Acute Myeloid LeukemiaPhase 1RACENCT00761722
Safety & Pharmacokinetics Study Of Azacitidine (SC And Oral) In Subjects With MDS, CMML, AML, Lymphoma And Multiple Myeloma
A Phase 1 study testing azacitidine in people with Acute Myeloid Leukemia and Myelodysplastic Syndromes, run by Celgene at 11 sites in United States.
Trial summary
The purpose of this study is to compare the amount of drug that gets into the bloodstream between different tablets taken by mouth and an injection under the skin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, Myelodysplastic Syndromes, Lymphoma
- What is being tested?
- azacitidine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 11 sitesUnited States
- Study dates
- 12 Aug 2008to 7 Apr 2016
- 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
- 18 years or older
- Diagnosis of MDS or CMML
- Diagnosis of AML, Multiple myeloma, Hodgkin's or Non-Hodgkin's lymphoma for whom standard curative or palliative measures do not exist or are no longer effective
- ECOG Performance Status 0-2
- Use of acceptable birth control
- Standard safety inclusion for serum creatinine, AST, ALT, bilirubin
Show all 10Show fewer
- Serum bicarbonate greater than or equal to 20 mEq/L
- Platelet count greater than or equal to 25,000/uL
- Hemoglobin greater than or equal to 500/uL
- Signed informed consent
Who cannot join
- Diagnosis of acute promyelocytic leukemia
- Treatment with demethylating agents within 21 days prior to Cycle 1, Day 1
- Treatment with any anticancer therapy (standard or investigational) within 21 days prior to Cycle 1, Day 1 or ongoing adverse events from previous treatment
- Hypersensitivity to azacitidine or mannitol
- Active, uncontrolled infection
- Presence of GI disease, malignant tumors or other conditions known to interfere with ADME
Show all 9Show fewer
- Known or active HIV, viral hepatitis B or C
- Breastfeeding or pregnant females
- Current or uncontrolled cardiac disease
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Northwest Cancer Specialists, P.C.
Albuquerque, New Mexico, 87109
California Cancer Care Inc
Greenbrae, California, 94904
University of Texas- MD Anderson
Houston, Texas, 77030
Indiana University School of Medicine
Indianapolis, Indiana, 46202
University of Kansas Medical Center
Kansas City, Kansas, 66160
Main Cancer Centers of Florida, P.A.
Ocoee, Florida, 34761
Hematology and Oncology Assoc. of South Texas
San Antonio, Texas, 78229
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-4417
Willamette Valley Cancer Institute
Springfield, Oregon, 97477
Washington University School of Medicine
St Louis, Missouri, 63110
Yakima Valley Memorial Hospital/ North Star Lodge
Yakima, Washington, 98902
About this study
Official title: A Phase I, Dose-Ranging Study to Evaluate the Pharmacokinetics and Safety of Azacitidine Administered Subcutaneously (SC) and as Different Oral Formulations in Subjects With Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), Acute Myelogenous Leukemia (AML), Lymphoma, and Multiple Myeloma
The purpose of this study is to compare the amount of drug that gets into the bloodstream between different tablets taken by mouth and an injection under the skin.
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndromes, Lymphoma, Multiple Myeloma, Leukemia, Myelomonocytic, Chronic
- Being tested
- azacitidine
- Keywords
- Acute Myeloid Leukemia, Myelodysplastic Syndromes, Lymphoma, Multiple Myeloma, Chronic Myelomonocytic Leukemia (CMML)
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Lymphoma, Multiple Myeloma, Leukemia, Myelomonocytic, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
azacitidineDrug
Also called Vidaza
Arm 1:
Cycle 1 (PK Phase) - Subjects will receive a single SC dose of 75 mg/m2 on Days 1 and 15. Single oral doses of a given formulation of azacitidine will be administered in increasing doses on Days 3 and 5, and at doses calculated to deliver 80% and 120% of the SC exposure, up to a maximum dose of 600 mg on Days 17 and 19.
