Phase 1
Completed N=20
A Phase 1, Dose-escalation Study of MEDI-551 in Japanese Adult Patients With Relapsed or Refractory Advanced B-cell Malignancies
Blood Cancer · Advanced B Cell Malignancies
Source: ClinicalTrials.gov NCT01957579 ↗
Enrolled (actual)
20
Serious AEs
5.0%
Results posted
Apr 2017
Primary outcomePrimary: Number of Participants With Adverse Events — 3; 6; 4; 6 Participants
Summary
The primary objective of this study is to evaluate the safety and tolerability of MEDI-551 in Japanese patients with relapsed or refractory advanced B-cell malignancies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
3; 6; 4; 6; 2; 2 | — |
| SECONDARY Number of Participants With Dose Limiting Toxicities |
0; 1; 0; 2; 0; 1 | — |
| SECONDARY Maximum Tolerated Dose |
8 | — |
| SECONDARY MEDI-551 Trough Concentration Levels at Day 0 (Pre-dose) |
NA; NA; NA; NA | — |
| SECONDARY MEDI-551 Trough Concentration Levels at Day 7 |
21.3; 39.2; 91.9; 104 | — |
| SECONDARY MEDI-551 Trough Concentration Levels at Day 28 |
23.2; 36.2; 103; 115 | — |
| SECONDARY MEDI-551 Trough Concentration Levels at Day 56 |
22.0; 33.2; 89.5; 114 | — |
| SECONDARY MEDI-551 Trough Concentration Levels at Day84 |
21.7; 33.7; 91.6; 103 | — |
| SECONDARY MEDI-551 Trough Concentration Levels at Day 112 |
22.9; 35.3; 85.5; 114 | — |
| SECONDARY MEDI-551 Trough Concentration Levels at Day 140 |
22.1; 36.3; 86.1; 117 | — |
| SECONDARY MEDI-551 Trough Concentration Levels at Day 168 |
20.0; 31.4; 94.1; 82.1 | — |
| SECONDARY Anti-MEDI-551 Antibodies |
0; 0; 1; 0; 3; 7 | — |
| SECONDARY Number of Participants With Tumour Response in FL Patients |
2; 3; 2; 2 | — |
| SECONDARY Number of Participants With Tumour Response in DLBCL Patients |
0; 1; 2 | — |
| SECONDARY Number of Participants With Tumour Response in CLL Patients |
1; 0 | — |
| SECONDARY Number of Participants With Tumour Response in MM Patients |
— | — |
Eligibility Criteria
Inclusion Criteria
- Japanese men or women at least 20 years of age
- Histologically confirmed CLL (excluding small lymphocytic lymphoma (SLL)), DLBCL, FL, or MM.
- Karnofsky Performance Status ≥70;
- Life expectancy of ≥12 weeks
Exclusion Criteria
- Any available standard line of therapy known to be life-prolonging or life-saving
- Any concurrent chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy for treatment of cancer
- Previous therapy directed against CD19, such as monoclonal antibodies or MAb conjugates
Data sourced from ClinicalTrials.gov (NCT01957579). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.