Myelodysplastic Syndrome (MDS)Phase 1NCT00533416
Safety of ON 01910.Na in Patients With Myelodysplasia
A Phase 1 study testing ON 01910 Na in people with Myelodysplastic Syndrome (MDS), run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial summary
This study will determine the highest dose of the experimental drug ON 01910.Na that can safely be given to patients with the bone marrow disorder myelodysplasia (MDS) and patients with refractory AML with trisomy 8. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Myelodysplastic Syndrome (MDS)
- What is being tested?
- ON 01910 Na
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2007to 4 Jun 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically documented or cytologically confirmed diagnosis of MDS with WHO classification of RAEB-1 or 2 or Intermediate to High IPSS risk group.
- OR
- Refractory acute myelogenous leukemia (AML) with trisomy 8
- Anemia requiring transfusion support with at least one unit of packed red blood cells per month for greater than or equal to 2 months
- OR
- Anemia (hemoglobin less than 9 or a reticulocyte count less than 60,000/microL)
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- OR
- thrombocytopenia (platelet count less than 50,000/microL)
- OR
- neutropenia (absolute neutrophil count less than 500/microL).
- Failed to respond to, relapsed following, or opted not to participate in bone marrow transplantation or other standard of care treatment options.
- ECOG Performance Status of 0, 1, or 2.
- Off all other treatments for MDS or AML (except filgrastim (G-CSF), erythropoietin, and transfusion support and related medications) for at least four weeks. Filgrastim (G-CSF) can be used before, during and after the protocol treatment for patients with documented neutropenia (less than 500/microL) as long as they meet the criteria for anemia and/or thrombocytopenia as stated above. Post transplant patients may continue to receive DLIs as needed.
- Ages 18-85.
Who cannot join
- Active infection not adequately responding to appropriate therapy.
- Hypoplastic MDS (cellularity less than 10 percent) or an absolute neutrophil count of less than 200 cells/microL.
- Active malignant disease (excluding non-melanoma skin carcinoma) other than AML.
- Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
- An expected survival, in the opinion of the investigator that would not permit a sufficient observation period for evaluating ON 01910.Na.
- HIV positive patients.
Show all 13Show fewer
- Total bilirubin greater than 1.5 mg/dL not related to hemolysis or Gilbert s disease.
- Serum creatinine greater than 1.5 mg/dL, or a calculated creatinine clearance of less than 60 mL/min/1.73 m(2).
- Ascites requiring active medical management including paracentesis, peripheral bilateral edema, hyponatremia (serum sodium less than 134 meq/L.
- Currently receiving any other investigational agents or concurrent chemotherapy, radiotherapy, or immunotherapy.
- Current pregnancy, unwilling to take oral contraceptives or refrain from pregnancy if of childbearing potential or currently breastfeeding. Pregnant and nursing women are excluded from this study.
- Psychiatric illness/social situations that would limit the patient s ability to tolerate and/or comply with study requirements.
- Unable to understand the investigational nature of the study or give informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: A Pilot Study of the Safety and Activity of Escalating Doses of ON 01910.Na in Patients With RAEB-1 AND RAEB-2 Myelodysplastic Syndrome (MDS) and AML With Trisomy 8
This study will determine the highest dose of the experimental drug ON 01910.Na that can safely be given to patients with the bone marrow disorder myelodysplasia (MDS) and patients with refractory AML with trisomy 8. In this disease, the bone marrow can make some blood cells, but very few of these cells are released into the blood for use in the body. ON 01910.Na is an experimental drug that inhibits a protein called cyclinD1that is important for keeping MDS cells alive. In laboratory experiments, ON 01910.Na has acted against cyclinD1, causing MDS cells to die. The study will also evaluate how the body handles ON 01910.Na, the effect of the drug on MDS and AML and its side effects.
Patients 18 to 85 years old with MDS or AML who do not have a suitable sibling donor for a marrow transplant or who are not willing to have a transplant may be eligible for this study.
Read more
Participants receive ON 01910.Na in 2-week treatment cycles, with 3 to 5 days of drug infusion through a vein followed by 9 to 11 days of observation. To find the highest safe dose of ON 01910.Na, the first person enrolled in the study is given the smallest study dose of the drug for 3 days, followed 2 weeks later with a second dose for 3 days. If these doses are found safe, the next two people receive the same dose. If these subjects do well, the next group of patients receives the next higher dose level. The dose continues to be increased in groups of 3 to 6 subjects until the fourth and highest dose level is reached. Patients who do well on the treatment may receive an additional six cycles of ON 01910.Na (3 to 5 days of infusion once every other week for 12 weeks).
Before, during and after the treatment period, patients are periodically evaluated and monitored with the following tests and procedures:
- Physical examination and review of medical and medication history.
- Blood and urine tests.
