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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01461538
Other study ID # SGN35-013
Secondary ID
Status Completed
Phase Phase 2
First received October 24, 2011
Last updated February 5, 2016
Start date October 2011
Est. completion date December 2014

Study information

Verified date February 2016
Source Seattle Genetics, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 84
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 6 Years and older
Eligibility 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

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
brentuximab vedotin
1.8 mg/kg every 3 weeks by intravenous (IV) infusion
brentuximab vedotin
2.4 mg/kg every 3 weeks by intravenous (IV) infusion
brentuximab vedotin
1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion

Locations

Country Name City State
United States New York Oncology Hematology, P.C. Albany New York
United States Rocky Mountain Cancer Centers - Aurora Aurora Colorado
United States Texas Oncology - Bedford Bedford Texas
United States University of Alabama at Birmingham Birmingham Alabama
United States Oncology and Hematology Assoc of SW VA DBA Blue Ridge Cancer Care Blacksburg Virginia
United States Dana-Farber Cancer Institute Boston Massachusetts
United States University Hospitals Case Medical Center Cleveland Ohio
United States Texas Oncology - Dallas Presbyterian Dallas Texas
United States Texas Oncology - Medical City Dallas Dallas Texas
United States Texas Oncology Denton South Denton Texas
United States City of Hope Duarte California
United States Puget Sound Cancer Centers Edmonds Washington
United States Willamette Valley Cancer and Research / USOR Eugene Oregon
United States Virginia Cancer Specialists, PC Fairfax Virginia
United States Texas Oncology - Fort Worth 12th Avenue Fort Worth Texas
United States St. Francis Hospital Greenville South Carolina
United States MD Anderson Cancer Center / University of Texas Houston Texas
United States MD Anderson Cancer Center Leukemia Group Houston Texas
United States Indiana University Simon Cancer Center Indianapolis Indiana
United States Mayo Clinic Cancer Center Jacksonville Florida
United States Minnesota Oncology Hematology P.A. Minneapolis Minnesota
United States Ocala Oncology Center Ocala Florida
United States PMK Medical Group Inc., DBA Ventura County Hematology Oncology Specialists Oxnard California
United States Texas Oncology - Central Austin Cancer Center Round Rock Texas
United States Cancer Centers of South Texas - HOAST San Antonio Texas
United States Cancer Care Northwest Spokane Valley Washington
United States Northwest Cancer Specialists, P.C. Tulatin Oregon
United States Texas Oncology - Waco Waco Texas
United States Yakima Valley Memorial Hospital / North Star Lodge Yakima Washington

Sponsors (1)

Lead Sponsor Collaborator
Seattle Genetics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Objective Response Rate (ORR) by Investigator Percentage of participants who achieved a best response of complete response/remission (CR), CR without hematologic recovery (CRi; leukemia only), or partial remission (PR) per the applicable response criteria. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003). Up to approximately 3 years No
Secondary Complete Remission (CR) Rate by Investigator Percentage of participants who achieved a best response of CR per the applicable response criteria. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003). Up to approximately 3 years No
Secondary Duration of Objective Response by Kaplan-Meier Analysis Duration of objective response (CR [+CRi; leukemia] + PR), defined as time of initial response until disease progression or death. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003). Up to approximately 2 years No
Secondary Duration of Complete Response by Kaplan-Meier Analysis Duration of CR, defined as time of initial response until disease progression or death. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003). Up to approximately 2 years No
Secondary Progression-Free Survival by Kaplan-Meier Analysis Progression-free survival, defined as time from start of study treatment to disease progression per investigator or death due to any cause Up to approximately 2 years No
Secondary Adverse Events by Severity, Seriousness, and Relationship to Treatment Counts of participants who had treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose on Study SGN35-013). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life-threatening/disabling, 5=fatal). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category. Up to approximately 3 years Yes
Secondary Laboratory Abnormalities >/= Grade 3 Counts of study participants with post-baseline laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 4.03. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category Up to approximately 3 years Yes
Secondary Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Concentration at End of Infusion (Ceoi) Up to approximately 3 years No
Secondary Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Trough Concentration (Ctrough) Up to approximately 3 years No
Secondary Maximum Concentration (Cmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE) Up to approximately 3 years No
Secondary Brentuximab Vedotin Monomethyl Auristatin E (MMAE) Trough Concentration (Ctrough) Up to approximately 3 years No
Secondary Incidence of Anti-therapeutic Antibodies (ATA) Counts of participants with post-baseline anti-brentuximab vedotin antibodies. Persistently positive is defined as confirmed ATA in more than 2 post-baseline samples and transiently positive is defined as confirmed ATA in 1 or 2 post-baseline samples. Up to approximately 3 years Yes
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