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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02308761
Other study ID # NP39142
Secondary ID
Status Completed
Phase Phase 1
First received November 14, 2014
Last updated December 7, 2017
Start date November 6, 2014
Est. completion date August 9, 2017

Study information

Verified date December 2017
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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 identiļ¬ed. Up to 51 adult participants with AML or MDS will be enrolled in the study.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date August 9, 2017
Est. primary completion date August 9, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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:

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:

- 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

Study Design


Intervention

Drug:
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.

Locations

Country Name City State
United States Dana Farber Cancer Institute Boston Massachusetts
United States Weill Cornell Medical College New York New York

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With Dose-Limiting Toxicities (DLTs) Cycle 1 (cycle length = 21 or 28 days)
Primary MTD of RO6870810 Cycle 1 (cycle length = 21 or 28 days)
Primary Percentage of Participants With Adverse Events (AEs) Baseline up to 30 days after last dose (up to approximately 2.75 years)
Secondary Area Under the Concentration Versus Time Curve from Time Zero to the End of Dosing Interval 24 Hours Later (AUC0-24) of RO6870810 Predose (Hour 0), immediately postdose and 0.25, 0.5, 1, 2, 4 hours postdose on Cycle 1 Day 1 and Cycle 1 Day 22 (Cycle 1 Day 22 is applicable only for 28-day continuous treatment); Predose (Hour 0), 4 hours postdose on Cycle 1 Day 2; Days 8, 15 of Cycle 1; Predose (Hour 0) on Day 1 of each treatment cycle from Cycle 2 up to end of treatment (approximately 2.75 years) (Cycle length = 21 or 28 days) Cycle 1 Day 1 up to 2.75 years (detailed timeframe is provided in outcome description)
Secondary Maximum Observed Plasma Concentration (Cmax) of RO6870810 Predose (Hour 0), immediately postdose and 0.25, 0.5, 1, 2, 4 hours postdose on Cycle 1 Day 1 and Cycle 1 Day 22 (Cycle 1 Day 22 is applicable only for 28-day continuous treatment); Predose (Hour 0), 4 hours postdose on Cycle 1 Day 2; Days 8, 15 of Cycle 1; Predose (Hour 0) on Day 1 of each treatment cycle from Cycle 2 up to end of treatment (approximately 2.75 years) (Cycle length = 21 or 28 days) Cycle 1 Day 1 up to 2.75 years (detailed timeframe is provided in outcome description)
Secondary Time to Cmax (Tmax) of RO6870810 Predose (Hour 0), immediately postdose and 0.25, 0.5, 1, 2, 4 hours postdose on Cycle 1 Day 1 and Cycle 1 Day 22 (Cycle 1 Day 22 is applicable only for 28-day continuous treatment); Predose (Hour 0), 4 hours postdose on Cycle 1 Day 2; Days 8, 15 of Cycle 1; Predose (Hour 0) on Day 1 of each treatment cycle from Cycle 2 up to end of treatment (approximately 2.75 years) (Cycle length = 21 or 28 days) Cycle 1 Day 1 up to 2.75 years (detailed timeframe is provided in outcome description)
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