- Pregnancy test for women of childbearing age.
- Electrocardiogram (EKG) and chest X-ray.
- Bone marrow biopsy.
Read the detailed description
The myelodysplastic syndromes (MDS) and acute myelogenous leukemias (AML) are a group of heterogeneous diseases with wide variation in clinical presentation and disease severity. Typically patients are older adults with co-morbidities. AML and MDS are characterized by variable degrees of cytopenias (anemia, neutropenia, thrombocytopenia) due to ineffective hematopoiesis and dysplastic bone marrow morphology or hematological malignancy.
Treatment of MDS is unsatisfactory: chemotherapy has a limited role in the management of leukemic progression; autologous stem cell transplantation does not prolong relapse-free survival and stem cell transplantation is poorly tolerated in older individuals. Some MDS patients have been shown to respond to a wide variety of immunosuppressive agents ranging from corticosteroids to cyclosporine (CsA) and horse antithymocyte globulin (h-ATG). However, the overall response rate is less than 30% and relapse continues to be a problem. Few treatments appear to change the natural history of MDS however, growth factors, decitabine, and lenalidomide can improve cytopenias, and 5-azacytidine, can reduce transfusion requirements, and improve quality of life when compared to supportive care. In addition most MDS patients are older and tolerate aggressive therapies poorly.
Some AML patients can be cured with chemotherapy or by allogeneic stem cell transplantation. However standard treatment approaches are not effective for patients who become refractory to chemotherapy, elderly patients, and those who relapse after transplantation.
The management of MDS and relapsed/refractory AML patients therefore remains unsatisfactory and targeted therapies are needed. One such investigational drug, ON 01910.Na, is a potent inhibitor of cyclin D1 and mitosis. ON01910.Na shows activity against a broad spectrum of tumor cell lines. Animal model studies show little toxicity with a high therapeutic index in these tumors. In addition, the fact that MDS bone marrow (particularly trisomy 8) and patients with AML with the trisomy 8 abnormality (Sloand, unpublished data) over-express cyclin D1 and in vitro studies have demonstrated activity against cytogenetically abnormal cells and blasts despite minimal inhibition of normal hematopoiesis provides a rationale for its use in select patients with MDS or AML.
We therefore propose a non-randomized, pilot, dose escalating Phase I study of ON 01910.Na in MDS and patients with refractory AML with trisomy 8.
The primary objective is to determine the safety (including the maximum tolerated dose and/or dosing regimen) of ON 01910.Na when administered in escalating doses in select patients with MDS or AML. Secondary objectives include plasma pharmacokinetics and biological effects of ON 01910.Na on cell-cycle pathways of MDS or AML cells, and bone marrow RNA analysis to assess if gene expression can predict clinical response to ON 01910.Na in subjects with MDS.
The primary endpoint will be the toxicity profile at each dose level. Secondary endpoints will include the evaluation of early evidence of disease response by blast and cytogenetic improvement.
- Conditions
- Myelodysplastic Syndrome (MDS)
- Being tested
- ON 01910 Na
- Keywords
- Myelodyplastic Syndrome (MDS), Selective Mitotic Inhibitor, Targeted Therapy, Myelodysplastic Syndrome, MDS
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ON 01910 NaDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The toxicity profile at each dose level.
Secondary outcomes (1)
Plasma pharmacokinetics, pharmacodynamics, and biological effects of hematologic improvement at each dose level.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2007 (estimated)
- Study start14 Sep 2007
- Primary completion4 Jun 2012
- Study completion4 Jun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Myelodysplastic Syndrome (MDS)Studies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Neal S Young, M.D., Principal investigator, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00533416
- Sponsor's protocol ID
- 070225
- Other IDs
- 07-H-0225
- Status last verified
- 27 Apr 2016
- First submitted
- 20 Sep 2007
- Last updated
- 17 Dec 2019
- Results posted
- No
Publications
Barrett J, Saunthararajah Y, Molldrem J. Myelodysplastic syndrome and aplastic anemia: distinct entities or diseases linked by a common pathophysiology? Semin Hematol. 2000 Jan;37(1):15-29. doi: 10.1016/s0037-1963(00)90027-1.
PubMed 10676908Toyama K, Ohyashiki K, Yoshida Y, Abe T, Asano S, Hirai H, Hirashima K, Hotta T, Kuramoto A, Kuriya S, et al. Clinical implications of chromosomal abnormalities in 401 patients with myelodysplastic syndromes: a multicentric study in Japan. Leukemia. 1993 Apr;7(4):499-508.
