Non Hodgkins LymphomaPhase 1NCT01659255
Study to Evaluate the Safety and Tolerability of Tirabrutinib (ONO/GS-4059) Given as Monotherapy in Participants With Relapsed/Refractory NHL and CLL
A Phase 1 study testing Tirabrutinib in people with Non Hodgkins Lymphoma and Chronic Lymphocytic Leukaemia, run by Gilead Sciences at 6 sites in 2 countries.
Trial summary
The primary objective of the study is to evaluate the safety and tolerability of tirabrutinib (formerly ONO/GS-4059) given as monotherapy to participants with relapsed/refractory non-Hodgkin's lymphoma (NHL) and chronic lymphocytic leukemia (CLL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Hodgkins Lymphoma, Chronic Lymphocytic Leukaemia
- What is being tested?
- Tirabrutinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 17 Aug 2012to 11 Jan 2016
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Males or females with a confirmed diagnosis of and documented history of relapsed or refractory malignant disease (B-cell lymphoma and/or CLL) for which no therapy of curative or high priority exists and for whom treatment with a Btk inhibitor may be deemed appropriate.
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
Who cannot join
- Central nervous system (CNS) lymphoma.
- Women who are pregnant or lactating.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
France3 sites
CHRU - Hopital Claude HURIEZ
Lille, 59037
Centre hospitalier Lyon Sud
Lyon, 69495
CHU St Eloi
Montpellier, 34295
United Kingdom3 sites
University Hospital of Wales
Cardiff, CF14 4XW
Leicester Royal Infirmary
Leicester, LE1 5WW
Derriford Hospital
Plymouth, PL6 8DH
About this study
Official title: An Open-label, Multi-Center, Non-Randomised Phase I Dose-Escalation Study to Investigate the Safety and Tolerability of ONO-4059 (ONO/GS-4059) Given as Monotherapy in Patients With Relapsed/Refractory Non-Hodgkin's Lymphoma (NHL) and Relapsed/Refractory Chronic Lymphocytic Leukaemia (CLL)
The primary objective of the study is to evaluate the safety and tolerability of tirabrutinib (formerly ONO/GS-4059) given as monotherapy to participants with relapsed/refractory non-Hodgkin's lymphoma (NHL) and chronic lymphocytic leukemia (CLL).
- Being tested
- Tirabrutinib
- Medical subject headings
- Lymphoma, Non-Hodgkin, Leukemia, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirabrutinibDrug
Also called ONO/GS-4059
Capsules administered orally
| Study group | Role | What they receive |
|---|---|---|
| Tirabrutinib 20 mg Once Daily (CLL) | Experimental | Participants with relapsed/refractory chronic lymphocytic leukaemia (CLL) received tirabrutinib 20 mg once daily. Receives: Drug: Tirabrutinib |
| Tirabrutinib 40 mg Once Daily (CLL) | Experimental | Participants with relapsed/refractory CLL received tirabrutinib 40 mg once daily. Receives: Drug: Tirabrutinib |
| Tirabrutinib 80 mg Once Daily (CLL) | Experimental | Participants with relapsed/refractory CLL received tirabrutinib 80 mg once daily. Receives: Drug: Tirabrutinib |
| Tirabrutinib 160 mg Once Daily (CLL) | Experimental | Participants with relapsed/refractory CLL received tirabrutinib 160 mg once daily. Receives: Drug: Tirabrutinib |
| Tirabrutinib 320 mg Once Daily (CLL) | Experimental | Participants with relapsed/refractory CLL received tirabrutinib 320 mg once daily. Receives: Drug: Tirabrutinib |
| Tirabrutinib 400 mg Once Daily (CLL) | Experimental | Participants with relapsed/refractory CLL received tirabrutinib 400 mg once daily. Receives: Drug: Tirabrutinib |
| Tirabrutinib 500 mg Once Daily (CLL) | Experimental | Participants with relapsed/refractory CLL received tirabrutinib 500 mg once daily. Receives: Drug: Tirabrutinib |
| Tirabrutinib 600 mg Once Daily (CLL) | Experimental | Participants with relapsed/refractory CLL received tirabrutinib 600 mg once daily. Receives: Drug: Tirabrutinib |
| Tirabrutinib 300 mg Twice Daily (CLL) | Experimental | Participants with relapsed/refractory CLL received tirabrutinib 300 mg twice daily. Receives: Drug: Tirabrutinib |
| Tirabrutinib 20 mg Once Daily (NHL) | Experimental | Participants with relapsed/refractory non-Hodgkin's lymphoma (NHL) received tirabrutinib 20 mg once daily. Receives: Drug: Tirabrutinib |
