Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT01461538
First received: October 24, 2011
Last updated: February 5, 2016
Last verified: February 2016

October 24, 2011
February 5, 2016
October 2011
December 2014   (final data collection date for primary outcome measure)
Objective Response Rate (ORR) by Investigator [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ]
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).
Objective response rate (ORR) [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01461538 on ClinicalTrials.gov Archive Site
  • Complete Remission (CR) Rate by Investigator [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ]
    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).
  • Duration of Objective Response by Kaplan-Meier Analysis [ Time Frame: Up to approximately 2 years ] [ Designated as safety issue: No ]
    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).
  • Duration of Complete Response by Kaplan-Meier Analysis [ Time Frame: Up to approximately 2 years ] [ Designated as safety issue: No ]
    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).
  • Progression-Free Survival by Kaplan-Meier Analysis [ Time Frame: Up to approximately 2 years ] [ Designated as safety issue: No ]
    Progression-free survival, defined as time from start of study treatment to disease progression per investigator or death due to any cause
  • Adverse Events by Severity, Seriousness, and Relationship to Treatment [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: Yes ]
    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.
  • Laboratory Abnormalities >/= Grade 3 [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: Yes ]
    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
  • Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Concentration at End of Infusion (Ceoi) [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ]
  • Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Trough Concentration (Ctrough) [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ]
  • Maximum Concentration (Cmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE) [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ]
  • Brentuximab Vedotin Monomethyl Auristatin E (MMAE) Trough Concentration (Ctrough) [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ]
  • Incidence of Anti-therapeutic Antibodies (ATA) [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: Yes ]
    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.
  • 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 ]
Not Provided
Not Provided
 
Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies
A Phase 2, Open-label Study of Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies
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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Acute Lymphoid Leukemia
  • Acute Myeloid Leukemia
  • Anemia, Refractory, With Excess of Blasts
  • Solid Tumors
  • Drug: brentuximab vedotin
    1.8 mg/kg every 3 weeks by intravenous (IV) infusion
    Other Name: Adcetris; SGN-35
  • Drug: brentuximab vedotin
    2.4 mg/kg every 3 weeks by intravenous (IV) infusion
    Other Name: Adcetris; SGN-35
  • Drug: brentuximab vedotin
    1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion
    Other Name: Adcetris; SGN-35
  • 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
  • Experimental: Brentuximab vedotin 1.2 mg/kg
    Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by IV infusion
    Intervention: Drug: brentuximab vedotin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
84
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
6 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01461538
SGN35-013
No
Not Provided
Not Provided
Seattle Genetics, Inc.
Seattle Genetics, Inc.
Not Provided
Study Director: Neil Josephson, MD Seattle Genetics, Inc.
Seattle Genetics, Inc.
February 2016

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