PubMed 8464227de Witte T, Suciu S, Verhoef G, Labar B, Archimbaud E, Aul C, Selleslag D, Ferrant A, Wijermans P, Mandelli F, Amadori S, Jehn U, Muus P, Boogaerts M, Zittoun R, Gratwohl A, Zwierzina H, Hagemeijer A, Willemze R. Intensive chemotherapy followed by allogeneic or autologous stem cell transplantation for patients with myelodysplastic syndromes (MDSs) and acute myeloid leukemia following MDS. Blood. 2001 Oct 15;98(8):2326-31. doi: 10.1182/blood.v98.8.2326.
PubMed 11588026Olnes MJ, Shenoy A, Weinstein B, Pfannes L, Loeliger K, Tucker Z, Tian X, Kwak M, Wilhelm F, Yong AS, Maric I, Maniar M, Scheinberg P, Groopman J, Young NS, Sloand EM. Directed therapy for patients with myelodysplastic syndromes (MDS) by suppression of cyclin D1 with ON 01910.Na. Leuk Res. 2012 Aug;36(8):982-9. doi: 10.1016/j.leukres.2012.04.002. Epub 2012 Apr 21.
PubMed 22524974
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Safety and Activity of Escalating Doses of ON 01910.Na in Patients With RAEB-1 AND RAEB-2 Myelodysplastic Syndrome (MDS) and AML With Trisomy 8
- ClinicalTrials.gov ID
- NCT00533416
- Acronym / sponsor ID
- 070225
- Conditions
- Myelodysplastic Syndrome (MDS)
- Keywords
- Myelodyplastic Syndrome (MDS), Selective Mitotic Inhibitor, Targeted Therapy, Myelodysplastic Syndrome, MDS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 14 Sep 2007
- Primary completion
- 4 Jun 2012 (actual)
- Study completion
- 4 Jun 2012 (actual)
- First posted
- 21 Sep 2007 (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 determine the highest dose of the experimental drug ON 01910.Na that can safely be given to patients with the bone marrow disorder myelodysplasia (MDS) and patients with refractory AML with trisomy 8. In this disease, the bone marrow can make some blood cells, but very few of these cells are released into the blood for use in the body. ON 01910.Na is an experimental drug that inhibits a protein called cyclinD1that is important for keeping MDS cells alive. In laboratory experiments, ON 01910.Na has acted against cyclinD1, causing MDS cells to die. The study will also evaluate how the body handles ON 01910.Na, the effect of the drug on MDS and AML and its side effects.
Patients 18 to 85 years old with MDS or AML who do not have a suitable sibling donor for a marrow transplant or who are not willing to have a transplant may be eligible for this study.
Participants receive ON 01910.Na in 2-week treatment cycles, with 3 to 5 days of drug infusion through a vein followed by 9 to 11 days of observation. To find the highest safe dose of ON 01910.Na, the first person enrolled in the study is given the smallest study dose of the drug for 3 days, followed 2 weeks later with a second dose for 3 days. If these doses are found safe, the next two people receive the same dose. If these subjects do well, the next group of patients receives the next higher dose level. The dose continues to be increased in groups of 3 to 6 subjects until the fourth and highest dose level is reached. Patients who do well on the treatment may receive an additional six cycles of ON 01910.Na (3 to 5 days of infusion once every other week for 12 weeks).
Before, during and after the treatment period, patients are periodically evaluated and monitored with the following tests and procedures:
- Physical examination and review of medical and medication history.
- Blood and urine tests.
- Pregnancy test for women of childbearing age.
- Electrocardiogram (EKG) and chest X-ray.
- Bone marrow biopsy.
Detailed description
The myelodysplastic syndromes (MDS) and acute myelogenous leukemias (AML) are a group of heterogeneous diseases with wide variation in clinical presentation and disease severity. Typically patients are older adults with co-morbidities. AML and MDS are characterized by variable degrees of cytopenias (anemia, neutropenia, thrombocytopenia) due to ineffective hematopoiesis and dysplastic bone marrow morphology or hematological malignancy.
Treatment of MDS is unsatisfactory: chemotherapy has a limited role in the management of leukemic progression; autologous stem cell transplantation does not prolong relapse-free survival and stem cell transplantation is poorly tolerated in older individuals. Some MDS patients have been shown to respond to a wide variety of immunosuppressive agents ranging from corticosteroids to cyclosporine (CsA) and horse antithymocyte globulin (h-ATG). However, the overall response rate is less than 30% and relapse continues to be a problem. Few treatments appear to change the natural history of MDS however, growth factors, decitabine, and lenalidomide can improve cytopenias, and 5-azacytidine, can reduce transfusion requirements, and improve quality of life when compared to supportive care. In addition most MDS patients are older and tolerate aggressive therapies poorly.
Some AML patients can be cured with chemotherapy or by allogeneic stem cell transplantation. However standard treatment approaches are not effective for patients who become refractory to chemotherapy, elderly patients, and those who relapse after transplantation.
