Myelodysplastic SyndromePhase 2NCT00045786
Study to Determine the Safety and Preliminary Efficacy of CC-1088 in the Treatment of Myelodysplastic Syndromes
A Phase 2 study testing CC-1088 in people with Myelodysplastic Syndrome, run by Celgene at 1 site in United States.
Trial summary
The primary objective of the study is to assess the safety of CC-1088 to patients with myelodysplastic syndromes (MDS). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myelodysplastic Syndrome
- What is being tested?
- CC-1088
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2001to Nov 2003
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible patients must have a diagnosis of MDS of at least 12 weeks that is not therapy related.
- Age ≥ 18 at the time of signing informed consent
- Patient must be able to adhere to the study visit schedule and other protocol requirements.
- Patient must understand and voluntarily sign an informed consent document.
- Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test.
- Sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner).
- Women must not be pregnant or lactating.
Who cannot join
- Pregnant and lactating women and WCBP who are not using adequate contraception.
- Myelosclerosis (or myelofibrosis) occupying >30% of marrow space
- Patients with iron deficiency (e.g., absent bone marrow iron store). If a marrow aspirate is not evaluable for storage iron, transferrin saturation must be 220% and serum femtin not less than 50 ng/mL.
- Patients with uncorrected Bl2 or folate deficiency.
- Patients with contributing causes of anemia such as autoimmune or heredity, hemolytic disorders, or GI blood loss.
- Patients with a history of malignancy, except basal cell or squamous cell carcinoma of the skin or cervical carcinoma in situ.
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- Patients with clinically significant, symptomatic and unstable pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal or genitourinary system diseases unrelated to their underlying hematologic disorder.
- Life-threatening or active infection requiring parenteral antibiotic therapy or other serious concurrent illness.
- Patients who have a history of testing positive for Hepatitis B surface antigenemia,'Hepatitis C, or HIV.
- Inadequate organ hction: renal insufficiency [serum creatinine levels >1.5 x upper limit of normal (ULN)] or hepatic impairment (bilirubin 22 mg/dL or AST/ALT 22 x ULN).
- Patients may not have received another investigational study drug within 30 days of entry in the present study.
- Requirement for ongoing therapy with corticosteroids.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush-Presbyterian-St Luke's Medical Center
Chicago, Illinois, 60612-3515
About this study
Official title: A Multi-center, An Open Label, Dose-Escalation Study to Determine the Safety and Preliminary Efficacy of CC-1088 in the Treatment for Myelodysplastic Syndromes
The primary objective of the study is to assess the safety of CC-1088 to patients with myelodysplastic syndromes (MDS).
- Conditions
- Myelodysplastic Syndrome
- Being tested
- CC-1088
- Keywords
- myelodysplastic syndrome
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-1088Drug
400 mg/day (200 mg orally twice a day) 800 mg/day (400 mg orally twice a day) 1200 mg/day (600 mg orally twice a day) 1500 mg/day (500 mg orally three times daily)
| Study group | Role | What they receive |
|---|---|---|
| 400 mg CC-1088 | Experimental | Not described Receives: Drug: CC-1088 |
| 800 mg CC-1088 | Experimental | Not described Receives: Drug: CC-1088 |
| 1200 mg CC-1088 | Experimental | Not described Receives: Drug: CC-1088 |
| 1500 mg CC-1088 | Experimental | Not described Receives: Drug: CC-1088 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2002 (estimated)
- Study startOct 2001
- Primary completionDec 2001
- Study completionNov 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromeStudies of the same condition, open and under way.
- More trials run by CelgeneThe 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Knight, Study director, Celgene Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00045786
- Sponsor's protocol ID
- CC-1088-MDS-801-001
- Status last verified
- Apr 2017
- First submitted
- 9 Sep 2002
- Last updated
- 25 Apr 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, An Open Label, Dose-Escalation Study to Determine the Safety and Preliminary Efficacy of CC-1088 in the Treatment for Myelodysplastic Syndromes
- ClinicalTrials.gov ID
- NCT00045786
- Acronym / sponsor ID
- CC-1088-MDS-801-001
- Conditions
- Myelodysplastic Syndrome
- Keywords
- myelodysplastic syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- Oct 2001
- Primary completion
- Dec 2001 (actual)
- Study completion
- Nov 2003 (actual)
- First posted
- 11 Sep 2002 (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.
The primary objective of the study is to assess the safety of CC-1088 to patients with myelodysplastic syndromes (MDS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 400 mg CC-1088 | Experimental | Drug: CC-1088 |
| 800 mg CC-1088 | Experimental | Drug: CC-1088 |
| 1200 mg CC-1088 | Experimental | Drug: CC-1088 |
| 1500 mg CC-1088 | Experimental | Drug: CC-1088 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Eligible patients must have a diagnosis of MDS of at least 12 weeks that is not therapy related.
- Age ≥ 18 at the time of signing informed consent
- Patient must be able to adhere to the study visit schedule and other protocol requirements.
- Patient must understand and voluntarily sign an informed consent document.
- Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test.
Key exclusion criteria (12 listed)
- Pregnant and lactating women and WCBP who are not using adequate contraception.
- Myelosclerosis (or myelofibrosis) occupying >30% of marrow space
- Patients with iron deficiency (e.g., absent bone marrow iron store). If a marrow aspirate is not evaluable for storage iron, transferrin saturation must be 220% and serum femtin not less than 50 ng/mL.
- Patients with uncorrected Bl2 or folate deficiency.
- Patients with contributing causes of anemia such as autoimmune or heredity, hemolytic disorders, or GI blood loss.
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 |
|---|---|---|
| CC-1088400 mg/day (200 mg orally twice a day) 800 mg/day (400 mg orally twice a day) 1200 mg/day (600 mg orally twice a day) 1500 mg/day (500 mg orally three times daily) | Drug | 1200 mg CC-1088, 1500 mg CC-1088, 400 mg CC-1088, 800 mg CC-1088 |
Primary outcome
Not reported in the source record.
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 25 Apr 2017.
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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.
Robert Knight study director
Celgene Corporation
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 CC-1088 in people with Myelodysplastic Syndrome, run by Celgene 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 7 inclusion and 12 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 25 Apr 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?
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.
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 25 Apr 2017.