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A Safety and Efficacy Study of CC-90009 Combinations in Subjects With Acute Myeloid Leukemia

  • Clinicaltrials.gov identifier

    NCT04336982

  • Recruitment Status

    Recruiting

  • First Posted

    April 7, 2020

  • Last update posted

    May 17, 2021

Study Description

Brief summary:

CC-90009-AML-002 is an exploratory Phase 1b open-label multi-arm trial to evaluate the safety and efficacy of CC-90009 in combination with anti-leukemia agents in subjects with acute myeloid leukemia (AML).

  • Condition or Disease:Leukemia, Myeloid, Acute
  • Intervention/Treatment: Drug: CC-90009
    Drug: Venetoclax
    Drug: Azacitidine
    Drug: Gilteritinib
  • Phase: Phase 1/Phase 2

Detailed Description

Study CC-90009-AML-002 is an open-label, multi-arm, parallel multi-cohort, multicenter, Phase 1b study to determine the safety, tolerability, PK, and efficacy of CC 90009 in combination with anti-leukemia agents used for the treatment of AML. CC 90009 will be given as a combination therapy to subjects with newly diagnosed (ND) or relapsed or refractory (R/R) AML. The dose and schedule finding part (Part A) of the study will evaluate the safety, PK and PD data, and preliminary efficacy information and determine the Part B dose and schedule for each arm. The expansion part (Part B) of the study will further evaluate the safety and efficacy of the CC-90009 containing combination at or below the maximum tolerated dose (MTD) in the selected cohorts in order to determine the recommended Phase 2 dose (RP2D) for subjects with AML.

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 66 participants
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: An Exploratory Phase 1/2 Open-Label Multi-Arm Trial to Evaluate the Safety and Efficacy of CC-90009 Combinations in Subjects With Acute Myeloid Leukemia
  • Actual Study Start Date: August 2020
  • Estimated Primary Completion Date: November 2023
  • Estimated Study Completion Date: November 2023

Arms and interventions

Arm Intervention/treatment
Experimental: CC-90009 in combination with venetoclax and azacitidine
CC-90009 will be administered intravenously per dosing schedule in a 28-day cycle. Venetoclax will be administered orally QD. Azacitidine will be administered intravenously or subcutaneously on planned dosing days for each cycle.
Drug: CC-90009
Injection

Drug: Venetoclax
Tablet

Drug: Azacitidine
Injection
Experimental: CC-90009 in combination with gilteritinib
CC-90009 will be administered intravenously per dosing schedule in a 28-day cycle. Gilteritinib will be administered orally QD.
Drug: Gilteritinib
Tablet

Outcome Measures

  • Primary Outcome Measures: 1. Dose Limiting Toxicity (DLT) [ Time Frame: Up to 28 days ]
    Number of participants with a DLT
  • 2. Maximum Tolerated Dose (MTD) [ Time Frame: Up to 28 days. ]
    The highest dose with DLT rate in Cycle 1 being lower than or close to the target level 0.3 and the toxicity probability within (0.25, 0.35) interval.
  • 3. Adverse Events (AEs) [ Time Frame: Up to 28 days after last dose of study drug. ]
    An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology.
  • Secondary Outcome Measures: 1. Complete Remission Rate (CRR), [ Time Frame: Up to 3 years ]
    is defined as the rate for any type of CR or CRh
  • 2. Objective Response Rate (ORR) [ Time Frame: Up to 3 years ]
    is defined as the rate for all types of CRs and PR for AML.
  • 3. Progression Free Survival (PFS) [ Time Frame: Up to 3 years ]
    is defined as the time from the first dose of study drug(s) to the first occurrence of relapse or progression or death from any cause
  • 4. Overall Survival (OS) [ Time Frame: Up to 3 years ]
    is measured as the time from the first dose of study drug(s) to death due to any cause and will be analyzed in a manner similar to that described for PFS.
  • 5. Duration of Remission [ Time Frame: Up to 3 years ]
    is measured from the time when criteria for CR/CRh/PR are first met (whichever is first recorded) until the first date at which relapse, or progressive disease is objectively documented.
  • 6. Time to Remission [ Time Frame: Up to 3 years ]
    is measured from the time when criteria for CR/CRh/PR are first met (whichever is first recorded)
  • 7. Pharmacokinetics - Cmax [ Time Frame: Until last CC-90009 dose in Cycle 3 (each cycle is 28 days. CC-90009 dosing days are Days 1-5 in Cycle 3) ]
    observed maximum concentration in plasma
  • 8. Pharmacokinetics - AUC24 [ Time Frame: Until last CC-90009 dose in Cycle 3 (each cycle is 28 days. CC-90009 dosing days are Days 1-5 in Cycle 3) ]
    area under the plasma concentration time-curve from time 0 to 24 hours postdose
  • 9. Pharmacokinetics - t1/2 [ Time Frame: Until last CC-90009 dose in Cycle 3 (each cycle is 28 days. CC-90009 dosing days are Days 1-5 in Cycle 3) ]
    terminal half life

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Adult subject must understand and voluntarily sign an ICF prior to any study-related
assessments/procedures being conducted.

