A Study of RO6870810/TEN-010 in Participants With Acute Myeloid Leukemia and Myelodysplastic Syndrome
NCT ID: NCT02308761
Last Updated: 2017-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
26 participants
INTERVENTIONAL
2014-11-06
2017-08-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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RO6870810
Participants with RR-AML and HMA-refractory MDS will receive RO6870810, as per schedule described in intervention description.
RO6870810
Participants will receive RO6870810 once daily (at escalated doses) via subcutaneous injection in either 28-day cycles (continuous 28 days dosing or 21 days dosing followed by 7 days off drug) or in 21-day cycle (14 days dosing followed by 7 days off drug), until MTD is identified.
Interventions
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RO6870810
Participants will receive RO6870810 once daily (at escalated doses) via subcutaneous injection in either 28-day cycles (continuous 28 days dosing or 21 days dosing followed by 7 days off drug) or in 21-day cycle (14 days dosing followed by 7 days off drug), until MTD is identified.
Eligibility Criteria
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Inclusion Criteria
* Relapsed/refractory MDS
* Participants with a history of allogeneic stem cell transplant are eligible for study participation provided the following eligibility criteria are met:
1. Transplant was more than (\>) 100 days prior to study enrollment
2. Participant has not taken immunosuppressive medications for at least 2 weeks
3. No signs or symptoms of graft versus host disease other than Grade 1 skin involvement
4. 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Dana Farber Cancer Institute
Boston, Massachusetts, United States
Weill Cornell Medical College
New York, New York, United States
Countries
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References
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Roboz GJ, Desai P, Lee S, Ritchie EK, Winer ES, DeMario M, Brennan B, Nuesch E, Chesne E, Brennan L, Lechner K, Kornacker M, DeAngelo DJ. A dose escalation study of RO6870810/TEN-10 in patients with acute myeloid leukemia and myelodysplastic syndrome. Leuk Lymphoma. 2021 Jul;62(7):1740-1748. doi: 10.1080/10428194.2021.1881509. Epub 2021 Feb 13.
Other Identifiers
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NP39142
Identifier Type: -
Identifier Source: org_study_id