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Acute Myeloid LeukemiaPhase 1NCT02308761

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

A Phase 1 study testing RO6870810 in people with Acute Myeloid Leukemia and Myelodysplastic Syndromes, run by Hoffmann-La Roche at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
RO6870810
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
2 sitesUnited States
Study dates
6 Nov 2014to 9 Aug 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Weill Cornell Medical College

    New York, New York, 10065

Other trials in United States

About this study

Official title: A Dose Escalation Study of RO6870810/TEN-010 in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome

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.

Being tested
RO6870810
Medical subject headings
Leukemia, Myeloid, Acute, Myelodysplastic Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RO6870810Drug

    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.

Study groups in NCT02308761
Study groupRoleWhat they receive
RO6870810ExperimentalParticipants with RR-AML and HMA-refractory MDS will receive RO6870810, as per schedule described in intervention description.
Receives: Drug: RO6870810

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Dose-Limiting Toxicities (DLTs)

    Measured: Cycle 1 (cycle length = 21 or 28 days)

  2. MTD of RO6870810

    Measured: Cycle 1 (cycle length = 21 or 28 days)

  3. Percentage of Participants With Adverse Events (AEs)

    Measured: Baseline up to 30 days after last dose (up to approximately 2.75 years)

Secondary outcomes (3)

  1. 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)

    Measured: Cycle 1 Day 1 up to 2.75 years (detailed timeframe is provided in outcome description)

  2. 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)

    Measured: Cycle 1 Day 1 up to 2.75 years (detailed timeframe is provided in outcome description)

  3. 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)

    Measured: Cycle 1 Day 1 up to 2.75 years (detailed timeframe is provided in outcome description)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2014 (estimated)
  2. Study start6 Nov 2014
  3. Primary completion9 Aug 2017
  4. Study completion9 Aug 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02308761
Sponsor's protocol ID
NP39142
Status last verified
Dec 2017
First submitted
14 Nov 2014
Last updated
11 Dec 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 33586590

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RO6870810 in people with Acute Myeloid Leukemia and Myelodysplastic Syndromes, run by Hoffmann-La Roche at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Dose-Limiting Toxicities (DLTs) (time frame: Cycle 1 (cycle length = 21 or 28 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02308761, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2017.

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