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NCT02457598 · ClinicalTrials.gov registry record · Phase 1
Dose Escalation and Dose Expansion Study of Tirabrutinib in Combination With Other Targeted Anti-cancer Therapies in Adults With B-cell Malignancies
A Phase 1 study, sponsored by Gilead Sciences.
- Terminated
- Registry status
- Phase 1
- Development phase
- 203
- Enrollment target
NCT02457598 is a Phase 1 study that was terminated before completion, run by Gilead Sciences. The registered enrollment target is 203 participants.
The verdict
NCT02457598, a Phase 1 study, was terminated before completion, sponsored by Gilead Sciences.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 203 participants
- Enrollment target
Study Summary
The primary objectives of this study are to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of tirabrutinib (ONO/GS-4059) in combination with other targeted anti-cancer therapies and to evaluate the long-term safety of tirabrutinib as a monotherapy and in combination with other targeted anti-cancer therapies in adults with relapsed or refractory B-cell lymphoproliferative malignancies. This study consists of three parts: Dose Escalation, Dose Expansion, and Long-term Safety Monitoring. During the Dose Escalation phase, participants will be sequentially enrolled in a standard 3 + 3 dose escalation study design, to receive oral tirabrutinib combined with idelalisib entospletinib +/- obinutuzumab. The Dose Expansion Phase will enroll additional participants with a single B-cell lymphoproliferative malignancy disease type to further evaluate efficacy, safety, tolerability, PK, and pharmacodynamics. The Long-term Safety Monitoring phase will evaluate the long-term safety of tirabrutinib both as a monotherapy and in combination with other anti-cancer therapies. As of Amendment 9, all participants currently on the study who have no clinical evidence of disease progression will transition into long-term safety monitoring. Participants from the ongoing Study GS-US-401-1787 and participants who came off Study GS-US-401-1757 and Study GS-US-401-1787 but continued to receive treatment via named patient use (or individual expanded use) will be enrolled into the long-term safety monitoring group (Group VI). Participants enrolled in Group VI will continue the same treatment regimen in Study GS-US-401-1787 or named patient use (or individual expanded use). As of Protocol Amendment 8, the maximum treatment duration for any participant is an additional 6 years from the date of this amendment (ie. until November 2025). As of Amendment 9, entospletinib will be provided until 31 December 2020 to participants who are currently receivi
Interventions
- DRUG Obinutuzumab
- DRUG Tirabrutinib
- DRUG Idelalisib
- DRUG Entospletinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 203 participants |
| Start Date | 2015-06-16 |
| Est. Completion | 2024-09-25 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02457598
The ClinicalTrials.gov registry entry for NCT02457598 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 203 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Obinutuzumab is the first listed.
NCT02457598 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02457598 about?
NCT02457598 is a clinical study titled "Dose Escalation and Dose Expansion Study of Tirabrutinib in Combination With Other Targeted Anti-cancer Therapies in Adults With B-cell Malignancies". The primary objectives of this study are to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of tirabrutinib (ONO/GS-4059) in combination with other targeted anti-cancer therapies and to evaluate the long-term safety of tirabrutinib as a monotherap...
What is the current status of trial NCT02457598?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 203 participants. The study started on 2015-06-16. Estimated completion is 2024-09-25.
What interventions are being tested in trial NCT02457598?
The interventions under investigation include: Obinutuzumab (DRUG), Tirabrutinib (DRUG), Idelalisib (DRUG), Entospletinib (DRUG).
Who is sponsoring clinical trial NCT02457598?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
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