A Study of RO6870810/TEN-010 in Participants With Acute Myeloid Leukemia and Myelodysplastic Syndrome

Completed · Phase 1

Conditions studied: Acute Myeloid Leukemia, Myelodysplastic Syndromes

In brief

RO6870810 (formerly TEN-010) is a small molecule, bromodomain and extra-terminal (BET) bromodomain inhibitor. This study is designed to characterize the safety, tolerability, and pharmacokinetics of RO6870810 monotherapy in participants with relapsed/refractory acute myeloid leukemia (RR-AML) and hypomethylating agent (HMA)-refractory myelodysplastic syndrome (MDS). The study will consist of a Screening Period, Treatment Period, and Post-Treatment Period. A standard 3+3 design will be used in which successive cohorts of three or more participants with RR-AML or HMA-refractory MDS will be treated at escalating doses until a maximum tolerated dose (MTD) is identiﬁed. Up to 51 adult participants with AML or MDS will be enrolled in the study.

Key facts

Study ID: NCT02308761
Run by: Hoffmann-La Roche
People needed: 26
Starts: 2014-11-06
Expected to finish: 2017-08-09
Last updated by the study team: 2017-12-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

RR-AML
Relapsed/refractory MDS
Participants with a history of allogeneic stem cell transplant are eligible for study participation provided the following eligibility criteria are met:
Transplant was more than (>) 100 days prior to study enrollment
Participant has not taken immunosuppressive medications for at least 2 weeks
No signs or symptoms of graft versus host disease other than Grade 1 skin involvement
No active infection
Eastern Cooperative Oncology Group Performance Status score equal to or less than (<=) 2
Life expectancy of at least 2 months
Disease-free of active second/secondary or prior malignancies for equal to or more than (>=) 1 year with the exception of currently treated basal cell or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix or breast
Adequate hematological, renal, hepatic and coagulation laboratory test results
Women of childbearing potential and men must agree to use adequate contraception from 28 days prior to the first dose of the study drug, during the entire Treatment Period, and for at least 28 days after the last dose of the study drug

You may not qualify if…

New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia
Have Fridericia-corrected QT interval > 470 milliseconds (msec) (female) or > 450 msec (male), or history of congenital long QT syndrome
Uncontrolled bacterial, viral, or fungal infections
Known clinically important respiratory impairment
Positive for human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C antibodies
History of major organ transplant
Symptomatic central nervous system disease, malignancy, or metastasis
Pregnant or nursing
Concomitant chemotherapy, radiation therapy, immunotherapy, biologic therapy, or hormonal therapy
Treatment with surgery or chemotherapy within 21 days prior to study entry
Prior treatment with small molecule bromodomain and extra terminal family inhibitor
Radiation for symptomatic lesions within 14 days of study enrollment
Active substance abuse

Where it is running

Dana Farber Cancer Institute — Boston, Massachusetts, United States
Weill Cornell Medical College — New York, New York, United States

Full record on ClinicalTrials.gov

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