LymphomaPhase 2NCT01485536
A Study of the HSP90 Inhibitor AUY922
A Phase 2 study testing AUY922 in people with Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if AUY922 can help to control refractory or recurrent lymphoma. The safety of AUY922 will also be studied. AUY922 is designed to block tumor growth by blocking a protein. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- AUY922
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Nov 2015
- Phase
- Phase 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
- Age >/= 18 years
- Able to sign Informed Consent
- Patients must have the following laboratory values: Hematologic: Absolute Neutrophil Count (ANC) >/=1.5x10^9/L; Hemoglobin (Hgb) >/=9 g/dl; Platelets (plt) >/=50 x10^9/L. Biochemistry: Potassium within normal limits; Total calcium (corrected for serum albumin) and Phosphorus within normal limits o Magnesium above LLN or correctable with supplements; Liver and Kidney Functions: aspartate aminotransferase (AST)/serum glutamate oxaloacetate transaminase (SGOT) and ALT/serum glutamate pyruvate transaminase (SGPT) </=1.5 x Upper Limit of Normal (ULN) if Alkaline Phosphate (AP) > 2.5 ULN AST/SGOT and ALT/SGPT </=2.5 x Upper Limit of Normal (ULN) if Alkaline Phosphate (AP) </=5.0 x ULN if liver metastases are present; Serum bilirubin </= 1.5 x ULN; Serum creatinine </=1.5 x ULN or 24-hour clearance >/= 50 ml/min.
- Negative serum pregnancy test. The serum pregnancy test must be obtained prior to the first administration of AUY922 (</= 72 hours prior to dosing) in all pre-menopausal women and women <2 years after the onset of menopause
- Histologically confirmed Diffuse Large B-cell Lymphoma (DLBCL), (primary mediastinal DLBCL, DLBCL-NOS, large B-cell transformation of indolent B-cell lymphoma including follicular lymphoma, small lymphocytic lymphoma and marginal zone lymphoma) or Peripheral T-cell Lymphoma (PTCL), including PTCL not otherwise specified, angioimmunoblastic lymphoma, anaplastic large T-cell lymphoma, hepatosplenic T-cell lymphoma, enteropathy associated T-cell lymphoma; nodal or extranodal NK/T-cell lymphoma, mycosis fungoides with radiographically measurable disease.
- Relapsed or refractory after standard treatments and with no curative option with conventional therapy.
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- Measurable disease.
- No known evidence of cerebral or meningeal involvement by lymphoma.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
Who cannot join
- Diarrhea > CTCAE (v4.02) grade 1 that cannot be controlled with oral anti-diarrhea medications.
- Pregnant or lactating women.
- Fertile women of childbearing potential (WCBP), a female that has not been surgically sterilized or that has not been amenorrheic for at least 24 consecutive months, not using double-barrier methods of contraception (abstinence, oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly, or surgically sterile). Male patients whose partners are WCBP not using double-barrier methods of contraception.
- Impaired cardiac function, including any one of the following: History (or family history) of long QT syndrome; Mean QTc >/= 450 msec on baseline ECG; History of clinically manifested ischemic heart disease </= 6 months prior to study start; History of heart failure or left ventricular (LV) dysfunction (LVEF </=45%) by multigated radionuclide angiography (MUGA) or ECHO; Clinically significant ECG abnormalities including 1 or more of the following: left bundle branch block (LBBB), right bundle branch block (RBBB) with left anterior hemiblock (LAHB). ST segment elevation or depression > 1mm, or 2nd (Mobitz II), or 3rd degree AV block.
- Continuation #4) History or presence of atrial fibrillation, atrial flutter or ventricular arrhythmias including ventricular tachycardia or Torsades de Pointes; Other clinically significant heart disease (e.g. congestive heart failure, uncontrolled hypertension (2 consecutive reading >140/90), history of labile hypertension, or history of poor compliance with an antihypertensive regimen); Clinically significant resting bradycardia (< 50 beats per minute); Patients who are currently receiving treatment with any medication which has a relative risk of prolonging the QTcF interval or inducing Torsades de Pointes and cannot be switched or discontinued to an alternative drug prior to commencing AUY922;
- Obligate use of a cardiac pacemaker.
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- All lymphomas except for Diffuse Large B-cell Lymphoma (DLBCL) and Peripheral T-cell Lymphoma (PTCL).
- Chemotherapy or radiation therapy or other investigational agents within 3 weeks prior to entering the study.
- Previous radioimmunotherapy within 12 weeks.
- Patient with known HIV infection.
- Known active viral hepatitis.
