Myelodysplastic SyndromesPhase 1NCT00750334
A Study of Oral Clofarabine in Adult Patients With Myelodysplastic Syndromes (MDS)
A Phase 1 study testing clofarabine in people with Myelodysplastic Syndromes, run by Genzyme, a Sanofi Company at 3 sites in United States.
Trial summary
This study will be used to determine the maximum tolerated dose of oral clofarabine when administered daily for 14 consecutive days repeated every 21 days. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndromes
- What is being tested?
- clofarabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2008to Oct 2008
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide signed, written informed consent.
- Be at least 18 years old.
- Have a pathologically confirmed MDS and score according to the IPSS at study entry. Pathologic confirmation is the responsibility of the investigator.
- Have been treated previously for MDS as follow: a.Patients must have had at least 1, but no more than 2, prior treatment regimens; b.Patients must not have refractory (i.e., disease progression or no evidence of response while on treatment) to more than 1 prior treatment regimen.
- Have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Be able to comply with study procedures and follow-up examinations.
- Have adequate hepatic and renal function.
- Be non-fertile or agree to use birth control during the study through the end of the last treatment visit and at least 90 days after.
Who cannot join
- Have had a readjustment of dose and/or schedule of erythropoietin, granulocyte colony stimulating factor(G-CSF) or other growth factors within 8 weeks prior to the first dose of oral clofarabine.
- Have had any other chemotherapy or any investigational therapy for MDS within 4 weeks of the first dose of oral clofarabine.
- Have not recovered to ≤ Grade 2 in severity of any drug-related non-hematologic toxicity prior to the first dose of oral clofarabine.
- Have an uncontrolled systemic fungal, bacterial, viral or other infection. Have a history of serious disease involving the heart.
- Have a clinically significant cardiac assessment at screening or a known family history QT prolongation.
- Currently uses a medication known to prolong the QT interval.
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- Have had any prior treatment with clofarabine (IV or oral).
- Have had a diagnosis of another malignancy, unless the patient has been disease free for at least 3 years after completing curative intent therapy except for the following: a. Patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment or the condition has been completed. b. Patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on prostate specific antigen (PSA) values are also eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performed.
- Have prior positive test for the human immunodeficiency virus (HIV).
- Have gastrointestinal disease or prior surgery, which may affect the ability of the patient to absorb oral clofarabine.
- Is currently participating in another concurrent investigational protocol that is not restricted to data and/or sample collection for patient demographic and/or disease purposes.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Division of Hematology Mayo Clinic
Rochester, Minnesota
Cancer Care Centers of South Texas
San Antonio, Texas
Malignant Hematology Administration, H. Lee Moffitt Cancer Center
Tampa, Florida
About this study
Official title: A Phase I, Open-Label, Dose-Finding and Food Effect Study of Oral Clofarabine in Previously Treated Adult Patients With Myelodysplastic Syndromes (MDS)
This study will be used to determine the maximum tolerated dose of oral clofarabine when administered daily for 14 consecutive days repeated every 21 days.
- Conditions
- Myelodysplastic Syndromes
- Being tested
- clofarabine
- Keywords
- Oral Clofarabine,, relapsed/refractory MDS,, Myelodysplastic
- Medical subject headings
- Myelodysplastic Syndromes, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clofarabineDrug
Drug given Daily x 14 days and 7 days of rest for 21 day cycle
clofarabineDrug
Drug given Daily X 14 days and 7 days of rest for 21 day cycle
| Study group | Role | What they receive |
|---|---|---|
| Part A | Experimental | clofarabine Dose Escalation Receives: Drug: clofarabine |
| Part B | Experimental | Part B is an open-label, replicated cross-over study in which 12 additional patients will be enrolled and treated at the MTD determined in part A to evaluate the effect of food on the PK disposition of oral clofarabine. Receives: Drug: clofarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated dose levels
Measured: First Cycle
Secondary outcomes (3)
PK profile
Measured: After MTD is established
Food effect on profile
Measured: After MTD is established
Activity of clofarabine in this dosing regimen
Measured: Duration of Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionOct 2008
- Study completionOct 2008
Why it stopped: Terminated to focus on comparable trial, CLOMDS02507
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromesStudies 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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Genzyme, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00750334
- Sponsor's protocol ID
- CLOMDS01206
- Status last verified
- May 2015
- First submitted
- 9 Sep 2008
- Last updated
- 21 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Dose-Finding and Food Effect Study of Oral Clofarabine in Previously Treated Adult Patients With Myelodysplastic Syndromes (MDS)
- ClinicalTrials.gov ID
- NCT00750334
- Acronym / sponsor ID
- CLOMDS01206
- Conditions
- Myelodysplastic Syndromes
- Keywords
- Oral Clofarabine,, relapsed/refractory MDS,, Myelodysplastic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated to focus on comparable trial, CLOMDS02507
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 10 Sep 2008 (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 be used to determine the maximum tolerated dose of oral clofarabine when administered daily for 14 consecutive days repeated every 21 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Drug: clofarabineclofarabine Dose Escalation |
| Part B | Experimental | Drug: clofarabinePart B is an open-label, replicated cross-over study in which 12 additional patients will be enrolled and treated at the MTD determined in part A to evaluate the effect of food on the PK disposition of oral clofarabine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Provide signed, written informed consent.
- Be at least 18 years old.
- Have a pathologically confirmed MDS and score according to the IPSS at study entry. Pathologic confirmation is the responsibility of the investigator.
- Have been treated previously for MDS as follow: a.Patients must have had at least 1, but no more than 2, prior treatment regimens; b.Patients must not have refractory (i.e., disease progression or no evidence of response while on treatment) to more than 1 prior treatment regimen.
- Have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Key exclusion criteria (11 listed)
- Have had a readjustment of dose and/or schedule of erythropoietin, granulocyte colony stimulating factor(G-CSF) or other growth factors within 8 weeks prior to the first dose of oral clofarabine.
- Have had any other chemotherapy or any investigational therapy for MDS within 4 weeks of the first dose of oral clofarabine.
- Have not recovered to ≤ Grade 2 in severity of any drug-related non-hematologic toxicity prior to the first dose of oral clofarabine.
- Have an uncontrolled systemic fungal, bacterial, viral or other infection. Have a history of serious disease involving the heart.
- Have a clinically significant cardiac assessment at screening or a known family history QT prolongation.
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 |
|---|---|---|
| clofarabineDrug given Daily x 14 days and 7 days of rest for 21 day cycle | Drug | Part A |
| clofarabineDrug given Daily X 14 days and 7 days of rest for 21 day cycle | Drug | Part B |
Primary outcome
Maximum Tolerated dose levels
Time frame: First Cycle
3 secondary outcomes
PK profile
Time frame: After MTD is established
Food effect on profile
Time frame: After MTD is established
Activity of clofarabine in this dosing regimen
Time frame: Duration of Study
Results and safety
The study was stopped early (reason given: Terminated to focus on comparable trial, CLOMDS02507). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2015.
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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.
Medical Monitor study director
Genzyme, a Sanofi Company
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing clofarabine in people with Myelodysplastic Syndromes, run by Genzyme, a Sanofi Company at 3 sites 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 8 inclusion and 11 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 21 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 stopped early (reason given: Terminated to focus on comparable trial, CLOMDS02507). Results are not available in the source record.
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?
Maximum Tolerated dose levels (time frame: First Cycle). 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 21 May 2015.