Cycles 2 and beyond - (Treatment phase) Oral azacitidine will be administered in a dose calculated to deliver 100% of the SC exposure up to a maximum of 600 mg on days 1 - 7 of a 28 day cycle.
Arm 2:
All Cycles - Oral azacitidine will be administered a maximum of 600 mg on Days 1 - 7 of a 28 days cycle.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | subcutaneous and oral azacitidine
Cycle 1 (PK Phase) - Subjects will receive a single SC dose of 75 mg/m2 on Days 1 and 15. Single oral doses of a given formulation of azacitidine will be administered in increasing doses on Days 3 and 5, and at doses calculated to deliver 80% and 120% of the SC exposure, up to a maximum dose of 600 mg on Days 17 and 19.
Cycles 2 and beyond - (Treatment phase) Oral azacitidine will be administered in a dose calculated to deliver 100% of the SC exposure up to a maximum of 600 mg on days 1 - 7 of a 28 day cycle. Receives: Drug: azacitidine |
| Arm 2 | Experimental | Oral Azacitidine
All Cycles - Oral azacitidine will be administered a maximum of 600 mg on Days 1 - 7 of a 28 days cycle. Receives: Drug: azacitidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate the dose for a given oral formulation that would yield similar exposure [area under the curve (AUC)] to 75 mg/m2 of the subcutaneous formulation.
Measured: 1 - 18 months
Secondary outcomes (6)
To determine the oral bioavailability of up to 6 different oral formulations in comparison to the subcutaneous formulation
Measured: 1 - 18 months
To assess the safety and tolerability of subcutaneous and oral formulations of azacitidine
Measured: 1 - 18 months
To assess response rates
Measured: 1 - 18 months
To assess RBC transfusion independence
Measured: 1 - 18 months
To investigate the pharmacokinetics of oral azacitidine
Measured: 1 -18 months
To assess the pharmacodynamic effects of oral azacitidine
Measured: 1 -18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2008 (estimated)
- Study start12 Aug 2008
- Primary completion6 Apr 2016
- Study completion7 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid LeukemiaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barry Skikne, MD, FACP, FCP (SA), Study director, Celgene Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00761722
- Sponsor's protocol ID
- AZA PH US 2008 CL008
- Acronym
- RACE
- Status last verified
- Nov 2019
- First submitted
- 25 Sep 2008
- Last updated
- 8 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Laille E, Savona MR, Scott BL, Boyd TE, Dong Q, Skikne B. Pharmacokinetics of different formulations of oral azacitidine (CC-486) and the effect of food and modified gastric pH on pharmacokinetics in subjects with hematologic malignancies. J Clin Pharmacol. 2014 Jun;54(6):630-9. doi: 10.1002/jcph.251. Epub 2014 Jan 18.
PubMed 24374798
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Dose-Ranging Study to Evaluate the Pharmacokinetics and Safety of Azacitidine Administered Subcutaneously (SC) and as Different Oral Formulations in Subjects With Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), Acute Myelogenous Leukemia (AML), Lymphoma, and Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00761722
- Acronym / sponsor ID
- RACE / AZA PH US 2008 CL008
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndromes, Lymphoma, Multiple Myeloma, Leukemia, Myelomonocytic, Chronic
- Keywords
- Acute Myeloid Leukemia, Myelodysplastic Syndromes, Lymphoma, Multiple Myeloma, Chronic Myelomonocytic Leukemia (CMML)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 12 Aug 2008 (actual)
- Primary completion
- 6 Apr 2016 (actual)
- Study completion
- 7 Apr 2016 (actual)
- First posted
- 29 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.