| Tirabrutinib 40 mg Once Daily (NHL) | Experimental | Participants with relapsed/refractory NHL received tirabrutinib 40 mg once daily. Receives: Drug: Tirabrutinib |
| Tirabrutinib 80 mg Once Daily (NHL) | Experimental | Participants with relapsed/refractory NHL received tirabrutinib 80 mg once daily. Receives: Drug: Tirabrutinib |
| Tirabrutinib 160 mg Once Daily (NHL) | Experimental | Participants with relapsed/refractory NHL received tirabrutinib 160 mg once daily. Receives: Drug: Tirabrutinib |
| Tirabrutinib 320 mg Once Daily (NHL) | Experimental | Participants with relapsed/refractory NHL received tirabrutinib 320 mg once daily. Receives: Drug: Tirabrutinib |
| Tirabrutinib 480 mg Once Daily (NHL) | Experimental | Participants with relapsed/refractory NHL received tirabrutinib 480 mg once daily. Receives: Drug: Tirabrutinib |
| Tirabrutinib 600 mg Once Daily (NHL) | Experimental | Participants with relapsed/refractory NHL received tirabrutinib 600 mg once daily. Receives: Drug: Tirabrutinib |
| Tirabrutinib 240 mg Twice Daily (NHL) | Experimental | Participants with relapsed/refractory NHL received tirabrutinib 240 mg twice daily. Receives: Drug: Tirabrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Experiencing Dose-Limiting Toxicities
Dose Limiting Toxicities (DLT) were defined as follows:
- All Common Terminology Criteria (CTC) Grade 4 tirabrutinib related adverse events
- All CTC Grade 3 tirabrutinib related adverse events, with the exception of the following:
- CTC Grade 3 lymphocytosis considered an expected outcome of therapy
Any toxicity which in the opinion of the Investigator is attributed to a participant's underlying disease was not considered a DLT.
Measured: Day 1 through Day 28
Secondary outcomes (3)
Overall Response Rate
Overall response rate (ORR) was defined as the percentage of participants who achieve a best overall response of complete remission (CR, unconfirmed complete response (CRu), complete response with incomplete marrow recovery (CRi)) or partial remission (PR, nodal PR) during study as assessed by the investigator.
ORR assessment was defined per following standardized criteria:
- NHL: Cheson, 1999
- CLL: International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008
Measured: Up to Cycle 37 (28 days for each cycle) plus 6-month intervals thereafter until disease progression (maximum: up to 39 months)
Pharmacokinetic (PK) Parameter: Cmax of Tirabrutinib
Cmax is defined as the maximum concentration of drug.
Measured: Pre-dose, then 30 minutes, 1, 2, 3, 4, 6, 8, 12 hours post-dose at Cycle 1, Day 28
PK Parameter: AUCtau of Tirabrutinib
AUCtau is defined as concentration of drug over dosing interval.
Measured: Pre-dose, then 30 minutes, 1, 2, 3, 4, 6, 8, 12 hours post-dose at Cycle 1, Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2012 (estimated)
- Study start17 Aug 2012
- Primary completion23 Feb 2015
- Study completion11 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Non Hodgkins LymphomaStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ono Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01659255
- Sponsor's protocol ID
- ONO-4059POE001
- Other IDs
- 2011-005033-39
- Status last verified
- Feb 2021
- First submitted
- 6 Jul 2012
- Last updated
- 16 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Walter HS, Salles GA, Dyer MJ. New Agents to Treat Chronic Lymphocytic Leukemia. N Engl J Med. 2016 Jun 2;374(22):2185-6. doi: 10.1056/NEJMc1602674. No abstract available.
PubMed 27248633Walter HS, Rule SA, Dyer MJ, Karlin L, Jones C, Cazin B, Quittet P, Shah N, Hutchinson CV, Honda H, Duffy K, Birkett J, Jamieson V, Courtenay-Luck N, Yoshizawa T, Sharpe J, Ohno T, Abe S, Nishimura A, Cartron G, Morschhauser F, Fegan C, Salles G. A phase 1 clinical trial of the selective BTK inhibitor ONO/GS-4059 in relapsed and refractory mature B-cell malignancies. Blood. 2016 Jan 28;127(4):411-9. doi: 10.1182/blood-2015-08-664086. Epub 2015 Nov 5.
PubMed 26542378Fegan, C, Bagshawe J, Salles G, et al. The Bruton's tyrosine kinase (BTK) inhibitor ONO-4059: promising single agent activity and well tolerated in patients with high risk chronic lymphocytic leukaemia (CLL). Paper presented at: 56th American Society of Hematology Annual Meeting and Exposition; December 6-9, 2014; San Franscisco, CA.
