A Study of CC-90002 in Subjects With Acute Myeloid Leukemia (AML) and High-risk Myelodysplastic Syndrome (MDS)
Status: | Terminated |
---|---|
Conditions: | Blood Cancer, Blood Cancer, Blood Cancer, Blood Cancer, Hematology |
Therapuetic Areas: | Hematology, Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/20/2018 |
Start Date: | March 1, 2016 |
End Date: | July 18, 2018 |
A Phase 1, Open-label, Dose Finding Study of CC-90002, a Monoclonal Antibody Directed Against CD47, in Subjects With Acute Myeloid Leukemia and High-Risk Myelodsplastic Syndrome
Study CC-90002-AML-001 is an open-label, Phase 1 dose escalation (Part A) and expansion (Part
B), clinical study of CC-90002, administered by intravenous (IV) infusion, in subjects with
relapsed and/or primary refractory AML and high-risk MDS. The study will explore escalating
doses of CC-90002 using a 3 + 3 dose escalation design in Part A, followed by dose expansion
in Part B.
The primary objective is to determine the safety and tolerability of CC-90002 and also to
define the non-tolerated dose (NTD), the maximum tolerated dose (MTD) and/or the recommended
Phase 2 dose (RP2D) of CC-90002.
B), clinical study of CC-90002, administered by intravenous (IV) infusion, in subjects with
relapsed and/or primary refractory AML and high-risk MDS. The study will explore escalating
doses of CC-90002 using a 3 + 3 dose escalation design in Part A, followed by dose expansion
in Part B.
The primary objective is to determine the safety and tolerability of CC-90002 and also to
define the non-tolerated dose (NTD), the maximum tolerated dose (MTD) and/or the recommended
Phase 2 dose (RP2D) of CC-90002.
In both Part A and Part B, treatments will be administered in two phases starting with an
induction phase followed by a maintenance phase. During the induction phase, treatments will
be administered in 42-day cycles in Cycles 1 through 4. Following completion of Cycle 4 in
the induction phase, subjects with non-progressive disease will enter the maintenance phase.
During the maintenance phase, treatments will be administered in 28 day cycles. Subjects may
continue CC-90002 for up to a maximum of 2 years (eg, induction phase Cycles 1 through 4 and
maintenance phase Cycles 5 through 24) or until clinically significant disease progression,
the occurrence of intolerable toxicity, or physician/subject decision to discontinue
CC-90002, whichever comes first.
induction phase followed by a maintenance phase. During the induction phase, treatments will
be administered in 42-day cycles in Cycles 1 through 4. Following completion of Cycle 4 in
the induction phase, subjects with non-progressive disease will enter the maintenance phase.
During the maintenance phase, treatments will be administered in 28 day cycles. Subjects may
continue CC-90002 for up to a maximum of 2 years (eg, induction phase Cycles 1 through 4 and
maintenance phase Cycles 5 through 24) or until clinically significant disease progression,
the occurrence of intolerable toxicity, or physician/subject decision to discontinue
CC-90002, whichever comes first.
Inclusion Criteria:
1. Men and women ≥ 18 years of age, at the time of signing the informed consent form
(ICF).
2. Relapsed and/or primary refractory Acute Myeloid Leukemia (AML) or Myelodysplastic
Syndrome (MDS) with subtype refractory anemia with excess blasts (RAEB)-2 defined as
high or very high-risk that is recurrent or refractory, or the patient is intolerant
to established therapy.
3. Subject consents to hospitalization for first (Cycle 1 Day 1) dose of CC-90002 and for
72 hours after.
4. Subject consents to serial bone marrow aspiration and biopsies as specified.
5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2.
6. Eligible study subjects must exhibit acceptable liver, renal, and coagulation function
as assessed by laboratory tests.
7. Females and males must practice true abstinence or agree to contraceptive methods
throughout the study, and for up to 8 weeks following the last dose of CC 90002.
Exclusion Criteria:
1. Active central nervous system (CNS) leukemia or known CNS leukemia.
2. Immediately life-threatening, severe complications of leukemia.
3. Impaired cardiac function or clinically significant cardiac diseases.
4. Glucose-6-phosphate dehydrogenase (G6PD) deficiency.
5. Prior autologous hematopoietic stem cell transplant ≤ 3 months.
6. Prior allogeneic hematopoietic stem cell transplant (HSCT) with either standard or
reduced intensity conditioning ≤ 6 months.
7. Systemic immunosuppressive therapy post HSCT or with clinically significant
graft-versus-host disease (GVHD).
8. Prior systemic cancer-directed treatments or investigational modalities ≤ 5 half lives
or 4 weeks whichever is shorter.
9. Major surgery ≤ 2 weeks and recovered from any clinically significant effects of
recent surgery.
10. Pregnant or nursing females.
11. Known HIV infection.
12. Known chronic hepatitis B or C (HBV/HCV) infection.
13. Ongoing treatment with chronic, therapeutic dosing of anti-coagulants.
14. History of autoimmune hemolytic anemia or autoimmune thrombocytopenia.
15. History of concurrent second cancers requiring active, ongoing systemic treatment.
16. Subjects for whom potentially curative anticancer therapy is available.
We found this trial at
6
sites
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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University of Chicago One of the world's premier academic and research institutions, the University of...
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Yale Cancer Center Yale Cancer Center combines a tradition of innovative cancer treatment and quality...
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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