Study of AG-120 (Ivosidenib) vs. Placebo in Combination With Azacitidine in Patients With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation



Status:Recruiting
Conditions:Blood Cancer, Blood Cancer, Blood Cancer, Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:June 26, 2017
End Date:June 2022
Contact:Medical Affairs Agios Pharmaceuticals, Inc.
Email:medinfo@agios.com
Phone:1.833.228.8474

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A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of AG-120 in Combination With Azacitidine in Subjects ≥ 18 Years of Age With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation

Study AG120-C-009 is a global, Phase 3, multicenter, double-blind, randomized,
placebo-controlled clinical trial to evaluate the efficacy and safety of AG-120 (ivosidenib)
+ azacitidine vs placebo + azacitidine in adult subjects with previously untreated IDH1m AML
who are considered appropriate candidates for non-intensive therapy. The primary endpoint is
Overall Survival (OS). The key secondary efficacy endpoints are Event free Survival (EFS),
rate of complete remission (CR), Rate of CR and complete remission with partial hematologic
recovery (CRh), and overall response rate (ORR). Subjects eligible for study treatment based
on Screening assessments will be randomized 1:1 to receive oral AG-120 or matched placebo,
both administered in combination with subcutaneous (SC) or intravenous (IV) azacitidine. An
estimated 392 subjects will participate in the study.


Inclusion Criteria:

1. Be ≥ 18 years of age.

2. Have previously untreated AML, defined according to WHO criteria, with ≥ 20% leukemic
blasts in the bone marrow. Subjects with extramedullary disease alone (ie, no
detectable bone marrow and no detectable peripheral blood AML) are not eligible for
the study.

3. Have an isocitrate dehydrogenase 1 (IDH1) mutation

4. Have an ECOG Performance Status score of 0 to 2.

5. Have adequate hepatic function

6. Have adequate renal function

7. Have agreed to undergo serial blood and bone marrow sampling.

8. Be able to understand and willing to sign an informed consent form (ICF).

9. Be willing to complete Quality of Life assessments during the study

10. If female with reproductive potential, must have a negative serum pregnancy test prior
to the start of study therapy. Females of reproductive potential, as well as fertile
men and their female partners of reproductive potential, must agree to use 2 effective
forms of contraception.

Exclusion Criteria:

1. Are candidates for and willing to receive intensive IC for their AML.

2. Have received any prior treatment for AML with the exception of hydroxyurea.

3. Have received a hypomethylating agent for myelodysplastic syndrome (MDS).

4. Subjects who had previously received an experimental agent for MDS may not be
randomized until a washout period has elapsed since the last dose of that agent.

5. Have received prior treatment with an IDH1 inhibitor.

6. Have a known hypersensitivity to any of the components of AG-120, matched placebo, or
azacitidine.

7. Are female and pregnant or breastfeeding.

8. Have an active, uncontrolled, systemic fungal, bacterial, or viral infection without
improvement despite appropriate antibiotics, antiviral therapy, and/or other
treatment.

9. Have a prior history of cancer other than MDS or myeloproliferative disorder, unless
the subject has been free of the disease for ≥ 1 year prior to the start of study
treatment.

10. Have had significant active cardiac disease within 6 months prior to the start of
study treatment

11. Have any condition that increases the risk of abnormal ECG or cardiac arrhythmia

12. Have a condition that limits the ingestion or absorption of drugs administered by
mouth

13. Have uncontrolled hypertension (systolic blood pressure [BP] > 180 mmHg or diastolic
BP > 100 mmHg).

14. Have clinical symptoms suggestive of active central nervous system (CNS) leukemia or
known CNS leukemia.

15. Have immediate, life-threatening, severe complications of leukemia, such as
uncontrolled bleeding, pneumonia with hypoxia or sepsis, and/or disseminated
intravascular coagulation.

16. Have any other medical or psychological condition deemed by the Investigator to be
likely to interfere with the subject's ability to give informed consent or participate
in the study.
We found this trial at
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185 Cambridge Street
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666 Elm Street
Buffalo, New York 14263
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Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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5801 South Ellis Avenue
Chicago, Illinois 60637
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40 Sunshine Cottage Road
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1365 Clifton Rd NE
Atlanta, Georgia 30322
(404) 778-1900
Winship Cancer Institute at Emory University Winship Cancer Institute of Emory University is Georgia
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22 S Greene St
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Camperdown, New South Wales 2050
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4875 Higbee Ave NW
Canton, Ohio 44718
330-492-3345
Gabrail Cancer Center Since 1990, Gabrail Cancer Center has built a national reputation for excellence...
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5053 Wooster Rd
Cincinnati, Ohio 45226
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Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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3310 Live Oak St
Dallas, Texas 75204
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1500 East Duarte Road
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2301 Erwin Rd
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Greenville, North Carolina 27834
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Greenville, South Carolina 29605
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Hackensack, New Jersey 07601
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Houston, Texas 77030
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1514 Jefferson Highway
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757 Westwood Plaza
Los Angeles, California 90024
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Louisville, Kentucky 40207
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New York, New York 10021
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8915 West Golf Road
Niles, Illinois 60714
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101 Nicolls Rd
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Stony Brook University Medical Center Stony Brook Medicine expresses our shared mission of research, clinical...
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