Acute Myeloid Leukemia Clinical Trial

A Study of Venetoclax in Combination With Cobimetinib and Venetoclax in Combination With Idasanutlin in Patients With Relapsed or Refractory Acute Myeloid Leukemia Who Are Not Eligible for Cytotoxic Therapy

Summary

The primary objective for this study is to assess the safety and tolerability as well as preliminary efficacy of venetoclax in combination with cobimetinib, and venetoclax in combination with idasanutlin in patients with relapsed or refractory acute myeloid leukemia (R/R) AML who are not eligible for cytotoxic therapy.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Histological confirmation of relapsed or refractory AML after prior anti-leukemic therapy by WHO classification

Ineligible for cytotoxic therapy defined by the following:

a. Age (>/=) 75 years or b. age 18- 74 years with at least one of the following comorbidities: i. Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 or 3 ii. Cardiac history of congestive heart failure requiring treatment or ejection fraction (/=) 30 mL/min to< 45 mL/min v. any other comorbidity that the physician judges to be incompatible with intensive chemotherapy must be reviewed and approved by the Medical Monitor before screening and study enrollment.

Life expectancy of at least 12 weeks
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
Adequate liver and renal function

Exclusion Criteria:

Patients with acute promyelocytic leukemia (French-American-British [FAB] class M3 AML)
Known active central nervous system (CNS) involvement with AML at study entry
ECOG Performance Status (>/=) 3 in patients who are (>/=) 75 years old or ECOG Performance Status of 4, regardless of age
Prior exposure to Bcl-2 inhibitors, murine double minute 2 (MDM2) antagonists or prior exposure to experimental treatment targeting Raf, mitogen-activated protein kinase (MEK), or the mitogen-activated protein kinase (MAPK) RAS/RAF/MEK/ERK MAPK pathway
Positive for hepatitis C virus (HCV), hepatitis B surface antigen (HBsAg) and known history of HIV, malignancy, active infection and cardiovascular diseases (CVs)
Received strong cytochrome (CYP) 3A inhibitors, moderate CYP3A inhibitors, strong CYP3A inducers and moderate CYP3A inducers within 7 days prior to initiation of study treatment
History of symptomatic Clostridium difficile infection within 1 month prior to dosing

Additional arm specific exclusion criteria:

Dose Escalation Arm A (Venetoclax and Cobimetinib):

History or evidence of retinal pathology on ophthalmologic examination that is considered a risk factor for neurosensory retinal detachment/central serous chorioretinopathy (CSCR), retinal vein occlusion (RVO), or neovascular macular degeneration
Left ventricular ejection fraction (LVEF) below institutional lower limit of normal (LLN) or below 50%, whichever is lower

Arm B (Venetoclax and Idasanutlin):

Received the following within 7 days prior to the initiation of study treatment: Strong CYP2C8 inhibitors or CYP2C8 substrates, OATP1B1/3 substrates
Received the following within 14 days prior to the initiation of study treatment: Strong CYP2C8 inducers
History of liver cirrhosis by radiologic, clinical or laboratory data, or biopsy despite normal liver function tests
Received treatment with oral or parenteral anticoagulants/anti-platelet agents within 7 days prior to initiation of study treatment.

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

88

Study ID:

NCT02670044

Recruitment Status:

Completed

Sponsor:

Hoffmann-La Roche

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There are 17 Locations for this study

See Locations Near You

USC Norris Cancer Center
Los Angeles California, 90033, United States
UC Davis; Comprehensive Cancer Center
Sacramento California, 95817, United States
Univ of Calif, San Francisco
San Francisco California, 94143, United States
University of Colorado
Aurora Colorado, 80045, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
Weill Cornell Medical College
New York New York, 10065, United States
Wake Forest Baptist Medical Center
Winston-Salem North Carolina, 27157, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
University of Alberta Hospital
Edmonton Alberta, T6G 1, Canada
Princess Margaret Cancer Center
Toronto Ontario, M5G 1, Canada
Jewish General Hospital
Montreal Quebec, H3T 1, Canada
Hopital Avicenne, Paris
Bobigny , 93009, France
Institut Paoli Calmettes
Marseille , 13009, France
CHU de Bordeaux
Pessac , 33600, France
University of Bologna
Bologna Emilia-Romagna, 40126, Italy
Presidio san salvatore muraglia
Pesaro Emilia-Romagna, 61122, Italy
Universita di Roma
Roma Emilia-Romagna, 100, Italy

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

88

Study ID:

NCT02670044

Recruitment Status:

Completed

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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