- Any serious active disease or co-morbid condition, which in the opinion of the principle investigator, will interfere with the safety or with compliance with the study.
- Serious nonmalignant disease (e.g., congestive heart failure, hydronephrosis); active uncontrolled bacterial, viral, or fungal infections; or other conditions which would compromise protocol objectives in the opinion of the investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Phase II Study of the HSP90 Inhibitor AUY922 in Patients With Relapsed and Refractory Lymphoma
The goal of this clinical research study is to learn if AUY922 can help to control refractory or recurrent lymphoma. The safety of AUY922 will also be studied.
AUY922 is designed to block tumor growth by blocking a protein.
Read the detailed description
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive AUY922 by vein over about 1 hour on Days 1, 8, 15, and 22 of each 28-day cycle.
Study Visits:
On Days 1 and 15 of Cycles 1-12:
- You will have a physical exam, including measurement of your vital signs (blood pressure, heart rate, temperature, and breathing rate).
- Your performance status will be recorded.
- You will be asked about any drugs you may be taking and any side effects you may have had.
- Blood (about 6-7 teaspoons) will be drawn for routine tests. On Day 1 of Cycle 1, this blood will also be used to check your heart function.
- You will have ECGs before and after the study drug infusion.
On Day 8 of Cycles 1-12:
- Your vital signs will be measured.
- You will be asked about any drugs you may be taking and any side effects you may have had.
- Blood (about 6-7 teaspoons) will be drawn for routine tests and to check your heart function.
- You will have ECGs before and after the study drug infusion.
On Day 1 of Cycles 1 and 2:
- Urine will be collected for routine tests.
- Blood (about 1 teaspoon) will be drawn to check your blood clotting function.
On Days 2 and 3 of Cycle 1:
- Blood (about 5-6 teaspoons) will be drawn for routine tests.
- You will have ECGs at about 24 and 48 hours after the end of the infusion.
- You will be asked about any drugs you may be taking, any side effects you may be having, and about your overall health.
On Day 22 of Cycle 1:
- You will have a physical exam, including measurement of your vital signs.
- Your performance status will be recorded.
- You will be asked about any drugs you may be taking, any side effects you may be having, and about your overall health.
- Blood (about 5-6 teaspoons) will be drawn for routine tests.
After every 2 cycles:
- You will have CT and PET scans to check the status of the disease.
- You will be asked about any side effects you may be having and about your overall health.
Anytime the study doctor thinks it is needed, you will have an eye exam or other tests.
Length of Study:
You may continue taking AUY922 for up to 12 cycles. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
End-of-Treatment Visit:
At 28 days after your last dose:
- Blood (about 5-6 teaspoons) and urine will be collected for routine tests.
- Blood (about 1 teaspoon) will be drawn to check your blood clotting function.
- You will have a physical exam, including measurement of your vital signs.
- Your performance status will be recorded.
- You will have an eye exam by an eye doctor.
- You will have CT and PET scans to check the status of the disease.
- You will be asked about any drugs you may be taking, any side effects you may be having, and about your overall health.
Long-Term Follow-Up:
After you stop the study drug, you will have a CT scan and physical exam every 3 months for 1 year, then every 4 months for another year, and every 6 months for 3 years and then 1 time a year after that.
This is an investigational study. AUY922 is not FDA approved or commercially available. It is currently being used for research purposes only.
Up to 42 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Lymphoma
- Being tested
- AUY922
- Keywords
- Lymphoma, Relapsed/refractory lymphoma, AUY922
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AUY922Drug
Starting Dose: 70 mg/m2 by vein on days 1, 8, 15, and 22 days of a 28 day cycle.
| Study group | Role | What they receive |
|---|---|---|
| AUY922 | Experimental | AUY922 starting dose 70 mg/m2 intravenous on Days 1, 8, 15, and 22 of 28 day cycle. Receives: Drug: AUY922 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response in Participants With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL) and Peripheral T-cell Lymphoma (PTCL)
Objective Response defined as Complete (CR) and Partial (PR) Response. Computed tomography (CT) and Positron emission tomography (PET) scans done after every 2 cycles to assess efficacy using Cheson Criteria (2007) which lists CR as disappearance of all evidence of disease, and PR as regression of measurable disease and no new sites.
Measured: 56 days
Overall Response Rate (ORR)
Percentage of participants with objective response defined as Complete (CR) and Partial (PR) Response. Computed tomography (CT) and Positron emission tomography (PET) scans done after every 2 cycles to assess efficacy using Cheson Criteria (2007) which lists CR as disappearance of all evidence of disease, and PR as regression of measurable disease and no new sites.