The purpose of this study is to compare the amount of drug that gets into the bloodstream between different tablets taken by mouth and an injection under the skin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: azacitidinesubcutaneous and oral azacitidine Cycle 1 (PK Phase) - Subjects will receive a single SC dose of 75 mg/m2 on Days 1 and 15. Single oral doses of a given formulation of azacitidine will be administered in increasing doses on Days 3 and 5, and at doses calculated to deliver 80% and 120% of the SC exposure, up to a maximum dose of 600 mg on Days 17 and 19. Cycles 2 and beyond - (Treatment phase) Oral azacitidine will be administered in a dose calculated to deliver 100% of the SC exposure up to a maximum of 600 mg on days 1 - 7 of a 28 day cycle. |
| Arm 2 | Experimental | Drug: azacitidineOral Azacitidine All Cycles - Oral azacitidine will be administered a maximum of 600 mg on Days 1 - 7 of a 28 days cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 18 years or older
- Diagnosis of MDS or CMML
- Diagnosis of AML, Multiple myeloma, Hodgkin's or Non-Hodgkin's lymphoma for whom standard curative or palliative measures do not exist or are no longer effective
- ECOG Performance Status 0-2
- Use of acceptable birth control
Key exclusion criteria (9 listed)
- Diagnosis of acute promyelocytic leukemia
- Treatment with demethylating agents within 21 days prior to Cycle 1, Day 1
- Treatment with any anticancer therapy (standard or investigational) within 21 days prior to Cycle 1, Day 1 or ongoing adverse events from previous treatment
- Hypersensitivity to azacitidine or mannitol
- Active, uncontrolled infection
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 |
|---|---|---|
| azacitidineAlso: VidazaArm 1: Cycle 1 (PK Phase) - Subjects will receive a single SC dose of 75 mg/m2 on Days 1 and 15. Single oral doses of a given formulation of azacitidine will be administered in increasing doses on Days 3 and 5, and at doses calculated to deliver 80% and 120% of the SC exposure, up to a maximum dose of 600 mg on Days 17 and 19. Cycles 2 and beyond - (Treatment phase) Oral azacitidine will be administered in a dose calculated to deliver 100% of the SC exposure up to a maximum of 600 mg on days 1 - 7 of a 28 day cycle. Arm 2: All Cycles - Oral azacitidine will be administered a maximum of 600 mg on Days 1 - 7 of a 28 days cycle. | Drug | Arm 1, Arm 2 |
Primary outcome
To estimate the dose for a given oral formulation that would yield similar exposure [area under the curve (AUC)] to 75 mg/m2 of the subcutaneous formulation.
Time frame: 1 - 18 months
6 secondary outcomes
To determine the oral bioavailability of up to 6 different oral formulations in comparison to the subcutaneous formulation
Time frame: 1 - 18 months
To assess the safety and tolerability of subcutaneous and oral formulations of azacitidine
Time frame: 1 - 18 months
To assess response rates
Time frame: 1 - 18 months
To assess RBC transfusion independence
Time frame: 1 - 18 months
To investigate the pharmacokinetics of oral azacitidine
Time frame: 1 -18 months
To assess the pharmacodynamic effects of oral azacitidine
Time frame: 1 -18 months
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 8 Nov 2019.
- Background: PubMed 24374798Laille E, Savona MR, Scott BL, Boyd TE, Dong Q, Skikne B. Pharmacokinetics of different formulations of oral azacitidine (CC-486) and the effect of food and modified gastric pH on pharmacokinetics in subjects with hematologic malignancies. J Clin Pharmacol. 2014 Jun;54(6):630-9. doi: 10.1002/jcph.251. Epub 2014 Jan 18.
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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.
Barry Skikne, MD, FACP, FCP (SA) study director
Celgene Corporation
11 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 azacitidine in people with Acute Myeloid Leukemia and Myelodysplastic Syndromes, run by Celgene at 11 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 10 inclusion and 9 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 8 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 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?
To estimate the dose for a given oral formulation that would yield similar exposure [area under the curve (AUC)] to 75 mg/m2 of the subcutaneous formulation. (time frame: 1 - 18 months). 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 NCT00761722, which also lists 1 linked publication.
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 8 Nov 2019.