Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies

This study is currently recruiting participants.

Verified May 2013 by Seattle Genetics, Inc.

Sponsor:

Information provided by (Responsible Party):

Seattle Genetics, Inc.

ClinicalTrials.gov Identifier:

NCT01461538

First received: October 24, 2011

Last updated: May 1, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

October 24, 2011

Last Updated Date

May 1, 2013

Start Date ^ICMJE

October 2011

Estimated Primary Completion Date

September 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01461538 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]
Area under the plasma concentration-time curve (AUC) [ Time Frame: Cycle 1: predose, end of infusion and 24, 48, 168, and 336 hours post-dose. Cycles 2 and later: pre-dose and end of infusion ] [ Designated as safety issue: No ]
Peak plasma concentration (Cmax) [ Time Frame: Cycle 1: predose, end of infusion and 24, 48, 168, and 336 hours post-dose. Cycles 2 and later: pre-dose and end of infusion ] [ Designated as safety issue: No ]
Plasma concentration at end of infusion (Ceoi) [ Time Frame: Cycle 1: predose, end of infusion and 24, 48, 168, and 336 hours post-dose. Cycles 2 and later: pre-dose and end of infusion ] [ Designated as safety issue: No ]
Incidence of antitherapeutic antibodies (ATA) [ Time Frame: Cycles 1, 2, 4, 8, 12, 16, and at the end of treatment assessment: predose ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Progression-free survival (PFS) [ 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 ]
Area under the plasma concentration-time curve (AUC) [ Time Frame: Cycle 1: predose, end of infusion and 24, 48, 168, and 336 hours post-dose. Cycles 2 and later: pre-dose and end of infusion ] [ Designated as safety issue: No ]
Peak plasma concentration (Cmax) [ Time Frame: Cycle 1: predose, end of infusion and 24, 48, 168, and 336 hours post-dose. Cycles 2 and later: pre-dose and end of infusion ] [ Designated as safety issue: No ]
Plasma concentration at end of infusion (Ceoi) [ Time Frame: Cycle 1: predose, end of infusion and 24, 48, 168, and 336 hours post-dose. Cycles 2 and later: pre-dose and end of infusion ] [ Designated as safety issue: No ]
Incidence of antitherapeutic antibodies (ATA) [ Time Frame: Cycles 1, 2, 4, 8, 12, 16 hours, and at the end of treatment assessment: predose ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies

Official Title ^ICMJE

A Phase 2, Open-label Study of Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Acute Lymphoid Leukemia
Acute Myeloid Leukemia
Chronic Lymphocytic Leukemia
Multiple Myeloma
Solid Tumors

Intervention ^ICMJE

Drug: brentuximab vedotin
2.4 mg/kg every 3 weeks by intravenous (IV) infusion

Other Name: SGN-35
Drug: brentuximab vedotin
1.8 mg/kg every 3 weeks by intravenous (IV) infusion

Other Name: SGN-35

Study Arm (s)

Experimental: Brentuximab vedotin 1.8 mg/kg
Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion

Intervention: Drug: brentuximab vedotin
Experimental: Brentuximab vedotin 2.4 mg/kg
Brentuximab vedotin 2.4 mg/kg every 3 weeks by IV infusion

Intervention: Drug: brentuximab vedotin

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

February 2014

Estimated Primary Completion Date

September 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

6 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Terri Lowe

866-333-7436

clinicaltrials@seagen.com

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01461538

Other Study ID Numbers ^ICMJE

SGN35-013

Has Data Monitoring Committee

Responsible Party

Seattle Genetics, Inc.

Study Sponsor ^ICMJE

Seattle Genetics, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Tina Albertson, MD, PhD

Seattle Genetics, Inc.

Information Provided By

Seattle Genetics, Inc.

Verification Date

May 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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