Trials / Completed
CompletedNCT02265731
Study Evaluating Venetoclax in Subjects With Hematological Malignancies
A Phase 1/2 Study Evaluating the Safety, Pharmacokinetics and Efficacy of Venetoclax in Japanese Subjects With Hematological Malignancies
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 38 (actual)
- Sponsor
- AbbVie · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
This study is evaluating the safety, pharmacokinetic profile and efficacy of venetoclax under a once daily dosing schedule in Japanese participants with hematological malignancies.
Conditions
- Non-Hodgkin Lymphoma (NHL)
- Multiple Myeloma (MM)
- Chronic Lymphocytic Leukemia (CLL)
- Small Lymphocytic Lymphoma (SLL)
- Acute Myeloid Leukemia (AML)
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | azacitadine | 75 mg/m2 by IV infusion or subcutaneous dosing |
| DRUG | venetoclax | Step-up doses of venetoclax to the designated cohort dose |
| DRUG | rituximab / IDEC-C2B8 | 375 mg/m2 on Week 6 |
| DRUG | rituximab / IDEC-C2B8 | 500 mg/m2 Week 10 Day 1 and thereafter |
Timeline
- Start date
- 2014-09-22
- Primary completion
- 2021-03-12
- Completion
- 2021-03-12
- First posted
- 2014-10-16
- Last updated
- 2021-08-02
Locations
14 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT02265731. Inclusion in this directory is not an endorsement.