2. Arm A (CC-90009 + venetoclax/azacitidine):

1. Newly diagnosed AML and is ≥ 75 years of age or intensive chemotherapy ineligible
OR

2. Refractory AML and is ≥ 18 years of age

3. Arm B (CC-90009 + gilteritinib):

1. Subject is ≥ 18 years of age.

2. FLT3-ITD positive relapsed or refractory AML.

3. Gilteritinib treatment naïve

4. Subject has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.

5. Subject must have the following screening laboratory values:

- Total White Blood Cell count (WBC) < 25 x 10^9 prior to study treatments. Treatment with hydroxyurea to achieve this level is allowed. - Selected electrolytes within normal limits or correctable with supplements. - Participant must have adequate liver function as demonstrated by: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN) and bilirubin ≤ 1.5 x ULN - Participant has adequate renal function as demonstrated by an estimated serum creatinine clearance of ≥ 60 mL/min using the Cockcroft-Gault equation. 6. Agree to follow the CC-90009 Pregnancy Prevention Plan (PPP) and combination agents' requirements. Exclusion Criteria: 1. Subject with acute promyelocytic leukemia (APL) 2. Subject has received systemic anticancer therapy (including investigational therapy) or radiotherapy < 28 days or 5 half-lives, whichever is shorter, prior to the start of study treatment 3. Patients with prior autologous hematopoietic stem cell transplant (HSCT) who, in the investigator's judgment, have not fully recovered from the effects of the last transplant (eg, transplant related side effects) 4. Prior allogeneic HSCT with either standard or reduced intensity conditioning ≤ 6 months prior to dosing 5. Subject on systemic immunosuppressive therapy post HSCT at the time of screening, or with clinically significant graft-versus-host disease (GVHD). The use of topical steroids for ongoing skin or ocular GVHD is permitted 6. Subject has persistent, clinically significant non-hematologic toxicities from prior therapies which have not recovered to < Grade 2 7. Subject has or is suspected of having central nervous system (CNS) leukemia. Evaluation of cerebrospinal fluid is only required if CNS involvement by leukemia is suspected during screening. 8. Disorders or conditions disrupting normal calcium homeostasis or preventing calcium supplementation. 9. Impaired cardiac function or clinically significant cardiac diseases, including any of the following: 1. Left ventricular ejection fraction (LVEF) 450 ms (Arm B) on Screening electrocardiogram (ECG)

6. Unstable angina pectoris or myocardial infarction ≤ 6 months prior to starting
study treatments or unstable arrhythmia.

7. Cardiovascular disability status of New York Heart Association Class ≥2. Class 2
is defined as cardiac disease in which patients are comfortable at rest but
ordinary physical activity results in fatigue, palpitations, dyspnea, or anginal
pain.

10. Subject is a pregnant or lactating female

11. Additional exclusion criteria based on combination agent:

a. For Combination Arm A (venetoclax/azacitidine):

- Received strong or moderate CYP3A inhibitors or inducers or P-gp inhibitors
within 7 days prior to initiation of first venetoclax dose.

- Subject has consumed grapefruit, grapefruit products, Seville oranges (including
marmalade containing Seville oranges), or Star fruit within 3 days prior to first
venetoclax dose through last dose of venetoclax.

12. Previous SARS-CoV-2 infection within 10 days for mild or asymptomatic infections or 20
days for severe/critical illness prior to C1D1.

a. Acute symptoms must have resolved and based on investigator assessment in
consultation with the medical monitor, there are no sequelae that would place the
participant at a higher risk of receiving study treatment.

13. Previous SARS-CoV-2 vaccine within 14 days of C1D1.

Contacts and Locations

Contacts

Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

Locations

United States, California
University of California, San Francisco
San Francisco

United States, Connecticut
Yale New Haven Hospital
New Haven

United States, Massachusetts
Dana-Farber/Mass General Brigham Cancer Care, Inc
Boston

United States, Missouri
Washington University School of Medicine
Saint Louis

United States, New Jersey
Hackensack University Medical Center
Hackensack

United States, Texas
The University of Texas - MD Anderson Cancer Center
Houston

United States, Washington
Fred Hutchinson Cancer Research Center
Seattle

Canada, Alberta
University of Alberta
Edmonton

Canada, Ontario
Princess Margaret Cancer Centre
Toronto

Canada, Quebec
Hopital Maisonneuve-Rosemont
Montreal

France
Institut Paoli-Calmettes
Marseille

France
Hopital Haut Leveque
Pessac Cedex

France
Institut Universitaire du Cancer de Toulouse (IUCT) - Oncopole
Toulouse Cedex 9

United Kingdom
John Radcliffe Hospital
Oxford

Sponsors and Collaborators

Celgene

AbbVie

Investigators

Study Director: Michael Pourdehnad, M.D. Celgene

More Information