Phase 1
Completed N=48
A Study of Obinutuzumab in Chinese Participants With CD20+ Malignant Disease
Source: ClinicalTrials.gov NCT01680991 ↗Enrolled (actual)
48
Serious AEs
18.8%
Results posted
Apr 2016
Primary outcomePrimary: Area Under the Serum Concentration Time Curve From Zero to Day 7 (AUC0-7) of Obinutuzumab on Day 1, Cycle 1 — 1458; 1750; 1647 day*micrograms per milliliter
Summary
This multi-center, open-label, single-arm study will evaluate the pharmacokinetics and safety of obinutuzumab in participants with cluster of differentiation (CD) 20 positive (+) malignant disease. Participants will receive multiple doses of obinutuzumab. The anticipated time on study treatment is 24 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Serum Concentration Time Curve From Zero to Day 7 (AUC0-7) of Obinutuzumab on Day 1, Cycle 1 |
1458; 1750; 1647 | — |
| PRIMARY Maximum Observed Serum Concentration (Cmax) of Obinutuzumab on Day 1, Cycle 1 |
369; 442; 437 | — |
| PRIMARY Area Under the Serum Concentration Versus Time Curve From 0 to Day 21 (AUC0-21) of Obinutuzumab at Cycle 8 |
12289; 13000; 11285 | — |
| PRIMARY Cmax of Obinutuzumab at Cycle 8 |
1050; 966; 867 | — |
| SECONDARY Time to Maximum Observed Serum Concentration (Tmax) of Obinutuzumab at Cycle 8 |
3.5; 7.25; 4.0 | — |
| SECONDARY Apparent Terminal Half-life (t1/2) |
21.5; 33.3; 26.7 | — |
| SECONDARY Volume of Distribution at Steady State (Vss) of Obinutuzumab at Cycle 8 |
3.32; 4.49; 4.03 | — |
| SECONDARY Total Systemic Clearance at Steady State (CLss) of Obinutuzumab at Cycle 8 |
81.4; 76.9; 88.6 | — |
| SECONDARY Minimum Observed Serum Concentration of Obinutuzumab |
156; 186; 148; 282; 350; 284 | — |
| SECONDARY Percentage of Participants With Complete Response (CR), CR Unconfirmed (CRu) at End of Treatment (1 Month After Cycle 8) in NHL Participants (DLBCL and FL Participants) Per Cheson 1999 Criteria |
0; 0; 4.3; 0 | — |
| SECONDARY Percentage of Participants With Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD) at End of Treatment (1 Month After Cycle 8) in NHL Participants (DLBCL and FL Participants) Per Cheson 1999 Criteria |
8.7; 46.2; 8.7; 30.8; 65.2; 23.1 | — |
| SECONDARY Percentage of Participants With Best Overall Response (BOR) of CR, CRu at Anytime During Study in NHL Participants (DLBCL and FL Participants) Per Cheson 1999 Criteria |
0; 0; 4.3; 0 | — |
| SECONDARY Percentage of Participants With BOR of PR, SD, and PD at Anytime During Study in NHL Participants (DLBCL and FL Participants) Per Cheson 1999 Criteria |
21.7; 61.5; 26.1; 30.8; 39.1; 7.7 | — |
| SECONDARY Percentage of Participants With Complete Remission (CRe), CRe With Incomplete BM Recovery (CRi) at End of Treatment (1 Month After Cycle 8) in CLL Participants According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 Guidelines |
0; 0 | — |
| SECONDARY Percentage of Participants With PR, SD, and PD at End of Treatment (1 Month After Cycle 8) in CLL Participants According to IWCLL 2008 Guidelines |
58.3; 8.3; 16.7 | — |
| SECONDARY Percentage of Participants With BOR of CRe, CRi at Anytime During the Study in CLL Participants According to IWCLL 2008 Guidelines |
0; 0 | — |
| SECONDARY Percentage of Participants With BOR of PR, SD, and PD at Anytime During Study in CLL Participants According to IWCLL 2008 Guidelines |
75.0; 8.3; 0 | — |
| SECONDARY Number of Participants With Positive Human Anti-Human Antibodies (HAHA) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Positive Human Anti-Chimeric Antibodies (HACA) |
2; 1; 0 | — |
| SECONDARY Number of Participants With B-cell Depletion or Recovery |
9; 23; 13; 4; 1; 1 | — |
| SECONDARY Duration of Depletion of CD19+ B-cell |
238.7; 141.0; 386.0 | — |
| SECONDARY Time to Recovery of CD19+ B-cell |
419; NA; 331.0; 229.0; 515.0; NA | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of CD20+ B-cell lymphoma or B-CLL
- Refractory/relapsed CLL, FL, and DLBCL
- At least 1 measurable lesion (greater than [>] 1.5 centimeters [cm] in its largest dimension) with the exception of CLL
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy >6 months
Exclusion Criteria
- Prior use of any investigational antibody therapy within 6 months of study start
- Prior use of any anti-cancer vaccine
- Prior administration of rituximab within 3 months of study start
- Prior administration of radioimmunotherapy 3 months prior to study entry
- Central nervous system lymphoma
- History of other malignancy
- Evidence of significant, uncontrolled concomitant disease
- Abnormal laboratory values
- Patients with progressive multifocalleukoencephalopathy (PML)
- Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C
Data sourced from ClinicalTrials.gov (NCT01680991). 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.