Measured: Up to 12 cycles or 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2011 (estimated)
- Study startAug 2012
- Primary completionNov 2015
- Study completionNov 2015
Why it stopped: Study halted early due to limited response.
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 LymphomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- Yasuhiro Oki, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01485536
- Sponsor's protocol ID
- 2011-0467
- Other IDs
- NCI-2012-00070
- Status last verified
- Dec 2015
- First submitted
- 29 Nov 2011
- Last updated
- 23 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of the HSP90 Inhibitor AUY922 in Patients With Relapsed and Refractory Lymphoma
- ClinicalTrials.gov ID
- NCT01485536
- Acronym / sponsor ID
- 2011-0467
- Conditions
- Lymphoma
- Keywords
- Lymphoma, Relapsed/refractory lymphoma, AUY922
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study halted early due to limited response.
- Enrolment
- 21 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Aug 2012
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 5 Dec 2011 (estimated)
- Results
- Posted 23 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn if AUY922 can help to control refractory or recurrent lymphoma. The safety of AUY922 will also be studied.
AUY922 is designed to block tumor growth by blocking a protein.
Detailed description
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive AUY922 by vein over about 1 hour on Days 1, 8, 15, and 22 of each 28-day cycle.
Study Visits:
On Days 1 and 15 of Cycles 1-12:
- You will have a physical exam, including measurement of your vital signs (blood pressure, heart rate, temperature, and breathing rate).
- Your performance status will be recorded.
- You will be asked about any drugs you may be taking and any side effects you may have had.
- Blood (about 6-7 teaspoons) will be drawn for routine tests. On Day 1 of Cycle 1, this blood will also be used to check your heart function.
- You will have ECGs before and after the study drug infusion.
On Day 8 of Cycles 1-12:
- Your vital signs will be measured.
- You will be asked about any drugs you may be taking and any side effects you may have had.
- Blood (about 6-7 teaspoons) will be drawn for routine tests and to check your heart function.
- You will have ECGs before and after the study drug infusion.
On Day 1 of Cycles 1 and 2:
- Urine will be collected for routine tests.
- Blood (about 1 teaspoon) will be drawn to check your blood clotting function.
On Days 2 and 3 of Cycle 1:
- Blood (about 5-6 teaspoons) will be drawn for routine tests.
- You will have ECGs at about 24 and 48 hours after the end of the infusion.
- You will be asked about any drugs you may be taking, any side effects you may be having, and about your overall health.
On Day 22 of Cycle 1:
- You will have a physical exam, including measurement of your vital signs.
- Your performance status will be recorded.
- You will be asked about any drugs you may be taking, any side effects you may be having, and about your overall health.
- Blood (about 5-6 teaspoons) will be drawn for routine tests.
After every 2 cycles:
- You will have CT and PET scans to check the status of the disease.
- You will be asked about any side effects you may be having and about your overall health.
Anytime the study doctor thinks it is needed, you will have an eye exam or other tests.
Length of Study:
You may continue taking AUY922 for up to 12 cycles. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
End-of-Treatment Visit:
At 28 days after your last dose:
- Blood (about 5-6 teaspoons) and urine will be collected for routine tests.
- Blood (about 1 teaspoon) will be drawn to check your blood clotting function.
- You will have a physical exam, including measurement of your vital signs.
- Your performance status will be recorded.
- You will have an eye exam by an eye doctor.
- You will have CT and PET scans to check the status of the disease.
- You will be asked about any drugs you may be taking, any side effects you may be having, and about your overall health.
Long-Term Follow-Up:
After you stop the study drug, you will have a CT scan and physical exam every 3 months for 1 year, then every 4 months for another year, and every 6 months for 3 years and then 1 time a year after that.
This is an investigational study. AUY922 is not FDA approved or commercially available. It is currently being used for research purposes only.
Up to 42 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AUY922 | Experimental | Drug: AUY922AUY922 starting dose 70 mg/m2 intravenous on Days 1, 8, 15, and 22 of 28 day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age >/= 18 years
- Able to sign Informed Consent
- Patients must have the following laboratory values: Hematologic: Absolute Neutrophil Count (ANC) >/=1.5x10^9/L; Hemoglobin (Hgb) >/=9 g/dl; Platelets (plt) >/=50 x10^9/L. Biochemistry: Potassium within normal limits; Total calcium (corrected for serum albumin) and Phosphorus within normal limits o Magnesium above LLN or correctable with supplements; Liver and Kidney Functions: aspartate aminotransferase (AST)/serum glutamate oxaloacetate transaminase (SGOT) and ALT/serum glutamate pyruvate transaminase (SGPT) </=1.5 x Upper Limit of Normal (ULN) if Alkaline Phosphate (AP) > 2.5 ULN AST/SGOT and ALT/SGPT </=2.5 x Upper Limit of Normal (ULN) if Alkaline Phosphate (AP) </=5.0 x ULN if liver metastases are present; Serum bilirubin </= 1.5 x ULN; Serum creatinine </=1.5 x ULN or 24-hour clearance >/= 50 ml/min.