The management of MDS and relapsed/refractory AML patients therefore remains unsatisfactory and targeted therapies are needed. One such investigational drug, ON 01910.Na, is a potent inhibitor of cyclin D1 and mitosis. ON01910.Na shows activity against a broad spectrum of tumor cell lines. Animal model studies show little toxicity with a high therapeutic index in these tumors. In addition, the fact that MDS bone marrow (particularly trisomy 8) and patients with AML with the trisomy 8 abnormality (Sloand, unpublished data) over-express cyclin D1 and in vitro studies have demonstrated activity against cytogenetically abnormal cells and blasts despite minimal inhibition of normal hematopoiesis provides a rationale for its use in select patients with MDS or AML.
We therefore propose a non-randomized, pilot, dose escalating Phase I study of ON 01910.Na in MDS and patients with refractory AML with trisomy 8.
The primary objective is to determine the safety (including the maximum tolerated dose and/or dosing regimen) of ON 01910.Na when administered in escalating doses in select patients with MDS or AML. Secondary objectives include plasma pharmacokinetics and biological effects of ON 01910.Na on cell-cycle pathways of MDS or AML cells, and bone marrow RNA analysis to assess if gene expression can predict clinical response to ON 01910.Na in subjects with MDS.
The primary endpoint will be the toxicity profile at each dose level. Secondary endpoints will include the evaluation of early evidence of disease response by blast and cytogenetic improvement.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histologically documented or cytologically confirmed diagnosis of MDS with WHO classification of RAEB-1 or 2 or Intermediate to High IPSS risk group.
- OR
- Refractory acute myelogenous leukemia (AML) with trisomy 8
- Anemia requiring transfusion support with at least one unit of packed red blood cells per month for greater than or equal to 2 months
- OR
Key exclusion criteria (13 listed)
- Active infection not adequately responding to appropriate therapy.
- Hypoplastic MDS (cellularity less than 10 percent) or an absolute neutrophil count of less than 200 cells/microL.
- Active malignant disease (excluding non-melanoma skin carcinoma) other than AML.
- Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
- An expected survival, in the opinion of the investigator that would not permit a sufficient observation period for evaluating ON 01910.Na.
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 |
|---|---|---|
| ON 01910 Na | Drug | – |
Primary outcome
The toxicity profile at each dose level.
1 secondary outcome
Plasma pharmacokinetics, pharmacodynamics, and biological effects of hematologic improvement at each dose level.
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 17 Dec 2019.
- Background: PubMed 10676908Barrett J, Saunthararajah Y, Molldrem J. Myelodysplastic syndrome and aplastic anemia: distinct entities or diseases linked by a common pathophysiology? Semin Hematol. 2000 Jan;37(1):15-29. doi: 10.1016/s0037-1963(00)90027-1.
- Background: PubMed 8464227Toyama K, Ohyashiki K, Yoshida Y, Abe T, Asano S, Hirai H, Hirashima K, Hotta T, Kuramoto A, Kuriya S, et al. Clinical implications of chromosomal abnormalities in 401 patients with myelodysplastic syndromes: a multicentric study in Japan. Leukemia. 1993 Apr;7(4):499-508.
- Background: PubMed 11588026de Witte T, Suciu S, Verhoef G, Labar B, Archimbaud E, Aul C, Selleslag D, Ferrant A, Wijermans P, Mandelli F, Amadori S, Jehn U, Muus P, Boogaerts M, Zittoun R, Gratwohl A, Zwierzina H, Hagemeijer A, Willemze R. Intensive chemotherapy followed by allogeneic or autologous stem cell transplantation for patients with myelodysplastic syndromes (MDSs) and acute myeloid leukemia following MDS. Blood. 2001 Oct 15;98(8):2326-31. doi: 10.1182/blood.v98.8.2326.
- Derived from this study: PubMed 22524974Olnes MJ, Shenoy A, Weinstein B, Pfannes L, Loeliger K, Tucker Z, Tian X, Kwak M, Wilhelm F, Yong AS, Maric I, Maniar M, Scheinberg P, Groopman J, Young NS, Sloand EM. Directed therapy for patients with myelodysplastic syndromes (MDS) by suppression of cyclin D1 with ON 01910.Na. Leuk Res. 2012 Aug;36(8):982-9. doi: 10.1016/j.leukres.2012.04.002. Epub 2012 Apr 21.
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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.
Neal S Young, M.D. principal investigator
National Heart, Lung, and Blood Institute (NHLBI)
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 ON 01910 Na in people with Myelodysplastic Syndrome (MDS), run by National Heart, Lung, and Blood Institute (NHLBI) 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 14 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: finished, as of the sponsor's last update on 17 Dec 2019. 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 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?
The toxicity profile at each dose level.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00533416, which also lists 4 linked publications.
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 17 Dec 2019.