Phase 2
N=83
Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies
Acute Lymphoid Leukemia · Acute Myeloid Leukemia · Anemia, Refractory, With Excess of Blasts · Solid Tumors
Bottom Line
View on ClinicalTrials.gov: NCT01461538 ↗Enrolled (actual)
83
Serious AEs
50.6%
Results posted
Mar 2016
Primary outcome: Primary: Objective Response Rate (ORR) by Investigator — 12; 14 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- brentuximab vedotin (Drug)
- Age
- Pediatric, Adult, Older Adult · 6+ yrs
- Sex
- All
- Sponsor
- Seagen Inc.
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) by Investigator |
12; 14 | — |
| SECONDARY Complete Remission (CR) Rate by Investigator |
2; 0 | — |
| SECONDARY Duration of Objective Response by Kaplan-Meier Analysis |
2.9; 2.1 | — |
| SECONDARY Duration of Complete Response by Kaplan-Meier Analysis |
22.3 | — |
| SECONDARY Progression-Free Survival by Kaplan-Meier Analysis |
2.1; 0.7 | — |
| SECONDARY Adverse Events by Severity, Seriousness, and Relationship to Treatment |
45; 28; 9; 31; 24; 5 | — |
| SECONDARY Laboratory Abnormalities >/= Grade 3 |
24; 12; 9; 0; 1; 1 | — |
| SECONDARY Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Concentration at End of Infusion (Ceoi) |
40; 54; 25 | — |
| SECONDARY Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Trough Concentration (Ctrough) |
0.36; 0.55; 1.5 | — |
| SECONDARY Maximum Concentration (Cmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE) |
4.0; 6.2; 2.6 | — |
| SECONDARY Brentuximab Vedotin Monomethyl Auristatin E (MMAE) Trough Concentration (Ctrough) |
0.22; 0.35; 1.5 | — |
| SECONDARY Incidence of Anti-therapeutic Antibodies (ATA) |
33; 21; 8; 14; 14; 8 | — |
Summary
This is an open-label, multicenter, phase 2 clinical trial to evaluate the antitumor activity of brentuximab vedotin as a single agent in patients with CD30-positive nonlymphomatous malignancies.
Eligibility Criteria
Inclusion Criteria
- Histologically-confirmed by central review CD30-positive nonlymphomatous malignancy
- Have failed, refused, or have been deemed ineligible for standard therapy
- Measurable disease
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 or a Karnofsky or Lansky Performance Status score greater than or equal to 70
Exclusion Criteria
- Primary diagnosis of lymphoma or central nervous system (CNS) malignancy
- History of another primary invasive malignancy that has not been definitively treated or in remission for at least 3 years
- Evidence of active cerebral/meningeal disease
Data sourced from ClinicalTrials.gov (NCT01461538). 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.