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NCT03328078 · ClinicalTrials.gov registry record · Phase 1
CA-4948-101: Open-Label, Dose Escalation and Expansion Trial of Emavusertib (CA-4948) in Relapsed or Refractory Primary Central Nervous System Lymphoma (R/R PCNSL)
A Phase 1 study of Relapsed Hematologic Malignancy and Refractory Primary Central Nervous System Lymphoma, sponsored by Curis.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 152
- Enrollment target
- 20
- Study locations
NCT03328078: Recruiting Phase 1 study of Relapsed Hematologic Malignancy and Refractory Primary Central Nervous System Lymphoma, sponsored by Curis.
NCT03328078 is a Phase 1 study of Relapsed Hematologic Malignancy and Refractory Primary Central Nervous System Lymphoma that is actively recruiting participants, run by Curis. The registered enrollment target is 152 participants, below the 383-participant average among 3 other Relapsed Hematologic Malignancy trials with a reported enrollment target (60% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03328078, a Phase 1 study of Relapsed Hematologic Malignancy and Refractory Primary Central Nervous System Lymphoma, is actively recruiting participants, sponsored by Curis.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 152 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a multi-center, open-label study to evaluate the safety, pharmacokinetics (PK), and anti-cancer activity of oral administration of emavusertib alone or in combination with ibrutinib in adult participants with relapsed or refractory (R/R) hematologic malignancies. This trial will be completed in four parts. In Part A1, emavusertib will be evaluated first in a dose escalating monotherapy setting to establish the safety and tolerability (complete). In Part A2, emavusertib will be evaluated in combination with ibrutinib at 560 milligrams (mg) once daily (QD) or 420 mg QD as indicated by disease (Part A2 complete). Part B will comprise 2 cohorts to assess safety and efficacy of emavusertib in combination with ibrutinib in participants with R/R primary central nervous system lymphoma (PCNSL) who have directly progressed on a bruton tyrosine kinase inhibitor (BTKi). In this part of the study, emavusertib will be dosed at 100 mg or 200 mg twice daily (BID) in combination with ibrutinib in 28-day treatment cycles. Part C will comprise 3 treatment arms in the second-line setting to assess the efficacy and safety of emavusertib monotherapy, ibrutinib monotherapy, and emavusertib in combination with ibrutinib in participants with R/R PCNSL who are naïve to BTKi treatment. In this part of the study, eligible second-line participants with R/R PCNSL who are naïve to BTKi treatment will be randomized 1:1:1 to 1 of 3 treatment arms: (1) emavusertib 200 mg BID, (2) ibrutinib 560 mg QD, or (3) emavusertib 200 mg BID in combination with ibrutinib 560 mg QD.
Primary Outcome
The number of participants with a dose-limiting toxicity (DLT) in the first treatment cycle
Conditions Studied
Interventions
- DRUG Ibrutinib
- DRUG Emavusertib
Study Locations (20)
New York
- Roswell Park Comprehensive Cancer Center - Buffalo
- Mt Sinai - New York
- Columbia University Irving Medical Center - New York
- Memorial Sloan Kettering Cancer Center - New York
California
- City of Hope - Duarte
- Providence St. John's Health Center - Santa Monica
- UCLA Department of Medicine - Hematology/Oncology - Santa Monica
Arizona
- St. Joseph's Hospital and Medical Center - Phoenix
- Mayo Clinic - Phoenix
Connecticut
- Smilow Cancer Hospital at Yale-New Haven - New Haven
Florida
- Mayo Clinic - Jacksonville
Illinois
- Northwestern Memorial Hospital - Chicago
Massachusetts
- Dana Farber Cancer Institute - Boston
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 152 participants |
| Start Date | 2017-12-28 |
| Est. Completion | 2026-10 |
| Phase | Phase 1 |
What NCT03328078 shows while recruiting
NCT03328078 is an interventional study that assigns participants to a tested intervention. The registered 152 participants enrollment target is mid-sized for trials with a published cap, below the 383-participant average among 3 other Relapsed Hematologic Malignancy trials with a reported enrollment target (60% lower).
The record links to 4 conditions, with Relapsed Hematologic Malignancy appearing as the primary indexed condition, and to 2 interventions - of which Ibrutinib is the first listed.
NCT03328078 names 20 study sites across 14 states, led by New York, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT03328078 about?
NCT03328078 is a clinical study titled "CA-4948-101: Open-Label, Dose Escalation and Expansion Trial of Emavusertib (CA-4948) in Relapsed or Refractory Primary Central Nervous System Lymphoma (R/R PCNSL)". This is a multi-center, open-label study to evaluate the safety, pharmacokinetics (PK), and anti-cancer activity of oral administration of emavusertib alone or in combination with ibrutinib in adult participants with relapsed or refractory (R/R) hematologic malignancies. This trial will be complete...
What is the current status of trial NCT03328078?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 152 participants. The study started on 2017-12-28. Estimated completion is 2026-10.
What conditions does trial NCT03328078 study?
This clinical trial studies the following conditions: Relapsed Hematologic Malignancy, Refractory Primary Central Nervous System Lymphoma, Refractory Hematologic Malignancy, Relapsed Primary Central Nervous System Lymphoma.
What interventions are being tested in trial NCT03328078?
The interventions under investigation include: Ibrutinib (DRUG), Emavusertib (DRUG).
Who is sponsoring clinical trial NCT03328078?
This trial is sponsored by Curis, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03328078 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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