Morschhauser F, Terriou L, Dyer M, et al. The Bruton's tyrosine kinase (BTK) inhibitor ONO-4059: promising single agent activity in patients with relapsed and refractory NHL. Haematologica. 2014 Jun; 99: 150.
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-Center, Non-Randomised Phase I Dose-Escalation Study to Investigate the Safety and Tolerability of ONO-4059 (ONO/GS-4059) Given as Monotherapy in Patients With Relapsed/Refractory Non-Hodgkin's Lymphoma (NHL) and Relapsed/Refractory Chronic Lymphocytic Leukaemia (CLL)
- ClinicalTrials.gov ID
- NCT01659255
- Acronym / sponsor ID
- ONO-4059POE001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Collaborators
- Ono Pharmaceutical Co., Ltd.
- Study start
- 17 Aug 2012 (actual)
- Primary completion
- 23 Feb 2015 (actual)
- Study completion
- 11 Jan 2016 (actual)
- First posted
- 7 Aug 2012 (estimated)
- Results
- Posted 28 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to evaluate the safety and tolerability of tirabrutinib (formerly ONO/GS-4059) given as monotherapy to participants with relapsed/refractory non-Hodgkin's lymphoma (NHL) and chronic lymphocytic leukemia (CLL).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 17
| Arm | Type | Receives |
|---|---|---|
| Tirabrutinib 20 mg Once Daily (CLL) | Experimental | Drug: TirabrutinibParticipants with relapsed/refractory chronic lymphocytic leukaemia (CLL) received tirabrutinib 20 mg once daily. |
| Tirabrutinib 40 mg Once Daily (CLL) | Experimental | Drug: TirabrutinibParticipants with relapsed/refractory CLL received tirabrutinib 40 mg once daily. |
| Tirabrutinib 80 mg Once Daily (CLL) | Experimental | Drug: TirabrutinibParticipants with relapsed/refractory CLL received tirabrutinib 80 mg once daily. |
| Tirabrutinib 160 mg Once Daily (CLL) | Experimental | Drug: TirabrutinibParticipants with relapsed/refractory CLL received tirabrutinib 160 mg once daily. |
| Tirabrutinib 320 mg Once Daily (CLL) | Experimental | Drug: TirabrutinibParticipants with relapsed/refractory CLL received tirabrutinib 320 mg once daily. |
| Tirabrutinib 400 mg Once Daily (CLL) | Experimental | Drug: TirabrutinibParticipants with relapsed/refractory CLL received tirabrutinib 400 mg once daily. |
| Tirabrutinib 500 mg Once Daily (CLL) | Experimental | Drug: TirabrutinibParticipants with relapsed/refractory CLL received tirabrutinib 500 mg once daily. |
| Tirabrutinib 600 mg Once Daily (CLL) | Experimental | Drug: TirabrutinibParticipants with relapsed/refractory CLL received tirabrutinib 600 mg once daily. |
| Tirabrutinib 300 mg Twice Daily (CLL) | Experimental | Drug: TirabrutinibParticipants with relapsed/refractory CLL received tirabrutinib 300 mg twice daily. |
| Tirabrutinib 20 mg Once Daily (NHL) | Experimental | Drug: TirabrutinibParticipants with relapsed/refractory non-Hodgkin's lymphoma (NHL) received tirabrutinib 20 mg once daily. |
| Tirabrutinib 40 mg Once Daily (NHL) | Experimental | Drug: TirabrutinibParticipants with relapsed/refractory NHL received tirabrutinib 40 mg once daily. |
| Tirabrutinib 80 mg Once Daily (NHL) | Experimental | Drug: TirabrutinibParticipants with relapsed/refractory NHL received tirabrutinib 80 mg once daily. |
| Tirabrutinib 160 mg Once Daily (NHL) | Experimental | Drug: TirabrutinibParticipants with relapsed/refractory NHL received tirabrutinib 160 mg once daily. |
| Tirabrutinib 320 mg Once Daily (NHL) | Experimental | Drug: TirabrutinibParticipants with relapsed/refractory NHL received tirabrutinib 320 mg once daily. |
| Tirabrutinib 480 mg Once Daily (NHL) | Experimental | Drug: TirabrutinibParticipants with relapsed/refractory NHL received tirabrutinib 480 mg once daily. |
| Tirabrutinib 600 mg Once Daily (NHL) | Experimental | Drug: TirabrutinibParticipants with relapsed/refractory NHL received tirabrutinib 600 mg once daily. |
| Tirabrutinib 240 mg Twice Daily (NHL) | Experimental | Drug: TirabrutinibParticipants with relapsed/refractory NHL received tirabrutinib 240 mg twice daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males or females with a confirmed diagnosis of and documented history of relapsed or refractory malignant disease (B-cell lymphoma and/or CLL) for which no therapy of curative or high priority exists and for whom treatment with a Btk inhibitor may be deemed appropriate.
