Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies - Full Text View

Purpose

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.

Condition	Intervention	Phase
Acute Lymphoid Leukemia Acute Myeloid Leukemia Anemia, Refractory, With Excess of Blasts Solid Tumors	Drug: brentuximab vedotin	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase 2, Open-label Study of Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies

Resource links provided by NLM:

Genetics Home Reference related topics: core binding factor acute myeloid leukemia cytogenetically normal acute myeloid leukemia familial acute myeloid leukemia with mutated CEBPA

MedlinePlus related topics: Acute Myeloid Leukemia Anemia Cancer Chronic Lymphocytic Leukemia Leukemia

Drug Information available for: Brentuximab vedotin

Genetic and Rare Diseases Information Center resources: Acute Lymphoblastic Leukemia Acute Myelocytic Leukemia Acute Myeloid Leukemia, Adult Acute Non Lymphoblastic Leukemia Leukemia, Myeloid Lymphosarcoma Myelodysplastic Syndromes

U.S. FDA Resources

Further study details as provided by Seattle Genetics, Inc.:

Primary Outcome Measures:

Objective response rate (ORR) [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression-free survival [ Time Frame: Until disease progression or study closure, up to 29 months ] [ Designated as safety issue: No ]
Complete remission (CR) rate [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: No ]
Duration of response [ Time Frame: Until disease progression or study closure, up to 29 months ] [ Designated as safety issue: No ]
Incidence of adverse events [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]
Incidence of laboratory abnormalities [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]
Blood concentrations of brentuximab vedotin and metabolites [ Time Frame: Through 3 weeks after dosing (1.8 and 2.4 mg/kg arms) ] [ Designated as safety issue: No ]
Blood concentrations of brentuximab vedotin and metabolites [ Time Frame: Through 1 week after dosing (1.2 mg/kg arm) ] [ Designated as safety issue: No ]
Incidence of antitherapeutic antibodies (ATA) [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]


Enrollment:	84
Study Start Date:	October 2011
Estimated Study Completion Date:	April 2015
Estimated Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Brentuximab vedotin 1.8 mg/kg Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion	Drug: brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion Other Name: Adcetris; SGN-35
Experimental: Brentuximab vedotin 2.4 mg/kg Brentuximab vedotin 2.4 mg/kg every 3 weeks by IV infusion	Drug: brentuximab vedotin 2.4 mg/kg every 3 weeks by intravenous (IV) infusion Other Name: Adcetris; SGN-35
Experimental: Brentuximab vedotin 1.2 mg/kg Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by IV infusion	Drug: brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion Other Name: Adcetris; SGN-35

Eligibility


Ages Eligible for Study:	6 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01461538

Show 29 Study Locations

Sponsors and Collaborators

Seattle Genetics, Inc.

Investigators


Study Director:	Neil Josephson, MD	Seattle Genetics, Inc.

More Information

No publications provided by Seattle Genetics, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Giannatempo P, Paolini B, Miceli R, Raggi D, Nicolai N, Farè E, Catanzaro M, Biasoni D, Torelli T, Stagni S, Piva L, Mariani L, Salvioni R, Colecchia M, Gianni AM, Necchi A. Persistent CD30 expression by embryonal carcinoma in the treatment time course: prognostic significance of a worthwhile target for personalized treatment. J Urol. 2013 Nov;190(5):1919-24. doi: 10.1016/j.juro.2013.04.057. Epub 2013 Apr 25.


Responsible Party:	Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:	NCT01461538 History of Changes
Other Study ID Numbers:	SGN35-013
Study First Received:	October 24, 2011
Last Updated:	December 22, 2014
Health Authority:	United States: Food and Drug Administration

Keywords provided by Seattle Genetics, Inc.:


Acute Lymphoid Leukemia Myelodysplastic Syndrome Acute Myeloid Leukemia Solid Tumors Anemia, Refractory, with Excess of Blasts Antibodies, Monoclonal	Antibody-Drug Conjugate Antigens, CD30 Drug Therapy Hematologic Diseases Immunotherapy Monomethyl Auristatin E

Additional relevant MeSH terms:


Anemia, Refractory Anemia, Refractory, with Excess of Blasts Leukemia Leukemia, Lymphoid Leukemia, Myeloid Leukemia, Myeloid, Acute Precursor Cell Lymphoblastic Leukemia-Lymphoma Anemia Bone Marrow Diseases Hematologic Diseases Immune System Diseases	Immunoproliferative Disorders Lymphatic Diseases Lymphoproliferative Disorders Myelodysplastic Syndromes Neoplasms Neoplasms by Histologic Type Antibodies, Monoclonal Immunologic Factors Pharmacologic Actions Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 27, 2015