A Study of Venetoclax in Combination With Cobimetinib and Venetoclax in Combination With Idasanutlin in Patients Aged >/= 60 Years With Relapsed or Refractory Acute Myeloid Leukemia Who Are Not Eligible for Cytotoxic Therapy



Status:Recruiting
Conditions:Blood Cancer, Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:60 - Any
Updated:3/10/2019
Start Date:March 31, 2016
End Date:June 30, 2020
Contact:Reference Study ID Number: GH29914 www.roche.com/about_roche/roche_worldwide.htm
Email:global.rochegenentechtrials@roche.com
Phone:888-662-6728 (U.S. and Canada)

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A Phase IB/II Multi-Arm Study With Venetoclax in Combination With Cobimetinib and Venetoclax in Combination With Idasanutlin in Patients Aged >/= 60 Years With Relapsed or Refractory Acute Myeloid Leukemia Who Are Not Eligible for Cytotoxic Therapy

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 >/= 60 years of age with relapsed or refractory
acute myeloid leukemia (R/R) AML who are not eligible for cytotoxic therapy.


Inclusion Criteria:

- Age >/= 60 years

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

- Not eligible for cytotoxic therapies

- Ineligible for allogeneic stem cell transplant

- 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

- 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 phase specific exclusion criteria:

Phase Ib 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

Phase Ib Dose-Escalation 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

- Received hormonal therapy (apart from luteinizing hormone releasing hormone
agonist/antagonist for prostate cancer and hormone replacement therapy) within 2 weeks
prior to the first dose of study treatment

- History of liver cirrhosis by radiologic, clinical or laboratory data, or biopsy
despite normal liver function tests

Phase II Expansion Arm A and Arm B:

- 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 or evidence of retinal pathology on ophthalmologic examination that is
considered a risk factor for neurosensory retinal detachment/CSCR, RVO, or neovascular
macular degeneration

- LVEF below institutional LLN or below 50%, whichever is lower

- Received hormonal therapy (apart from luteinizing hormone releasing hormone
agonist/antagonist for prostate cancer and hormone replacement therapy) within 2 weeks
prior to the first dose of study treatment

- History of liver cirrhosis by radiologic, clinical or laboratory data, or biopsy
despite normal liver function tests
We found this trial at
11
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New York, New York 10021
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Aurora, Colorado 80045
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Commack, New York 11725
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Edmonton, Alberta
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Houston, Texas 77030
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Los Angeles, California 90033
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4501 X St
Sacramento, California 95817
(916) 734-5800
UC Davis Comprehensive Cancer Center When faced with cancer, you want the best hope for...
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505 Parnassus Avenue
San Francisco, California 94143
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Stanford, California 94305
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Winston-Salem, North Carolina 27157
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