- Negative serum pregnancy test. The serum pregnancy test must be obtained prior to the first administration of AUY922 (</= 72 hours prior to dosing) in all pre-menopausal women and women <2 years after the onset of menopause
- Histologically confirmed Diffuse Large B-cell Lymphoma (DLBCL), (primary mediastinal DLBCL, DLBCL-NOS, large B-cell transformation of indolent B-cell lymphoma including follicular lymphoma, small lymphocytic lymphoma and marginal zone lymphoma) or Peripheral T-cell Lymphoma (PTCL), including PTCL not otherwise specified, angioimmunoblastic lymphoma, anaplastic large T-cell lymphoma, hepatosplenic T-cell lymphoma, enteropathy associated T-cell lymphoma; nodal or extranodal NK/T-cell lymphoma, mycosis fungoides with radiographically measurable disease.
Key exclusion criteria (13 listed)
- Diarrhea > CTCAE (v4.02) grade 1 that cannot be controlled with oral anti-diarrhea medications.
- Pregnant or lactating women.
- Fertile women of childbearing potential (WCBP), a female that has not been surgically sterilized or that has not been amenorrheic for at least 24 consecutive months, not using double-barrier methods of contraception (abstinence, oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly, or surgically sterile). Male patients whose partners are WCBP not using double-barrier methods of contraception.
- Impaired cardiac function, including any one of the following: History (or family history) of long QT syndrome; Mean QTc >/= 450 msec on baseline ECG; History of clinically manifested ischemic heart disease </= 6 months prior to study start; History of heart failure or left ventricular (LV) dysfunction (LVEF </=45%) by multigated radionuclide angiography (MUGA) or ECHO; Clinically significant ECG abnormalities including 1 or more of the following: left bundle branch block (LBBB), right bundle branch block (RBBB) with left anterior hemiblock (LAHB). ST segment elevation or depression > 1mm, or 2nd (Mobitz II), or 3rd degree AV block.
- Continuation #4) History or presence of atrial fibrillation, atrial flutter or ventricular arrhythmias including ventricular tachycardia or Torsades de Pointes; Other clinically significant heart disease (e.g. congestive heart failure, uncontrolled hypertension (2 consecutive reading >140/90), history of labile hypertension, or history of poor compliance with an antihypertensive regimen); Clinically significant resting bradycardia (< 50 beats per minute); Patients who are currently receiving treatment with any medication which has a relative risk of prolonging the QTcF interval or inducing Torsades de Pointes and cannot be switched or discontinued to an alternative drug prior to commencing AUY922;
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 |
|---|---|---|
| AUY922Starting Dose: 70 mg/m2 by vein on days 1, 8, 15, and 22 days of a 28 day cycle. | Drug | AUY922 |
Primary outcome
Objective Response in Participants With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL) and Peripheral T-cell Lymphoma (PTCL)
Time frame: 56 days
Objective Response defined as Complete (CR) and Partial (PR) Response. Computed tomography (CT) and Positron emission tomography (PET) scans done after every 2 cycles to assess efficacy using Cheson Criteria (2007) which lists CR as disappearance of all evidence of disease, and PR as regression of measurable disease and no new sites.
Overall Response Rate (ORR)
Time frame: Up to 12 cycles or 48 weeks
Percentage of participants with objective response defined as Complete (CR) and Partial (PR) Response. Computed tomography (CT) and Positron emission tomography (PET) scans done after every 2 cycles to assess efficacy using Cheson Criteria (2007) which lists CR as disappearance of all evidence of disease, and PR as regression of measurable disease and no new sites.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Yasuhiro Oki, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AUY922 in people with Lymphoma, run by M.D. Anderson Cancer Center 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 9 inclusion and 13 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: stopped early, as of the sponsor's last update on 23 Jan 2017. 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 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 23 Jan 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?
Objective Response in Participants With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL) and Peripheral T-cell Lymphoma (PTCL) (time frame: 56 days). 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 23 Jan 2017.