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
Key exclusion criteria (3 listed)
- Central nervous system (CNS) lymphoma.
- Women who are pregnant or lactating.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TirabrutinibAlso: ONO/GS-4059Capsules administered orally | Drug | Tirabrutinib 160 mg Once Daily (CLL), Tirabrutinib 160 mg Once Daily (NHL), Tirabrutinib 20 mg Once Daily (CLL), Tirabrutinib 20 mg Once Daily (NHL), Tirabrutinib 240 mg Twice Daily (NHL), Tirabrutinib 300 mg Twice Daily (CLL), Tirabrutinib 320 mg Once Daily (CLL), Tirabrutinib 320 mg Once Daily (NHL), Tirabrutinib 40 mg Once Daily (CLL), Tirabrutinib 40 mg Once Daily (NHL), Tirabrutinib 400 mg Once Daily (CLL), Tirabrutinib 480 mg Once Daily (NHL), Tirabrutinib 500 mg Once Daily (CLL), Tirabrutinib 600 mg Once Daily (CLL), Tirabrutinib 600 mg Once Daily (NHL), Tirabrutinib 80 mg Once Daily (CLL), Tirabrutinib 80 mg Once Daily (NHL) |
Primary outcome
Percentage of Participants Experiencing Dose-Limiting Toxicities
Time frame: Day 1 through Day 28
Dose Limiting Toxicities (DLT) were defined as follows: * All Common Terminology Criteria (CTC) Grade 4 tirabrutinib related adverse events * All CTC Grade 3 tirabrutinib related adverse events, with the exception of the following: * CTC Grade 3 lymphocytosis considered an expected outcome of therapy Any toxicity which in the opinion of the Investigator is attributed to a participant's underlying disease was not considered a DLT.
3 secondary outcomes
Overall Response Rate
Time frame: Up to Cycle 37 (28 days for each cycle) plus 6-month intervals thereafter until disease progression (maximum: up to 39 months)
Pharmacokinetic (PK) Parameter: Cmax of Tirabrutinib
Time frame: Pre-dose, then 30 minutes, 1, 2, 3, 4, 6, 8, 12 hours post-dose at Cycle 1, Day 28
PK Parameter: AUCtau of Tirabrutinib
Time frame: Pre-dose, then 30 minutes, 1, 2, 3, 4, 6, 8, 12 hours post-dose at Cycle 1, Day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27248633Walter HS, Salles GA, Dyer MJ. New Agents to Treat Chronic Lymphocytic Leukemia. N Engl J Med. 2016 Jun 2;374(22):2185-6. doi: 10.1056/NEJMc1602674. No abstract available.
- Results publication: PubMed 26542378Walter HS, Rule SA, Dyer MJ, Karlin L, Jones C, Cazin B, Quittet P, Shah N, Hutchinson CV, Honda H, Duffy K, Birkett J, Jamieson V, Courtenay-Luck N, Yoshizawa T, Sharpe J, Ohno T, Abe S, Nishimura A, Cartron G, Morschhauser F, Fegan C, Salles G. A phase 1 clinical trial of the selective BTK inhibitor ONO/GS-4059 in relapsed and refractory mature B-cell malignancies. Blood. 2016 Jan 28;127(4):411-9. doi: 10.1182/blood-2015-08-664086. Epub 2015 Nov 5.
- Results publicationFegan, C, Bagshawe J, Salles G, et al. The Bruton's tyrosine kinase (BTK) inhibitor ONO-4059: promising single agent activity and well tolerated in patients with high risk chronic lymphocytic leukaemia (CLL). Paper presented at: 56th American Society of Hematology Annual Meeting and Exposition; December 6-9, 2014; San Franscisco, CA.
- Results publicationMorschhauser F, Terriou L, Dyer M, et al. The Bruton's tyrosine kinase (BTK) inhibitor ONO-4059: promising single agent activity in patients with relapsed and refractory NHL. Haematologica. 2014 Jun; 99: 150.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilead Study Director study director
Gilead Sciences
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tirabrutinib in people with Non Hodgkins Lymphoma and Chronic Lymphocytic Leukaemia, run by Gilead Sciences at 6 sites in 2 countries.
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 3 inclusion and 3 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 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France, United Kingdom. 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?
Yes. Results are posted in the registry (first posted 28 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Experiencing Dose-Limiting Toxicities (time frame: Day 1 through Day 28). 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 NCT01659255, which also lists 4 linked publications.
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 16 Mar 2021.