Clinical Trial: Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Summary:
Sponsor: Seattle Genetics, Inc.

Current Primary Outcome: Objective Response Rate (ORR) by Investigator [ Time Frame: Up to approximately 3 years ]

Original Primary Outcome: Objective response rate (ORR) [ Time Frame: Through 1 month following last dose ]

Current Secondary Outcome:

• Complete Remission (CR) Rate by Investigator [ Time Frame: Up to approximately 3 years ]
  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 ]
  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 ]
  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 ]
  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 ]
  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 ]
  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 ]
• Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Trough Concentration (Ctrough) [ Time Frame: Up to approximately 3 years ]
• Maximum Concentration (Cmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE) [ Time Frame: Up to approximately 3 years ]
• Brentuximab Vedotin Monomethyl Auristatin E (MMAE) Trough Concentration (Ctrough) [ Time Frame: Up to approximately 3 years ]
• Incidence of Anti-therapeutic Antibodies (ATA) [ Time Frame: Up to approximately 3 years ]
  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.

Original Secondary Outcome:

• Progression-free survival (PFS) [ Time Frame: Until disease progression or study closure, up to 29 months ]
• Complete remission (CR) rate [ Time Frame: Through 1 month following last dose ]
• Duration of response [ Time Frame: Until disease progression or study closure, up to 29 months ]
• Incidence of adverse events [ Time Frame: Through 1 month following last dose ]
• Incidence of laboratory abnormalities [ Time Frame: Through 1 month following last dose ]
• 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 ]
• 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 ]
• 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 ]
• Incidence of antitherapeutic antibodies (ATA) [ Time Frame: Cycles 1, 2, 4, 8, 12, 16 hours, and at the end of treatment assessment: predose ]

Dates:
Date Received: October 24, 2011
Date Started: October 2011
Date Completion:
Last Updated: February 5, 2016
Last Verified: February 2016