 Nov 2016. 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 phase mean?
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?
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?
Number of participants who have a complete response (CR) or partial response (PR) during the study (time frame: Tumor assessments will be performed every 9 weeks for the first year the participant is on treatment, every 12 weeks in year 2, and every 6 months in year 3 and beyond). 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 7 Nov 2016.