Trials / Terminated
TerminatedNCT02292225
Duvelisib With Obinutuzumab in Patients With CLL/SLL Previously Treated With a BTKi (SYNCHRONY)
A Phase 1b Study of Duvelisib Administered in Combination With Obinutuzumab in Patients With CLL/SLL Previously Treated With a Bruton's Tyrosine Kinase Inhibitor (BTKi) (SYNCHRONY)
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 3 (actual)
- Sponsor
- SecuraBio · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the safety, pharmacokinetics, and pharmacodynamics of Duvelisib (IPI-145) in combination with obinutuzumab in patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma previously treated with a BTKi.
Detailed description
This is a Phase 1b, open-label, dose escalation, safety and tolerability study of Duvelisib (IPI-145) in combination with obinutuzumab in subjects with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma previously treated with a BTKi therapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | IPI-145 (duvelisib) | 25mg and/or 5mg oral capsule |
| DRUG | Obinutuzumab | 1000mg/40mL single-use vials |
Timeline
- Start date
- 2015-02-01
- Primary completion
- 2016-11-01
- Completion
- 2016-11-01
- First posted
- 2014-11-17
- Last updated
- 2023-02-27
Locations
7 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT02292225. Inclusion in this directory is not an endorsement.